MEPROBAMATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Meprobamate (UNII: 9I7LNY769Q) (meprobamate - UNII:9I7LNY769Q)

제공처:

Dr.Reddy's Laboratories Limited

INN (International Name):

Meprobamate

구성:

Meprobamate 200 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Meprobamate tablets are indicated for the management of anxietydisorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usuallydo not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient. Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.

제품 요약:

Meprobamate Tablets USP 200 mg are white, round, biconvex tabletsdebossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100 and 1000. Bottles of 100: NDC 55111-640-01 Bottles of 1000: NDC 55111-640-10 Meprobamate Tablets USP 400 mg are white, round, biconvex tabletsdebossed with I and 4 on one side and bisect on the other. Supplied in bottles of 100 and 500. Bottles of 100: NDC 55111-641-01 Bottles of 500: NDC 55111-641-05 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled RoomTemperature]. Manufactu red by: In vaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Manufactured for: Dr. Reddy's Laboratories Inc., Bridgewater, NJ 08807 USA Rev: 05/09

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MEPROBAMATE- MEPROBAMATE TABLET
DR.REDDY'S LABORATORIES LIMITED
----------
MEPROBAMATE TABLETS
DESCRIPTION
Meprobamate is awhite powder with a characteristic odor and a
bittertaste. It is slightly soluble in
water, freely soluble in acetone andalcohol, and sparingly soluble in
ether. The structural formula of
meprobamate is:
C H N O M.W.218.25
Meprobamate Tablets USP 200 mg and 400 mg for oral
administrationcontain the following inactive
ingredients: microcrystalline cellulose,sodium starch glycolate,
pre-gelatinized starch, colloidal
silicondioxide, stearic acid and magnesium stearate.
CLINICAL PHARMACOLOGY
Meprobamate is a carbamate derivative which has been shown inanimal
studies to have effects at
multiple sites in the central nervoussystem including the thalamus and
limbic system.
INDICATIONS AND USAGE
Meprobamate tablets are indicated for the management of
anxietydisorders or for the short-term relief
of the symptoms of anxiety.Anxiety or tension associated with the
stress of everyday life usuallydo not
require treatment with an anxiolytic.
The effectiveness of meprobamate tablets in long-term use, that
is,more than 4 months, has not been
assessed by systematic clinicalstudies. The physician should
periodically reassess the usefulness ofthe
drug for the individual patient.
CONTRAINDICATIONS
Acute intermittent porphyria as well as allergic or
idiosyncraticreactions to meprobamate or related
compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.
WARNINGS
DRUG DEPENDENCE
Physical dependence, psychological dependence, and abuse haveoccurred.
When chronic intoxication
from prolonged use occurs, itusually involves ingestion of greater
than recommended doses and
ismanifested by ataxia, slurred speech, and vertigo. Therefore,
carefulsupervision of dose and amounts
9
18
2
4
prescribed is advised, as well asavoidance of prolonged
administration, especially for alcoholics
andother patients with a known propensity for taking excessive
quantitiesof drugs.
Sudden withdrawal of the drug after prolonged and exc