Carisoprodol and Aspirin

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Overview

What is Carisoprodol and Aspirin?

Carisoprodol and Aspirin tablets, USP are a fixed-dose combination product containing the following two products:

It is available as a two-layered, Red and White, round tablet for oral administration.

Carisoprodol:

Aspirin:

Other ingredients in the Carisoprodol and Aspirin Tablets, drug product are Corn starch, FD&C Red # 40 Aluminum Lake, Hydroxypropyl Cellulose, Lactose Anhydrous, Microcrystalline Cellulose, Magnesium Stearate, Pregelatinized Starch, Sodium Starch Glycolate and Sodium Lauryl Sulfate.

What does Carisoprodol and Aspirin look like?

What are the available doses of Carisoprodol and Aspirin?

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What should I talk to my health care provider before I take Carisoprodol and Aspirin?

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How should I use Carisoprodol and Aspirin?

Carisoprodol and Aspirin is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and Aspirin should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see ).

The recommended dose of Carisoprodol and Aspirin tablets, is 1 or 2 tablets, four times daily in adults. One Carisoprodol and Aspirin tablet contains 200 mg of Carisoprodol and 325 mg of Aspirin. The maximum daily dose (i.e., two tablets taken four times daily) will provide 1600 mg of carisoprodol and 2600 mg of aspirin per day. The recommended maximum duration of Carisoprodol and Aspirin tablets use is up to two or three weeks.

What interacts with Carisoprodol and Aspirin?

Carisoprodol and Aspirin is contraindicated in patients with a history of:

- a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use
- aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other NSAIDs)
- hypersensitivity reaction to carbamate such as meprobamate
- acute intermittent prophyria

What are the warnings of Carisoprodol and Aspirin?

Carisoprodol:

Sedation

Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricylic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Drug Dependence, Withdrawal, and Abuse

Carisoprodol, and one of its metabolites, meprobamate (a controlled substance), may cause dependence (see ).

Aspirin:

Serious Gastrointestinal Adverse Reactions

What are the precautions of Carisoprodol and Aspirin?

Patients with impaired renal or hepatic function

Carisoprodol:

Seizures

Aspirin:

Adverse Reactions

Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery (see ).
Patients should be advised to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives (see ).
Patients should be advised that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Patients should be warned that aspirin can cause epigastric discomfort, gastric and duodenal ulcers, and serious GI adverse reactions, such as bleeding, perforation, and/or obstruction of the stomach or intestines, which may result in hospitalization and death. Although serious GI bleeding can occur without warning symptoms (e.g., hematemesis, melena, hematochezia), patients should be alert for these symptoms and should seek urgent medical care if any of these indicative symptoms occur (see ). In addition, patients should be alert for symptoms of ulcers (e.g., night time epigastric discomfort, vomiting, weight loss) and should seek medical attention if these symptoms occur. Patients who consume three or more alcoholic drinks every day should be counseled about the GI bleeding risks involved with the use of aspirin with alcohol.
Patients should be informed of the symptoms of an anaphylactoid reaction or anaphylaxis (e.g., hives, difficulty breathing, swelling of face or throat). If these symptoms occur, patients should be instructed to seek immediate emergency help.

Information for Patients:

Carisoprodol:

Aspirin:

Drug Interactions

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Aspirin:

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Antihypertensives:

Corticosteroids:

Methotrexate:

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Oral Hypoglycemics Agents:

Products that effect urinary pH:

Uricosuric Agents:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carisoprodol:

Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison.

The significance of these findings for human fertility is not known.

Aspirin:

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

Carisoprodol:

Teratogenic effects:

Nonteratogenic effects:

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What are the side effects of Carisoprodol and Aspirin?

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or .

The following adverse reactions which have occurred with the administration of the individual products alone may also occur with the use of Carisoprodol and Aspirin tablets. The following events have been reported during post-approval individual use of carisoprodol and aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Carisoprodol:

Cardiovascular:

Central Nervous System:

Gastrointestinal:

Hematologic:

Aspirin:

What should I look out for while using Carisoprodol and Aspirin?

Carisoprodol and Aspirin is contraindicated in patients with a history of:

Carisoprodol:

Sedation

Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricylic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Drug Dependence, Withdrawal, and Abuse

Carisoprodol, and one of its metabolites, meprobamate (a controlled substance), may cause dependence (see ).

Aspirin:

Serious Gastrointestinal Adverse Reactions

Anaphylaxis and Anaphylactoid Reactions

What might happen if I take too much Carisoprodol and Aspirin?

Signs and Symptoms:

Carisoprodol:

Aspirin:

Symptoms and signs of severe salicylate poisoning, associated with plasma salicylic concentrations greater that 400 g/mL, include hyperthermia, dehydration, delirium, GI hemorrhage, pulmonary edema, and CNS depression (e.g., coma). Death is usually due to respiratory failure or cardiovascular collapse.

Overdose of aspirin in pediatric patients:

Treatment of Overdosage:

contact a Poison Control Center

Carisoprodol:

Aspirin:

Additional treatment of aspirin overdose in pediatric patients:

How should I store and handle Carisoprodol and Aspirin?

Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with “CL” over “023” and plain on the white layer. The tablets are available in:Bottles of 100 NDC 52682-023-01.Bottles of 500 NDC 52682-023-03.Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with “CL” over “023” and plain on the white layer. The tablets are available in:Bottles of 100 NDC 52682-023-01.Bottles of 500 NDC 52682-023-03.

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Carisoprodol:

Aspirin:

Non-Clinical Toxicology

Carisoprodol and Aspirin is contraindicated in patients with a history of:

Carisoprodol:

Sedation

Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricylic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Drug Dependence, Withdrawal, and Abuse

Carisoprodol, and one of its metabolites, meprobamate (a controlled substance), may cause dependence (see ).

Aspirin:

Serious Gastrointestinal Adverse Reactions

Anaphylaxis and Anaphylactoid Reactions

Drug Interactions

Aspirin:

Antihypertensives:

Corticosteroids:

Methotrexate:

Oral Hypoglycemics Agents:

Products that effect urinary pH:

Uricosuric Agents:

Patients with impaired renal or hepatic function

Carisoprodol:

Seizures

Aspirin:

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or .

The following adverse reactions which have occurred with the administration of the individual products alone may also occur with the use of Carisoprodol and Aspirin tablets. The following events have been reported during post-approval individual use of carisoprodol and aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Carisoprodol:

Cardiovascular:

Central Nervous System:

Gastrointestinal:

Hematologic:

Aspirin:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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