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oxymetholone

30/06/10

Generic Name: oxymetholone (OKS ee METH oh lone)
Brand Names: Anadrol-50

What is oxymetholone?

Oxymetholone is an anabolic steroid, which is a man-made form of a hormone similar to testosterone.

Oxymetholone is used to treat certain types of anemia (lack of red blood cells), including aplastic anemia, myelofibrosis, or hypoplastic anemia caused by chemotherapy.

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

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

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to oxymetholone, or if you have prostate cancer, male breast cancer, female breast cancer with high levels of calcium in the blood, severe liver or kidney disease, or if you are pregnant.

Before using oxymetholone, tell your doctor if you have liver or kidney disease, heart disease, congestive heart failure, high cholesterol or triglycerides, coronary artery disease, or an enlarged prostate.

Call your doctor at once if you have a serious side effect such as swelling, rapid weight gain, increased or ongoing erection of the penis, changes in skin color, urination problems, or signs of liver damage (nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes). Women receiving oxymetholone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor as soon as possible if you notice increased acne, changes in menstrual periods, a deepened voice, male pattern baldness or hair growth, an enlarged clitoris, or changes in your sex drive.

To be sure oxymetholone is helping your condition and is not causing harmful effects on your liver, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

It may take up to 6 months of using this medicine before your symptoms improve. Tell your doctor if your symptoms do not improve after 3 months of treatment.

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

You should not use this medication if you are allergic to oxymetholone, or if you have:

prostate cancer;
male breast cancer;
female breast cancer with high levels of calcium in the blood;
severe liver disease;
severe kidney disease; or
if you are pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using oxymetholone, tell your doctor if you have:

liver disease;
kidney disease;
heart disease, congestive heart failure;
high cholesterol or triglycerides;
coronary artery disease (atherosclerosis); or
an enlarged prostate.

FDA pregnancy category X. This medication can cause birth defects. Do not use oxymetholone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication. It is not known whether oxymetholone 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. Children being treated with oxymetholone may need x-ray examinations every 6 months to make sure the medication is not causing harmful effects on bone growth. Oxymetholone will not enhance athletic performance and should not be used for that purpose or shared with another person.

How should I take oxymetholone?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure oxymetholone is helping your condition and is not causing harmful effects on your liver, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using oxymetholone.

It may take up to 6 months of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 months of treatment.

Once your condition is under control, you may be able to stop taking oxymetholone. However, some people must continue to use at least a small amount of the medicine to keep their red blood cells from getting too low. You may need to take oxymetholone for the rest of your life. Follow your doctor’s instructions.

Anemia is often treated with a combination of different drugs, including antibiotics and vitamin or mineral supplements. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Store oxymetholone at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Anabolic steroids are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

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, wait until then to take the medicine and skip the missed dose. 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 received too much of this medicine.

An overdose of oxymetholone is not expected to produce life-threatening symptoms.

What should I avoid while taking oxymetholone?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using oxymetholone.

Oxymetholone 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. Call your doctor at once if you have a serious side effect such as:

swelling, rapid weight gain;
increased or ongoing erection of the penis;
changes in skin color;
urination problems; or
nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).

Women receiving oxymetholone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor as soon as possible if you notice any of these side effects:

acne;
changes in your menstrual periods;
hoarse or deepened voice;
male-pattern hair growth (such as on the chin or chest);
male pattern baldness;
enlarged clitoris; or
increase or decrease in sex drive.

Less serious side effects may include:

breast swelling in men;
feeling restless or excited;
sleep problems (insomnia); or
diarrhea.

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.

Oxymetholone Dosing Information

Usual Adult Dose for Anemia:

1 to 5 mg/kg/day orally. Usual effective dose is 1 to 2 mg/kg/day. Response is often not immediate. Give for a minimum trial of 3 to 6 months.

What other drugs will affect oxymetholone?

The following drugs can interact with oxymetholone. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin); or
insulin or diabetes medication you take by mouth.

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

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.

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oxymetazoline (Ophthalmic route)

30/06/10

ox-i-me-TAZ-oh-leen

Commonly used brand name(s):

In the U.S.

Ocuclear
Visine L.R.

Available Dosage Forms:

Solution

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For oxymetazoline

Oxymetazoline is used to relieve redness due to minor eye irritations, such as those caused by colds, dust, wind, smog, pollen, swimming, or wearing contact lenses.

Oxymetazoline is available without a prescription.

