Niravam

DRUG DESCRIPTION

NIRAVAM (alprazolam orally disintegrating tablets) contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

NIRAVAM is an orally administered formulation of alprazolam which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-?] [1,4] benzodiazepine. The empirical formula is C17H13CIN4 and the molecular weight is 308.76. The structural formula is:

NIRAVAM® (alprazolam) Structural Formula Illustration

Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.

Niravam Tablets

Each orally disintegrating tablet contains either 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, natural and artificial orange flavor, sucralose and sucrose. In addition, the 0.25 mg and 0.5 mg tablets contain yellow iron oxide.

What are the possible side effects of alprazolam (Niravam, Xanax, Xanax XR)?

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

Call your doctor at once if you have any of these serious side effects:

  • unusual risk-taking behavior, decreased inhibitions, no fear of danger;
  • depressed mood, thoughts of suicide or hurting yourself;
  • hyperactivity, agitation, hostility, hallucinations;
  • feeling light-headed, fainting;
  • seizure...

Read All Potential Side Effects and See Pictures of Niravam »

What are the precautions when taking alprazolam (Niravam)?

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...

Read All Potential Precautions of Niravam »


Niravam Consumer (continued)

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.


Niravam Patient Information Including Side Effects

Brand Names: Niravam, Xanax, Xanax XR

Generic Name: alprazolam (Pronunciation: al PRAY zoe lam)

  • What is alprazolam (Niravam)?
  • What are the possible side effects of alprazolam (Niravam)?
  • What is the most important information I should know about alprazolam (Niravam)?
  • What should I discuss with my healthcare provider before taking alprazolam (Niravam)?
  • How should I take alprazolam (Niravam)?
  • What happens if I miss a dose (Niravam)?
  • What happens if I overdose (Niravam)?
  • What should I avoid while taking alprazolam (Niravam)?
  • What other drugs will affect alprazolam (Niravam)?
  • Where can I get more information?

What is alprazolam (Niravam)?

Alprazolam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Alprazolam affects chemicals in the brain that may become unbalanced and cause anxiety.

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

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

What are the possible side effects of alprazolam (Niravam)?

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

Call your doctor at once if you have any of these serious side effects:

  • unusual risk-taking behavior, decreased inhibitions, no fear of danger;
  • depressed mood, thoughts of suicide or hurting yourself;
  • hyperactivity, agitation, hostility, hallucinations;
  • feeling light-headed, fainting;
  • seizure (convulsions);
  • urinating less than usual or not at all;
  • muscle twitching, tremor; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • drowsiness, dizziness, feeling irritable;
  • amnesia or forgetfulness, trouble concentrating;
  • sleep problems (insomnia);
  • muscle weakness, lack of balance or coordination, slurred speech;
  • blurred vision;
  • nausea, vomiting, constipation, appetite or weight changes;
  • dry or watery mouth, increased sweating; or
  • loss of interest in sex.

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 is the most important information I should know about alprazolam (Niravam)?

Do not use this medication if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

This medication can cause birth defects in an unborn baby. Do not use alprazolam if you are pregnant.

Before taking alprazolam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking alprazolam. This medication can increase the effects of alcohol.

Alprazolam may be habit-forming and should be used only by the person it was prescribed for. Alprazolam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase alprazolam on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of alprazolam purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

Related Drug Centers
  • Xanax
  • Niravam
  • Xanax XR


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