CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonazepam 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, clonazepam 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 re-establish efficacy. Clonazepam 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 clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY :  Clinic

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Clonazepam Tablets, USP are available as: 0.5 mg: light yellow, flat-faced beveled edge tablets, scored, debossed "2530" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 15, 30, 45, 60, 90, 100, 120, 150, 500 and 1000. 1 mg: light blue, flat-faced beveled edge tablets, unscored, debossed "2531" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 15, 30, 45, 60, 90, 100, 120, 500 and 1000. 2 mg: white, flat-faced beveled edge tablets, unscored, debossed "2532" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 30, 60, 90, 100, 500 and 1000.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Read this Medication Guide before you start taking clonazepam tablets
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 can cause serious side effects. Because stopping
clonazepam tablets suddenly can
also cause serious problems, do not stop taking clonazepam tablets
without talking to your healthcare
provider first.
What is the most important information I should know about clonazepam
tablets?
Do not stop taking clonazepam tablets without first talking to your
healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems.
Clonazepam tablets can cause serious side effects, including:
1. Clonazepam tablets can slow your thinking and motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clonazepam tablets affect you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clonazepam tablets until you talk to your healthcare provider. When
taken with alcohol or drugs
that cause sleepiness or dizziness, clonazepam tablets may make your
sleepiness or dizziness
worse.
2. Like other antiepileptic drugs, clonazepam tablets 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 unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
CLONAZEPAM TABLETS, USP
0.5 MG, 1 MG AND 2 MG
CIV
RX ONLY
DESCRIPTION
Clonazepam Tablets USP, a benzodiazepine, is available as scored
tablets containing 0.5 mg of
clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam.
Each tablet also contains
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate,
magnesium stearate and
microcrystalline cellulose, with the following colorants: 0.5 mg –
D&C Yellow #10 aluminum lake; 1
mg – FD&C Blue #1 aluminum lake.
Chemically, clonazepam is
5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-benzodiazepin-2-one.
It is a
light yellow crystalline powder. It has a molecular weight of 315.72
and the following structural
formula:
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 reductio