CLONAZEPAM tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Aidarex Pharmaceuticals LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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, USP 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 tablets, USP are 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 tablets, USP was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of

Produktsammanfattning:

Clonazepam Tablets, USP, for oral administration, are available as: 2 mg: Round, white, biconvex tablet, debossed “E” over “65” on one side and bisected on the other side and supplied as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Aidarex Pharmaceuticals LLC
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MEDICATION GUIDE
Clonazepam Tablets, USP CIV
(kloe-NAZ-eh-pam)
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 affects 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

Produktens egenskaper

CLONAZEPAM- CLONAZEPAM TABLET
AIDAREX PHARMACEUTICALS LLC
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CLONAZEPAM TABLETS, USP CIV
RX ONLY
DESCRIPTION
Clonazepam tablets, USP, for oral administration, contain 0.5 mg, 1 mg
or 2 mg clonazepam. In addition,
each tablet also contains the following inactive ingredients: corn
starch, lactose anhydrous, magnesium
stearate and microcrystalline cellulose with the following colorants:
0.5 mg - D&C yellow No. 10
aluminum lake; 1 mg - FD&C blue No. 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 reduction of the 7-nitro group to
the 4-amino derivative. This
derivative can be acetylated, hydroxylated and