Generic Name: Oxiconazole (ox-ee-KON-uh-zole)
Brand Name: Oxistat

Oxiconazole Cream is used for:

Treating fungal infections, such as athlete’s foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.

Oxiconazole Cream is an antifungal. It works by killing or preventing the growth of the fungus.

Do NOT use Oxiconazole Cream if:

• you are allergic to any ingredient in Oxiconazole Cream
• you are taking astemizole or terfenadine

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

Before using Oxiconazole Cream:

Some medical conditions may interact with Oxiconazole Cream. 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

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

• Anticoagulants (eg, warfarin), H₁ antagonists (eg, astemizole, terfenadine), or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased by Oxiconazole Cream

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

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

• Oxiconazole Cream is for external use only. Avoid contact with the eyes, nose, mouth, genital area, and other mucous membranes.
• Clean the affected area with soap and water and dry thoroughly.
• Apply enough medicine to cover the affected area. Rub in gently.
• Do not cover area with bandages or other occlusive dressings unless directed otherwise by your doctor.
• Wash your hands immediately after using Oxiconazole Cream, unless your hands are a part of the treated area.
• To clear up your infection completely, use Oxiconazole Cream for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Oxiconazole Cream 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 Oxiconazole Cream.

Important safety information:

• Be sure to use Oxiconazole Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• If your symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxiconazole Cream while you are pregnant. Oxiconazole Cream is found in breast milk. Do not breast-feed while taking Oxiconazole Cream.

Possible side effects of Oxiconazole Cream:

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:

Mild stinging.

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); nodules; reddening, blistering, peeling, itching, or burning of skin; scaling; skin cracking; swelling of the hair follicles.

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. Oxiconazole Cream may be harmful if swallowed.

Proper storage of Oxiconazole Cream:

Store Oxiconazole Cream between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep Oxiconazole Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Oxiconazole Cream, please talk with your doctor, pharmacist, or other health care provider.
• Oxiconazole Cream 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 Oxiconazole Cream. 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.

Generic Name: Oxiconazole (ox-ee-KON-uh-zole)
Brand Name: Oxistat

Oxiconazole Lotion is used for:

Treating fungal infections, such as athlete’s foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.

Oxiconazole Lotion is an antifungal. It works by different mechanisms to treat a wide variety of fungi.

Do NOT use Oxiconazole Lotion if:

• you are allergic to any ingredient in Oxiconazole Lotion
• you are taking astemizole or terfenadine

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

Before using Oxiconazole Lotion:

Some medical conditions may interact with Oxiconazole Lotion. 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

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

• Anticoagulants (eg, warfarin), H₁ antagonists (eg, diphenhydramine), astemizole, terfenadine, or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased by Oxiconazole Lotion

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

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

• Oxiconazole Lotion is for external use only. Avoid contact with the eyes, nose, mouth, genital area, and other mucous membranes.
• Shake well before each use.
• Clean the affected area with soap and water and dry thoroughly.
• Apply enough medicine to cover the affected area. Rub in gently.
• Do not cover area with bandages or other occlusive dressings unless directed otherwise by your doctor.
• Wash your hands immediately after using Oxiconazole Lotion, unless your hands are a part of the treated area.
• To clear up your infection completely, use Oxiconazole Lotion for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Oxiconazole Lotion 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 Oxiconazole Lotion.

Important safety information:

• Be sure to use Oxiconazole Lotion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• If your symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxiconazole Lotion while you are pregnant. Oxiconazole Lotion is found in breast milk. Do not breast-feed while taking Oxiconazole Lotion.

Possible side effects of Oxiconazole Lotion:

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:

Mild stinging.

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); nodules; reddening, blistering, peeling, itching, or burning of skin; scaling; skin cracking; swelling of the hair follicles.

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. Oxiconazole Lotion may be harmful if swallowed.

Proper storage of Oxiconazole Lotion:

Store Oxiconazole Lotion between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep Oxiconazole Lotion out of the reach of children and away from pets.

General information:

• If you have any questions about Oxiconazole Lotion, please talk with your doctor, pharmacist, or other health care provider.
• Oxiconazole Lotion 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 Oxiconazole Lotion. 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.

Brand names: Oxistat

Why is Oxiconazole nitrate prescribed?

Oxistat is used to treat fungal skin diseases commonly called ringworm (tinea). Oxistat is prescribed for athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm of the entire body (tinea corporis), and tinea versicolor, which appears as patches on the skin. It is available as a cream or lotion.

