CLONAZEPAM- clonazepam tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Major Pharmaceuticals

DCI (Dénomination commune internationale):

CLONAZEPAM

Composition:

CLONAZEPAM 0.5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Clonazepam Tablets, USP, for oral administration, are available as: 0.5 mg: Round, light yellow, biconvex tablet, debossed "E" over "63" on one side and bisected on the other. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC904-6101-61 1 mg: Round, light blue, biconvex tablet, debossed "E" over "64" on one side and bisected on the other. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6102-61 2 mg: Round, white, biconvex tablet, debossed "E" over "65" on one side and bisected on the other. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6103-61 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. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN .

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

CLONAZEPAM- CLONAZEPAM TABLET
Major Pharmaceuticals
----------
MEDICATION GUIDE
Clonazepam Tablets, USP CIV
(kloe-NAZ-eh-pam)
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

Résumé des caractéristiques du produit

CLONAZEPAM- CLONAZEPAM TABLET
MAJOR PHARMACEUTICALS
----------
CLONAZEPAM TABLETS, USP
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 glucuronid