Pronunciation: (ore-FEN-uh-dreen SIH-trate)
Class: Skeletal muscle relaxant

Trade Names:
Norflex
- Injection 30 mg/mL

Trade Names:
Orphenadrine Citrate
- Tablets, sustained-release 100 mg

Orfenace (Canada)
Sandoz Orphenadrine (Canada)

Pharmacology

Unknown; may be related to analgesic properties since drug acts on brain stem and does not act directly on muscles; possesses anticholinergic actions.

Pharmacokinetics

Absorption

Readily absorbed from the GI tract. T _max is 2 h.

Distribution

Not fully characterized.

Metabolism

Degraded to 8 known metabolites.

Elimination

Eliminated through urine (as metabolites, small amount as unchanged) and feces. The t _½ is approximately 14 h (parent drug). The t _½ is 2 to 25 h (metabolites).

Duration

4 to 6 h.

Indications and Usage

Adjunctive treatment for acute, painful musculoskeletal conditions.

Unlabeled Uses

Treatment of quinine-resistant leg cramps.

Contraindications

Glaucoma; pyloric or duodenal obstruction; stenosing peptic ulcers; prostatic hypertrophy; obstruction of bladder neck; esophageal achalasia; myasthenia gravis.

Dosage and Administration

Adults

IV/IM 60 mg every 12 h as needed.

Adults

PO 100 mg twice daily.

Drug Interactions

Alcohol, other CNS depressants

Increased CNS depression.

Haloperidol

Worsening schizophrenic symptoms, decreased haloperidol levels, tardive dyskinesia.

Phenothiazines

Decreased effects of phenothiazines.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia; palpitations; transient syncope.

CNS

Weakness; headache; dizziness; lightheadedness; confusion (especially in elderly); hallucinations; agitation; tremor; drowsiness.

Dermatologic

Hypersensitivity reactions (eg, rashes).

EENT

Blurred vision; pupil dilation; increased ocular tension.

GI

Dry mouth; vomiting; nausea; constipation; gastric irritation.

Genitourinary

Urinary hesitancy and retention.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

May be more sensitive to anticholinergic effects.

Hypersensitivity

May occur.

Sulfite Sensitivity

Some products contain bisulfites, which may cause allergic-type reactions in certain persons.

Cardiac disease

Use drug with caution in patients with cardiac decompensation, coronary insufficiency, cardiac arrhythmias or tachycardia.

Heat prostration

Can occur in presence of high environmental temperature.

Overdosage

Symptoms

Cardiac arrhythmias, seizures, coma, shock.

Patient Information

• Tell patient not to increase dosage of medication. Even slight overdose may be highly toxic.
• Instruct patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Advise patient that drug may cause drowsiness or dizziness, and to use caution while driving or performing other tasks requiring mental alertness.
• Instruct patient to report the following symptoms to health care provider: urinary retention, constipation, palpitations, or tremors.
• Instruct patient to avoid alcohol or other CNS depressants.

Copyright © 2009 Wolters Kluwer Health.

Generic Name: acetaminophen and pseudoephedrine (a SEET a MIN oh fen and SOO doe ee FED rin)
Brand Names: Alka-Seltzer Cold and Sinus, Allerest No Drowsiness, Bayer Select Decongestant, Benadryl Allergy Sinus Headache, Dristan Cold Non-Drowsy, Ornex, Ornex Maximum Strength, Sinarest Sinus, Sine-Off Maximum Strength, Tavist Sinus, Triaminic Softchews Allergy Sinus, Tylenol Sinus Childrens

What is Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

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

The combination of acetaminophen and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever caused by the common cold.

Acetaminophen and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

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. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen (sometimes abbreviated as “APAP”) or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor’s advice.

What should I discuss with my healthcare provider before taking Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine. Do not use this medication 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 a decongestant before the MAO inhibitor has cleared from your body.

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

• cirrhosis or other liver disease;

• a history of alcoholism;

• heart disease or high blood pressure;

• glaucoma;

• an enlarged prostate;

• diabetes; or

• a thyroid disorder.

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. It is not known whether this medication is harmful to an unborn baby. Before taking acetaminophen and pseudoephedrine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and pseudoephedrine 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 cough-and-cold medications 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 Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

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 should be taken only for a short time until your symptoms clear up.

Drink extra fluids while you are taking acetaminophen and pseudoephedrine. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen and pseudoephedrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. 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.

