add to fAvorites

Drugs & Medications:A-Z

A
Advanced
B
C
Concise
D
Detailed
E
F
G
H
I
K
L
M
Med-facts
N
O
P
Professional
Q
R
S
T
U
Uncategorized
V
X
Z

Rynatuss

30/06/10

Generic Name: chlorpheniramine, carbetapentane, ephedrine, and phenylephrine (klor feh NEER a meen., kar be ta PEN tane, eh FEH drin, and feh nill EH frin)
Brand Names: Rentamine, Rynatuss, Tuss Tan

What is Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Carbetapentane is a cough suppressant. It suppresses an area in the brain that causes coughing.

Ephedrine and phenylephrine are decongestants. They constrict blood vessels (veins and arteries). This reduces the blood flow and allows nasal passages to open up.

Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.

Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine, carbetapentane, ephedrine, and phenylephrine.

Do not take more of this medication than is recommended. If your symptoms do not improve or if they worsen, talk to your doctor.

Who should not take Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Do not take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

kidney disease,
liver disease,
diabetes,
glaucoma,
heart disease or high blood pressure,
thyroid disease,
emphysema or chronic bronchitis, or
difficulty urinating or have an enlarged prostate.

You may not be able to take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether chlorpheniramine, carbetapentane, ephedrine, and phenylephrine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from chlorpheniramine, carbetapentane, ephedrine, and phenylephrine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. To ensure that you get a correct dose, measure the liquid form of chlorpheniramine, carbetapentane, ephedrine, and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine, carbetapentane, ephedrine, and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine, carbetapentane, ephedrine, and phenylephrine overdose include dry mouth, large pupils, flushing, nausea and vomiting, hyperactivity, and hallucinations.

What should I avoid while taking Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Chlorpheniramine, carbetapentane, ephedrine, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine, carbetapentane, ephedrine, and phenylephrine is taken with any of these medications.

Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine, carbetapentane, ephedrine, and phenylephrine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine, carbetapentane, ephedrine, and phenylephrine and talk to your doctor or try another similar medication if you experience

dryness of the eyes, nose, and mouth;
drowsiness or dizziness;
blurred vision;
difficulty urinating; or
excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking chlorpheniramine, carbetapentane, ephedrine, and phenylephrine without first talking to your pharmacist or doctor. Other medications may also contain chlorpheniramine, carbetapentane, ephedrine, phenylephrine, or other similar drugs, and you may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with chlorpheniramine, carbetapentane, ephedrine, and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about chlorpheniramine/ carbetapentane/ephedrine/phenylephrine written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Rynatuss Pediatric Suspension

30/06/10

Generic Name: Carbetapentane/Chlorpheniramine/Ephedrine/Phenylephrine (car-beta-PEN-tane/klor-fen-EER-a-meen/e-FED-rin/fen-ill-EF-rin)
Brand Name: Examples include Quad-Tuss and Rynatuss Pediatric

Rynatuss Pediatric Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Rynatuss Pediatric Suspension is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing, while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Rynatuss Pediatric Suspension if:

you are allergic to any ingredient in Rynatuss Pediatric Suspension
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you are unable to urinate or are having an asthma attack
you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rynatuss Pediatric Suspension:

Some medical conditions may interact with Rynatuss Pediatric Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a fast, slow, or irregular heartbeat
if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid
if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Rynatuss Pediatric Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Rynatuss Pediatric Suspension may be increased
Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased
Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Rynatuss Pediatric Suspension
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Rynatuss Pediatric Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rynatuss Pediatric Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rynatuss Pediatric Suspension:

Use Rynatuss Pediatric Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Rynatuss Pediatric Suspension may be taken with or without food.
Shake well before using.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Rynatuss Pediatric Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rynatuss Pediatric Suspension.

Important safety information:

Rynatuss Pediatric Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rynatuss Pediatric Suspension. Using Rynatuss Pediatric Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take diet or appetite control medicines while you are taking Rynatuss Pediatric Suspension without checking with your doctor.
Rynatuss Pediatric Suspension contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
Do NOT exceed the recommended dose or take Rynatuss Pediatric Suspension for longer than prescribed without checking with your doctor.
If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
Rynatuss Pediatric Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Rynatuss Pediatric Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
If you are scheduled for allergy skin testing, do not take Rynatuss Pediatric Suspension for several days before the test because it may decrease your response to the skin tests.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Rynatuss Pediatric Suspension.
Use Rynatuss Pediatric Suspension with caution in the ELDERLY because they may be more sensitive to its effects.
Caution is advised when using Rynatuss Pediatric Suspension in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Rynatuss Pediatric Suspension, discuss with your doctor the benefits and risks of using Rynatuss Pediatric Suspension during pregnancy. It is unknown if Rynatuss Pediatric Suspension is excreted in breast milk. Do not breast-feed while taking Rynatuss Pediatric Suspension.