Most important fact about Oxiconazole nitrate

Oxistat should not be used in, on, or near the eyes, or applied to the vagina.

How should you take Oxiconazole nitrate?

Use Oxistat exactly as prescribed.

Wash and dry the area to be treated before applying Oxistat and then apply the cream or lotion so that it covers the entire affected area and the area right around it.

Be careful when applying to raw, blistered, or oozing skin.

• If you miss a dose…
  Apply the cream or lotion when you remember, then return to your regular schedule.

• Storage instructions…
  Store Oxistat at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, notify your doctor as soon as possible. Only your doctor can determine whether it is safe for you to continue using Oxistat.

• Side effects may include:
  Allergic skin inflammation, burning, cracks in the skin, eczema, irritation, itching, pain, rash, scaling, skin redness, skin softening, small, firm, raised skin eruptions similar to those of chickenpox, stinging, tingling

Why should Oxiconazole nitrate not be prescribed?

Do not use Oxistat if you have ever had an allergic reaction or are sensitive to oxiconazole or any other ingredients in the cream.

Special warnings about Oxiconazole nitrate

If you develop an irritation or sensitivity to the medication, notify your doctor.

Possible food and drug interactions when taking Oxiconazole nitrate

No interactions have been reported.

Special information if you are pregnant or breastfeeding

Oxistat has not been proved safe during pregnancy. If you are pregnant or plan to become pregnant, inform your doctor immediately.

Oxistat appears in breast milk and could affect a nursing infant. If Oxistat is essential to your health, your doctor may advise you to stop breastfeeding until your treatment is finished.

Recommended dosage for Oxiconazole nitrate

ADULTS AND CHILDREN

For athlete’s foot, jock itch, or ringworm of the body, use Oxistat cream or lotion once or twice a day. Athlete’s foot is treated for 1 month. Jock itch and ringworm of the body are treated for 2 weeks.

For tinea versicolor, apply Oxistat cream once a day for 2 weeks.

Overdosage

Overdose of Oxistat has not been reported. However, if you suspect an overdose, seek medical attention immediately.

Generic Name: oxcarbazepine (ox kar BAY zeh peen)
Brand Names: Trileptal

What is oxcarbazepine?

Oxcarbazepine is in a group of drugs called anticonvulsants, or antiepileptic drugs. It works by decreasing nerve impulses that cause seizures.

Oxcarbazepine is used to treat partial seizures in adults and children who are at least 2 years old.

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

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

Do not take this medication if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol).

Before taking oxcarbazepine, tell your doctor if you have liver or kidney disease.

Do not use this medication without your doctor’s consent if you are pregnant. It could cause harm to the unborn baby. Oxcarbazepine should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking oxcarbazepine. Tell your doctor if you become pregnant during treatment.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea with vomiting, weakness, headache, confusion, mood changes, and/or increased or more severe seizures.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

There are many other medicines that can interact with oxcarbazepine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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

Do not take this medication if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol).

Before taking oxcarbazepine, tell your doctor if you have liver or kidney disease. If you have any of these conditions you may not be able to use oxcarbazepine, or you may require a dose adjustment or special tests during treatment.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Oxcarbazepine should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking oxcarbazepine. Tell your doctor if you become pregnant during treatment. Oxcarbazepine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 2 years old.

How should I take oxcarbazepine?

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

Take oxcarbazepine with a full glass of water. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, use the oral dosing syringe provided with this medicine. If you did not receive an oral syringe with your medication, ask your pharmacist for one.

Give the oral liquid directly from the oral syringe, or mix the medicine with a small glass of water. After using the syringe, rinse it with water and allow it to air dry.

Do not stop taking the medication even if you feel better. It is important to take oxcarbazepine regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Carry an ID card or wear a medical alert bracelet stating that you are taking oxcarbazepine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a seizure disorder.

Seizures are often treated with a combination of different drugs. 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 oxcarbazepine at room temperature away from moisture and heat.

See also: Oxcarbazepine 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.

Symptoms of an oxcarbazepine overdose are unknown.

What should I avoid while taking oxcarbazepine?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Oxcarbazepine 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. Do not drink alcohol while taking oxcarbazepine. Alcohol may increase drowsiness caused by oxcarbazepine. It may also increase the risk of seizures.

Oxcarbazepine 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.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea, vomiting, weakness, thirst, loss of appetite, headache, confusion, hallucinations, muscle pain or weakness, and/or increased or more severe seizures.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• sore throat, and headache with a severe blistering, peeling, and red skin rash;

• jaundice (yellowing of the skin or eyes);

• fever, swollen glands, flu-like symptoms;

• easy bruising or bleeding, unusual weakness;

• urinating less than usual or not at all; or

• increased seizures.