Measure the liquid form of acetaminophen and pseudoephedrine 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.

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.

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 medication at room temperature, away from heat, light, and moisture.

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 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, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and pseudoephedrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

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.

Ornex Maximum Strength (acetaminophen and pseudoephedrine) 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;

• 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:

• mild loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia); or

• skin rash or itching;

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 Ornex Maximum Strength (acetaminophen and pseudoephedrine)?

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

• isoniazid;

• zidovudine (Retrovir, AZT);

• medicines to treat high blood pressure;

• gout medications such as probenecid (Benemid) or sulfinpyrazone;

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

• stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);

• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others; or

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen and pseudoephedrine. 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 acetaminophen and pseudoephedrine.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.01. Revision Date: 01/26/2010 11:57:12 AM.

Generic Name: orphenadrine (or FEN a drin)
Brand names: Norflex, …show all 10 brand names.Banflex, Orphenate, Flexoject, Flexon, Mio-Rel, Myolin, Orfro, Norflex Injectable, Antiflex

What is orphenadrine?

Orphenadrine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Orphenadrine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Orphenadrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about orphenadrine?

Do not take this medication if you are allergic to orphenadrine, or if you have problems with urination, an enlarged prostate, glaucoma, a blockage in your stomach or intestines, trouble swallowing, or myasthenia gravis. Do not crush, chew, or break the extended-release tablet. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time. Orphenadrine may be habit-forming and should be used only by the person it was prescribed for. Orphenadrine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Orphenadrine 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, which can increase some of the side effects of orphenadrine.

What should I discuss with my healthcare provider before taking orphenadrine?

Do not take this medication if you are allergic to orphenadrine, or if you have:

• problems with urination;

• enlarged prostate;

• glaucoma;

• a blockage in your stomach or intestines;

• trouble swallowing; or

• myasthenia gravis.

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

• heart disease;

• a heart rhythm disorder; or

• coronary artery disease.

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

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. It is not known whether orphenadrine 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.

How should I take orphenadrine?

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.

Take this medicine with a full glass of water. Do not crush, chew, or break the extended-release tablet. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time.

Orphenadrine is only part of a complete program of treatment that may also include rest, physical therapy, or other pain relief measures. Follow your doctor’s instructions.

Orphenadrine may be habit-forming and should be used only by the person it was prescribed for. Orphenadrine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Store orphenadrine at room temperature away from moisture, heat, and light.

See also: Orphenadrine dosage in more detail

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. An overdose of orphenadrine can be fatal.

Overdose symptoms may include blurred vision, fast heart rate, confusion, weak or shallow breathing, cold or clammy skin, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking orphenadrine?

Orphenadrine 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, which can increase some of the side effects of orphenadrine. Cold or allergy medicine, narcotic pain medicine, sleeping pills, and medicine for seizures, depression or anxiety can add to sleepiness caused by orphenadrine. Tell your doctor if you regularly use any of these medicines, or any other muscle relaxer.

Orphenadrine 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 orphenadrine and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeats;

• confusion, anxiety, agitation, tremors, hallucinations;

• seizure (convulsions); or

• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth or throat;

• blurred vision, dilated pupils;

• headache;

• drowsiness, dizziness;

• nausea, vomiting, constipation; or

• weakness.

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.

Orphenadrine Dosing Information

Usual Adult Dose for Muscle Spasm:

Acute musculoskeletal conditions:

100 mg orally twice a day (morning and evening).

-or-

60 mg by intramuscular or intravenous injection. May repeat every 12 hours.

Quinine-resistant leg cramps:

100 mg orally at bedtime.

What other drugs will affect orphenadrine?

Before taking orphenadrine, tell your doctor if you are taking any of the following medicines:

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

• glycopyrrolate (Robinul);

• mepenzolate (Cantil);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), 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 orphenadrine. 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 orphenadrine.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.05. Revision Date: 4/12/2009 4:38:47 PM.

or-FEN-a-dreen

Commonly used brand name(s):

In the U.S.

• Norflex

Available Dosage Forms:

• Tablet
• Tablet, Extended Release

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Pharmacologic Class: Antimuscarinic

Uses For orphenadrine

Orphenadrine is used to help relax certain muscles in your body and relieve the stiffness, pain, and discomfort caused by strains, sprains, or other injury to your muscles. One form of orphenadrine is also used to relieve trembling caused by Parkinson’s disease. However, orphenadrine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem.

Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects. Orphenadrine also has other actions (anticholinergic) that produce its helpful effects in Parkinson’s disease. Orphenadrine’s CNS and anticholinergic actions may also be responsible for some of its side effects.

orphenadrine is available only with your doctor’s prescription.

Before Using orphenadrine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For orphenadrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to orphenadrine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of orphenadrine in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of orphenadrine in geriatric patients. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution in patients receiving orphenadrine .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using orphenadrine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Perphenazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of orphenadrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged esophagus or
• Enlarged prostate or
• Glaucoma or
• Intestinal blockage or
• Myasthenia gravis or
• Stomach ulcer or
• Urinary tract blockage—Orphenadrine should not be used in patients with these conditions .

• Heart problems (e.g., fast or irregular heartbeats, heart failure)—Use with caution. Orphenadrine may worsen these conditions .

Proper Use of orphenadrine

Swallow the extended-release tablet whole. Do not crush, break, or chew it .

Dosing

The dose of orphenadrine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of orphenadrine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For relaxing stiff, sore muscles:
    • Adults and teenagers—100 milligrams (mg) two times a day, one tablet each in the morning and evening.
    • Children—Use and dose must be determined by your doctor .
• For oral dosage form (tablets):
  • For relaxing stiff, sore muscles and for Parkinson’s disease:
    • Adults—50 milligrams (mg) three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of orphenadrine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using orphenadrine

It is very important that your doctor check your progress at regular visits to make sure that orphenadrine is working properly. Blood tests may be needed to check for unwanted effects .

Orphenadrine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after using orphenadrine .

orphenadrine may cause some people to become dizzy, lightheaded, faint, or less alert than they are normally. It may also cause muscle weakness in some people. Make sure you know how you react to orphenadrine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.

orphenadrine may add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using orphenadrine.

Orphenadrine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. .

orphenadrine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Chest pain
• chills
• cough
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache
• shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• skin rash, hives, itching, or redness
• sores, ulcers, or white spots on lips or in mouth
• swollen and/or painful glands
• unusual bruising or bleeding
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain
• diarrhea
• fainting
• fast, pounding irregular heartbeat or pulse
• glaucoma
• joint or muscle pain
• nausea
• numbness or tingling of face, hands, or feet
• redness and soreness of eyes
• swelling of feet or lower legs
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose

• Blurred vision
• confusion, delirium, or hallucinations
• constipation
• difficult urination
• drowsiness
• dry eyes, mouth, nose, or throat
• eye pain
• flushing or redness of face
• troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Dizziness or lightheadedness
• excitement, irritability, nervousness, or restlessness
• headache
• muscle weakness
• unusually large pupils of eyes

Incidence not known

• Anxiety
• deep or fast breathing with dizziness
• itching skin
• mental confusion
• numbness of feet, hands and around mouth
• trembling or shaking of hands or feet shakiness in legs, arms, hands, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

or-FEN-a-dreen

Commonly used brand name(s):

In the U.S.

• Antiflex
• Mio-Rel
• Norflex
• Orfro
• Orphenate

Available Dosage Forms:

• Solution

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Pharmacologic Class: Antimuscarinic

Uses For orphenadrine

Orphenadrine is used to help relax certain muscles in your body and relieve the stiffness, pain, and discomfort caused by strains, sprains, or other injury to your muscles. However, orphenadrine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem .

Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects .

orphenadrine is available only with your doctor’s prescription .

Before Using orphenadrine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For orphenadrine, the following should be considered:

Allergies

The dose of orphenadrine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of orphenadrine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of orphenadrine in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of orphenadrine in geriatric patients. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution in patients receiving orphenadrine .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using orphenadrine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Perphenazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of orphenadrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Enlarged esophagus or
• Enlarged prostate or
• Glaucoma or
• Intestinal blockage or
• Myasthenia gravis or
• Stomach ulcer or
• Urinary tract blockage—Orphenadrine should not be used in patients with these conditions .

• Heart problems (e.g., fast or irregular heartbeats, heart failure)—Use with caution. Orphenadrine may worsen these conditions .

Proper Use of orphenadrine

A nurse or other trained health professional will give you orphenadrine. orphenadrine is given through a needle placed in one of your veins or into your muscle .