Before Using oxymetazoline

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 oxymetazoline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxymetazoline 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

Check with your doctor before using oxymetazoline eye drops in children up to 6 years of age. Eye redness in children can occur with illnesses, such as allergies, fevers, colds, and measles, that may require medical attention.

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 oxymetazoline in the elderly with use in other age groups.

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of oxymetazoline

Do not use oxymetazoline ophthalmic solution if it becomes cloudy or changes color.

To use:

First, wash your hands. With the middle finger, apply pressure to the inside corner of the eye (and continue to apply pressure for 1 or 2 minutes after the medicine has been placed in the eye). Tilt the head back and with the index finger of the same hand, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use oxymetazoline only as directed. Do not use more of it, do not use it more often, and do not use it for more than 72 hours, unless otherwise directed by your doctor. To do so may make your eye irritation worse and may also increase the chance of side effects.

Dosing

The dose of oxymetazoline 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 oxymetazoline. 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 ophthalmic solution (eye drops) dosage form:
- For eye redness:
  - Adults and children 6 years of age and older—Use 1 drop in the eye every six hours.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

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.

Precautions While Using oxymetazoline

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

oxymetazoline 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.

When oxymetazoline is used for short periods of time at low doses, side effects usually are rare.

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

With overuse or long-term use

Increase in irritation or redness of eyes

Symptoms of too much medicine being absorbed into the body

Fast, irregular, or pounding heartbeat
headache or lightheadedness
nervousness
trembling
trouble in sleeping

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.

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oxymetazoline (Nasal route)

30/06/10

ox-i-me-TAZ-oh-leen

Commonly used brand name(s):

In the U.S.

4-Way Long Lasting
Afrin
Duramist Plus
Duration
Genasal
Mucinex Full Force
Mucinex Moisture Smart
Nasacon
Nasin
Neo-Synephrine 12 Hour
Nostrilla
NRS-Nasal Relief
Sinarest Nasal
Vicks Sinex 12 Hour

Available Dosage Forms:

Solution
Spray

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For oxymetazoline

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

oxymetazoline may also be used for other conditions as determined by your doctor.

oxymetazoline is available without a prescription.

Before Using oxymetazoline

Allergies

Pediatric

Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Geriatric

Many medicines have not been tested 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 about the use of oxymetazoline in the elderly.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of oxymetazoline

To use the nose drops:

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

Use oxymetazoline only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing

For nasal dosage form (nose drops or spray):
- For nasal congestion or stuffiness:
  - Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of oxymetazoline, 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.

oxymetazoline 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 as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Blurred vision
fast, irregular, or pounding heartbeat
headache, dizziness, drowsiness, or lightheadedness
high blood pressure
nervousness
trembling
trouble in sleeping
weakness.

Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of oxymetazoline may be absorbed into the body.

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:

Burning, dryness, or stinging inside of nose
increase in nasal discharge
sneezing

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.

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Oxymetazoline Solution

30/06/10

Generic Name: Oxymetazoline (OX-ee-MET-azz-oh-leen)
Brand Name: Examples include Afrin and Nostrilla 12 Hour

Oxymetazoline Solution is used for:

Relieving nasal congestion due to the common cold, hay fever, other upper respiratory tract allergies, or sinus infection. It may also be used to treat other conditions as determined by your doctor.

Oxymetazoline Solution is a decongestant. It works by shrinking swollen and congested nasal tissues (mucous membranes) by constricting blood vessels. This results in relief of congestion (stuffy feeling), improved drainage of mucus, and improved breathing through the nose. Local application (eg, nose drops and sprays) causes more intense and rapid vasoconstriction than oral medicines (eg, tablets, syrups).

Do NOT use Oxymetazoline Solution if:

you are allergic to any ingredient in Oxymetazoline Solution
you are also taking furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

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

Before using Oxymetazoline Solution:

Some medical conditions may interact with Oxymetazoline Solution. 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 high blood pressure, enlarged prostate, diabetes, overactive thyroid, or heart disease

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

Tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Oxymetazoline Solution may be decreased
Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects, such as headache, fever, or high blood pressure, may be increased
Bromocriptine or cocaine because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxymetazoline Solution 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 Oxymetazoline Solution:

Use Oxymetazoline Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use nose drops, gently blow your nose. Lie down and tilt your head back. Breathe through your mouth. Insert the dropper tip in the nose no more than 1/3 inch. Try not to touch the dropper tip to the inside of your nose. Place the correct number of drops in your nose. Continue to lie down with your head tilted back for 2 minutes.
To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
If you miss a dose of Oxymetazoline Solution and are using it regularly, use it as soon as possible. If it is much more than 1 hour since your missed dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxymetazoline Solution.