Possible side effects of Rynatuss Pediatric Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Rynatuss Pediatric Suspension:

Store Rynatuss Pediatric Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rynatuss Pediatric Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Rynatuss Pediatric Suspension, please talk with your doctor, pharmacist, or other health care provider.
Rynatuss Pediatric Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rynatuss Pediatric Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

Comments (0)

Ryna-12S

30/06/10

Generic Name: phenylephrine and pyrilamine (FEN il EFF rin and pir IL a meen)
Brand Names: Aldex D, Deconsal CT Tannate, K-Tan, Pyril Tann-12, Pyrlex PD, Ry-T-12, Ryna-12, Ryna-12S, Rynesa 12S, V-Tann, Viravan-S, Viravan-T

What is this drug?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about this drug?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine.

What should I discuss with my health care provider before taking this drug?

Do not use this medication if you are allergic to phenylephrine or pyrilamine, or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
kidney disease;
an enlarged prostate; or
problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take this drug?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking this drug?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, fever, chills, body aches, flu symptoms;
urinating less than usual or not at all; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

nausea, stomach pain, constipation, mild loss of appetite;
dry mouth;
warmth, tingling, or redness under your skin;
blurred vision;
dizziness, drowsiness;
problems with memory or concentration;
restless or excitability (especially in children);
sleep problems (insomnia); or
skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:

a diuretic (water pill);
salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with phenylephrine and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about phenylephrine and pyrilamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Ryna-12X

30/06/10

Generic Name: guaifenesin, phenylephrine, and pyrilamine (gwye FEN e sin, fen il EFF rin, and pir IL a meen)
Brand Names: A-Tan 12X, Ryna-12X

What is Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of guaifenesin, phenylephrine, and pyrilamine is used to treat runny or stuffy nose, sinus congestion, sneezing, watery eyes, and cough caused by allergies, the common cold, or the flu.

Guaifenesin, phenylephrine, and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Tell your doctor if you regularly use other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by pyrilamine. Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin, phenylephrine, or pyrilamine.

What should I discuss with my healthcare provider before taking Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Do not use this medication if you are allergic to guaifenesin, pyrilamine, phenylephrine or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to any other drugs, or if you have:

heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
a peripheral vascular disorder (poor circulation);
kidney disease;
an enlarged prostate; or
problems with urination.

If you have any of these conditions, may need a dose adjustment or special tests to safely take this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take this medicine with food or milk if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Some antihistamines can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking this medication.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Tell your doctor if you regularly use other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by pyrilamine. Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine.

Ryna-12X (guaifenesin, phenylephrine, and pyrilamine) side effects

fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

blurred vision;
dry mouth;
dizziness, drowsiness, headache;
problems with memory or concentration;
ringing in your ears;
restless or excitability (especially in children);
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
skin rash or itching; or
mild nausea, stomach pain, constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

an antidepressant;
a diuretic (water pill);
medicines to treat high blood pressure;
medication to treat irritable bowel syndrome;
seizure medication;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with guaifenesin, phenylephrine, and pyrilamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about guaifenesin, phenylephrine, and pyrilamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Ryna-12X Suspension

30/06/10

Generic Name: Guaifenesin/Phenylephrine/Pyrilamine (gwye-FEN-e-sin/fen-ill-EF-rin/peer-IL-a-meen)
Brand Name: A-Tan 12X and Ryna-12X

Ryna-12X Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and throat and airway irritation due to colds, upper respiratory infections, and allergies. It may also be used for conditions as determined by your doctor.

Ryna-12X Suspension is an expectorant, decongestant, and antihistamine combination. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, making it easier to breathe. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing.

Do NOT use Ryna-12X Suspension if:

you are allergic to any ingredient in Ryna-12X Suspension
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you are unable to urinate or are having an asthma attack
you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ryna-12X Suspension:

Some medical conditions may interact with Ryna-12X Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a fast, slow, or irregular heartbeat
if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; asthma; lung problems (eg, emphysema); blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid

Some MEDICINES MAY INTERACT with Ryna-12X Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Ryna-12X Suspension may be increased
Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased
Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Ryna-12X Suspension
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Ryna-12X Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ryna-12X Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ryna-12X Suspension:

Use Ryna-12X Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ryna-12X Suspension may be taken with or without food.
Shake well before using.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Ryna-12X Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ryna-12X Suspension.

Important safety information:

Ryna-12X Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ryna-12X Suspension. Using Ryna-12X Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take diet or appetite control medicines while you are taking Ryna-12X Suspension without checking with your doctor.
Ryna-12X Suspension contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
Do NOT exceed the recommended dose or take Ryna-12X Suspension for longer than prescribed without checking with your doctor.
If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
Ryna-12X Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ryna-12X Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
If you are scheduled for allergy skin testing, do not take Ryna-12X Suspension for several days before the test because it may decrease your response to the skin tests.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ryna-12X Suspension.
Use Ryna-12X Suspension with caution in the ELDERLY because they may be more sensitive to its effects.
Caution is advised when using Ryna-12X Suspension in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ryna-12X Suspension, discuss with your doctor the benefits and risks of using Ryna-12X Suspension during pregnancy. It is unknown if Ryna-12X Suspension is excreted in breast milk. Do not breast-feed while taking Ryna-12X Suspension.