Precautions While Using orphenadrine

Your doctor will only give you a few doses of orphenadrine until your condition improves, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

orphenadrine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in chest
• unusual tiredness or weakness
• wheezing

Incidence not known

• Abdominal or stomach pain
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• fever
• glaucoma
• joint or muscle pain
• nausea
• numbness or tingling of face, hands, or feet
• redness and soreness of eyes
• shortness of breath
• sores in mouth
• swelling of feet or lower legs
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose

• Blurred vision
• confusion, delirium, or hallucinations
• constipation
• difficult urination
• drowsiness
• dry eyes, mouth, nose, or throat
• eye pain
• flushing or redness of face
• troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Anxiety
• deep or fast breathing with dizziness
• headache
• irritability
• itching skin
• mental confusion
• nervousness
• numbness of feet, hands and around mouth
• restlessness
• trembling or shaking of hands or feet shakiness in legs, arms, hands, or feet
• unusually large pupils of eyes
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)
Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R

What is Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

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.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

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

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine.

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 Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine 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,

• any type of heart disease or high blood pressure,

• thyroid disease,

• emphysema or chronic bronchitis, or

• difficulty urinating or an enlarged prostate.

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

Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication 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 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. 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 Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

Take chlorpheniramine and phenylpropanolamine 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. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine 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 and phenylpropanolamine 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 and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine is taken with any of these medications.

Ornade Spansules (chlorpheniramine and phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine 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.

What other drugs will affect Ornade Spansules (chlorpheniramine and phenylpropanolamine)?

Do not take chlorpheniramine and phenylpropanolamine 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.

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

Chlorpheniramine and phenylpropanolamine 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 and phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine and phenylpropanolamine. 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 and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 4/26/06 4:12:59 PM.

Generic Name: acetaminophen and pseudoephedrine (a SEET a MIN oh fen and SOO doe ee FED rin)
Brand Names: Alka-Seltzer Cold and Sinus, Allerest No Drowsiness, Bayer Select Decongestant, Benadryl Allergy Sinus Headache, Dristan Cold Non-Drowsy, Ornex, Ornex Maximum Strength, Sinarest Sinus, Sine-Off Maximum Strength, Tavist Sinus, Triaminic Softchews Allergy Sinus, Tylenol Sinus Childrens

What is Ornex (acetaminophen and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

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

The combination of acetaminophen and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever caused by the common cold.

Acetaminophen and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ornex (acetaminophen and pseudoephedrine)?

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. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen (sometimes abbreviated as “APAP”) or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor’s advice.

What should I discuss with my healthcare provider before taking Ornex (acetaminophen and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine. Do not use this medication 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 a decongestant before the MAO inhibitor has cleared from your body.

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

• cirrhosis or other liver disease;

• a history of alcoholism;

• heart disease or high blood pressure;

• glaucoma;

• an enlarged prostate;

• diabetes; or

• a thyroid disorder.

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. It is not known whether this medication is harmful to an unborn baby. Before taking acetaminophen and pseudoephedrine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and pseudoephedrine 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 cough-and-cold medications 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 Ornex (acetaminophen and pseudoephedrine)?

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 should be taken only for a short time until your symptoms clear up.

Drink extra fluids while you are taking acetaminophen and pseudoephedrine. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen and pseudoephedrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. 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.

Measure the liquid form of acetaminophen and pseudoephedrine 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.

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.

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 medication at room temperature, away from heat, light, and moisture.

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 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, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Ornex (acetaminophen and pseudoephedrine)?

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and pseudoephedrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

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.

Ornex (acetaminophen and pseudoephedrine) 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;

• 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:

• mild loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia); or

• skin rash or itching;

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 Ornex (acetaminophen and pseudoephedrine)?

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

• isoniazid;

• zidovudine (Retrovir, AZT);

• medicines to treat high blood pressure;

• gout medications such as probenecid (Benemid) or sulfinpyrazone;

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

• stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);

• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others; or

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen and pseudoephedrine. 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 acetaminophen and pseudoephedrine.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.01. Revision Date: 01/26/2010 11:57:12 AM.

Generic Name: levomethadyl (Oral route)

lee-voe-METH-a-dil

Commonly used brand name(s):

In the U.S.

• Orlaam

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Orlaam

Levomethadyl belongs to the group of medicines known as narcotic analgesics. It is used as a substitute for illegal narcotics in addiction treatment programs. This medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by your doctor.