Less serious side effects may include:

• mild nausea, vomiting, stomach pain, diarrhea;

• problems with speech, balance, or coordination;

• blurred vision;

• mental slowness, trouble concentrating;

• tremors or shaking;

• dizziness, drowsiness; or

• skin rash.

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.

Oxcarbazepine Dosing Information

Usual Adult Dose for Seizures:

For use as adjunctive treatment or monotherapy in the treatment of partial seizures:

Adjunctive Therapy:
Initial Dose: 600 mg/day, (given as 300 mg twice a day). If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day have shown somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant antiepileptic drugs be monitored during the period of oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day.

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at 600 mg/day (given as 300 mg twice a day) while simultaneously reducing the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. Patients should be observed closely during this transition phase.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 600 mg/day (given as 300 mg twice a day); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine.

Usual Pediatric Dose for Seizures:

For use as adjunctive treatment for partial seizures in children ages 2 to 16:

Initial Dose: 8-10 mg/kg generally not to exceed 600 mg/day, (given as 300 mg twice a day). The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20-29 kg: 900 mg/day

29.1-39 kg: 1200 mg/day

>39 kg: 1800 mg/day

2 to<4 years: Treatment should also be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice daily regimen.

For patients under 20 kg: A starting dose of 16 to 20 mg/kg may be considered. The
maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice daily regimen.

In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to
reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

When normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.

For use as monotherapy for partial seizures in patients ages 4 to 16:

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 10 mg/kg/day given in a twice daily regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
while oxcarbazepine may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine is shown below.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 10 mg/kg/day given in a twice daily regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown below.

Range of Maintenance Doses of oxcarbazepine for Children by Weight During Monotherapy:
If the patient’s weight is 20 kg, then dose from 600 to 900 mg/day.
If the patient’s weight is 25 kg, then dose from 900 to 1200 mg/day.
If the patient’s weight is 30 kg, then dose from 900 to 1200 mg/day.
If the patient’s weight is 35 kg, then dose from 900 to 1500 mg/day.
If the patient’s weight is 40 kg, then dose from 900 to 1500 mg/day.
If the patient’s weight is 45 kg, then dose from 1200 to 1500 mg/day.
If the patient’s weight is 50 kg, then dose from 1200 to 1800 mg/day.
If the patient’s weight is 55 kg, then dose from 1200 to 1800 mg/day.
If the patient’s weight is 60 kg, then dose from 1200 to 2100 mg/day.
If the patient’s weight is 65 kg, then dose from 1200 to 2100 mg/day.
If the patient’s weight is 70 kg, then dose from 1500 to 2100 mg/day.

What other drugs will affect oxcarbazepine?

Before using oxcarbazepine, tell your doctor about all other seizure medications you are taking, including:

• carbamazepine (Carbatrol, Tegretol);

• phenobarbital (Luminal, Solfoton);

• phenytoin (Dilantin); or

• valproic acid (Depakene).

There are many other medicines that can interact with oxcarbazepine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist has information about oxcarbazepine.

• 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 condition 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: 05/07/2009 3:17:54 PM.

ox-kar-BAZ-e-peen

Commonly used brand name(s):

In the U.S.

• Trileptal

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Anticonvulsant

Chemical Class: Dibenzazepine Carboxamide

Uses For oxcarbazepine

Oxcarbazepine is used in the treatment of epilepsy to control partial seizures. oxcarbazepine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it .

oxcarbazepine is available only with your doctor’s prescription .

Before Using oxcarbazepine

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 oxcarbazepine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxcarbazepine 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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oxcarbazepine in children 2 years of age and older .

Geriatric

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

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 oxcarbazepine 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.

• Selegiline

Using oxcarbazepine 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.

• Tolvaptan

Using oxcarbazepine 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.

• Carbamazepine
• Ethinyl Estradiol
• Etonogestrel
• Felodipine
• Fosphenytoin
• Ginkgo
• Lamotrigine
• Levonorgestrel
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestrel
• Phenobarbital
• Phenytoin
• Simvastatin
• Valproic Acid
• Verapamil

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 oxcarbazepine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hyponatremia (low sodium in the blood) or
• Prior hypersensitivity reaction to carbamazepine—May make these conditions worse .

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of oxcarbazepine

Take oxcarbazepine only as directed by your doctor. Do not take more or less of it, and do not take it more or less often than your doctor ordered .

