On very rare occasions, the first dose of carisoprodol has been followed by an idiosyncratic reaction with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue Carisoprodol and Aspirin Tablets and initiate appropriate supportive and symptomatic therapy which may include epinephrine and/or antihistamines. In severe cases, corticosteriods may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness angioneurotic edema, smarting eyes, hypotension and anaphylactoid shock.

The effects of carisoprodol with agents such as alcohol, other CNS depressants, or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who may take one or more of these agents simultaneously with Carisoprodol and Aspirin Tablets.

General

To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use Carisoprodol and Aspirin Tablets with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY).

Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy and in addiction-prone individuals.

Information for Patients

See PATIENT INFORMATION section.

Drug Interactions

See DRUG INTERATIONS section.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been done with Carisoprodol and Aspirin Tablets.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with Carisoprodol and Aspirin Tablets. It is also not known whether Carisoprodol and Aspirin Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Carisoprodol and Aspirin Tablets should be given to a pregnant woman only if clearly needed.

Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation, in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring.

Labor and Delivery

Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus or neonate.

Nursing Mothers

Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma. Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children below the age of twelve have not been established.

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