Niravam

Niravam is a prescription medication used to treat anxiety and panic disorders. Niravam belongs to a group of drugs called benzodiazepines. It works by lowering abnormal excitement in the brain.

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

• Jazz Pharmaceuticals, Inc.

Serious side effects have been reported with Niravam. See “Drug Precautions” section.

Common side effects of Niravam include:

• sedation
• low blood pressure
• coordination problems
• increased libido
• light-headedness
• dizziness
• restlessness 
• increased salivation
• dry mouth

Niravam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• chlordiazepoxide (Librium, Librax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), estazolam (ProSom), flurazepam (Dalmane), halazepam (Paxipam), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), quazepam (Doral), temazepam (Restoril), triazolam (Halcion), or any other medications
• amiodarone (Cordarone, Pacerone)
• antidepressants ('mood elevators') such as desipramine (Norpramin), imipramine (Tofranil), and nefazodone
• antifungals such as fluconazole (Diflucan), posaconazole (Noxafil), voriconazole (Vfend), itraconazole (Sporanox), and ketoconazole (Nizoral)
• antihistamines such as cimetidine (Tagamet)
• clarithromycin (Biaxin) and erythromycin (E.E.S., E-Mycin, Erythrocin)
• cyclosporine (Neoral, Sandimmune)
• diltiazem (Cardizem, Dilacor, Tiazac)
• ergotamine (Cafatine, Cafergot, Wigraine, others)
• isoniazid (INH, Nydrazid)
• nicardipine (Cardene) and nifedipine (Adalat, Procardia)
• oral contraceptives (birth control pills)
• propoxyphene (Darvon)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• sedatives, sleeping pills,  and tranquilizers
• St. John's wort

This is not a complete list of Niravam drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Niravam including:

• shortness of breath
• seizures
• seeing things or hearing voices that do not exist (hallucinating)
• severe skin rash
• yellowing of the skin or eyes
• depression
• memory problems
• confusion
• problems with speech
• unusual changes in behavior or mood
• thinking about harming or killing yourself or trying to do so
• problems with coordination or balance

Niravam can cause serious withdrawal side effects. To avoid these side effects (such as seizures, headaches, blurry vision, or irritability), do not suddenly stop taking Niravam. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

Do not use Niravam if you:

• have a known sensitivity or allergy to this drug or other benzodiazepines.
• develop acute narrow angle glaucoma. Niravam may be used in those with open angle glaucoma who are taking appropriate therapy.
• are taking ketoconazole and itraconazole

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. Talk to your doctor about drinking grapefruit juice while taking this medicine. 

Before taking Niravam, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have glaucoma (increased pressure in the eye that may cause loss of sight).
• have or have ever had depression; if you have had thoughts of suicide or harming yourself.
• have alcoholism or if you drink or have ever drunk large amounts of alcohol.
• use or have ever used street drugs or have overused prescription medications.
• smoke.
• have had seizures.
• have or have ever had lung, kidney, or liver disease.
• are pregnant, plan to become pregnant, or are breastfeeding. Niravam may harm the fetus. If you become pregnant while taking Niravam, call your doctor.
• are having surgery, including dental surgery. Tell the doctor or dentist that you are taking Niravam.

Talk to your doctor about the risks and benefits of taking Niravam if you are 65 years of age or older. Older adults should receive lower doses of Niravam because higher doses may not work better and may actually cause serious side effects.

Niravam may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Talk to your doctor about the use of alcohol while you are taking Niravam. Alcohol can worsen the side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Niravam falls into category D. Niravam passes to the baby and may cause harm to the unborn baby. In addition, the baby may be born with respiratory and other problems if the mother uses Niravam while pregnant. 

Tell your doctor if you are breastfeeding or plan to breastfeed. Benzodiazepines are known to be excreted in human milk. Because of the possibility for adverse reactions in nursing infants from Niravam, a choice should be made whether to stop nursing or to stop use of Niravam. Determining the importance of the drug to the mother should be considered.

Niravam comes as an orally disintegrating tablet and is usually taken 3 times a day. It is placed on the tongue where it will disintegrate and be swallowed with saliva.

1) Just prior to administration, with dry hands, remove the tablet from the blister.

2) Immediately place the Niravam Orally Disintegrating Tablet on top of the tongue where it will disintegrate and be swallowed with saliva. (It is not necessary to take with liquid)

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take two doses at one time.

Take Niravam exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of alprazolam must be individualized.

Anxiety Disorders and Transient Symptoms of Anxiety:

Starting dose: 0.25 to 0.5 mg given three times daily. The dose may be increased to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be used and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

Panic Disorder:

The successful treatment of many panic disorder patients may require doses greater than 4 mg daily. 

Treatment may be started at a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days. Slower titration may be needed. To lessen the possibility of symptoms between doses, you may be prescribed to take Niravam 3 or 4 times a day.

Dosing in special populations:

In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• confusion
• problems with coordination
• loss of consciousness

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).