IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

OXAZEPAM - ORAL

(ox-AZ-eh-pam)

COMMON BRAND NAME(S): Serax

USES: Oxazepam is used to treat anxiety and also acute alcohol withdrawal. This medication belongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming and an anti-seizure effect. It works by enhancing the effects of a certain natural substance in the body (GABA). This medication may also be used for sleep (insomnia)

HOW TO USE: Take this medication by mouth as directed by your doctor. The dosage is based on your medical condition and response to therapy. Use this medication exactly as prescribed. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased to avoid side effects such as seizures. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, slurred speech, clumsiness, trouble walking, decreased/increased interest in sex, tremor, trouble urinating, sleep disturbances. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, stomach/abdominal pain, persistent nausea, vomiting, fatigue, yellowing eyes or skin, dark urine, persistent sore throat or fever. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking oxazepam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung/breathing problems (e.g., COPD, sleep apnea), drug or alcohol abuse. This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the drowsiness effect. This medication is not recommended for use during pregnancy due to the potential for harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate. If you are currently using any of these medications, tell your doctor or pharmacist before starting oxazepam. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: clozapine, digoxin, kava, levodopa. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. Smoking can decrease the effectiveness of this drug (through liver enzyme induction). Tell your doctor if you smoke or if you have recently stopped smoking because your dose may need to be adjusted. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe drowsiness, slowed/reduced reflexes, slowed breathing, fainting, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law. If this drug is used for an extended period of time, laboratory and/or medical tests (e.g., liver function tests, complete blood count) may be performed periodically to check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

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