This is a combination product containing Carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic, and anti-inflammatory properties. It is available as a two layered, white and light lavender round tablet for oral administration. Chemically, Carisoprodol is N-isopropyl-2-methyl-2-propyl- 1,3-propanediol dicarbamate. Its empirical formula is C₁₂H₂₄N₂O₄, with a molecular weight of 260.33.

Chemically, aspirin is benzoic acid, 2-(acetyloxy)-. Its empirical formula is C₉H₈O₄ with a molecular weight of 180.16. The structural formula is:

Each tablet for oral administration contains Carisoprodol 200 mg and Aspirin 325 mg.

Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #30, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid and other ingredients.

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).

Tablets containing Carisoprodol 200 mg and Aspirin 325 mg are white and light lavender colored, double layered round shape, unscored debossed with "Par 246". Available in bottles of 100 (NDC 49884-246-01), 500 (NDC 49884-246-05), 1000 (NDC 49884-246-10).

Storage: Store at controlled room temperature 15°C -30°C (59°F -86°F) protect from moisture.

Manufactured by:
PAR PHARMACEUTICAL, INC.
Spring Valley, NY 10977

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

The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination.

Carisoprodol

Central Nervous System: Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope and insomnia have been infrequent or rare.

Idiosyncratic: Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS).

Allergic: Skin rash, erythema multiforme, pruritus, eosinophilia and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue Carisoprodol and Aspirin Tablets and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients.

Cardiovascular: Tachycardia, postural hypotension and facial flushing.

Gastrointestinal: Nausea, vomiting, epigastric distress and hiccup.

Hematologic: No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible.

Aspirin

The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE).

Aspirin Intolerance: Allergic type reactions in aspirin-sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma, and the latter may consist of uticaria, edema, rash or angioedema (giant hives). These may occur independently or in combination.

DRUG ABUSE AND DEPENDENCE

Abuse: In clinical use, abuse has been rare.

Dependence: In clinical use, dependence with Carisoprodol and Aspirin Tablets have been rare and there have been no reports of significant abstinence signs. Nevertheless, the following information on the individual ingredients should be kept in mind.

Carisoprodol: In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. In a study in man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chills, headache and nausea. Delirium and convulsions did not occur (see PRECAUTIONS).

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 the 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 Drug - 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. Corticosteriods - salicylate plasma levels may be decreased when adrenal corticosteriods are given, and may be increased substantially when they are discontinued.

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.

Signs and Symptoms

Any of the following which have been reported with the individual ingredients may occur and may be modified to a varying degree by the effects of the other ingredients present in Carisoprodol and Aspirin Tablets.

Carisoprodol: Stupor, coma, shock, respiratory depression and very rarely, death. Overdosage with carisoprodol in combination with alcohol, other CNS depressants, or psychotropic agents can have additive effects, even when one of the agents has been taken in the usually recommended dosage.

Aspirin: Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating and occasionally diarrhea are characteristic of mild to moderate salicylate poisoning. Salicylate poisoning should be considered in children with symptoms of vomiting, hyperpnea, and hyperthermia.

Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at plasma levels above 50 mg/dl. These respiratory changes eventually lead to serious acid-base disturbances, Metabolic acidosis is a constant finding in infants but occurs in older children only with severe poisoning; adults usually exhibit respiratory alkalosis initially and acidosis terminally.

Other symptoms of severe salicylate poisoning include hyperthermia, dehydration, delirium and mental disturbances. Skin eruptions, GI hemorrhage, or pulmonary edema are less common.

Early CNS stimulation is replaced by increasing depression, stupor, and coma. Death is usually due to respiratory failure or cardiovascular collapse.

Treatment

General: Provide symptomatic and supportive treatment, as indicated. Any drug remaining in the stomach should be removed using appropriate procedures and caution to protect the airway and prevent aspiration, especially in the stuporous or comatose patient. Incomplete gastric emptying with delayed absorption of carisoprodol has been reported as a cause for relapse. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants and pressor agents should be administered cautiously as indicated.

Carisoprodol: The following have been used successfully in overdosage with the related drug meprobamate: diuretics, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis (see CLINICAL PHARMACOLOGY). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Carisoprodol can be measured in biological fluid by gas chromatography (Douglas, J.F., et al: J Pharm Sci 58: 145, 1969).