Important safety information:

Do not use Oxymetazoline Solution for more than 3 days unless advised to do so by your health care provider. Frequent or long-term use of Oxymetazoline Solution may cause nasal congestion to recur or worsen.
Do not share Oxymetazoline Solution with anyone else; this may cause the infection to spread.
Diabetes patients – Oxymetazoline Solution may affect your blood sugar level. Your doctor may need to change the amount of diabetes medicine you are taking.
Oxymetazoline Solution is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Oxymetazoline Solution during pregnancy. It is unknown if Oxymetazoline Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Oxymetazoline Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Oxymetazoline Solution:

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:

Increase in nasal discharge; sneezing; stinging; temporary burning.

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).

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.

Proper storage of Oxymetazoline Solution:

Store Oxymetazoline Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oxymetazoline Solution out of the reach of children and away from pets.

General information:

If you have any questions about Oxymetazoline Solution, please talk with your doctor, pharmacist, or other health care provider.
Oxymetazoline Solution 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 Oxymetazoline Solution. 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

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Oxymetazoline Drops

30/06/10

Generic Name: Oxymetazoline (OX-ee-MET-azz-oh-leen)
Brand Name: Examples include OcuClear and Visine LR

Oxymetazoline Drops are used for:

Relieving redness in the eye caused by minor irritation.

Oxymetazoline Drops are a decongestant used in the eye. It works by narrowing the blood vessels in the eye, which helps you by relieving irritation.

Do NOT use Oxymetazoline Drops if:

you are allergic to any ingredient in Oxymetazoline Drops
you are also taking furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

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

Before using Oxymetazoline Drops:

Some medical conditions may interact with Oxymetazoline Drops. 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 glaucoma, high blood pressure, diabetes, or heart or thyroid problems, or are taking medicine for high blood pressure

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

Tricyclic antidepressants (eg, amitriptyline) because the effectiveness of Oxymetazoline Drops may be decreased
Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects, such as headache, fever, and high blood pressure, may be increased
Bromocriptine or cocaine because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxymetazoline Drops 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 Oxymetazoline Drops:

Use Oxymetazoline Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

If you wear contact lenses, remove them before using Oxymetazoline Drops.
To use Oxymetazoline Drops, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye and continue to apply pressure for 1 to 2 minutes after using the medicine. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from entering your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
If you miss a dose of Oxymetazoline Drops and are using it regularly, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxymetazoline Drops.

Important safety information:

Do not exceed the recommended dose or use Oxymetazoline Drops for longer than 3 days without checking with your doctor. If your symptoms do not improve within 3 days or if they become worse, check with your doctor.
Oxymetazoline Drops are not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY AND BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Oxymetazoline Drops during pregnancy. It is unknown if Oxymetazoline Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Oxymetazoline Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Oxymetazoline Drops:

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:

Short period of stinging when the medicine is dropped into the eye.

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); changes in vision; eye pain.

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. Oxymetazoline Drops may be harmful if swallowed.

Proper storage of Oxymetazoline Drops:

Store Oxymetazoline Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat and light. Keep Oxymetazoline Drops out of the reach of children and away from pets.

General information:

If you have any questions about Oxymetazoline Drops, please talk with your doctor, pharmacist, or other health care provider.
Oxymetazoline Drops are 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 Oxymetazoline Drops. 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,O

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Oxyfast Concentrate

30/06/10

Generic Name: Oxycodone (ox-ee-KOE-dohn)
Brand Name: Examples include Oxyfast and Roxicodone

Oxyfast Concentrate is used for:

Treating moderate to severe pain. It may be used before surgery to sedate the patient and reduce fear. It may also be used for other conditions as determined by your doctor.

Oxyfast Concentrate is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use Oxyfast Concentrate if:

you are allergic to any ingredient in Oxyfast Concentrate or any other oxycodone- or morphine-related medicine (eg, codeine)
you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
you have severe bowel motility problems (eg, paralytic ileus) or severe diarrhea associated with antibiotic use (pseudomembranous colitis)
you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack

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

Before using Oxyfast Concentrate:

Some medical conditions may interact with Oxyfast Concentrate. 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 history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors), or seizures
if you have a history of heart problems, low blood pressure, liver or kidney problems, an underactive thyroid, adrenal gland problems (eg, Addison disease), stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria
if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

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

Cimetidine, furazolidone, MAO inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased
Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of Oxyfast Concentrate may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxyfast Concentrate 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 Oxyfast Concentrate:

Use Oxyfast Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Oxyfast Concentrate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Use the dropper that comes with Oxyfast Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Oxyfast Concentrate and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxyfast Concentrate.

