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Indications:

used to control certain types of seizures in the treatment of epilepsy and for the treatment of panic disorders. Clonazepam may also be used for other purposes not listed in this medication guide.

Contraindications:

should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

Adverse reactions:

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: *confusion, hallucinations, unusual thoughts or behavior; *hyperactivity, agitation, hostility; * unusual or involuntary eye movements; *weak or shallow breathing; *depressed mood, thoughts of suicide or hurting yourself; * chest tightness, fast or pounding heartbeats; * painful or difficult urination, urinating more or less than usual; *pale skin, easy bruising or bleeding; or * new or worsening seizures. Less serious clonazepam side effects may include: * drowsiness, dizziness, spinning sensation; *memory problems; *tired feeling, muscle weakness, lack of balance or coordination; *slurred speech; *drooling or dry mouth, sore gums; * runny or stuffy nose; * loss of appetite, nausea, diarrhea, constipation; *blurred vision; *headache; * nervousness, sleep problems (insomnia); *skin rash; or *weight changes.

Interactions:

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by clonazepam. Tell your doctor if you regularly use any of these medicines, or any other seizure medications. Also tell your doctor if you are using any of the following drugs: *propantheline (Pro-Banthine); *an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); *an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; *a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); *an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or * medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

Warnings:

General Worsening of Seizures: When used in patients in whom several different types of seizure disorders coexist, Klonopin may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Klonopin may produce absence status. Laboratory Testing During Long-Term Therapy Periodic blood counts and liver function tests are advisable during long-term therapy with Klonopin. Risks of Abrupt Withdrawal The abrupt withdrawal of Klonopin, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Therefore, when discontinuing Klonopin, gradual withdrawal is essential. While Klonopin is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated. Caution in Renally Impaired Patients Metabolites of this medicine are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Hypersalivation this medicine may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions. Because of this and the possibility of respiratory depression, this medicine should be used with caution in patients with chronic respiratory diseases. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with clonazepam. The data currently available are not sufficient to determine the genotoxic potential of clonazepam. In a two-generation fertility study in which clonazepam was given orally to rats at 10 and 100 mg/kg/day (low dose approximately 5 times and 24 times the maximum recommended human dose of 20 mg/day for seizure disorder and 4 mg/day for panic disorder, respectively, on a mg/m2 basis), there was a decrease in the number of pregnancies and in the number of offspring surviving until weaning. Pregnancy Teratogenic Effects: Pregnancy Category D The effect of this medicine on labor and delivery in humans has not been specifically studied; however, perinatal complications have been reported in children born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena (see WARNINGS: Pregnancy Risks). Nursing Mothers Mothers receiving this medicine should not breastfeed their infants. Pediatric Use Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of this medicine is important in pediatric patients being treated for seizure disorder (see INDICATIONS and DOSAGE AND ADMINISTRATION). Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established. Geriatric Use Clinical studies of this medicine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Because clonazepam undergoes hepatic metabolism, it is possible that liver disease will impair clonazepam elimination. Metabolites of this medicine are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of this medicine and observed closely.

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