Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Equagesic should be prescribed cautiously and in small quantities to patients with suicidal tendencies.
Additive Effects: Since CNS-suppressant effects of meprobamate and alcohol or meprobamate and other psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously.
Alcohol Warning: Patients who consume three or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
Coagulation Abnormalities: Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders.
Gastrointestinal Side Effects (GI): GI side effects include gross GI bleeding, heartburn, nausea, stomach pain, and vomiting. Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms. Physicians should inform patients about the signs and symptoms of GI side effects and what steps to take if they occur.
Peptic Ulcer Disease: Patients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding.
Potentially Hazardous Tasks
Patients should be warned that meprobamate may impair the mental and/or physical abilities required for performance of potentially hazardous tasks, such as driving a motor vehicle or operating machinery. Such tasks should be avoided while taking this product.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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, and perinatal mortality. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. Meprobamate passes the placental barrier. It is present both in umbilical-cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breast-feeding patients, the drug’s higher concentrations in breast milk as compared to maternal plasma levels should be considered.
Equagesic is contraindicated in patients with acute intermittent porphyria and in patients with allergic or idiosyncratic reactions to aspirin, meprobamate, or related compounds, such as carbromal, carisoprodol, mebutamate, nonsteroidal anti-inflammatory drug products, salicylates, or tybamate. Equagesic is also contraindicated in patients with the syndrome of asthma, rhinitis, and nasal polyps. The aspirin component of Equagesic may cause severe angioedema, bronchospasm (asthma), or urticaria. Reye’s syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses.
There is currently no drug history available for this drug.
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 C9H18N2O4 with a molecular weight of 218.25.
Chemically, aspirin is benzoic acid 2-(acetyloxy)-. Its molecular formula is C9H8O4 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:
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.