Important safety information:

Oxyfast Concentrate may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Oxyfast Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Oxyfast Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Oxyfast Concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Tell your doctor or dentist that you take Oxyfast Concentrate before you receive any medical or dental care, emergency care, or surgery.
Use Oxyfast Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.
Oxyfast Concentrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxyfast Concentrate while you are pregnant. Oxyfast Concentrate is found in breast milk. Do not breast-feed while taking Oxyfast Concentrate.

When used for long periods of time or at high doses, Oxyfast Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Oxyfast Concentrate stops working well. Do not take more than prescribed.

Some people who use Oxyfast Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Oxyfast Concentrate, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Oxyfast Concentrate:

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; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; 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 cold and clammy skin; confusion; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; slow breathing; slow heartbeat.

Proper storage of Oxyfast Concentrate:

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

General information:

If you have any questions about Oxyfast Concentrate, please talk with your doctor, pharmacist, or other health care provider.
Oxyfast Concentrate 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 Oxyfast Concentrate. 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,O

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Oxyfrin

30/06/10

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)
Brand Names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day

What is Oxyfrin (oxymetazoline nasal)?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

Oxymetazoline nasal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Oxyfrin (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use Oxyfrin (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have

high blood pressure;
any type of heart disease, hardening of the arteries, or irregular heart beats;
thyroid problems;
diabetes;
glaucoma or increased pressure in the eye;
an enlarged prostate or difficulty urinating; or
liver or kidney disease.

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use Oxyfrin (oxymetazoline nasal)?

Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking Oxyfrin (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

Oxyfrin (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
seizures;
unusual behavior or hallucinations; or
an irregular or fast heartbeat.

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

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 Oxyfrin (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

furazolidone (Furoxone);
guanethidine (Ismelin);
indomethacin (Indocin);
methyldopa (Aldomet);
bromocriptine (Parlodel);
caffeine in cola, tea, coffee, chocolate and other products;
theophylline (Theo-Dur, Theochron, Theolair, others);
tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);
other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);
phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and
other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. 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 oxymetazoline nasal 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,O

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OxyIR

30/06/10

Generic Name: Oxycodone (ox-ee-KOE-dohn)
Brand Name: Examples include OxyIR and Roxicodone

OxyIR is used for:

Treating moderate to severe pain. It may be used before surgery to sedate the patient and reduce fear. It may also be used for other conditions as determined by your doctor.

OxyIR is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use OxyIR if:

you are allergic to any ingredient in OxyIR or any other oxycodone- or morphine-related medicine (eg, codeine)
you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
you have severe bowel motility problems (eg, paralytic ileus) or severe diarrhea associated with antibiotic use (pseudomembranous colitis)
you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack

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

Before using OxyIR:

Some medical conditions may interact with OxyIR. 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 history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors), or seizures
if you have a history of heart problems, low blood pressure, liver or kidney problems, an underactive thyroid, adrenal gland problems (eg, Addison disease), stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria
if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

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

Cimetidine, furazolidone, MAO inhibitors (eg, phenelzine ), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased
Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of OxyIR may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if OxyIR 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 OxyIR:

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

Take OxyIR by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
If you miss a dose of OxyIR and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use OxyIR.

Important safety information:

OxyIR may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use OxyIR with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using OxyIR; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
OxyIR may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Tell your doctor or dentist that you take OxyIR before you receive any medical or dental care, emergency care, or surgery.
Use OxyIR with caution in the ELDERLY; they may be more sensitive to its effects.
OxyIR should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using OxyIR while you are pregnant. OxyIR is found in breast milk. Do not breast-feed while taking OxyIR.

When used for long periods of time or at high doses, OxyIR may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if OxyIR stops working well. Do not take more than prescribed.

Some people who use OxyIR for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking OxyIR, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of OxyIR:

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; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; vision changes.

