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CARISAVA

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our Analgesic range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as CARISAVA which contains Carisoprodol USP.....350mg.


 


 

CARISAVA

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Details

 Each Uncoated Tablet contains:

Carisoprodol USP.....350mg

Excipients     Q.S.

DESCRIPTION

White colour, circular shaped, flat beveled edged, uncoated tablet bisected on one side and plain on other side.

CLINICAL PHARMACOLOGY

Carisoprodol is a centrally acting skeletal 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. Carisoprodol is metabolized in the liver and is excreted by the kidneys. One of the products of metabolism, meprobamate, is active as an anxiolytic. The degree to which it contributes to the efficacy of carisoprodol is unknown. Carisoprodol is dialyzable by peritoneal and hemodialysis.

 INDICATIONS

Carisoprodol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

CONTRAINDICATIONS

Carisoprodol is contraindicated in patients with acute intermittent porphyria, and in patients who are allergic to or who have had idiosyncratic reactions to carisoprodol or meprobamate related compounds.

WARNINGS

Potentially Hazardous Tasks -- Patients should be warned that carisoprodol may have sedative properties and 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. Drug Dependence, Withdrawal and Abuse - In postmarketing experience, cases of drug abuse, dependence and withdrawal have been reported. Carisoprodol should be used with caution in addiction-prone individuals.

 

Allergic Reactions -- Occasionally, within the period of the first to fourth dose of carisoprodol allergic reactions have occurred in patients who have had no previous contact with the drug. Skin rash, erythema multiform, pruritus, eosinophilia, and fixed drug eruption have been reported with Carisoprodol with cross reaction to meprobamate.Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock.

Usage in Pregnancy and Lactation The safety of this drug in pregnancy or lactation has not been established. Therefore, use of this drug in pregnancy, in nursing mothers, or in women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to mother and child. Carisoprodol is present in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. This factor should be taken into account when use of the drug is contemplated in breast-feeding patients.

Usage in Children --The efficacy and safety of carisoprodol in patients under 12 years of age has not been determined.

PRECAUTIONS

Seizure Disorders: There have been rare reports of seizures in postmarketing

surveillance in temporal association with carisoprodol. These events have involved patients with and without previous medical histories of seizures and have occurred during therapeutic   use, with overdose and during withdrawal from prolonged use. The role of carisoprodol in the causality of these seizures has not been established.

Carisoprodol is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function.

ADVERSE REACTIONS

Cardiovascular --Tachycardia, postural hypotension, and facial flushing.

Central Nervous System --Drowsiness and other CNS effects may require dosage reduction. Also observed: dizziness, vertigo, ataxia, tremor, agitation, irritability,headache, depressive reactions, syncope, seizures, and insomnia.

Gastrointestinal --Nausea, vomiting, hiccup, and epigastric distress.

Hematologic --Leukopenia, in which other drugs or viral infection may have been

responsible, and pancytopenia, attributed to phenylbutazone, have been reported. No serious blood dyscrasias have been attributed to carisoprodol.

OVERDOSAGE

Over dosage of Carisoprodol produces CNS depression, and in severe cases coma. Shock,respiratory depression, seizures and death have also been reported rarely. The following signs and symptoms may be associated with carisoprodol overdosage: horizontal and vertical nystagmus, blurred vision, mydriasis, mild tachycardia and hypotension,respiratory depression, euphoria, CNS stimulation, muscular incoordination, and/or rigidity, confusion, headache, hallucinations, and dystonic reactions. The effects of an overdosage of carisoprodol and alcohol or other CNS depressants or psychotropic agents can be additive even when one of the drugs has been taken in the usual recommended dosage. Fatal accidental and non-accidental overdoses have been reported alone or in combination with alcohol or psychotropic drugs.

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation. Induced emesis is not recommended due to the risk of CNS and respiratory depression. Gastric lavage should be considered soon after ingestion (usually within 1 hour.) In cases of severe CNS depression, airway protective reflexes may be compromised. In such cases, tracheal intubation should be considered for airway protection and respiratory support. Circulatory support should be administered with volume infusion and pressor agents as indicated. Seizures should be treated with a benzodiazepine IV and may be followed with phenobarbital if seizures recur.

Carisoprodol is metabolized in the liver and excreted by the kidney. The following types of treatment have been used successfully with the related drug meprobamate: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is dialyzable). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. Carisoprodol can be measured in biological fluids by gas chromatography.

DOSAGE AND ADMINISTRATION

The usual adult dosage of Carisoprodol Tablets, USP is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended.

Packeging- Available in blister of 10.

Storage: Store in cool dry place .Protect from light.

 

 

 

 

 
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