CLONAZEPAM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Quality Care Products, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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-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 , Clinical

Ringkasan produk:

Clonazepam tablets 0.5 mg are available as yellow, round, single-scored tablets debossed "832" above the scored line and "TEVA" on the unscored side. Clonazepam tablets 1 mg are available as mottled green, round, single-scored tablets debossed "833" above the scored line and "TEVA" on the unscored side. 35356-722-30 35356-722-60 35356-722-90 Clonazepam tablets 2 mg are available as white to off-white, round, single-scored tablets debossed "834" above the scored line and "TEVA" on the unscored side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. P 9/2010

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Quality Care Products, LLC
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Medication Guide
Clonazepam Tablets, USP CIV
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 affect 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 unusual changes

Karakteristik produk

CLONAZEPAM- CLONAZEPAM TABLET
QUALITY CARE PRODUCTS, LLC
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CLONAZEPAM TABLETS, USP CIV
0832
0833
0834
RX ONLY
DESCRIPTION
Each single-scored tablet, for oral administration, contains 0.5 mg, 1
mg, or 2 mg clonazepam, a
benzodiazepine. Each tablet also contains lactose monohydrate,
magnesium stearate, microcrystalline
cellulose, povidone, purified water, and corn starch. Clonazepam
tablets 0.5 mg contain Yellow D&C
No. 10 Aluminum Lake. Clonazepam tablets 1 mg contain Yellow D&C No.
10 Aluminum Lake, as well
as FD&C Blue No. 1 Aluminum Lake.
Chemically, clonazepam is
5-(_o_-chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-benzodiazepin-2-one.
It is a
light yellow crystalline powder. It has the following structural
formula:
C
H ClN O M.W. 315.72
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
15
10
3
3
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