Possible side effects of Ryna-12X Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ryna-12X Suspension:

Store Ryna-12X Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ryna-12X Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Ryna-12X Suspension, please talk with your doctor, pharmacist, or other health care provider.
Ryna-12X Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ryna-12X Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

Comments (0)

Rynatan

30/06/10

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)
Brand Names: Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, C Phen Drops, Cardec, Cardec Drops, Ceron, Ceron Drops, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, CP Dec Drops, Dallergy Drops, Dallergy-JR, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rescon-Jr, Rinate Pediatric, Rondec, Rondec Drops, Rondex, Rondex Drops, Ry-Tann, Rynatan, Rynatan Pediatric, Sildec-PE, Sildec-PE Drops, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Tannate Pediatric, Triaminic Cold & Allergy

What is Rynatan (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rynatan (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and phenylephrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and phenylephrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

What should I discuss with my healthcare provider before taking Rynatan (chlorpheniramine and phenylephrine)?

severe or uncontrolled high blood pressure;
severe coronary artery disease;
narrow angle glaucoma;
a stomach ulcer; or
if you are unable to urinate.

Do not use this medication during an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

kidney disease;
liver disease;
diabetes;
glaucoma;
circulation problems;
heart disease or high blood pressure;
overactive thyroid;
a seizure disorder such as epilepsy;
asthma, emphysema or chronic bronchitis; or
urination problems or an enlarged prostate.

FDA pregnancy category C. It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take Rynatan (chlorpheniramine and phenylephrine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

Store chlorpheniramine and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, diarrhea, stomach pain, problems with balance or coordination, headache, urination problems, dizziness, feeling excited or irritable, hallucinations (seeing things), metallic taste in your mouth, tremors, fever, flushed face, and seizure (convulsions).

What should I avoid while taking Rynatan (chlorpheniramine and phenylephrine)?

Avoid using other medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the stimulant effects of phenylephrine.

Rynatan (chlorpheniramine and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using chlorpheniramine and phenylephrine and call your doctor at once if you have any of these serious side effects:

fast or uneven heart beats;
feeling light-headed, fainting;
seizure (convulsions);
hallucinations (seeing things that are not there); or
tremors.

Less serious side effects may include:

heartburn, nausea, vomiting, diarrhea, loss of appetite;
dry nose or mouth;
drowsiness, dizziness, weakness, headache;
dry eyes, blurred vision;
painful or difficult urination;
sleep problems (insomnia);
feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rynatan (chlorpheniramine and phenylephrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

mecamylamine (Inversine);
methyldopa (Aldomet);
reserpine;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with chlorpheniramine and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Ry-Tann

30/06/10

What is Ry-Tann (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ry-Tann (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use this medication during an asthma attack.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

What should I discuss with my healthcare provider before taking Ry-Tann (chlorpheniramine and phenylephrine)?

severe or uncontrolled high blood pressure;
severe coronary artery disease;
narrow angle glaucoma;
a stomach ulcer; or
if you are unable to urinate.

Do not use this medication during an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

kidney disease;
liver disease;
diabetes;
glaucoma;
circulation problems;
heart disease or high blood pressure;
overactive thyroid;
a seizure disorder such as epilepsy;
asthma, emphysema or chronic bronchitis; or
urination problems or an enlarged prostate.

How should I take Ry-Tann (chlorpheniramine and phenylephrine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

Store chlorpheniramine and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

What should I avoid while taking Ry-Tann (chlorpheniramine and phenylephrine)?

Ry-Tann (chlorpheniramine and phenylephrine) side effects

fast or uneven heart beats;
feeling light-headed, fainting;
seizure (convulsions);
hallucinations (seeing things that are not there); or
tremors.

Less serious side effects may include:

heartburn, nausea, vomiting, diarrhea, loss of appetite;
dry nose or mouth;
drowsiness, dizziness, weakness, headache;
dry eyes, blurred vision;
painful or difficult urination;
sleep problems (insomnia);
feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ry-Tann (chlorpheniramine and phenylephrine)?

Tell your doctor about all other medications you use, especially:

mecamylamine (Inversine);
methyldopa (Aldomet);
reserpine;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Rybix ODT

30/06/10

Generic Name: tramadol hydrochloride
Dosage Form: tablet, orally disintegrating

RYBIXTM ODT
(tramadol hydrochloride) Orally Disintegrating Tablets

Rx Only

DESCRIPTION

RYBIX™ ODT (tramadol hydrochloride) Orally Disintegrating Tablets is a centrally acting analgesic in an orally disintegrating formulation using a tablet formulation base. The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

Rybix ODT is supplied as orally disintegrating tablets containing 50 mg of tramadol hydrochloride for oral administration.

Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7.

The tablets are white in color and contain the inactive ingredients aspartame, copovidone, crospovidone, ethylcellulose, magnesium stearate, mannitol, mint flavor, and silicon dioxide.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Rybix ODT (tramadol HCl) is a centrally acting synthetic opioid analgesic in an orally disintegrating tablet form. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of reuptake of norephinephrine and serotonin.

Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

Apart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.

