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Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation
containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation
containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium
stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5
mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2
Klonopin is also available as an orally disintegrating tablet containing 0.125 mg, 0.25
mg, 0.5 mg, 1 mg or 2 mg clonazepam. Each orally disintegrating tablet also contains
gelatin, mannitol, methylparaben sodium, propylparaben sodium and xanthan gum.

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Seizure Disorders: Klonopin is useful alone or as an adjunct in the treatment of the
Lennox-Gastaut syndrome (petit mal variant), akinetic and 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 loss of anticonvulsant activity, often
within 3 months of administration. In some cases, dosage adjustment may reestablish
Panic Disorder: Klonopin is indicated for the treatment of panic disorder, with or
without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the
occurrence of unexpected panic attacks and associated concern about having additional
attacks, worry about the implications or consequences of the attacks, and/or a significant
change in behavior related to the attacks.
The efficacy of Klonopin was established in two 6- to 9-week trials in panic disorder
patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a
discrete period of intense fear or discomfort in which four (or more) of the following
symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations,
pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4)
sensations of shortness of breath or smothering; (5) feeling of choking; (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 from
oneself); (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 controlled clinical trials. The physician who elects to use
Klonopin for extended periods should periodically reevaluate the long-term usefulness of
the drug for the individual patient.

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How To Take

Clonazepam is available as a tablet. The tablets should be administered with water by
swallowing the tablet whole.
Seizure Disorders: Adults: The initial dose for adults with seizure disorders should not
exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of
0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects
preclude any further increase. Maintenance dosage must be individualized for each
patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse
effects. This should be considered before adding Klonopin to an existing anticonvulsant
Pediatric Patients: Klonopin is administered orally. In order to minimize drowsiness, the
initial dose for infants and children (up to 10 years of age or 30 kg of body weight)
should be between 0.01 and 0.03 mg/kg/day but 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 third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has
been reached, unless seizures are controlled or side effects preclude further increase.
Whenever possible, the daily dose should be divided into three equal doses. If doses are
not equally divided, the largest dose should be given before retiring.
Geriatric Patients: There is no clinical trial experience with Klonopin in seizure disorder
patients 65 years of age and older. In general, elderly patients should be started on low
doses of Klonopin and observed closely (see PRECAUTIONS: Geriatric Use).
Panic Disorder: Adults: The initial dose for adults with panic disorder is 0.25 mg bid. An
increase to the target dose for most patients of 1 mg/day may be made after 3 days. The
recommended dose of 1 mg/day is based on the results from a fixed dose study in which
the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study
were less effective than the 1 mg/day dose and were associated with more adverse
effects. Nevertheless, it is possible that some individual patients may benefit from doses
of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased
in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or
until side effects make further increases undesired. To reduce the inconvenience of
somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every
3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient
treated with clonazepam should remain on it. Therefore, the physician who elects to use
Klonopin for extended periods should periodically reevaluate the long-term usefulness of
the drug for the individual patient.
Pediatric Patients: There is no clinical trial experience with Klonopin in panic disorder
patients under 18 years of age.

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Side Effects

The adverse experiences for Klonopin are provided separately for patients with seizure
disorders and with panic disorder.
Seizure Disorders: The most frequently occurring side effects of Klonopin are referable
to CNS depression. Experience in treatment of seizures has shown that drowsiness has
occurred in approximately 50% of patients and ataxia in approximately 30%. In some
cases, these may diminish with time; behavior problems have been noted in
approximately 25% of patients. Others, listed by system, are:
Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia,
dysarthria, dysdiadochokinesis, ‘‘glassy-eyed’’ appearance, headache, hemiparesis,
hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo
Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido,
insomnia, psychosis (the behavior effects are more likely to occur in patients with ahistory of psychiatric disturbances). The following paradoxical reactions have been
observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility,
anxiety, sleep disturbances, nightmares and vivid dreams
Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper
respiratory passages
Cardiovascular: Palpitations
Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema
Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis,
gastritis, increased appetite, nausea, sore gums
Genitourinary: Dysuria, enuresis, nocturia, urinary retention
Musculoskeletal: Muscle weakness, pains
Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss
or gain
Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia
Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline
Panic Disorder: Adverse events during exposure to Klonopin were obtained by
spontaneous report and recorded by clinical investigators using terminology of their own
choosing. Consequently, it is not possible to provide a meaningful estimate of the
proportion of individuals experiencing adverse events without first grouping similar types
of events into a smaller number of standardized event categories. In the tables and
tabulations that follow, CIGY dictionary terminology has been used to classify reported
adverse events, except in certain cases in which redundant terms were collapsed into
more meaningful terms, as noted below.
The stated frequencies of adverse events represent the proportion of individuals who
experienced, at least once, a treatment-emergent adverse event of the type listed. An
event was considered treatment-emergent if it occurred for the first time or worsened
while receiving therapy following baseline evaluation.

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Klonopin is contraindicated in patients with the following conditions:
• History of sensitivity to benzodiazepines
• Clinical or biochemical evidence of significant liver disease
• Acute narrow angle glaucoma (it may be used in patients with open angle
glaucoma who are receiving appropriate therapy).

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