For patients taking the oral suspension form of oxcarbazepine :

• Shake the bottle well before measuring the dose.
• Use the oral dosing syringe supplied to measure each dose accurately.
• The dose of medicine can be mixed in a small glass of water just before taking it or you may swallow it directly from the syringe.
• After each use, close the bottle and rinse the syringe with warm water and allow it to dry completely before the next use.

Do not stop taking oxcarbazepine without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount of oxcarbazepine you are taking before stopping it completely .

Dosing

The dose of oxcarbazepine 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 oxcarbazepine. 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 suspension and tablets):
  • For epilepsy:
    • Adults and teenagers 17 years of age and older—At first, 300 milligrams (mg) two times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 2400 mg a day.
    • Children 2 to 16 years of age—Dose is based on body weight. The usual dose is 8 to 10 milligrams (mg) per kilogram (kg) (3.7 to 4.5 mg per pound) of body weight per day, divided into two doses. Your doctor may adjust the dose as needed.
    • Children up to 2 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of oxcarbazepine, 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 oxcarbazepine

Your doctor will check your progress at regular visits. This is to make sure the medicine is working for you and to allow the dosage to be changed if needed. If your symptoms do not improve within a few days or if they become worse, check with your doctor .

oxcarbazepine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using oxcarbazepine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your face, eyes, lips, or tongue while you are using oxcarbazepine .

Tell your doctor right away if a skin reaction occurs while you are taking oxcarbazepine. There have been serious skin reactions associated with oxcarbazepine .

If you develop a fever along with a rash or swollen glands, contact your doctor right away .

oxcarbazepine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to oxcarbazepine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor .

Do not take other medicines unless they have been discussed with your doctor. oxcarbazepine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; and other medicines for seizures .

Oral contraceptives (birth control pills) containing estrogen or progestin, contraceptive progestin injections (e.g., Depo-Provera®), and contraceptive implant forms of progestin (e.g., Norplant®) may not work properly if you take them while you are taking oxcarbazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking oxcarbazepine. If you have any questions about this, check with your doctor .

oxcarbazepine 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:

More common

• Change in vision
• change in walking or balance
• clumsiness or unsteadiness
• cough, fever, sneezing, or sore throat
• crying
• dizziness
• double vision
• false sense of well-being
• feeling of constant movement of self or surroundings
• mental depression
• sensation of spinning
• uncontrolled back-and-forth and/or rolling eye movements

Less common

• Agitation
• awkwardness
• bloody or cloudy urine
• blurred vision
• bruising
• confusion
• congestion
• convulsions (seizures)
• decreased urination
• difficulty with focusing eyes
• disorientation
• faintness or light-headedness when getting up from a lying or sitting position suddenly
• fast or irregular heartbeat
• frequent falls
• frequent urge to urinate
• general feeling of illness
• headache
• hoarseness
• increased thirst
• itching of the vagina, with or without white vaginal discharge
• loss of consciousness
• memory loss
• muscle cramps
• pain or burning while urinating
• pain or tenderness around eyes or cheekbones
• poor control in body movements—for example, when reaching or stepping
• problems with coordination
• shaking or trembling of arms, legs, hands, and feet
• shortness of breath
• skin rash
• stuffy or runny nose
• tightness in chest
• trouble with walking
• troubled breathing
• unusual feelings
• unusual tiredness or weakness
• wheezing

Rare

• Anxiety
• bleeding or crusting sores on lips
• burning feeling in chest or stomach
• chest pain
• chills
• decreased response to stimulation
• hives or itching
• irritability
• joint pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle pain or weakness
• nervousness
• purple spots on skin
• rectal bleeding
• redness, blistering, peeling, or loosening of skin
• restlessness
• sores, ulcers, or white spots in mouth or on lips
• stomach upset
• swelling of legs
• swollen glands

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 pain
• burning feeling in chest or stomach
• nausea and vomiting
• runny or stuffy nose
• sleepiness or unusual drowsiness

Less common

• Acid or sour stomach
• acne
• back pain
• belching
• bloody nose
• blurred vision
• change in your sense of taste
• constipation
• diarrhea
• difficulty in speaking
• dryness of mouth
• feeling of warmth and redness of face, neck, arms, and occasionally chest
• heartburn
• increased sweating
• increased urination
• nervousness
• trouble with 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.

Generic Name: Oxcarbazepine (OX-kar-BAZ-e-peen)
Brand Name: Trileptal

Oxcarbazepine Suspension is used for:

Treating certain type of seizures in patients with epilepsy. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Oxcarbazepine Suspension is an anticonvulsant. It works by slowing abnormal nerve impulses in the brain.

