CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 0.5 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 reestablish efficacy. Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. 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

Product summary:

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 30 NDC 66267-708-30 Bottles of 45 NDC 66267-708-45 Bottles of 56 NDC 66267-708-56 Bottles of 60 NDC 66267-708-60 Bottles of 90 NDC 66267-708-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No. : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 0533 0 667114 Issued April 2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals, Inc.
----------
Medication Guide
Clonazepam Tablets, USP
(kloe-NA-za-pam)
CIV
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 ear

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
CLONAZEPAM TABLETS, USP
CIV
RX ONLY
DESCRIPTION
Clonazepam, a benzodiazepine, is available as scored tablets debossed
with “1” and “2” containing 0.5
mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg
tablets and “C 2” on 2 mg tablets
containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous
lactose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose and starch (corn), with
the following colorants: 0.5 mg-
FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 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 occur