Pharmacokinetics

The analgesic activity of tramadol is due to both parent drug and the M1 metabolite (see CLINICAL PHARMACOLOGY, Pharmacodynamic). Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol has a volume of distribution of approximately 2.7 L/kg and is 20% bound to plasma proteins. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. One metabolite, M1, is pharmacologically active in animal models. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS, Drug Interactions). Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state.

Absorption:

Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~ 10%) exist in the absolute amount of each enantiomer present

Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with q.i.d. dosing. There is no evidence of self-induction (see Figure 1 and Table 1 below).

Figure 1: Mean Tramadol and M1 Plasma Concentration Profiles after a Single 100 mg Oral Dose and after Twenty-Nine 100 mg Oral Doses of Tramadol HCl given q.i.d.

Table 1. Mean (%CV) Pharmacokinetic Parameters for Racemic Tramadol and M1 Metabolite
a	SD = single dose, MD = multiple dose, p.o. = oral administration i.v. = Intravenous administration, q.i.d. = Four times daily
b	F represents the bioavailability of tramadol
c	Not applicable
d	Not measured
Population/ Dosage Regimena	Parent Drug/ Metabolite	Peak Conc. (ng/mL)	Time to Peak (hrs)	Clearance/Fb (mL/min/kg)	t1/2(hrs)
Healthy Adults, 100 mg qid, MD p.o.	Tramadol	592 (30)	2.3 (61)	5.90 (25)	6.7 (15)
Healthy Adults, 100 mg qid, MD p.o.	M1	110 (29)	2.4 (46)	c	7.0 (14)
Health Adults, 100 mg SD p.o.	Tramadol	308 (25)	1.6 (63)	8.50 (31)	5.6 (20)
Health Adults, 100 mg SD p.o.	M1	55.0 (36)	3.0 (51)	c	6.7 (16)
Geriatric, (>75 yrs) 50 mg SD p.o.	Tramadol	208 (31)	2.1 (19)	6.89 (25)	7.0 (23)
Geriatric, (>75 yrs) 50 mg SD p.o.	M1	d	d	c	d
Hepatic Impaired 50 mg SD p.o.	Tramadol	217 (11)	1.9 (16)	4.23 (56)	13.3 (11)
Hepatic Impaired 50 mg SD p.o.	M1	19.4 (12)	9.8 (20)	c	18.5 (15)
Renal Impaired CLcr 10-30 mL/min 100 mg SD i.v.	Tramadol	c	c	4.23 (54)	10.6 (31)
Renal Impaired CLcr 10-30 mL/min 100 mg SD i.v.	M1	c	c	c	11.5 (40)
Renal Impaired, CLcr <5 mL/min 100 mg SD i.v.	Tramadol	c	c	3.73 (17)	11.0 (29)
Renal Impaired, CLcr <5 mL/min 100 mg SD i.v.	M1	c	c	c	16.9 (18)

Food and Water Effects: Oral administration of Rybix ODT with food does not significantly affect its extent of absorption, however, food does delay tmax by about 30 minutes compared to fasting conditions. The clinical significance of this delay is not known. No difference has been identified in systemic exposure (AUC), peak exposure (Cmax), time to peak exposure (Tmax), and apparent elimination half-life (t1/2) of tramadol and metabolites M1 and M5 between administration of Rybix ODT with and without water and Ultram®.

Distribution:

The volume of distribution of tramadol was 2.6 and 2.9 liters/kg in male and female subjects, respectively, following a 100 mg intravenous dose. The binding of tramadol to human plasma proteins is approximately 20% and binding also appears to be independent of concentration up to 10 μg/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range.

Metabolism:

Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The remainder is excreted either as unidentified or as unextractable metabolites. The major metabolic pathways appear to be N- and O- demethylation and glucuronidation or sulfation in the liver. One metabolite (O – desmethyltramadol, denoted M1) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS, Drug Interaction).

Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. These individuals are “poor metabolizers” of debrisoquine, dextromethorphan, tricyclic antidepressants, among other drugs. Based on a population PK analysis of Phase I studies in healthy subjects, concentrations of tramadol were approximately 20% higher in “poor metabolizers” versus “extensive metabolizers,” while M1 concentrations were 40% lower. Concomitant therapy with inhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. In vitro drug interaction studies in human liver microsomes indicate that inhibitors of CYP2D6 such as fluoxetine and its metabolite norfluoxetine, amitriptyline and quinidine inhibit the metabolism of tramadol to various degrees, suggesting that concomitant administration of these compounds could result in increases in tramadol concentrations and decreased concentrations of M1. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown. Concomitant use of SEROTONIN re-uptake INHIBITORS and MAO INHIBITORS may enhance the risk of adverse events, including seizure (see WARNINGS) and serotonin syndrome.

Elimination:

Tramadol is eliminated primarily through metabolism by the liver and the metabolites are eliminated primarily by the kidneys. The mean terminal plasma elimination half-lives of racemic tramadol and racemic M1 are 6.3 ± 1.4 and 7.4 ± 1.4 hours, respectively. The plasma elimination half-life of racemic tramadol increased from approximately six hours to seven hours upon multiple dosing.

