Niravam

Name: Niravam

Uses of Niravam

Niravam is a prescription medicine used to treat anxiety disorder (unrealistic or excessive worrying) and panic disorders (sudden, unexpected attacks of extreme fear).

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

Other Requirements

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). 

 

What is Niravam (alprazolam)?

Alprazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Alprazolam affects chemicals in the brain that may be unbalanced in people with anxiety.

Alprazolam is used to treat anxiety disorders, panic disorders, and anxiety caused by depression.

Alprazolam may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Niravam (alprazolam)?

It is dangerous to purchase alprazolam on the Internet or from vendors outside the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. The sale and distribution of alprazolam outside the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

You should not take alprazolam if you have:

  • narrow-angle glaucoma;

  • if you are also taking itraconazole or ketoconazole; or

  • if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

To make sure alprazolam is safe for you, tell your doctor if you have:

  • seizures or epilepsy;

  • kidney or liver disease (especially alcoholic liver disease);

  • asthma or other breathing disorder;

  • open-angle glaucoma;

  • a history of depression or suicidal thoughts or behavior;

  • a history of drug or alcohol addiction; or

  • if you also use a narcotic (opioid) medication.

Do not use alprazolam if you are pregnant. This medicine can cause birth defects. Your baby could also become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are taking alprazolam.

Alprazolam can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using alprazolam.

The sedative effects of alprazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking alprazolam.

Alprazolam is not approved for use by anyone younger than 18 years old.

What should I avoid while taking Niravam (alprazolam)?

Alprazolam may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. Dangerous side effects could occur.

Grapefruit and grapefruit juice may interact with alprazolam and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Niravam (alprazolam) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • depressed mood, thoughts of suicide or hurting yourself;

  • racing thoughts, increased energy, unusual risk-taking behavior;

  • confusion, agitation, hostility, hallucinations;

  • uncontrolled muscle movements, tremor, seizure (convulsions); or

  • pounding heartbeats or fluttering in your chest.

Common side effects may include:

  • drowsiness, feeling tired;

  • slurred speech, lack of balance or coordination;

  • memory problems; or

  • feeling anxious early in the morning.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Niravam (alprazolam)?

Taking alprazolam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cimetidine;

  • digoxin;

  • fluvoxamine;

  • nefazodone;

  • ritonavir or other medicines to treat HIV or AIDS; or

  • antifungal medicine--fluconazole, voriconazole.

This list is not complete. Other drugs may interact with alprazolam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses of Niravam

  • It is used to treat anxiety.
  • It is used to treat panic attacks.

How is this medicine (Niravam) best taken?

Use Niravam (alprazolam orally disintegrating tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • Use right away after this medicine is removed from the foil. Do not store any part of the tablet for use at a later time.

What do I do if I miss a dose?

  • If you take Niravam on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Niravam is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Niravam or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Niravam. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Contraindications

Niravam is contraindicated in patients with acute narrow angle glaucoma. Niravam can exacerbate narrow angle closure. Niravam may be used in patients with open angle glaucoma who are receiving appropriate therapy.

Niravam is contraindicated in patients treated with potent CYP3A4 inhibitors (e.g., ketoconazole and itraconazole), because these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) and can increase alprazolam exposures [see Clinical Pharmacology (12.3), Warnings and Precautions (5.7), and Drug Interactions (7.4)].

Overdosage

Human Clinical Experience

Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.

Management of Overdose

For the most up to date information on management of alprazolam overdose, contact a certified poison center in your area (1-800-222-1222 or www.poison.org). In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be consulted prior to use.

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