Do NOT use Oxcarbazepine Suspension if:

• you are allergic to any ingredient in Oxcarbazepine Suspension

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

Before using Oxcarbazepine Suspension:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to carbamazepine
• if you have kidney or liver problems or low blood sodium levels
• if you have a history of mental or mood problems or suicidal thoughts or actions

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

• Carbamazepine because it may decrease Oxcarbazepine Suspension’s effectiveness
• Hydantoins (eg, phenytoin) or phenobarbital because they may decrease Oxcarbazepine Suspension’s effectiveness. The risk of their side effects may also be increased by Oxcarbazepine Suspension
• Cyclosporine, felodipine, hormonal contraceptives (birth control pills), or tramadol because their effectiveness may be decreased by Oxcarbazepine Suspension
• Tricyclic antidepressants (eg, amitriptyline) because they may decrease the effectiveness of Oxcarbazepine Suspension and the side effects of both medicines may be increased

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

How to use Oxcarbazepine Suspension:

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

• Take Oxcarbazepine Suspension by mouth with or without food.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Oxcarbazepine Suspension may be mixed in a small glass of water just before taking/giving it or it may be swallowed directly from the syringe.
• After each use, close the bottle and rinse the syringe with warm water. Allow it to dry thoroughly.
• Taking Oxcarbazepine Suspension at the same times each day will help you remember to take it.
• Continue to take Oxcarbazepine Suspension even if you feel well. Do not miss any doses. Oxcarbazepine Suspension works best when there is a constant level of it in your body.
• If Oxcarbazepine Suspension is stopped, it should be done gradually. The risk of seizures may be increased if Oxcarbazepine Suspension is suddenly stopped.
• If you miss a dose of Oxcarbazepine Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Oxcarbazepine Suspension may cause dizziness, drowsiness, changes in vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Oxcarbazepine Suspension 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 Oxcarbazepine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• If you have a history of seizures, you may suddenly lose consciousness while you are taking Oxcarbazepine Suspension. Avoid activities where loss of consciousness could be dangerous to you or others (eg, driving, swimming, climbing, operating heavy machinery).
• Carry identification (eg, MedicAlert) if Oxcarbazepine Suspension is used for seizures. Carry an ID card at all times that says you take Oxcarbazepine Suspension.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Oxcarbazepine Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Oxcarbazepine Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Oxcarbazepine Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Do not suddenly stop taking Oxcarbazepine Suspension. Oxcarbazepine Suspension must be gradually decreased when discontinued. Talk to your doctor about the proper way to stop Oxcarbazepine Suspension.
• Notify your doctor if seizure control worsens.
• Lab tests, including sodium blood levels, may be performed while you use Oxcarbazepine Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Oxcarbazepine Suspension should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Oxcarbazepine Suspension may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxcarbazepine Suspension while you are pregnant. Oxcarbazepine Suspension is found in breast milk. Do not breast-feed while taking Oxcarbazepine Suspension.

Possible side effects of Oxcarbazepine Suspension:

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

Acne; constipation; dizziness; drowsiness; dry mouth; headache; indigestion; nausea; stomach pain; tiredness; tremor; trouble sleeping; unusual walk; vomiting.

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; unusual hoarseness); blood in stool; chest pain; dark urine; decreased urination; difficulty speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fever, chills, or sore throat; joint pain; loss of coordination; low sodium levels (nausea; general body discomfort; headache; lack of energy; confusion; decreased consciousness; increased frequency or severity of seizures); mental/mood changes; nosebleed; red, swollen, blistered, or peeling skin; seizures; stomach pain; suicidal thoughts or actions; swollen lymph nodes; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

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 Oxcarbazepine Suspension:

Store Oxcarbazepine Suspension in the original container at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Use within 7 weeks of first opening the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oxcarbazepine Suspension out of the reach of children and away from pets.

General information:

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

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

ox-AZ-e-pam

Commonly used brand name(s):

In the U.S.

• Serax

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For oxazepam

Oxazepam is used to relieve symptoms of anxiety, including anxiety caused by depression, and the symptoms of alcohol withdrawal. oxazepam may also be used to treat tension, agitation, and irritability in older patients.

Oxazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

oxazepam is available only with your doctor’s prescription.

Before Using oxazepam

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 oxazepam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxazepam 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 oxazepam in children below 6 years of age. 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 oxazepam in the elderly. However, severe drowsiness, dizziness, lightheadedness, fainting, or unusual behavior are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving oxazepam.