Levomethadyl helps prevent the withdrawal symptoms that may occur when an addict stops using other narcotics. In detoxification programs, the amount of levomethadyl used is slowly decreased until an addict becomes drug-free. In maintenance programs, it is used on a long-term basis to help narcotic addicts stay away from street drugs. With long-term use, levomethadyl may decrease an addict’s craving for other narcotics.

Another narcotic, methadone, is also used in detoxification and maintenance programs. Methadone begins to work faster than levomethadyl does when treatment is started, but it has to be taken every day. Levomethadyl starts to work slowly, but it does not have to be taken every day. Therefore, some people may start treatment with methadone and then change over to levomethadyl after several weeks. Other people may receive only one medicine or the other during the entire time of treatment. Your doctor and your counselor at the clinic will decide on the best treatment plan for you.

In the U.S., levomethadyl was available only in government-approved treatment clinics.

The manufacturer discontinued ORLAAM® (levomethadyl) in the United States in September 2003.

Before Using Orlaam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

In the U.S., the law does not allow levomethadyl to be used for treating addicts younger than 18 years of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of levomethadyl in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acecainide
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Aprindine
• Astemizole
• Azimilide
• Bepridil
• Bretylium
• Brofaromine
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cisapride
• Citalopram
• Clarithromycin
• Clorgyline
• Desipramine
• Dibenzepin
• Disopyramide
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• Ebastine
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• Erythromycin
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• Fluoxetine
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• Furazolidone
• Halofantrine
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• Hydroquinidine
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• Imipramine
• Iproniazid
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• Isradipine
• Itraconazole
• Lazabemide
• Lidoflazine
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• Lorcainide
• Mefloquine
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• Nortriptyline
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• Pargyline
• Pentamidine
• Phenelzine
• Pimozide
• Pirmenol
• Prajmaline
• Primaquine
• Probucol
• Procainamide
• Procarbazine
• Propafenone
• Protriptyline
• Quinidine
• Rasagiline
• Risperidone
• Selegiline
• Sematilide
• Sertindole
• Sertraline
• Sotalol
• Spiramycin
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• Trimeprazine
• Trimethoprim
• Trimipramine
• Vasopressin
• Zimeldine
• Ziprasidone
• Zolmitriptan
• Zotepine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetazolamide
• Amiloride
• Arsenic Trioxide
• Azosemide
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Bumetanide
• Canrenoate
• Castor Oil
• Chlorthalidone
• Clopamide
• Cyclothiazide
• Docusate
• Enflurane
• Ethacrynic Acid
• Etozolin
• Fenquizone
• Furosemide
• Gemifloxacin
• Halothane
• Hydrochlorothiazide
• Hydroflumethiazide
• Indapamide
• Isoflurane
• Ketoconazole
• Lactulose
• Magnesium
• Mannitol
• Metolazone
• Piretanide
• Polythiazide
• Prochlorperazine
• Quinethazone
• Sorbitol
• Spironolactone
• Tapentadol
• Telithromycin
• Ticrynafen
• Torsemide
• Triamterene
• Trichlormethiazide
• Trifluoperazine
• Urea
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Phenobarbital
• Phenytoin
• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, emphysema, or other chronic lung disease, or
• Brain disease or head injury or
• Colitis or
• Crohn’s disease or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones or
• Heart disease or
• High blood pressure—Levomethadyl has side effects that could be dangerous to people with these conditions.

• Kidney disease or
• Liver disease or
• Underactive thyroid—The chance of side effects may be increased.

Proper Use of Orlaam

Most patients are given their dose of levomethadyl at the clinic. You may be able to take some doses of your levomethadyl at home if your health care professional feels you are responsible to do that. Most people will have to go to the clinic 3 times a week.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (oral solution):
  • For treating narcotic addiction:
    • Adults—The first dose of levomethadyl for patients who have not started treatment with methadone is between 20 and 40 milligrams (mg). The first dose for patients who have been receiving methadone will be a little higher than the amount of methadone that was being taken every day, but not more than 120 mg. Your doctor will then adjust your dose, depending on whether you experience withdrawal symptoms or side effects after the first dose. More than one change in the dose may be needed, until the right dose for you has been found. Most people will receive levomethadyl 3 times a week, either on Monday, Wednesday, and Friday or on Tuesday, Thursday, and Saturday. Some people need a larger dose on Friday or Saturday, so that the medicine will last until the next visit. In detoxification programs, the dose of levomethadyl will gradually be decreased until the patient is able to stop taking it. In maintenance programs, treatment may be continued as long as needed. If you miss one treatment in your program, your health care professional will have to adjust your treatment schedule and dose; you may need to start a new program with a lower starting dose if you miss more than one treatment or have been off the treatment for more than one week.
    • Children—In the U.S., levomethadyl cannot be used for patients younger than 18 years of age.