If OVERDOSE is suspected:

Proper storage of OxyIR:

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

General information:

If you have any questions about OxyIR, please talk with your doctor, pharmacist, or other health care provider.
OxyIR 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 OxyIR. 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,O

Comments (0)

Oxymeta-12

30/06/10

What is Oxymeta-12 (oxymetazoline nasal)?

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

Oxymetazoline nasal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Oxymeta-12 (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use Oxymeta-12 (oxymetazoline nasal)?

Before taking this medication, tell your doctor if you have

high blood pressure;
any type of heart disease, hardening of the arteries, or irregular heart beats;
thyroid problems;
diabetes;
glaucoma or increased pressure in the eye;
an enlarged prostate or difficulty urinating; or
liver or kidney disease.

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

How should I use Oxymeta-12 (oxymetazoline nasal)?

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking Oxymeta-12 (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

Oxymeta-12 (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
seizures;
unusual behavior or hallucinations; or
an irregular or fast heartbeat.

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

What other drugs will affect Oxymeta-12 (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

furazolidone (Furoxone);
guanethidine (Ismelin);
indomethacin (Indocin);
methyldopa (Aldomet);
bromocriptine (Parlodel);
caffeine in cola, tea, coffee, chocolate and other products;
theophylline (Theo-Dur, Theochron, Theolair, others);
tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);
other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);
phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and
other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. 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 oxymetazoline nasal 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,O

Comments (0)

Oxycontin CR

30/06/10

Generic Name: oxycodone (Oral route)

ox-i-KOE-done

Oral routeTablet, Extended Release

Oxycodone hydrochloride is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Oxycodone hydrochloride can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone hydrochloride in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OxyContin(R) tablets (oxycodone hydrochloride controlled-release tablets) are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Oxycodone hydrochloride controlled-release tablets are not intended for use on an as-needed basis.

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Oxycodone hydrochloride controlled-release 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction.

Oxycodone hydrochloride controlled-release tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved oxycodone hydrochloride controlled-release tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

The concomitant use of oxycodone hydrochloride controlled-release tablets with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving oxycodone hydrochloride controlled-release tablets and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted .

Oxycodone hydrochloride is an opioid agonist and a Schedule II controlled substance with an abuse potential similar to morphine. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Oxycodone hydrochloride controlled-release tablets are indicated for continuous, around the clock analgesia for an extended period of time; not for use on an as needed basis. The 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg, are only for use in opioid-tolerant patients as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Oxycodone hydrochloride controlled-release tablets must be swallowed whole to avoid a rapid release of the drug which can be potentially fatal. Concomitant use with CYP3A4 inhibitors may result in an increase in oxycodone plasma concentrations and may cause potentially fatal respiratory depression .

Commonly used brand name(s):

In the U.S.

Dazidox
Eth-Oxydose
Oxycontin
Oxycontin CR
Oxydose
Oxyfast
Oxy IR
Roxicodone
Roxicodone Intensol

Available Dosage Forms:

Tablet, Extended Release
Tablet
Capsule
Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Oxycontin CR

Oxycodone is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor’s prescription.

Before Using Oxycontin CR

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

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

Naltrexone

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.

Acetophenazine
Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aprobarbital
Brofaromine
Bromazepam
Brotizolam
Buprenorphine
Buspirone
Butabarbital
Butalbital
Butorphanol
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clorgyline
Codeine
Dantrolene
Desflurane
Dexmedetomidine
Dezocine
Diazepam
Diphenhydramine
Doxylamine
Enflurane
Escitalopram
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Fentanyl
Flumazenil
Flunitrazepam
Fluphenazine
Flurazepam
Fluvoxamine
Fospropofol
Furazolidone
Halazepam
Halothane
Hydrocodone
Hydromorphone
Hydroxyzine
Iproniazid
Isocarboxazid
Isoflurane
Ketamine
Ketazolam
Lazabemide
Levorphanol
Linezolid
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Mesoridazine
Metaxalone
Methdilazine
Methocarbamol
Methohexital
Midazolam
Moclobemide
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nialamide
Nitrazepam
Nitrous Oxide
Nordazepam
Opium
Oxazepam
Oxycodone
Oxymorphone
Pargyline
Pentazocine
Pentobarbital
Perphenazine
Phenelzine
Phenobarbital
Prazepam
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propiomazine
Propofol
Propoxyphene
Quazepam
Ramelteon
Rasagiline
Remifentanil
Secobarbital
Selegiline
Sertraline
Sevoflurane
Sodium Oxybate
Sufentanil
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thioridazine
Toloxatone
Tranylcypromine
Triazolam
Trifluoperazine
Triflupromazine
Trimeprazine
Zaleplon
Zolpidem

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.

