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|Niravam Orally Disintegrating Tablets

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Niravam Orally Disintegrating Tablets

Generic Name: Alprazolam Orally Disintegrating Tablets (al-PRAY-zoe-lam)
Brand Name: Niravam

Niravam Orally Disintegrating Tablets is used for:

Treating anxiety and panic disorder. It may also be used to treat other conditions as determined by your doctor.

Niravam Orally Disintegrating Tablets is a benzodiazepine. It works by slowing down the movement of chemicals in the brain. This results in a reduction in nervous tension (anxiety).

Do NOT use Niravam Orally Disintegrating Tablets if:

you are allergic to any ingredient in Niravam Orally Disintegrating Tablets or other benzodiazepines (eg, diazepam)
you have acute narrow-angle glaucoma, severe liver disease, or certain severe mental problems (eg, psychosis)
you are taking an azole antifungal (eg, itraconazole, ketoconazole), delavirdine, or sodium oxybate (GHB)

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

Before using Niravam Orally Disintegrating Tablets:

Some medical conditions may interact with Niravam Orally Disintegrating Tablets. 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 or other substances
if you have glaucoma or a predisposition for glaucoma, liver problems, lung problems or chronic obstructive pulmonary disease (COPD), muscle problems, depression, suicidal tendencies, a blood disorder known as porphyria, or a history of substance abuse or dependence

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

Rifampin or St. John"s wort because the effectiveness of Niravam Orally Disintegrating Tablets may be decreased
Azole antifungals (eg, itraconazole, ketoconazole), cimetidine, clozapine, delavirdine, fluvoxamine, HIV protease inhibitors (eg, ritonavir), fluoxetine, macrolides and ketolides (eg, erythromycin, azithromycin), nefazodone, omeprazole, propoxyphene, sodium oxybate (GHB), or valproic acid because side effects such as increased sedation or heart problems may occur
Clozapine, hydantoins (eg, phenytoin), or valproic acid because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Niravam Orally Disintegrating Tablets 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 Niravam Orally Disintegrating Tablets:

Use Niravam Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Niravam Orally Disintegrating Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Do not remove the blister from the outer pouch until you are ready to take Niravam Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Niravam Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use. If you are only taking a half tablet for your dose, throw away the other half. Do not save it for later use.
Eating grapefruit or drinking grapefruit juice may affect the amount of Niravam Orally Disintegrating Tablets in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
If you miss a dose of Niravam Orally Disintegrating Tablets and you are using it regularly, 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 Niravam Orally Disintegrating Tablets.

Important safety information:

Niravam Orally Disintegrating Tablets may cause drowsiness, dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Niravam Orally Disintegrating Tablets. Using Niravam Orally Disintegrating Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Niravam Orally Disintegrating Tablets. Niravam Orally Disintegrating Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Do not smoke while using Niravam Orally Disintegrating Tablets. Cigarette smoking decreases blood levels of Niravam Orally Disintegrating Tablets. Tell your doctor if you smoke or if you have recently stopped smoking.
Use Niravam Orally Disintegrating Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Use Niravam Orally Disintegrating Tablets with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: Niravam Orally Disintegrating Tablets has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Niravam Orally Disintegrating Tablets during pregnancy. Niravam Orally Disintegrating Tablets is excreted in breast milk. Do not breast-feed while taking Niravam Orally Disintegrating Tablets.

When used for long periods of time or at high doses, Niravam Orally Disintegrating Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Niravam Orally Disintegrating Tablets stops working well. Do not take more than prescribed.

Niravam Orally Disintegrating Tablets may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high dosage therapy, you may have WITHDRAWAL symptoms (eg, convulsions, tremor, stomach and muscle cramps, vomiting, sweating) if you suddenly stop taking Niravam Orally Disintegrating Tablets. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Niravam Orally Disintegrating Tablets:

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:

Appetite changes; attention disturbance; clumsiness; constipation; dizziness; drowsiness; flu; increased salivation; restlessness; unusual tiredness or weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sex drive; depression; fast or irregular heartbeat; impaired coordination/balance; involuntary movements; memory impairment; severe dizziness, fainting, or lightheadedness; weight gain or loss.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately. Symptoms may include loss of consciousness; loss of coordination; severe confusion; severe drowsiness or deep sleep; slow reflexes.

Proper storage of Niravam Orally Disintegrating Tablets:

Store Niravam Orally Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Niravam Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Niravam Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Niravam Orally Disintegrating Tablets 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 Niravam Orally Disintegrating Tablets. 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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