CARISOPRODOL AND ASPIRIN- carisoprodol and aspirin tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

可用日期:

Rising Pharmaceuticals, Inc.

INN（国际名称）:

CARISOPRODOL

组成:

CARISOPRODOL 200 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Carisoprodol and Aspirin is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and Aspirin should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see DOSAGE AND ADMINISTRATION ). Carisoprodol and Aspirin is contraindicated in patients with a history of: - a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use - aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other NSAIDs) - hypersensitivity reaction to carbamate such as meprobamate - acute intermittent prophyria The efficacy, safety, and pharmacokinetics of carisoprodol and Aspirin in pediatric patients less than 16 years

產品總結:

Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with "CL" over "023" and plain on the white layer. The tablets are available in: Bottles of 100 NDC 64980-175-01. Bottles of 500 NDC 64980-175-05.

授权状态:

Abbreviated New Drug Application

产品特点

CARISOPRODOL AND ASPIRIN- CARISOPRODOL AND ASPIRIN TABLET
RISING PHARMACEUTICALS, INC.
----------
CARISOPRODOL AND ASPIRIN
TABLETS, USP
200 MG/325 MG
CIV
RX ONLY
DESCRIPTION
Carisoprodol and Aspirin tablets, USP are a fixed-dose combination
product containing the following
two products:
200 mg of carisoprodol, a centrally-acting muscle relaxant
325 mg of aspirin, an analgesic with antipyretic and anti-inflammatory
properties
It is available as a two-layered, Red and White, round tablet for oral
administration.
_CARISOPRODOL:_ Chemically, carisoprodol is
_N_-isopropyl-2-methyl-2-propyl-1,3propanediol dicarbamate
and its molecular formula is C
H N O , with a molecular weight of 260.33. The structural formula
of carisoprodol is:
_ASPIRIN:_ Chemically, aspirin (acetylsalicylic acid) is
2-(acetyloxy-, benzoic acid and its molecular
formula is C H O , with a molecular weight of 180.16. The structural
formula of aspirin is:
Other ingredients in the Carisoprodol ·and Aspirin Tablets, drug
product are Com starch, FD&C Red #
40 Aluminum Lake, Hydroxypropyl Cellulose, Lactose Anhydrous,
Microcrystalline Cellulose,
Magnesium Stearate, Pregelatinized Starch, Sodium Starch Glycolate and
Sodium Lauryl Sulfate.
CLINICAL PHARMACOLOGY
12
24
2
4
9
8
4
MECHANISM OF ACTION
_CARISOPRODOL:_ The mechanism of action of carisoprodol in relieving
discomfort associated with acute
painful musculoskeletal conditions has not been clearly identified. In
animal studies, muscle relaxation
induced by carisoprodol is associated with altered interneuronal
activity in the spinal cord and in the
descending reticular formation of the brain.
_ASPIRIN:_ The mechanism of action of aspirin in relieving pain is by
inhibition of the body's production of
prostaglandins, which are thought to cause pain sensations by
stimulating muscle contractions and
dilating blood vessels.
PHARMACODYNAMICS
_CARISOPRODOL:_ Carisoprodol is a centrally-acting muscle relaxant
that does not directly relax tense
skeletal muscles. A metabolite of carisoprodol, meprobamate, has
anx