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 oxazepam 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.

• Alfentanil
• Amobarbital
• Anileridine
• Aprobarbital
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Ethchlorvynol
• Fentanyl
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Primidone
• Propoxyphene
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Zolpidem

Using oxazepam 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.

• St John’s Wort
• Theophylline

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.

Using oxazepam with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use oxazepam, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

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

• Alcohol abuse, or history of, or
• Drug abuse or dependence, or history of—Dependence on oxazepam may develop.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Mental illness (e.g., bipolar disorder, schizophrenia)—Should not be used in patients with this condition.

Proper Use of oxazepam

Take oxazepam 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.

Dosing

The dose of oxazepam 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 oxazepam. 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 (capsules):
  • For anxiety:
    • Adults—10 to 30 milligrams (mg) three or four times per day.
    • Older Adults—At first, 10 milligrams (mg) three times per day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For alcohol withdrawal:
    • Adults—15 to 30 milligrams (mg) three or four times per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of oxazepam, 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 oxazepam

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

Using oxazepam while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

oxazepam may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to oxazepam before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

oxazepam will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking oxazepam. Check with your doctor before taking any of the above while you are using oxazepam.

Do not stop taking oxazepam without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, tremors, vomiting, or sweating.

oxazepam is for short-term use only, which is generally considered less than 4 months. If your condition does not improve or if it becomes worse, check with your doctor.

oxazepam 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

• Abdominal or stomach pain
• black, tarry stools
• chest pain
• chills
• clay-colored stools
• cough
• dark urine
• dizziness
• fainting
• fever with or without chills
• headache
• itching
• light-colored stools
• loss of appetite
• nausea and vomiting
• painful or difficult urination
• rash
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swelling
• swollen glands
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Being forgetful
• confusion about identity, place, and time
• cough or hoarseness
• decreased awareness or responsiveness
• false or unusual sense of well-being
• fever and sore throat
• general feeling of tiredness or weakness
• hallucinations
• loss of bladder control
• loss of memory
• lower back or side pain
• nightmares
• pale skin
• problems with memory
• severe sleepiness
• trouble sleeping
• unusual excitement, nervousness, restlessness, or irritability

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

Symptoms of overdose

• Blurred vision
• change in consciousness
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness
• loss of consciousness
• loss of strength or energy
• muscle pain or weakness
• sweating
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weak feeling

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:

Rare

• Decreased interest in sexual intercourse
• feeling of constant movement of self or surroundings
• inability to have or keep an erection
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss in sexual ability, desire, drive, or performance
• rash with flat lesions or small raised lesions on the skin
• sensation of spinning

Incidence not known

• Double vision
• menstrual changes
• seeing double

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: oxazepam (ox A ze pam)
Brand Names: Serax

What is oxazepam?

Oxazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Oxazepam affects chemicals in the brain that may become unbalanced and cause anxiety.

Oxazepam is used to treat anxiety disorders or alcohol withdrawal symptoms.

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

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

Do not use this medication if you are allergic to oxazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or lorazepam (Ativan). This medication can cause birth defects in an unborn baby. Do not use oxazepam if you are pregnant.

Before taking oxazepam, tell your doctor if you have any breathing problems, glaucoma, porphyria, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking oxazepam. This medication can increase the effects of alcohol.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by oxazepam.

Oxazepam may be habit-forming and should be used only by the person it was prescribed for. Oxazepam should never be shared with 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.

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

Do not use this medication if you are allergic to oxazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or lorazepam (Ativan).

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

• glaucoma;

• asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;

• kidney or liver disease;

• a history of depression or suicidal thoughts or behavior; or

• a history of drug or alcohol addiction.

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

Oxazepam can cause birth defects in an unborn baby. Do not use oxazepam without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Oxazepam 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. The sedative effects of oxazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking oxazepam.

How should I take oxazepam?

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.

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

Oxazepam should be used for only a short time. Do not take this medication for longer than 4 months without your doctor’s advice. Oxazepam may be habit-forming and should be used only by the person it was prescribed for. Oxazepam should never be shared with 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. Contact your doctor if this medicine seems to stop working as well in treating your symptoms. Do not stop using oxazepam suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Your symptoms may return when you stop using oxazepam after using it over a long period of time. You may also have seizures or withdrawal symptoms when you stop using oxazepam. Withdrawal symptoms may include tremor, sweating, trouble sleeping, muscle cramps, stomach pain, vomiting, diarrhea, confusion, unusual thoughts or behavior, and seizure (convulsions).