Aspirin: Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate and prevent or reduce further absorption; to correct any fluid electrolyte or metabolic imbalance; and to provide general and cardiorespiratory support. If acidosis is present, intravenous sodium bicarbonate must be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range. To enhance elimination, forced diuresis and alkalinization of the urine may be beneficial. The need for hemoperfusion or hemodialysis is rare and should be used only when other measures have failed.

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

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 non-narcotic analgesic with anti-inflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its anti-inflammatory 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.

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 INTERATIONS).

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CARISOPRODOL/ASPIRIN - ORAL

(kar-iss-oh-PRO-dole/ASP-er-in)

COMMON BRAND NAME(S): Soma Compound

USES: This medication is a combination of carisoprodol and aspirin. It provides temporary relief of pain and discomfort from muscle injuries such as strains, sprains, and spasms. It is usually used along with rest, physical therapy, and other treatments.

Carisoprodol relaxes tight muscles and relieves pain, cramping, and stiffness so you can move around more and get back to doing your daily activities. Carisoprodol belongs to a class of drugs called muscle relaxants. Aspirin helps decrease pain and swelling.

HOW TO USE: Take this medication by mouth, usually 4 times a day or as directed by your doctor.

Take with food or milk if stomach upset occurs.

Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug.

The dosage is based on your medical condition and response to therapy.

Carisoprodol may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., stomach cramps, trouble sleeping, headache, nausea) may occur if you suddenly stop this drug. To prevent withdrawal when stopping extended/regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach upset, headache, drowsiness, dizziness, lightheadedness, or flushing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, hearing problems (e.g., ringing in the ears), fast heartbeat, difficult/painful swallowing.

Sometimes carisoprodol may cause a very rare but serious reaction that occurs within minutes or hours of the first dose of this medication. Stop taking this medication and seek immediate medical attention if any of these symptoms occur: unable to move arms/legs, shaky/unsteady movement, loss of balance, joint pain, mental/mood changes (e.g., agitation, confusion, unexplained mood swings), vision problems (e.g., blurred vision, double vision, loss of vision), extreme weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody/tarry stools, easy bruising/bleeding, persistent nausea/vomiting, severe stomach/abdominal pain, change in amount/color of urine, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to carisoprodol or aspirin; or to related medications such as meprobamate, tybamate, NSAIDs such as ibuprofen or naproxen, or other salicylates such as salsalate; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding/clotting problems (e.g., coagulopathy, bleeding peptic ulcers), certain genetic blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, certain genetic conditions (G6PD deficiency, pyruvate kinase deficiency), gout, growths in the nose (nasal polyps), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., fast/irregular heartbeat, heart failure), high blood pressure, kidney disease, liver disease, stomach/intestine/esophagus problems (e.g., bleeding, heartburn, ulcers).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages.

To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and problems with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: cidofovir, ketorolac, mifepristone, flu vaccine given in the nose.

If you are currently using any of these medications listed above or received the flu vaccine in the last month, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-platelet drugs (e.g., clopidogrel), "blood thinners" (e.g., heparin, warfarin), bisphosphonates taken by mouth (e.g., alendronate), carbonic anhydrase inhibitors (e.g., acetazolamide), corticosteroids (e.g., prednisone), cyclosporine, drugs for diabetes (e.g., insulin, sulfonylureas such as glipizide), drugs for gout (e.g., probenecid, sulfinpyrazone), drugs for high blood pressure (e.g., ACE inhibitors such as captopril/lisinopril, angiotensin II receptor blockers such as as losartan, and beta blockers such as metoprolol), drugs that change the acidity of urine (e.g., antacids, citrates, sodium bicarbonate, high doses of vitamin C/ascorbic acid), lithium, methotrexate, NSAIDs and other salicylates (e.g., ibuprofen, naproxen, salsalate), pemetrexed, SSRI antidepressants (e.g., fluoxetine, paroxetine), "water pills" (diuretics such as furosemide, hydrochlorothiazide).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that are similar to the aspirin in this product. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms may include: ringing in ears, confusion, fast/irregular heartbeat, seizures, loss of consciousness.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., complete blood count, kidney/liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.