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Klonopin (Clonazepam) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Seizure Disorders

Klonopin is useful alone or as an adjunct in thetreatment of the Lennox-Gastaut syndrome (petit mal variant), akineticand myoclonic seizures. In patients with absence seizures (petit mal)who have failed to respond to succinimides, Klonopin may be useful.

In some studies, up to 30% of patients have shown a lossof anticonvulsant activity, often within 3 months of administration.In some cases, dosage adjustment may reestablish efficacy.

Panic Disorder

Klonopin is indicated for the treatment of panicdisorder, with or without agoraphobia, as defined in DSM-IV. Panicdisorder is characterized by the occurrence of unexpected panic attacksand associated concern about having additional attacks, worry aboutthe implications or consequences of the attacks, and/or a significantchange in behavior related to the attacks.

Theefficacy of Klonopin was established in two 6- to 9-week trials inpanic disorder patients whose diagnoses corresponded to the DSM-IIIRcategory of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).

Panic disorder (DSM-IV) is characterized by recurrent unexpectedpanic attacks, ie, a discrete period of intense fear or discomfortin which four (or more) of the following symptoms develop abruptlyand reach a peak within 10 minutes: (1) palpitations, pounding heartor accelerated heart rate; (2) sweating; (3) trembling or shaking;(4) sensations of shortness of breath or smothering; (5) feeling ofchoking; (6) chest pain or discomfort; (7) nausea or abdominal distress;(8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization(feelings of unreality) or depersonalization (being detached fromoneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias(numbness or tingling sensations); (13) chills or hot flushes.

The effectiveness of Klonopin in long-term use, that is,for more than 9 weeks, has not been systematically studied in controlledclinical trials. The physician who elects to use Klonopin for extendedperiods should periodically reevaluate the long-term usefulness ofthe drug for the individual patient (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Clonazepam is available as a tablet or an orallydisintegrating tablet (wafer). The tablets should be administeredwith water by swallowing the tablet whole. The orally disintegratingtablet should be administered as follows: After opening the pouch,peel back the foil on the blister. Do not push tablet through foil.Immediately upon opening the blister, using dry hands, remove thetablet and place it in the mouth. Tablet disintegration occurs rapidlyin saliva so it can be easily swallowed with or without water.

Seizure Disorders

Adults

The initial dose for adults with seizure disordersshould not exceed 1.5 mg/day divided into three doses. Dosage maybe increased in increments of 0.5 to 1 mg every 3 days until seizuresare adequately controlled or until side effects preclude any furtherincrease. Maintenance dosage must be individualized for each patientdepending upon response. Maximum recommended daily dose is 20 mg.

The use of multiple anticonvulsants may result in an increaseof depressant adverse effects. This should be considered before addingKlonopin to an existing anticonvulsant regimen.

Pediatric Patients

Klonopin is administered orally. In order to minimizedrowsiness, the initial dose for infants and children (up to 10 yearsof age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/daybut not to exceed 0.05 mg/kg/day given in two or three divided doses.Dosage should be increased by no more than 0.25 to 0.5 mg every thirdday until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weighthas been reached, unless seizures are controlled or side effects precludefurther increase. Whenever possible, the daily dose should be dividedinto three equal doses. If doses are not equally divided, the largestdose should be given before retiring.

Geriatric Patients

There is no clinical trial experience with Klonopinin seizure disorder patients 65 years of age and older. In general,elderly patients should be started on low doses of Klonopin and observedclosely (see PRECAUTIONS: GeriatricUse).

Panic Disorder

Adults

The initial dose for adults with panic disorder is0.25 mg bid. An increase to the target dose for most patients of 1mg/day may be made after 3 days. The recommended dose of 1 mg/dayis based on the results from a fixed dose study in which the optimaleffect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day inthat study were less effective than the 1 mg/day dose and were associatedwith more adverse effects. Nevertheless, it is possible that someindividual patients may benefit from doses of up to a maximum doseof 4 mg/day, and in those instances, the dose may be increased inincrements of 0.125 to 0.25 mg bid every 3 days until panic disorderis controlled or until side effects make further increases undesired.To reduce the inconvenience of somnolence, administration of one doseat bedtime may be desirable.

Treatment shouldbe discontinued gradually, with a decrease of 0.125 mg bid every 3days, until the drug is completely withdrawn.

There is no body of evidence available to answer the question ofhow long the patient treated with clonazepam should remain on it.Therefore, the physician who elects to use Klonopin for extended periodsshould periodically reevaluate the long-term usefulness of the drugfor the individual patient.

Pediatric Patients

There is no clinical trial experience with Klonopinin panic disorder patients under 18 years of age.

Geriatric Patients

There is no clinical trial experience with Klonopinin panic disorder patients 65 years of age and older. In general,elderly patients should be started on low doses of Klonopin and observedclosely (see PRECAUTIONS: GeriatricUse).

HOW SUPPLIED

Klonopin tablets are available as scored tabletswith a K-shaped perforation—0.5 mg, orange (NDC 0004-0068-01);and unscored tablets with a K-shaped perforation—1 mg, blue(NDC 0004-0058-01); 2 mg, white (NDC 0004-0098-01)—bottlesof 100.

Imprint on tablets:

0.5 mg — 1/2 KLONOPIN (front)    <<tabletillustration>>
                  ROCHE(scored side)

   1mg — 1 KLONOPIN (front)    <<tabletillustration>>
                  ROCHE(reverse side)

   2mg — 2 KLONOPIN (front)    <<tabletillustration>>
                  ROCHE(reverse side)

KlonopinWafers (clonazepam orally disintegrating tablets) are white, roundand debossed with the tablet strength expressed as a fraction or wholenumber (1/8, 1/4, 1/2, 1, or 2). The tablets are available in blisterpackages of 60 (10 pouches/carton) as follows:

  0.125 mg debossed 1/8, (NDC 0004-0279-22)

    0.25 mgdebossed 1/4, (NDC0004-0280-22)

      0.5mg debossed 1/2, (NDC 0004-0281-22)

          1mg debossed 1, (NDC 0004-0282-22)

          2mgdebossed 2, (NDC 0004-0283-22)

Store at25°C (77°F); excursions permitted to 15° to 30°C(59° to 86°F).

PI Revised: April 2009

Distributed by:

Roche LaboratoriesInc.
340 Kingsland Street
Nutley, New Jersey 07110-1199

27899652
KNTW_54023_PI_012009_N(1)

Copyright © 1997-2009 by Roche Laboratories Inc. All rightsreserved.

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