Oxazepam

IMPORTANT WARNING:

Oxazepam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take oxazepam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Oxazepam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with oxazepam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Oxazepam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping oxazepam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your oxazepam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in your hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

WHY is this medicine prescribed?

Oxazepam is used to relieve anxiety, including anxiety caused by alcohol withdrawal (symptoms that may develop in people who stop drinking alcohol after drinking large amounts for a long time). Oxazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow for relaxation.

Are there OTHER USES for this medicine?

Oxazepam is also used to treat irritable bowel syndrome. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Oxazepam comes as a capsule to take by mouth. It is usually taken three or four times a day and may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxazepam exactly as directed.

Oxazepam may help control your symptoms but will not cure your condition. Continue to take oxazepam even if you feel well. Do not skip doses even if you feel that you do not need them.

What SPECIAL PRECAUTIONS should I follow?

Before taking oxazepam,

• tell your doctor and pharmacist if you are allergic to oxazepam, any other medications, or any of the ingredients in oxazepam capsules. Ask your doctor or pharmacist for more information.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; digoxin (Lanoxin); levodopa (in Ritary, in Sinemet, in Stalevo); medication for depression, seizures, Parkinson's disease, asthma, colds, or allergies; muscle relaxants; oral contraceptives; phenytoin (Dilantin, Phenytek); probenecid (Probalan, in Col-Probenecid); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; theophylline (Elixophyllin, Theo 24, Theochron); or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had glaucoma or seizures, or lung, heart, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking oxazepam, call your doctor immediately.

• talk to your doctor about the risks and benefits of taking oxazepam if you are 65 years of age or older. Older adults should take lower doses of oxazepam because higher doses may not be more effective and are more likely to cause serious side effects.

• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Oxazepam may cause side effects. Call your doctor if any of the symptoms are severe or do not go away:

• drowsiness
• dizziness
• tiredness
• weakness
• dry mouth
• diarrhea
• upset stomach
• changes in appetite
• restlessness or excitement
• constipation
• difficulty urinating
• frequent urination
• blurred vision
• changes in sex drive or ability

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• shuffling walk
• persistent, fine tremor or inability to sit still
• fever
• difficulty breathing or swallowing
• severe skin rash
• yellowing of the skin or eyes
• irregular heartbeat

Oxazepam may cause other side effects. Call your doctor if you experience any unusual problems during your treatment with oxazepam.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Oxazepam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.