CARISOPRODOL (CARISOPRODOL)

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Trade Name: CARISOPRODOL

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 350 mg/1

Storage and handling

CARISOPRODOL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Warnings and Precautions, Sedationn n n 10/2009n nn
Warnings and Precautions, Drug Dependence, Withdrawal, and Abusen n n 10/2009n nn

CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. CARISOPRODOL 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. [n n n ].n nn
CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. n n n n n Important Limitations:n nn

Should only be used for acute treatment periods up to two or three weeksn n n n
Not recommended in pediatric patients less than 16 years of agen n n n

The recommended dose of CARISOPRODOL is 350 mg three times a day and at bedtime. The recommended maximum duration of CARISOPRODOL use is up to two or three weeks.

Recommended dose is 350 mg three times a day and at bedtime.n n n n

350 mg Tablets: White to off white, round convex tablets, debossed with u2018CLu2019 above u2018022u2019
Tablets: 350 mg n n n n

CARISOPRODOL is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

Acute intermittent porphyria n n n n
Hypersensitivity reactions to a carbamate such as meprobamate n n n n

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Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery n n n n
Additive sedative effects when used with other CNS depressants including alcohol n n n n
Cases of Drug Dependence, Withdrawal, and Abuse n n n n
Seizures n n n n

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache n n n n
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals at 1-201-961-9000 or FDA at 1-800-FDA-1088 or n n n n

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CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) u2013 additive sedative effects (n n n and n n n )nttttttn n n

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CARISOPRODOL is not a controlled substance [n n n ].n nn
Discontinuation of carisoprodol in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human carisoprodol dependence.
In vitro

Overdosage of CARISOPRODOL commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with CARISOPRODOL overdosage. Many of the CARISOPRODOL overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of CARISOPRODOL and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of CARISOPRODOL have been reported alone or in combination with CNS depressants.
Treatment of Overdosage:
The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of CARISOPRODOL: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of CARISOPRODOL,n n n n

CARISOPRODOL Tablets are available as 350 mg round, white to off white, tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is Cn n n Hn n n Nn n n On n n , with a molecular weight of 260.33. The structural formula is: n nn
Other ingredients in the CARISOPRODOL drug product include Hydroxypropyl cellulose, Lactose Anhydrous, Microcrystalline cellulose, Magnesium stearate, Pregelatinised starch, Sodium lauryl sulfate and Sodium starch glycolate.

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Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.
CARISOPRODOL was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the n n n 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 n n n 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 n n n strains with or without metabolizing enzymes, and was not clastogenic in an n n n mouse micronucleus assay of circulating blood cells.n nn
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.

The safety and efficacy of carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (< 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation.
Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.
In Study 1, patients were randomized to one of two treatment groups (i.e., CARISOPRODOL 350 mg, or placebo). In the study, patients received study medication three times a day and at bedtime for seven days.
The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day #3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the CARISOPRODOL 250 mg and placebo groups in both studies. The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.
The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.

350 mg Tablets: White to off white, Round convex tablets, debossed with u2018CLu2019 above u2018022u2019 on one side available in:
Bottles of 20 NDC 66267-043-20.
Bottles of 30 NDC 66267-043-30.
Bottles of 60 NDC 66267-043-60.
Bottles of 90 NDC 66267-043-90.
Bottles of 120 NDC 66267-043-120.
Storage:

Patients should be advised to contact their physician if they experience any adverse reactions to CARISOPRODOL.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of CARISOPRODOL (CARISOPRODOL) which is also known as CARISOPRODOL and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 350 mg/1.

CARISOPRODOL (CARISOPRODOL) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.