To be sure this medication is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

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

Keep track of how many pills have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Oxazepam 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 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. An overdose of oxazepam can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, weakness or tired feeling, muscle weakness, loss of balance or coordination, feeling light-headed, fainting, or coma.

What should I avoid while taking oxazepam?

Do not drink alcohol while taking oxazepam. This medication can increase the effects of alcohol. Oxazepam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or depression). They can add to sleepiness caused by oxazepam.

Oxazepam 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 any of these serious side effects:

• confusion;

• unusual risk-taking behavior, decreased inhibitions, no fear of danger;

• hyperactivity, agitation, hostility;

• hallucinations;

• feeling lightheaded, fainting;

• jaundice (yellowing of the skin or eyes); or

• problems with urination.

Less serious side effects may include:

• drowsiness, dizziness;

• amnesia or forgetfulness, trouble concentrating;

• slurred speech;

• swelling;

• headache;

• skin rash;

• nausea, vomiting, constipation;

• irregular menstrual periods; or

• loss of interest in sex.

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.

Oxazepam Dosing Information

Usual Adult Dose for Anxiety:

For mild to moderate anxiety: 10 to 15 mg orally 3 to 4 times a day.
For severe anxiety: 15 to 30 mg orally 3 to 4 times a day.

Usual Adult Dose for Alcohol Withdrawal:

15 to 30 mg orally 3 to 4 times a day for alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal.

Usual Geriatric Dose for Anxiety:

Initial dose: 10 mg orally 3 times a day.
If necessary, increase cautiously to 15 mg orally 3 to 4 times a day.

Usual Pediatric Dose for Anxiety:

The safety and efficacy of oxazepam in children < 6 years has not been established. Absolute dosage for children 6 to 12 years has not been established. However, the use of oxazepam in children 6 to 12 years may be appropriate is some situations.

>= 6 years to 12 years: 1 mg/kg/day.

>= 13 years: For mild to moderate anxiety: 10 to 15 mg orally 3 to 4 times a day.
For severe anxiety: 15 to 30 mg orally 3 to 4 times a day.

What other drugs will affect oxazepam?

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

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril);

• narcotic medications such as butorphanol (Stadol), codeine, hydrocodone (Lortab, Vicodin), levorphanol (Levo-Dromoran), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), naloxone (Narcan), oxycodone (OxyContin), propoxyphene (Darvon, Darvocet); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), or trimipramine (Surmontil).

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

• 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: 6.02. Revision Date: 4/12/2009 4:22:27 PM.

ox-a-PROE-zin

Commonly used brand name(s):

In the U.S.

• Daypro

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For oxaprozin

Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. oxaprozin does not cure arthritis and will help you only as long as you continue to take it .

oxaprozin is available only with your doctor’s prescription .

Before Using oxaprozin

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 oxaprozin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxaprozin 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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oxaprozin in children 6 to 16 years of age. Safety and efficacy have not been established in children below 6 years of age .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of oxaprozin in the elderly. However, elderly patients may be more sensitive to the effects of oxaprozin than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving oxaprozin .

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 oxaprozin 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.

• Ketorolac

Using oxaprozin 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.

• Ardeparin
• Beta Glucan
• Certoparin
• Dalteparin
• Danaparoid
• Desirudin
• Enoxaparin
• Ginkgo
• Methotrexate
• Nadroparin
• Parnaparin
• Pemetrexed
• Reviparin
• Tacrolimus
• Tinzaparin

Using oxaprozin 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.

• Acetohexamide
• Alacepril
• Amiloride
• Azosemide
• Bemetizide
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Bumetanide
• Buthiazide
• Candesartan Cilexetil
• Canrenoate
• Captopril
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cilazapril
• Citalopram
• Clopamide
• Clopidogrel
• Clovoxamine
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Delapril
• Desvenlafaxine
• Duloxetine
• Enalaprilat
• Enalapril Maleate
• Eprosartan
• Escitalopram
• Ethacrynic Acid
• Femoxetine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Fosinopril
• Furosemide
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Hydrochlorothiazide
• Hydroflumethiazide
• Imidapril
• Indapamide
• Irbesartan
• Lisinopril
• Losartan
• Methyclothiazide
• Metolazone
• Milnacipran
• Moexipril
• Nefazodone
• Olmesartan Medoxomil
• Paroxetine
• Pentopril
• Perindopril
• Piretanide
• Polythiazide
• Quinapril
• Quinethazone
• Ramipril
• Sertraline
• Spirapril
• Spironolactone
• Tasosartan
• Telmisartan
• Temocapril
• Tolazamide
• Tolbutamide
• Torsemide
• Trandolapril
• Triamterene
• Trichlormethiazide
• Valsartan
• Venlafaxine
• Xipamide
• Zimeldine
• Zofenopril

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 oxaprozin. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Asthma or
• Bleeding problems or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease (e.g., congestive heart failure) or
• High blood pressure or
• Kidney disease or
• Liver disease (e.g., hepatitis) or
• Stomach or intestinal ulcers or bleeding or
• Stroke, history of—Use with caution. oxaprozin may make these conditions worse .

