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.

ALPRAZOLAM DISINTEGRATING TABLET - ORAL

(al-PRA-zoe-lam)

COMMON BRAND NAME(S): Niravam

USES: This medication is used to treat certain anxiety and panic disorders. Alprazolam belongs to a class of medications called benzodiazepines. It acts on the brain and nerves to produce a calming effect and helps relieve panic and anxiety symptoms. It works by enhancing the effects of a certain natural chemical in the body (GABA).

HOW TO USE: Take this medication by mouth as directed by your doctor. Dosage is based on your medical condition and response to treatment. Your dose may be gradually increased until the drug starts working well. Follow your doctor's instructions closely to reduce the risk of side effects. It is best not to take this medication with a high-fat meal because absorption may be slowed. Make sure your hands are dry before you are ready to take this medication. Place the tablet on top of your tongue immediately after removing it from the bottle. The tablet will dissolve in your mouth. Although it is not necessary to take this medication with any liquid, you may take it with water. If your dose is only half a tablet, be sure to throw away the unused portion of the tablet. Do not save it for future use because it may become inactive. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions immediately. Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, increased saliva production, or change in sex drive/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. 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 right away if any of these unlikely but serious side effects occur: mental/mood changes (such as hallucinations, thoughts of suicide), slurred speech or difficulty talking, loss of coordination, trouble walking, memory problems. Get medical help right away if these rare but very serious side effects occur: yellowing eyes or skin, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 alprazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); 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: severe lung/breathing problems (such as COPD, sleep apnea), liver disease, kidney disease, drug or alcohol abuse, glaucoma. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness. Alprazolam is not recommended for use during pregnancy due to the potential for harm to an unborn baby. Consult your doctor for more details. This drug passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: kava, sodium oxybate, drugs that affect stomach acid (such as antacids, famotidine, omeprazole). Other medications can affect the removal of alprazolam from your body, which may affect how alprazolam works. Examples include azole antifungals (such as itraconazole, ketoconazole), cimetidine, certain anti-depressants (such as fluoxetine, fluvoxamine, nefazodone), drugs to treat HIV (delavirdine, protease inhibitors such as indinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Tell your doctor or pharmacist if you also take drugs that cause drowsiness, such as certain antihistamines (such as diphenhydramine), medicine for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients which cause drowsiness. Ask your pharmacist about the safe use of those products. Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slowed/reduced reflexes, slowed breathing, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take 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 in a tightly sealed container provided by your pharmacist, at room temperature, away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. After opening the bottle, throw away any cotton that you find inside. Reseal the bottle tightly to prevent moisture from getting into the bottle. If the tablets are exposed to moisture, they may not work properly. 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.

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