CLORAZEPATE DIPOTASSIUM tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)

Disponibil de la:

Contract Pharmacy Services-PA

INN (nume internaţional):

CLORAZEPATE DIPOTASSIUM

Compoziție:

CLORAZEPATE DIPOTASSIUM 7.5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Clorazepate dipotassium tablets, USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets, USP are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets, USP in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets, USP are indicated for the symptomatic relief of acute alcohol withdrawal. Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

Rezumat produs:

Clorazepate dipotassium tablets, USP 7.5 mg are peach colored, round tablets, debossed with “ RX ” above the break-line and “ 553 ” below the break-line on one side and plain on the other side. They are supplied as follows: NDC 67046-904-07 blisterpacks of 7 NDC 67046-904-14 blisterpacks of 14 NDC 67046-904-15 blisterpacks of 15 NDC 67046-904-20 blisterpacks of 20 NDC 67046-904-21 blisterpacks of 21 NDC 67046-904-28 blisterpacks of 28 NDC 67046-904-30 blisterpacks of 30 NDC 67046-904-60 blisterpacks of 60 Clorazepate dipotassium tablets, USP 15 mg are red colored, round tablets debossed with “ RX ” above the break-line and “ 554 ” below the break-line on one side and plain on the other side. They are supplied as follows: NDC 67046-907-07 blisterpacks of 7 NDC 67046-907-14 blisterpacks of 14 NDC 67046-907-15 blisterpacks of 15 NDC 67046-907-20 blisterpacks of 20 NDC 67046-907-21 blisterpacks of 21 NDC 67046-907-28 blisterpacks of 28 NDC 67046-907-30 blisterpacks of 30 NDC 67046-907-60 blisterpacks of 60 Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20 - 25° C (68 - 77 ° F) [See USP Controlled Room Temperature]. Dispense in a USP tight, light–resistant container. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA September 2010

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Contract Pharmacy Services-PA
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MEDICATION GUIDE
CLORAZEPATE DIPOTASSIUM TABLETS, USP
Rx only
Read this Medication Guide before you start taking clorazepate
dipotassium 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.
What is the most important information I should know about clorazepate
dipotassium tablets, USP?
Do not stop taking clorazepate dipotassium tablets, USP without first
talking to your healthcare provider.
Stopping clorazepate dipotassium tablets, USP suddenly can cause
serious problems.
Clorazepate dipotassium tablets, USP can cause serious side effects,
including:
1. Clorazepate dipotassium tablets, USP can make you sleepy or dizzy
and can slow your thinking and
motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clorazepate dipotassium tablets, USP affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clorazepate dipotassium tablets, USP without first talking to your
healthcare provider. When taken
with alcohol or drugs that cause sleepiness or dizziness, clorazepate
dipotassium tablets, USP may
make your sleepiness or dizziness much worse.
2. Clorazepate dipotassium tablets, USP can cause abuse and
dependence.
•
Do not stop taking clorazepate dipotassium tablets, USP all of a
sudden. Stopping clorazepate
dipotassium tablets, USP suddenly can cause seizures that do not stop,
hearing or seeing things
that are not there (hallucinations), shaking, and stomach and muscle
cramps.
•
Talk to your doctor about slowly stopping clorazepate dipotassium
tablets, USP to avoid
getting sick with withdrawal symptoms.
•
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell
you more about the differences between physical dependence and drug
addiction.
Clorazepate dipotassium tablets, USP is a federally controlled
su

Caracteristicilor produsului

CLORAZEPATE DIPOTASSIUM- CLORAZEPATE DIPOTASSIUM TABLET
CONTRACT PHARMACY SERVICES-PA
----------
904 CLORAZEPATE 7.5 MG
907 CLORAZEPATE 15 MG
RX ONLY
DESCRIPTION
Chemically, clorazepate dipotassium is a benzodiazepine. The molecular
formula is C
H
ClK
N
O
; the molecular weight is 408.92; 1 _H_-1,
4-Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-
2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide
(1:1) and the structural formula
may be represented as follows:
The compound occurs as a light yellow, crystalline powder. It darkens
on exposure to light. It is
soluble in water but upon standing may precipitate from the solution,
slightly soluble in alcohol and in
isopropyl alcohol, practically insoluble in acetone, in benzene, in
chloroform, in ether and in methylene
chloride.
Clorazepate dipotassium tablets, USP contain either 3.75 mg, 7.5 mg or
15 mg of clorazepate
dipotassium, USP for oral administration.
Inactive ingredients for clorazepate dipotassium tablets, USP:
colloidal silicon dioxide, FD&C Blue
No. 2 aluminum lake (3.75 mg only), FD&C Yellow No. 6 aluminum lake
(7.5 mg only), FD&C Red No.
40 aluminum lake (15 mg only), magnesium oxide, magnesium stearate,
microcrystalline cellulose,
potassium carbonate, and potassium chloride.
CLINICAL PHARMACOLOGY
Pharmacologically, clorazepate dipotassium has the characteristics of
the benzodiazepines. It has
depressant effects on the central nervous system. The primary
metabolite, nordiazepam, quickly appears
in the blood stream. The serum half-life is about 2 days. The drug is
metabolized in the liver and
excreted primarily in the urine.
Studies in healthy men have shown that clorazepate dipotassium has
depressant effects on the central
nervous system. Prolonged administration of single daily doses as high
as 120 mg was without toxic
effects. Abrupt cessation of high doses was followed in some patients
by nervousness, insomnia,
irritability, diarrhea, muscle aches, or memory impairment.
Since orally administered clorazepate dipotassium is rapidly