Niravam orally disintegrating tablets

Generic Name: alprazolam (al-PRA-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 in the brain to decrease 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
  • you are taking delavirdine, itraconazole, ketoconazole, or sodium oxybate (GHB)

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

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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 able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, glaucoma or increased pressure in the eye, kidney or liver problems, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], sleep apnea), myasthenia gravis, phenylketonuria (PKU), or a blood disorder known as porphyria
  • if you have a history of other mental or mood problems (eg, depression), alcohol or other substance abuse or dependence, or suicidal thoughts or actions
  • if you are in poor health, are very overweight, or are experiencing abnormal muscle movements
  • if you drink alcoholic beverages or you smoke

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:

  • Methadone because it may increase the risk of serious and sometimes fatal breathing problems
  • Amiodarone, azole antifungals (eg, itraconazole, ketoconazole), cimetidine, cyclosporine, delavirdine, diltiazem, ergot alkaloids (eg, ergotamine), fluoxetine, fluvoxamine, isoniazid, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, nicardipine, nifedipine, omeprazole, oral contraceptives (birth control pills), paroxetine, propoxyphene, protease inhibitors (eg, boceprevir, ritonavir), sodium oxybate (GHB), telithromycin, or valproic acid because they may increase the risk of Niravam orally disintegrating tablets's side effects
  • Carbamazepine, rifamycins (eg, rifampin), or St. John's wort because they may decrease Niravam orally disintegrating tablets's effectiveness
  • Hydantoins (eg, phenytoin) because the risk of their side effects may be increased and they may decrease Niravam orally disintegrating tablets's effectiveness
  • Clozapine or tricyclic antidepressants (eg, desipramine, imipramine) because the risk of their side effects may be increased by Niravam orally disintegrating tablets

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.
  • If you are taking Niravam orally disintegrating tablets regularly, do not suddenly stop taking it without checking with your doctor. You may have an increased risk of side effects (eg, seizures). If you need to stop Niravam orally disintegrating tablets or add a new medicine, your doctor will gradually lower your dose.
  • 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, light-headedness, 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.
  • Do not drink alcohol while you are using Niravam orally disintegrating tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Niravam orally disintegrating tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Smoking may decrease Niravam orally disintegrating tablets's effectiveness. Tell your doctor if you smoke or if you have recently stopped smoking.
  • Tell your doctor or dentist that you take Niravam orally disintegrating tablets before you receive any medical or dental care, emergency care, or surgery.
  • This product contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your doctor before using Niravam orally disintegrating tablets.
  • Use Niravam orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased coordination and drowsiness.
  • Use Niravam orally disintegrating tablets with extreme caution in CHILDREN younger than 18 years of age; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Niravam orally disintegrating tablets may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Niravam orally disintegrating tablets during pregnancy. Niravam orally disintegrating tablets is found 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.

Some people who use Niravam orally disintegrating tablets may develop a need to continue taking it. People who take higher doses (eg, some patients with panic disorder) or use Niravam orally disintegrating tablets for a long time have a greater risk. This is known as DEPENDENCE or addiction. If you stop taking Niravam orally disintegrating tablets suddenly, you may have WITHDRAWAL symptoms. These may include blurred vision; burning, numbness, or tingling; changes in smell or other senses; decreased appetite; decreased awareness of your surroundings; decreased concentration; diarrhea; muscle cramps or twitches; seizures; or weight loss.

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:

Changes in appetite; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; light-headedness; nausea; tiredness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blurred vision; burning, numbness, or tingling; chest pain; confusion; dark urine; decreased coordination; decreased urination; fainting; fast or irregular heartbeat; hallucinations; loss of balance or muscle control; memory or attention problems; menstrual changes; muscle twitching; new or worsening mental or mood changes (eg, depression, irritability, anxiety; exaggerated feeling of well-being); overstimulation; red, swollen blistered, or peeling skin; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath or trouble breathing; suicidal thoughts or actions; tremor; trouble speaking; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; loss of consciousness; loss of coordination; 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Niravam orally disintegrating tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Niravam orally disintegrating tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Niravam orally disintegrating tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Niravam orally disintegrating tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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