CLONAZEPAM- clonazepam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)

Available from:

Caraco Pharmaceutical Laboratories, Ltd.

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Seizure Disorders: Clonazepam tablets USP are 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, clonazepam tablets 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 efficacy. Panic Disorder: Clonazepam tablets USP are 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 Clonazepam tablets USP were established in two 6- to 9-week trials in panic disorder patients whose diagnoses correspon

Product summary:

Clonazepam Tablets USP, 0.5 mg are round, yellow colored, uncoated, flat face beveled edge tablets, scored and debossed ".5" on one side and ID code "273" on the other side, in bottles of 100 (NDC 57664-273-08), Bottles of 500 (57664-273-13) and Bottles of 1000 (NDC 57664-273-18). Clonazepam Tablets USP, 1 mg are round, blue colored, uncoated, flat face beveled edge tablets, scored and debossed "1" on one side and ID code "274" on the other side, in bottles of 100 (NDC 57664-274-08), Bottles of 500 (NDC 57664-274-13) and Bottles of 1000 (NDC 57664-274-18). Clonazepam Tablets USP, 2 mg are round, white colored, uncoated, flat face beveled edge tablets, scored and debossed "2" on one side and ID code "275" on the other side, in bottles of 100 (NDC 57664-275-08), Bottles of 500 (NDC-57664-275-13) and Bottles of 1000 (NDC 57664-275-18). Store at controlled room temperature 15° to 30°C (59° to 86°F). Dispense in tight, light resistant containers as defined in USP. Klonapin® is a registered trademark of Roche Pharmaceuticals.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Caraco Pharmaceutical Laboratories, Ltd.
----------
MEDICATION GUIDE
Clonazepam Tablets, USP
Read this Medication Guide before you start taking Clonazepam Tablets,
USP and each time you get a
refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your medical condition or treatment.
Clonazepam Tablets, USP can cause serious side effects. Because
stopping Clonazepam Tablets, USP
suddenly can also cause serious problems, do not stop taking
Clonazepam Tablets, USP without talking to
your healthcare provider first.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
CLONAZEPAM TABLETS, USP?
Do not stop taking Clonazepam Tablets, USP without first talking to
your healthcare provider.
Stopping Clonazepam Tablets, USP suddenly can cause serious problems.
Clonazepam Tablets, USP can cause serious side effects, including:
1. Clonazepam Tablets, USP can slow your thinking and motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
Clonazepam Tablets, USP affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
Clonazepam Tablets, USP until you talk to your healthcare provider.
When taken with alcohol or
drugs that cause sleepiness or dizziness, Clonazepam Tablets, USP may
make your sleepiness or
dizziness worse.
2. Like other antiepileptic drugs, Clonazepam Tablets, USP may cause
suicidal thoughts or actions in a
very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other un

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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CLONAZEPAM TABLETS, USP
CIV
RX ONLY
DESCRIPTION
Clonazepam USP is a benzodiazepine and is chemically designated as
5-(2-chlorophenyl)- 1,3-dihydro-
7-nitro-_2H_-1,4-benzodiazepine-2-one. It is a light yellow
crystalline powder. It has a molecular weight
of 315.72 and the following structural formula.
Each tablet for oral administration, contains 0.5 mg, 1 mg, or 2 mg of
clonazepam. In addition each tablet
contains the following inactive ingredients: Lactose Monohydrate,
Microcrystalline Cellulose,
Pregelatinized Starch, Magnesium Stearate, D&C Yellow No. 10 Aluminum
Lake (0.5 mg only), FD&C
Blue No.1 Aluminum Lake (1 mg only).
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
The precise mechanism by which clonazepam exerts its antiseizure and
antipanic effects is unknown,
although it is believed to be related to its ability to enhance the
activity of gamma aminobutyric acid
(GABA), the major inhibitory neurotransmitter in the central nervous
system. Convulsions produced in
rodents by pentylenetetrazol or, to a lesser extent, electrical
stimulation are antagonized, as are
convulsions produced by photic stimulation in susceptible baboons. A
taming effect in aggressive
primates, muscle weakness and hypnosis are also produced. In humans,
clonazepam is capable of
suppressing the spike and wave discharge in absence seizures (petit
mal) and decreasing the frequency,
amplitude, duration and spread of discharge in minor motor seizures.
_PHARMACOKINETICS_
Clonazepam is rapidly and completely absorbed after oral
administration. The absolute bioavailability
of clonazepam is about 90%. Maximum plasma concentrations of
clonazepam are reached within 1 to 4
hours after oral administration. Clonazepam is approximately 85% bound
to plasma proteins.
Clonazepam is highly metabolized, with less than 2% unchanged
clonazepam being excreted in the urine.
Biotransformation occurs mainly by reduction of the 7-nitro group to
the 4-amino derivative. This
derivative ca