Precautions While Using Orlaam

Taking levomethadyl is only part of your treatment. Your doctor and your counselor at the clinic will make a treatment plan for you to follow. This plan may include seeing your counselor at the clinic regularly, attending support group meetings, and making changes in your lifestyle that will help you stay away from illegal drugs. The success of your treatment will depend on how carefully you follow your treatment plan.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. It is very important that you do not drink alcoholic beverages or take any CNS depressants during levomethadyl treatment unless you have been directed to do so by a doctor who knows that you are taking levomethadyl. Even if you continue to have some withdrawal symptoms and to crave narcotics for a while after levomethadyl treatment has been started, do not use illegal narcotics or other CNS depressant “street” drugs. Taking “street” drugs together with levomethadyl has caused some people to die from an overdose.

Levomethadyl may cause some people to become drowsy, especially when treatment is started or the dose is increased. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or are not alert and clearheaded. This effect usually goes away after a few days, when your body gets used to the medicine. However, tell your counselor at your next visit to the clinic if any dose causes drowsiness that is severe enough to interfere with your activities.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Tell all health care professionals you go to that you are taking levomethadyl. This is especially important if any kind of surgery or emergency treatment is needed. Serious side effects can occur if your health care professional gives you certain other medicines without knowing that you are taking levomethadyl.

Using narcotics such as levomethadyl for a long time can cause severe constipation. To prevent this, your counselor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Levomethadyl may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For women only:

• Although there may be rare exceptions, levomethadyl is not recommended for use by pregnant women. Pregnancy tests will be given once a month during treatment. If you miss any of these tests you may not be able to continue receiving levomethadyl.
• Women who may become pregnant should use effective birth control during levomethadyl treatment. If you are not sure what method of birth control will work best for you, check with your counselor at the clinic.
• If you plan to become pregnant, you should first discuss your plans with your doctor or your counselor. They can arrange for you to receive methadone instead of levomethadyl.
• If you think you have become pregnant during treatment, tell your counselor right away.

Some people may be transferred to methadone after receiving levomethadyl for a while. If you are given any take-home doses of methadone, do not take the first dose of methadone for at least 48 hours (2 days) after your last dose of levomethadyl. Taking the 2 medicines too close together may cause an overdose.

If you think you may have taken an overdose of narcotics, get emergency help right away. Taking an overdose of narcotics, or taking alcohol or CNS depressants with narcotics, may lead to unconsciousness or death. Signs of overdose include convulsions (seizures); confusion; severe dizziness, drowsiness, nervousness, restlessness, or weakness; and very slow or troubled breathing. It is very important that the emergency room doctor knows that you are physically dependent on a narcotic called levomethadyl, that using naloxone to treat your overdose is very likely to cause withdrawal symptoms, and that you will need to be watched for a long time because levomethadyl’s effects last for several days. However, you may not be able to give this information to the doctor yourself. Therefore, you should direct friends and family members to give this information to the doctor, if necessary.

Orlaam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Signs and symptoms of overdose

• Cold, clammy skin
• confusion
• convulsions (seizures)
• dizziness (severe)
• drowsiness (severe)
• low blood pressure
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• weakness (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Mental depression
• skin rash
• swelling of face, fingers, feet, and/or lower legs
• weight gain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Signs of too much levomethadyl

• Drowsiness (severe)
• feeling “wired”

Signs of not enough levomethadyl (withdrawal symptoms)

• Body aches, diarrhea
• fast heartbeat
• gooseflesh
• increased sweating
• loss of appetite
• nausea or vomiting
• nervousness, restlessness, or irritability
• runny nose
• shivering or trembling
• sneezing
• stomach cramps
• trouble in sleeping
• unexplained fever
• unusually large pupils of eyes
• weakness
• yawning

The withdrawal side effects listed above may also occur after levomethadyl treatment has been stopped or during a changeover from levomethadyl to methadone. Always check with your counselor at the clinic if withdrawal side effects occur after you stop taking levomethadyl.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• constipation
• general feeling of discomfort or illness
• joint pain
• sexual problems in males

Less common or rare

• Anxiety
• back pain
• blurred vision
• chills
• coughing
• decreased desire for sex
• dizziness, lightheadedness, or feeling faint when rising from a lying or sitting position
• drowsiness
• dry mouth
• false sense of well-being
• flu-like symptoms
• headache
• hot flashes
• muscle pain
• unusual dreams
• watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Brand names: Xenical

Why is Orlistat prescribed?