Special Populations

Renal:

Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION). The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose.

Hepatic:

Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver, resulting in both a larger area under the concentration time curve for tramadol and longer tramadol and M1 elimination half-lives (13 hrs. for tramadol and 19 hrs. for M1). In cirrhotic patients, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION).

Geriatric:

Healthy elderly subjects aged 65 to 75 years have plasma tramadol concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. In subjects over 75 years, maximum serum concentrations are elevated (208 vs. 162 ng/mL) and the elimination half-life is prolonged (7 vs. 6 hours) compared to subjects 65 to 75 years of age. Adjustment of the daily dose is recommended for patients older than 75 years (see DOSAGE AND ADMINISTRATION).

Gender:

Following a single oral dose of Rybix ODT to healthy volunteers, no gender effect was observed. The AUC and Cmax values for Rybix ODT were similar in males and females. Dosage adjustment based on gender is not recommended.

The absolute bioavailability of tramadol was 73% in males and 79% in females. The plasma clearance was 6.4 mL/min/kg in males and 5.7 mL/min/kg in females following a 100 mg dose of tramadol.

CLINICAL STUDIES

Rybix ODT is an orally disintegrating tablet, but there are no studies that indicate that its onset of action is faster than tramadol tablets.

An orally swallowed immediate release tablet of tramadol has been given in single oral doses of 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars).

In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg of orally swallowed immediate release tablet of tramadol tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg.

An orally swallowed immediate release tablet of tramadol has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving an orally swallowed immediate release tablet of tramadol. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of an orally swallowed immediate release tablet of tramadol in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg daily.

Titration Trials

In a randomized, blinded clinical study with 129 to 132 patients per group, a 10-day titration to a daily orally swallowed immediate release tablet of tramadol dose of 200 mg (50 mg q.i.d.), attained in 50 mg increments every 3 days, was found to result in fewer discontinuations due to dizziness or vertigo than titration over only 4 days or no titration.

Figure 2: Protocol CAPSS – 047 Time to Discontinuation Due to Nausea and Vomiting

INDICATIONS AND USAGE

Rybix ODT is indicated for the management of moderate to moderately severe pain in adults.

CONTRAINDICATIONS

Rybix ODT should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or other opioids. Rybix ODT is contraindicated in any situation where other opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Rybix ODT may worsen central nervous system and respiratory depression in these patients.

WARNINGS

Seizure Risk

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of Rybix ODT increases the seizure risk in patients taking:

Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
Other Opioid drugs.

Administration of Rybix ODT may enhance the seizure risk in patients taking:

MAO inhibitors (see also WARNINGS – Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors),
Neuroleptics, or
Other drugs that reduce the seizure threshold.

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In Rybix ODT overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

Do not prescribe Rybix ODT for patients who are suicidal or addiction-prone
Prescribe Rybix ODT with caution for patients who are taking tranquilizers or antidepressant drug and patients who use alcohol in excess and who suffer from emotional disturbance or depression.

The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics.

Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS active drugs (see WARNINGS, Risk of Overdosage).

Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including Rybix ODT, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Anaphylactoid Reactions

Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Rybix ODT (see CONTRAINDICATIONS).

Respiratory Depression

Administer Rybix ODT cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see WARNINGS, Seizure Risk and OVERDOSAGE).

Interaction With Central Nervous System (CNS) Depressants

Rybix ODT should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, other opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol increases the risk of CNS and respiratory depression in these patients.

Interactions with Alcohol and Drugs of Abuse

Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nevous system depression.

Increased Intracranial Pressure or Head Trauma

Rybix ODT should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving Rybix ODT (see Respiratory Depression).

Sensitivity to phenylketone

Patients with a history of sensitivity to phenylketones may be at increased risk and therefore should not receive Rybix ODT.

Use in Ambulatory Patients

Rybix ODT may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Use With MAO Inhibitors And Serotonin Re-Uptake Inhibitors

Use Rybix ODT with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of tramadol with MAO inhibitors or SSRI’s increases the risk of adverse events, including seizure and serotonin syndrome.

Misuse, Abuse and Diversion

Tramadol has mu-opioid agonist activity. Rybix ODT can be sought by drug abusers and people with addiction disorders and may be subject to criminal diversion. The possibility of illegal or illicit use should be considered when prescribing or dispensing Rybix ODT in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Misuse or abuse poses a significant risk to the abuser that could result in overdose and death (see DRUG ABUSE AND DEPENDENCE and OVERDOSAGE).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.

Risk of Overdosage

Patients taking tramadol should be warned not to exceed the dose recommended by their physician. Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a cause of drug-related deaths. Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS depressant drugs. Patients should be advised of the additive depressant effects of these combinations.

Serious potential consequences of overdosage with tramadol hydrochloride tablets are central nervous system depression, respiratory depression and death. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (see OVERDOSAGE).

Withdrawal

Withdrawal symptoms may occur if Rybix ODT is discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE) Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with tramadol discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol at the time of discontinuation.

