MEDICATION GUIDE

Oxazepam (ox-AZE-e-pam) Capsules, C-IV

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

• Oxazepam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
• Oxazepam can make you sleepy or dizzy, and can slow your thinking and motor skill.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how oxazepam affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking oxazepam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, oxazepam may make your sleepiness or dizziness much worse.
• Do not take more oxazepam than prescribed.

What is oxazepam?

• Oxazepam is a prescription medicine used:
• to treat anxiety disorders
• for the short-term relief of the symptoms of anxiety or anxiety that can happen with depression
• to treat anxiety, tension, agitation and irritability in elderly people
• to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), anxiety associated with acute alcohol withdrawal.
• Oxazepam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep oxazepam in a safe place to prevent misuse and abuse. Selling or giving away oxazepam may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
• It is not known if oxazepam is safe and effective in children under 6 years of age.
• It is known if oxazepam is safe and effective for use longer than 4 months.

Do not take oxazepam if you:

• are allergic to oxazepam or any of the ingredients in oxazepam. See the end of this Medication Guide for a complete list of ingredients in oxazepam.

Before you take oxazepam, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have liver or kidney problems
• have or have had problems with fainting or low blood pressure
• are pregnant or plan to become pregnant. Oxazepam may harm your unborn baby. You and your healthcare provider should decide if you should take oxazepam while you are pregnant.
• are breastfeeding or plan to breastfeed. Oxazepam may pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take oxazepam.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking oxazepam with certain other medicines can cause side effects or affect how well oxazepam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take oxazepam?

• See “What is the most important information I should know about oxazepam?”
• Take oxazepam exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much oxazepam to take and when to take it.
• If you take too much oxazepam, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking oxazepam?

• Oxazepam can cause you to be drowsy. Do not drive a car, operate heavy machinery, or do other dangerous activity until you know how oxazepam affects you.
• You should not drink alcohol while taking oxazepam. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of oxazepam?

Oxazepam may cause serious side effects, including:

• See “What is the most important information I should know about oxazepam?”
• Low blood pressure. Oxazepam can cause low blood pressure especially in elderly people.
• Withdrawal symptoms. You may have withdrawal symptoms if you stop taking oxazepam suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping oxazepam to avoid withdrawal symptoms.
• Abuse and dependence. Taking oxazepam can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

The most common side effects of oxazepam include:

• drowsiness
• vertigo (sensation of loss of balance)
• dizziness
• headache

These are not all the possible side effects of oxazepam. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store oxazepam?

• Store oxazepam at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep oxazepam in a tightly closed container and out of the light.
• Keep oxazepam and all medicines out of the reach of children.

General information about the safe and effective use of oxazepam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxazepam for a condition for which it was not prescribed. Do not give oxazepam to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about oxazepam that is written for health professionals.

What are the ingredients in oxazepam?

Active ingredient: oxazepam

Inactive ingredients: hypromellose, lactose (monohydrate), magnesium stearate and corn starch. The capsule shells and imprinting inks contain: gelatin, titanium dioxide, shellac, black iron oxide, propylene glycol and D&C Red #7 Calcium Lake E180. The 10 mg capsules also contain: methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate, edetate calcium disodium and sodium lauryl sulfate. The 15 mg ink also contains: D&C Yellow #10 Aluminum Lake. The 30 mg ink also contains: FD&C Red #40 Aluminum Lake #129 and FD&C Blue #2 Aluminum Lake #132.

For more information about Oxazepam Capsules, call 1-800-525-8747.

This Medication Guide has been approved by the U.S. Food and Drug Administration

For Medication Guides, please call 1-800-507-2130