• Aspirin sensitivity, history of—oxaprozin should NOT be used in patients with this condition .

• Dehydration—Should be treated first before starting treatment with oxaprozin .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—oxaprozin should NOT be used to relieve pain right before or after the surgery .

Proper Use of oxaprozin

For safe and effective use of oxaprozin, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of oxaprozin may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, oxaprozin must be taken regularly as ordered by your doctor in order for it to help you. oxaprozin usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of oxaprozin.

Dosing

The dose of oxaprozin 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 oxaprozin. 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 (tablets):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—1200 milligrams (mg) (two 600-mg tablets) once a day.
    • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor.
    • Children below 6 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of oxaprozin, 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using oxaprozin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

oxaprozin may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use oxaprozin for a long time might also have a higher risk .

oxaprozin may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with oxaprozin. Check with your doctor right away if you have any of the following symptoms while taking oxaprozin: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with oxaprozin may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking oxaprozin and check with your doctor immediately if you notice any of these warning signs .

oxaprozin may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using oxaprozin while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .

oxaprozin may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

Before having any kind of surgery or medical tests, tell your doctor that you are taking oxaprozin. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

oxaprozin 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:

More common

• Skin rash

Less common

• Bloating
• bloody or black, tarry stools
• burning upper abdominal pain
• burning while urinating
• cloudy urine
• constipation
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficult or painful urination
• frequent urination
• headache
• heartburn
• indigestion
• itching skin
• loss of appetite
• nausea or vomiting
• pale skin
• severe abdominal pain, cramping, or burning
• severe and continuing nausea
• swelling
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight loss

Rare

• Agitation
• bleeding gums
• blistering, peeling, loosening of skin
• blurred vision
• body aches or pain
• burning feeling in chest or stomach
• changes in blood pressure
• chest pain
• clay-colored stools
• coma
• confusion
• cough or hoarseness
• cracks in the skin
• dark urine
• depression
• difficult or labored breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• ear congestion
• extreme fatigue
• fainting
• feeling of discomfort
• fever or chills
• fluid-filled skin blisters
• high fever
• hives or welts
• hostility
• increased sensitivity of skin to sunlight
• increased thirst
• increased volume of pale, dilute urine
• inflammation of joints
• irregular, fast or slow, or shallow breathing
• irritability
• joint or muscle pain
• large, flat, blue or purplish patches in the skin
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• lightheadedness
• loss of heat from the body
• loss of voice
• lower back or side pain
• muscle aches
• muscle twitching
• nasal congestion
• nervousness
• noisy breathing
• pain or burning in throat
• pain or tenderness around eyes and cheekbones
• pale or blue lips, fingernails, or skin
• pinpoint red or purple spots on skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• redness or other discoloration of skin
• redness, swelling, or soreness of tongue
• scaly skin
• seizures
• severe sunburn
• shortness of breath
• skin thinness
• slow, fast, irregular, pounding, or racing heartbeat or pulse
• sneezing
• sore throat
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• stomach upset
• stuffy or runny nose
• stupor
• swelling of face, fingers, feet, or lower legs
• swelling or inflammation of the mouth
• swollen lymph glands
• tenderness in stomach area
• tightness in chest
• unpleasant breath odor
• upper right abdominal pain
• wheezing
• yellow eyes or skin

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

• Acid or sour stomach
• belching
• stomach discomfort

Less common

• Continuing ringing or buzzing or other unexplained noise in ears
• excess air or gas in stomach or intestines
• hearing loss
• passing gas
• relaxed and calm
• sleepiness or unusual drowsiness
• trouble sleeping

Rare

• Anxiety
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• burning, dry, or itching eyes
• change in taste
• decreased hearing
• discharge, excessive tearing
• dry mouth
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• lack or loss of strength
• redness, pain, swelling of eye, eyelid, or inner lining of eyelid
• sensation of spinning
• shakiness in legs, arms, hands, feet
• sleeplessness
• trembling or shaking of hands or feet
• unable to sleep

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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