DailyMed Label: Carisoprodol and Aspirin

DailyMed Label: Carisoprodol and Aspirin

2010

DailyMed Prescription

Carisoprodol and Aspirin

Carisoprodol and Aspirin

Rebel Distributors Corp

NDC: 21695-570

NDC: 21695-570

Carisoprodol and Aspirin Tablets, USP is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and antiinflammatory properties. Chemically, carisoprodol is ( + )-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone. Its molecular formula is C 12 H 24 N 2 0 4 , with a molecular weight of 260.34. The structural formula is: Chemically, aspirin is salicylic acid acetate. It can appear as white crystals, commonly tabular or needle-like, or white crystalline powder. It is odorless or has a faint odor. It is slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether.  Its molecular formula is C 9 H 8 0 4 , with a molecular weight of 180.16. The structural formula is: Each tablet, for oral administration, contains 200 mg of carisoprodol and 325 mg of aspirin. In addition, each tablet contains the following inactive ingredients: Colloidal silicon dioxide, corn starch, croscarmellose sodium, FD and C Blue #1, D and C #30 Aluminum Lake, magnesium stearate, microcrystalline cellulose, povidone, and stearic acid. image of structural formula image of aspirin formula

Carisoprodol and Aspirin Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions.

Usual Adult Dosage: 1 or 2 tablets, four times daily. Not recommended for use in children under age twelve (see PRECAUTIONS) .

Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, or related compounds.

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. 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). 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. No long-term studies have been done with Carisoprodol and Aspirin Tablets. 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. Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus, or neonate. 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. Safety and effectiveness in pediatric patients below the age of twelve have not been established.

  If severe reactions occur, discontinue Carisoprodol and Aspirin Tablets and initiate appropriate symptomatic and supportive therapy.

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.

Tablets containing Carisoprodol 200 mg and Aspirin 325 mg are white and light lavender colored with double layered round shape, unscored debossed with E724 and are available as follows 21695-570-30 Bottle of 30 21695-570-60 Bottle of 60 Store at controlled room temperature 15°C - 30°C (59°F - 86°F) protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Manufactured for Sandoz Inc. Princeton, NJ 08540 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Carisoprodol: Carisoprodol is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours. Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis. Aspirin: Aspirin is a nonnarcotic analgesic with antiinflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its antiinflammatory and for at least part of its analgesic and antipyretic properties. Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolites. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions) and is reduced by renal dysfunction.

30 Tablets NDC 21695-570-30 Carisoprodol and Aspirin Tablets, USP Rx Only 200mg/325mg Each Tablet Contains: Carisoprodol 200mg Aspirin 325mg Carisoprodol 20mg/Aspirin 325mg