Xenical blocks absorption of dietary fat into the bloodstream, thereby reducing the number of calories you get from a meal. At the usual dosage level, it cuts fat absorption by almost one-third. Combined with a low-calorie diet, it is used to promote weight loss and discourage the return of unwanted pounds.

The drug is prescribed for obese individuals and for overweight people who have other health problems such as high blood pressure, diabetes, or high cholesterol levels. Your weight status is determined by your body mass index (BMI), a comparison of height to weight.

Most important fact about Orlistat

Along with dietary fat, Xenical decreases the absorption of some fat-soluble vitamins and beta-carotene. To compensate, it is strongly recommended that you take a multivitamin containing vitamins A, E, D, K, and beta-carotene once a day, at least 2 hours before or 2 hours after taking Xenical.

How should you take Orlistat?

Take a capsule of Xenical during, or up to 1 hour after, each main meal. You should follow a nutritionally balanced, low-calorie diet that provides no more than 30 percent of its calories from fat. If you miss a meal, or the meal contains no fat, you can skip the accompanying dose of Xenical.

• If you miss a dose…
  Resume taking Xenical at the next meal. Don’t try to make up the loss with a double dose. The extra drug won’t help.

• Storage instructions…
  Store at room temperature, in a tightly sealed container.

What side effects may occur?

Side effects of Xenical are more common during the first year of treatment. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Xenical.

• Side effects may include:
  Abdominal discomfort or pain, anxiety, arthritis, back pain, diarrhea, dizziness, earache, fatigue, fatty or oily stools, fecal urgency or incontinence, flu, gas with fecal discharge, gum problems, headache, increased defecation, menstrual problems, muscle pain, nausea, oily discharge, rectal discomfort or pain, respiratory tract infections, skin rash, sleep problems, tooth problems, urinary tract infections, vaginal inflammation, vomiting

Side effects that usually occur after the first year of treatment with Xenical include: depression, leg pain, swollen feet, and tendonitis.

Why should Orlistat not be prescribed?

Do not take Xenical if you suffer from chronic malabsorption syndrome—a condition that prevents nutrients from passing from your stomach into your bloodstream—or from cholestasis, a blockage in the supply of bile needed for digestion. You’ll also need to avoid Xenical if it gives you an allergic reaction.

Special warnings about Orlistat

Weight loss begins within 2 weeks and continues for 6 to 12 months. The effect of using Xenical for more than 2 years is still unknown.

Side effects such as diarrhea and abdominal pain may be worse if you continue eating a high fat diet or even take a high-fat meal. Limit your fat intake.

Your doctor will test your thyroid function before starting you on Xenical to make sure that your weight problem is not due to an underactive thyroid gland (hypothyroidism). Xenical is not an appropriate remedy for this problem.

Xenical increases the likelihood of kidney stones. Use it with caution if you have a history of this problem.

If you have diabetes, weight-loss is likely to reduce your blood sugar levels. If you’re taking an oral diabetes medication or insulin, your dose may have to be reduced.

Note that the safety and efficacy of Orlistat in children younger than 12 years old have not been established.

Possible food and drug interactions when taking Orlistat

If Xenical is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Xenical with the following:

Cyclosporine
Warfarin

Special information if you are pregnant or breastfeeding

The effects of Xenical during pregnancy have not been adequately studied and the drug is not recommended for pregnant women. If you are pregnant or plan to become pregnant, inform your doctor immediately.

It is not known whether Xenical appears in breast milk. Do not take it while breastfeeding.

Recommended dosage for Orlistat

ADULTS AND CHILDREN 12 YEARS AND OLDER

The recommended dose is one 120-milligram capsule 3 times daily with each main meal containing fat.

Overdosage

The results of a massive overdose of Xenical are unknown, although the drug seems relatively harmless. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention.