Niravam

PATIENT INFORMATION

Counseling Information For All Users of Niravam

To assure safe and effective use of benzodiazepines, all patients prescribed NIRAVAM should be provided with the following guidance.

  1. Do not remove NIRAVAM tablets from the bottle until just prior to dosing. With dry hands, open the bottle, remove the tablet, and immediately place on the tongue to dissolve and be swallowed with the saliva. The tablet may also be taken with water.
  2. Discard any cotton that was included in the bottle and reseal the bottle tightly to prevent introducing moisture that might cause the tablets to disintegrate.
  3. Store at room temperature in a dry place. Protect from moisture.
  4. Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines.
  5. NIRAVAM is not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication.
  6. Inform your physician if you are nursing.
  7. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
  8. Do not increase the dose even if you think the medication “does not work anymore” without consulting your physician. Benzodiazepines, even after relatively short-term use at the doses recommended, may produce emotional and/or physical dependence.
  9. Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur even after relatively short-term use at the doses recommended. You should follow a gradual dosage tapering schedule.

Additional Counseling Information for Panic Disorder Patients

The use of NIRAVAM at doses greater than 4 mg per day, often necessary to treat panic disorder, is accompanied by risks that you need to carefully consider. When used at doses greater than 4 mg per day, which may or may not be required for your treatment, NIRAVAM has the potential to cause severe psychological and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment. In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue medication was measured, 7 to 29% of patients treated with NIRAVAM did not completely taper off therapy. In a controlled postmarketing discontinuation study of panic disorder patients, the patients treated with doses of NIRAVAM greater than 4 mg per day had more difficulty tapering to zero dose than patients treated with less than 4 mg per day. In all cases, it is important that your physician help you discontinue this medication in a careful and safe manner to avoid overly extended use of NIRAVAM.

In addition, the extended use at doses greater than 4 mg per day appears to increase the incidence and severity of withdrawal reactions when NIRAVAM is discontinued. These are generally minor but seizure can occur, especially if you reduce the dose too rapidly or discontinue the medication abruptly. Seizure can be life-threatening.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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