Rifampin
Voriconazole

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of oxycodone

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Oxycontin CR. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Oxycodone extended-release tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release tablets whole on an empty stomach. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Oxymorphone extended-release tablets work differently from the regular oxymorphone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

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.

For oral dosage form (controlled-release tablets):
- For moderate to severe pain:
  - Patients switching from regular oxycodone forms:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from other narcotic medicines:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
For oral dosage forms (liquid concentrate, solution, or tablets):
- For moderate to severe pain:
  - Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

Oxycodone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused extended-release tablets down the toilet.

Precautions While Using Oxycontin CR

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or 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 the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. 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 dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor 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.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

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.

Oxycontin CR 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:

Less common

Chills
cold sweats
confusion
difficult or labored breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever
shortness of breath
tightness in the chest
twitching
wheezing

Rare

Abdominal or stomach pain
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine
burning while urinating burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
convulsions
cough
decrease in the frequency of urination
decrease in urine volume
decreased urine output
difficult or painful urination
difficulty in passing urine (dribbling)
difficulty with swallowing
dizziness
dry mouth
fainting
fast or irregular heartbeat
fast, irregular, pounding, or racing heartbeat or pulse
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
frequent urination
headache
hives
increase in heart rate
increased thirst
increased volume of pale, dilute urine
itching
lightheadedness
muscle pain or cramps
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid breathing
rapid weight gain
severe constipation
severe vomiting
shakiness in the legs, arms, hands, or feet
skin rash
sunken eyes
sweating
swelling or puffiness of the face
swollen, painful, or tender lymph glands in the neck, armpit, or groin
thirst
tingling of the hands or feet
trembling or shaking of the hands or feet
unusual tiredness or weakness
unusual weight gain or loss
wrinkled skin

Incidence not known

Blurred vision
cold, clammy skin
fast, weak pulse
irregular, fast, slow, or shallow breathing
low blood pressure or pulse
pale or blue lips, fingernails, or skin
unconsciousness
very slow breathing
very slow heartbeat

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

Symptoms of overdose

Change in consciousness
chest pain or discomfort
constricted, pinpoint, or small pupils (black part of the eye)
decreased awareness or responsiveness
extreme drowsiness
loss of consciousness
no muscle tone or movement
severe sleepiness
slow or irregular heartbeat

More common

Difficulty having a bowel movement (stool)
drowsiness
headache
lack or loss of strength
relaxed and calm feeling
sleepiness or unusual drowsiness

Less common

Abnormal dreams
acid or sour stomach
anxiety
belching
burning feeling in the chest or stomach
diarrhea
false or unusual sense of well-being
heartburn
hiccups
indigestion
loss of appetite
nervousness
sleeplessness
stomach discomfort, upset, or pain
tenderness in the stomach area
trouble sleeping
unable to sleep
weight loss

Rare

Absent, missed, or irregular menstrual periods
bad, unusual or unpleasant (after) taste
bloated, full feeling
body aches or pain
change in taste
change in walking and balance
changes in vision
clumsiness or unsteadiness
congestion
continuing ringing or buzzing or other unexplained noise in the ears
cracks in the skin
crying
decreased interest in sexual intercourse
depersonalization
depression
difficulty with speaking
dry skin
dryness or soreness of the throat
dysphoria
excess air or gas in the stomach or intestines
excessive muscle tone
feeling of constant movement of self or surroundings
feeling of unreality
general feeling of discomfort or illness
headache, severe and throbbing
hearing loss
hives or welts
hoarseness
hyperventilation
inability to have or keep an erection
increase in body movements
increased appetite
increased cough
irritability
loss in sexual ability, desire, drive, or performance
loss of appetite
loss of heat from the body
loss of memory
loss of strength or energy
mental depression
muscle pain or weakness
muscle stiffness
muscle tension or tightness
neck pain
paranoia
passing of gas
problems with memory
quick to react or overreact emotionally
rapidly changing moods
red, swollen skin
restlessness
runny nose
scaly skin
sensation of spinning
sense of detachment from self or body
severe sleepiness
stomach pain, fullness, or discomfort
stopping of menstrual bleeding
swelling or inflammation of the mouth
tender, swollen glands in the neck
unusual weak feeling
voice changes

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.

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