PRECAUTIONS

Acute Abdominal Conditions

The administration of Rybix ODT may complicate the clinical assessment of patients with acute abdominal conditions.

Use in Renal and Hepatic Disease

Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION).

With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop.

Information for Patients

Patients should be informed that Rybix ODT may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.
Rybix ODT may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Rybix ODT should not be taken with alcohol containing beverages.
Rybix ODT should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Female patients should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (see PRECAUTIONS, Labor and Delivery).
The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures and death.
To open the blister pack, peel back the foil on the blister. Do not push tablet through the foil. Remove the tablet and place it in the mouth, where it will dissolve in seconds and then be swallowed with the saliva.
Tablet may be taken with or without water.
Do NOT chew, break, or split the tablet.
Phenylketonurics: Rybix ODT contains phenylalanine.

Drug Interactions

CYP2D6 and CYP3A4 Inhibitors

Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors (see CLINICAL PHARMACOLOGY, Pharmacokinetics), such as quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of tramadol increasing the risk for serious adverse events including seizures and serotonin syndrome.

Serotonergic Drugs

There have been postmarketing reports of serotonin syndrome with use of tramadol and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Rybix ODT is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, or St. John’s Wort. If concomitant treatment of Rybix ODT with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see WARNINGS, Serotonin Syndrome).

Triptans

Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when Rybix ODT is coadministered with a triptan. If concomitant treatment of Rybix ODT with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see WARNINGS, Serotonin Syndrome)

Use With Carbamazepine

Patients taking carbamazepine may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of Rybix ODT and carbamazepine is not recommended.

Use With Quinidine

Tramadol is metabolized to M1 by CYP2D6. Quinidine is a selective inhibitor of the isoenyzme, so that concomitant administration of quinidine and tramadol results in increased concentrations of tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism.

Potential for Other Drugs to Affect Tramadol

In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of tramadol. Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John’s Wort, with Ultram® may affect the metabolism of tramadol leading to altered tramadol exposure.

Potential for Tramadol to Affect Other Drugs

In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at therapeutic doses. Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals.

Use With Cimetidine

Concomitant administration with cimetidine does not result in clinically significant changes in tramadol pharmacokinetics. Therefore, no alteration of the Rybix ODT dosage regimen is recommended.

Use With MAO Inhibitors

Interactions with MAO Inhibitors, due to interference with detoxification mechanisms, have been reported for some centrally acting drugs (see WARNINGS, Use With MAO Inhibitors).

Use With Digoxin and Warfarin

Post-marketing surveillance of tramadol has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m2 or 0.36 times the maximum daily human dosage of 246 mg/m2) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m2, or 0.73 times the maximum daily human dosage).

Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.

No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg (300 mg/m2) in male rats and 75 mg/kg (450 mg/m2) in female rats. These dosages are 1.2 and 1.8 times the maximum daily human dosage of 246 mg/m2, respectively.

Pregnancy, Teratogenic Effects: Pregnancy Category C.

Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m2), rats (≥ 25 mg/kg or 150 mg/m2) and rabbits (≥ 75 mg/kg or 900 mg/m2) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m2 basis are 1.4, ≥ 0.6, and ≥ 3.6 times the maximum daily human dosage (246 mg/m2) for mouse, rat and rabbit, respectively.

No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m2), rats (up to 80 mg/kg or 480 mg/m2) or rabbits (up to 300 mg/kg or 3600 mg/m2) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m2), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m2), respectively.

Non-teratogenic Effects

Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 and higher the maximum daily human dose).

There are no adequate and well-controlled studies in pregnant women. Tramadol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing.

Labor and Delivery

Rybix ODT should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn (see DRUG ABUSE AND DEPENDENCE). Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.

The effect of tramadol if any, on the later growth, development, and functional maturation of the child is unknown.

Nursing Mothers

Rybix ODT is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 μg of tramadol (0.1% of the maternal dose) and 27 μg of M1.

Pediatric Use

The safety and efficacy of Rybix ODT in patients under 16 years of age have not been established. The use of Rybix ODT in the pediatric population is not recommended.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. In patients over 75 years of age, daily doses in excess of 300 mg are not recommended (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

A total of 455 elderly (65 years of age or older) subjects were exposed to tramadol in controlled clinical trials. Of those, 145 subjects were 75 years of age and older.

In studies including geriatric patients, treatment-limiting adverse events were higher in subjects over 75 years of age compared to those under 65 years of age. Specifically, 30% of those over 75 years of age had gastrointestinal treatment-limiting adverse events compared to 17% of those under 65 years of age. Constipation resulted in discontinuation of treatment in 10% of those over 75.

Adverse Reactions

An orally swallowed immediate release tablet of tramadol was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol and the active control groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the tramadol groups.

Table 2: Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N = 427)
1 “CNS Stimulation” is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional liability, and hallucinations.
	Up to 7 Days	Up to 30 Days	Up to 90 Days
Dizziness/Vertigo	26%	31%	33%
Nausea	24%	34%	40%
Constipation	24%	38%	46%
Headache	18%	26%	32%
Somnolence	16%	23%	25%
Vomiting	9%	13%	17%
Pruritus	8%	10%	11%
“CNS Stimulation”1	7%	11%	14%
Asthenia	6%	11%	12%
Sweating	6%	7%	9%
Dyspepsia	5%	9%	13%
Dry Mouth	5%	9%	10%
Diarrhea	5%	6%	10%

Incidence 1% to less than 5%, possibly casually related:
the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with tramadol exists.

: Body as a Whole: Malaise.
: Cardiovascular: Vasodilation.
: Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
: Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
: Musculoskeletal: Hypertonia.
: Skin: Rash.
: Special Senses: Visual disturbance.
: Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.

Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.

: Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).
: Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
: Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure (see WARNINGS), Tremor.
: Respiratory: Dyspnea.
: Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.
: Special Senses: Dysgeusia.
: Urogenital: Dysuria, Menstrual disorder.

Other adverse experiences, causal relationship unknown: A variety of other adverse events were reported infrequently in patients taking tramadol during clinical trials and/or reported in post-marketing experience. A causal relationship between tramadol and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.

: Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.
: Central Nervous System: Migraine, Speech disorders.
: Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
: Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.
: Sensory: Cataracts, Deafness, Tinnitus.

DRUG ABUSE AND DEPENDENCE

Abuse

Tramadol has mu-opioid agonist activity. Rybix ODT can be abused and may be subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of Rybix ODT can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.

Concerns about abuse and addiction should not prevent the proper management of pain. However all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product.

Rybix ODT is intended for oral use only.

Dependence

Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist (see also WARNINGS, Withdrawal).

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with Rybix ODT.

OVERDOSAGE

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death. Deaths due to overdose have been reported with abuse and misuse of tramadol (see WARNINGS, Misuse, Abuse, and Diversion). Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

In the treatment of tramadol overdose, primary attention should be given to reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

DOSAGE AND ADMINISTRATION

Do NOT chew, break, or split the tablet.

Adults (17 years of age and over)

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol can be improved by initiating therapy with a titration regimen. The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, Rybix ODT 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, Rybix ODT 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.

Place Rybix ODT tablet on the tongue until it completely disintegrates and then swallow it. It may take approximately one minute for the tablet to disintegrate on the tongue. Tablet may be taken with or without water.

Individualization of Dose

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of Rybix ODT be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.

The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.

In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

HOW SUPPLIED

RYBIX™ ODT (tramadol hydrochloride) Orally Disintegrating Tablets are 50 mg white tablet, debossed with “T” on one side and “50″ on the other side, and supplied in cartons of 30 tablets (5 cards of 6 single dose units) in child resistant blister packs.

NDC 68453-825-03

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Manufactured by:
Ethypharm S.A.
ZI Saint Arnoult
Route de Brezolles
28170
Chateauneuf-en-Thymerais
France

Manufactured for:
Victory Pharma, Inc.
San Diego, CA 92130

LB0051-00
Rev. 12/09

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 MG CARTON

30 Tablets
NDC 68453-825-03

Rybix™ODT

(tramadol HCl) Orally Disintegrating Tablets

50 mg
Rx only

Dosage and Administration:
See package insert for prescribing information.

Store at 25° C (77°F); excursions permitted to
15°-30° C (59°-86°F).

Victory Pharma

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 MG SAMPLE CARTON

4 Tablets
NDC 68453-825-01

Rybix™ODT

(tramadol HCl) Orally Disintegrating Tablets

50 mg

PROFESSIONAL SAMPLE: NOT FOR SALE

Rx only

Dosage and Administration:
See package insert for prescribing information.

Store at 25° C (77°F); excursions permitted to
15°-30° C (59°-86°F).

Victory Pharma

RYBIX
tramadol hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68453-825
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tramadol hydrochloride (tramadol)	tramadol hydrochloride	50 mg

Inactive Ingredients
Ingredient Name	Strength
aspartame
copovidone
crospovidone
ethylcellulose
magnesium stearate
mannitol
mint
silicon dioxide

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor	MINT (MINT)	Imprint Code	T;50
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68453-825-01	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		4 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (68453-825-01)
2	68453-825-03	5 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (68453-825-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021693	05/01/2010

Labeler - Victory Pharma, Inc. (143180318)

Establishment
Name	Address	ID/FEI	Operations
Ethypharm SA (CET)		399026934	MANUFACTURE

Revised: 12/2009Victory Pharma, Inc.

Professional,R

Comments (0)

Ryna-12

30/06/10

What is this drug?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about this drug?

What should I discuss with my health care provider before taking this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
kidney disease;
an enlarged prostate; or
problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

How should I take this drug?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

The chewable tablet must be chewed before you swallow it.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking this drug?

This drug side effects

fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, fever, chills, body aches, flu symptoms;
urinating less than usual or not at all; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

nausea, stomach pain, constipation, mild loss of appetite;
dry mouth;
warmth, tingling, or redness under your skin;
blurred vision;
dizziness, drowsiness;
problems with memory or concentration;
restless or excitability (especially in children);
sleep problems (insomnia); or
skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:

a diuretic (water pill);
salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

Where can I get more information?

Your pharmacist can provide more information about phenylephrine and pyrilamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Ryna-12 S Suspension

30/06/10

Generic Name: Phenylephrine/Pyrilamine (fen-il-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Ryna-12 S and Rynesa 12S

Ryna-12 S Suspension is used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Ryna-12 S Suspension is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Ryna-12 S Suspension if:

you are allergic to any ingredient in Ryna-12 S Suspension
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ryna-12 S Suspension:

Some medical conditions may interact with Ryna-12 S Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a fast, slow, or irregular heartbeat
if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with Ryna-12 S Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Ryna-12 S Suspension may be increased
Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased
Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Ryna-12 S Suspension
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Ryna-12 S Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ryna-12 S Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ryna-12 S Suspension:

Use Ryna-12 S Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ryna-12 S Suspension may be taken with or without food.
Shake well before using.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Ryna-12 S Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ryna-12 S Suspension.

Important safety information:

Ryna-12 S Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ryna-12 S Suspension. Using Ryna-12 S Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take diet or appetite control medicines while you are taking Ryna-12 S Suspension without checking with you doctor.
Do NOT exceed the recommended dose or take Ryna-12 S Suspension for longer than prescribed without checking with your doctor.
If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
Ryna-12 S Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ryna-12 S Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
If you are scheduled for allergy skin testing, do not take Ryna-12 S Suspension for several days before the test because it may decrease your response to the skin tests.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ryna-12 S Suspension.
Use Ryna-12 S Suspension with caution in the ELDERLY because they may be more sensitive to its effects.
Caution is advised when using Ryna-12 S Suspension in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ryna-12 S Suspension, discuss with your doctor the benefits and risks of using Ryna-12 S Suspension during pregnancy. It is unknown if Ryna-12 S Suspension is excreted in breast milk. Do not breast-feed while taking Ryna-12 S Suspension.

Possible side effects of Ryna-12 S Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

If OVERDOSE is suspected:

Proper storage of Ryna-12 S Suspension:

Store Ryna-12 S Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ryna-12 S Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Ryna-12 S Suspension, please talk with your doctor, pharmacist, or other health care provider.
Ryna-12 S Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ryna-12 S Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

Comments (0)

Page 2 of 61«123 4 5 6 7 8 9 10 »20 30 40...Last »

Drugs & Medications:A-Z

Recent Posts

Blogroll

30/06/10

What is Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

What is the most important information I should know about Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Who should not take Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

How should I take Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine) side effects

What other drugs will affect Rynatuss (chlorpheniramine, carbetapentane, ephedrine, and phenylephrine)?

Where can I get more information?

30/06/10

Rynatuss Pediatric Suspension is used for:

Do NOT use Rynatuss Pediatric Suspension if:

Before using Rynatuss Pediatric Suspension:

How to use Rynatuss Pediatric Suspension:

Important safety information:

Possible side effects of Rynatuss Pediatric Suspension:

If OVERDOSE is suspected:

General information:

30/06/10

What is this drug?

What is the most important information I should know about this drug?

What should I discuss with my health care provider before taking this drug?

How should I take this drug?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking this drug?

This drug side effects

What other drugs will affect this drug?

Where can I get more information?

30/06/10

What is Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

What is the most important information I should know about Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

What should I discuss with my healthcare provider before taking Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

How should I take Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Ryna-12X (guaifenesin, phenylephrine, and pyrilamine) side effects

What other drugs will affect Ryna-12X (guaifenesin, phenylephrine, and pyrilamine)?

Where can I get more information?

30/06/10

Ryna-12X Suspension is used for:

Do NOT use Ryna-12X Suspension if:

Before using Ryna-12X Suspension:

How to use Ryna-12X Suspension:

Important safety information:

Possible side effects of Ryna-12X Suspension:

If OVERDOSE is suspected:

General information:

30/06/10

What is Rynatan (chlorpheniramine and phenylephrine)?

What is the most important information I should know about Rynatan (chlorpheniramine and phenylephrine)?

What should I discuss with my healthcare provider before taking Rynatan (chlorpheniramine and phenylephrine)?

How should I take Rynatan (chlorpheniramine and phenylephrine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Rynatan (chlorpheniramine and phenylephrine)?

Rynatan (chlorpheniramine and phenylephrine) side effects

What other drugs will affect Rynatan (chlorpheniramine and phenylephrine)?

Where can I get more information?

30/06/10

What is Ry-Tann (chlorpheniramine and phenylephrine)?

What is the most important information I should know about Ry-Tann (chlorpheniramine and phenylephrine)?

What should I discuss with my healthcare provider before taking Ry-Tann (chlorpheniramine and phenylephrine)?

How should I take Ry-Tann (chlorpheniramine and phenylephrine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Ry-Tann (chlorpheniramine and phenylephrine)?

Ry-Tann (chlorpheniramine and phenylephrine) side effects

What other drugs will affect Ry-Tann (chlorpheniramine and phenylephrine)?

Where can I get more information?

30/06/10

DESCRIPTION

CLINICAL PHARMACOLOGY

Pharmacodynamics