equagesic- meprobamate and aspirin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

meprobamate (UNII: 9I7LNY769Q) (meprobamate - UNII:9I7LNY769Q), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)

Available from:

Mikart, Inc.

INN (International Name):

meprobamate and aspirin

Pharmaceutical form:

TABLET

Composition:

200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

As an adjunct in the short-term treatment of pain accompanied by tension and/or anxiety in patients with musculoskeletal disease. Clinical trials have demonstrated that in these situations relief of pain is somewhat greater than with aspirin alone.  Equagesic is not intended for use longer than 10 days. Usage in Pregnancy and Lactation An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide, and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. Because of the known effect of non-steroidal anti-inflammatory drugs (NSAIDs) on the fetal cardiovascular system (closure of the ductus arteriosus), use during the third trimester of pregnancy should be avoided. Salicylate products have also been associated with alterations in maternal and neonatal hemostasis mechanisms, decreased birth weight, a

Product summary:

Equagesic® (meprobamate and aspirin tablets) Tablets, 200 mg meprobamate and 325 mg aspirin, are available as follows: NDC 10551-091-10, pink and yellow, double-layer, round, scored tablet marked “LP” and “91”, in bottles of 100 tablets.   Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from moisture. Keep tightly closed. Protect from light. Dispense in light-resistant, tight container. Manufactured for: Leitner Pharmaceuticals™, LLC Bristol, TN 37620 www.leitnerpharma.com Manufactured by: Mikart, Inc . Atlanta, GA 30318 1019A00 09/06 1-0047-1

Summary of Product characteristics

EQUAGESIC- MEPROBAMATE AND ASPIRIN TABLET
MIKART, INC.
----------
EQUAGESIC ® (MEPROBAMATE AND ASPIRIN TABLETS) CIV
Code 1019A00
Rev. 09/06
1-0047-1
Rx only
DESCRIPTION
Each tablet of Equagesic, for oral administration, contains 200 mg
meprobamate and 325 mg aspirin.
Chemically, meprobamate is 2-methyl-2-propyl-1,3- propanediol
dicarbamate. Its molecular formula is
C H N O with a molecular weight of 218.25.
Chemically, aspirin is benzoic acid 2-(acetyloxy)-. Its molecular
formula is C H O with a molecular
weight of 180.16. It occurs as an odorless white, needle like
crystalline or powdery substance. When
exposed to moisture, aspirin hydrolyzes into salicylic and acetic
acids, and gives off a vinegary odor. It
is highly lipid soluble and slightly soluble in water. The structural
formulas of meprobamate and aspirin
are:
MEPROBAMATE
ASPIRIN
The inactive ingredients present are D&C Yellow 10, FD&C Red 3, FD&C
Yellow 6, hydrogenated
vegetable oil, magnesium stearate, microcrystalline cellulose,
polacrilin potassium, and starch.
CLINICAL PHARMACOLOGY
Meprobamate is a carbamate derivative which has been shown (in animal
and/or human studies) to have
effects at multiple sites in the central nervous system, including the
thalamus and limbic system. Aspirin
is a nonnarcotic analgesic with antipyretic and anti-inflammatory
properties.
INDICATIONS AND USAGE
9
18
2
4
9
8
4
As an adjunct in the short-term treatment of pain accompanied by
tension and/or anxiety in patients with
musculoskeletal disease. Clinical trials have demonstrated that in
these situations relief of pain is
somewhat greater than with aspirin alone. Equagesic is not intended
for use longer than 10 days.
CONTRAINDICATIONS
USAGE IN PREGNANCY AND LACTATION
AN INCREASED RISK OF CONGENITAL MALFORMATIONS ASSOCIATED WITH THE USE
OF MINOR TRANQUILIZERS
(MEPROBAMATE, CHLORDIAZEPOXIDE, AND DIAZEPAM) DURING THE FIRST
TRIMESTER OF PREGNANCY HAS
BEEN SUGGESTED IN SEVERAL STUDIES. BECAUSE USE OF THESE DRUGS IS
RARELY A MATTER OF URGENCY, THEIR
USE DURING THIS PERIOD SHOU