WARNINGS
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, corticosteroids 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.
PRECAUTIONS
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
Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery.
Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard.
Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions ).
Drug Interactions
Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin-containing drugs.
1. Oral Anticoagulants-By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants.
2. Methotrexate -aspirin enhances the toxic effects of this drug.
3. Probenecid and Sulfinpyrazone -large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced.
4. Oral Antidiabetic Drugs -enhancement of hypoglycemia may occur.
5. Antacids -to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase.
6. Ammonium Chloride -this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations.
7. Ethyl Alcohol -enhanced aspirin-induced fecal blood loss has been reported.
8. Corticosteroids -salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued.
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 pediatric patients below the age of twelve have not been established.
|
