CARISOPRODOL AND ASPIRIN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Avet Pharmaceuticals Inc.

INN (שם בינלאומי):

CARISOPRODOL

הרכב:

CARISOPRODOL 200 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carisoprodol and aspirin tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and aspirin tablets 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 tablets are 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 a carbamate such as meprobamate - acute intermittent porphyria Controlled Substance Carisoprodol and aspirin tablets contain carisoprodol, a Sche

leaflet_short:

Carisoprodol and aspirin tablets are round, convex, two-layered and debossed on the white layer with HP 145 and plain on the light lavender layer. The tablets are available in bottles of 100 (NDC 23155-145-01). Storage: Store at 20°- 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. MANUFACTURED FOR: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1-866-901-DRUG (3784) MF # 0214-05 Issued 10/13

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CARISOPRODOL AND ASPIRIN- CARISOPRODOL AND ASPIRIN TABLET
AVET PHARMACEUTICALS INC.
----------
CARISOPRODOL AND ASPIRIN TABLETS, USP FOR ORAL USE CIV RX ONLY
DESCRIPTION
Carisoprodol and aspirin tablets, USP is 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, white and lavender, round tablet for
oral administration.
_CARISOPRODOL:_ Chemically, carisoprodol is
N-isopropyl-2-methyl-2-propyl-1,3-propanediol 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 (acetylsalicyclic 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 drug product are
croscarmellose sodium, D&C
Red#30, FD&C Blue #1, magnesium stearate, microcrystalline cellulose,
povidone, starch, and stearic
acid.
CLINICAL PHARMACOLOGY
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
12
24
2
4
9
8
4
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 skeletal
muscles. A metabolite of carisoprodol, meprobamate, has anxiolytic and
sedative properties. The
degree to which these properties of meprob