Carisoprodol (Soma)

Trade Name : Soma

Meda Pharmaceuticals

TABLET

Strength 350 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Carisoprodol (Soma) which is also known as Soma and Manufactured by Meda Pharmaceuticals. It is available in strength of 350 mg/1 per ml. Read more

Carisoprodol (Soma) 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. Read less

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About GNH

No data

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
SOMA 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 [].
SOMA is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. n n n n

u2022
(1)

The recommended dose of SOMA is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of SOMA use is up to two or three weeks.

u2022
(2)

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350
Tablets: 250 mg, 350 mg n

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

No data

(5.2,n- 9.2,n- 9.3)

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache
u00a0
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

No data

No data

Clinical Presentation
Overdosage of SOMA 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 SOMA overdosage. Serotonin syndrome has been reported with carisoprodol intoxication. 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 SOMA have been reported alone or in combination with CNS depressants.
Treatment of Overdosage
Basic life support measures should be instituted as dictated by the clinical presentation of the SOMA overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration. Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway.
For more information on the management of an overdose of SOMA, n

SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, 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 (u00b1)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is CHNO, with a molecular weight of 260.33. The structural formula is:
Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.

No data

No data

The safety and efficacy of SOMA 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 (u2264 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 pulposus, 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 three treatment groups (i.e., SOMA 250 mg, SOMA 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., SOMA 250 mg or placebo). In both studies, 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 SOMA 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.
Patients treated with SOMA experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250; available in bottles of 100 (NDC 0037-2250-10) and bottles of 30 (NDC 0037-2250-30).
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350; available in bottles of 100 (NDC 0037-2001-01).
Storage

Patients should be advised to contact their physician if they experience any adverse reactions to SOMA.
Sedation
Advise patients that SOMA may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking SOMA before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [].
Avoidance of Alcohol and Other CNS Depressants
Advise patients to avoid alcoholic beverages while taking SOMA and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [].
SOMA Should Only Be Used for Short-Term Treatment
Advise patients that treatment with SOMA 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 SOMA, 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.
Lactation
Advise nursing mothers using SOMA to monitor neonates for signs of sedation n
SOMA and MEDA PHARMACEUTICALS are registered trademarks of MEDA AB or a related entity.
Manufactured for:n Somerset, New Jersey 08873-4120
SOMA is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company
u00a92019 Mylan Specialty LP
IN-90H2-22
Revised: 3/2019500491-04

NDC 0037-2250-30
30 Tablets
Soma CIVn
Rx Only
MEDA
Package circular attached.
Usual adult dosage: 1 tabletthree times daily and at bedtime.
Dispense in tight container.Store at controlled roomtemperature 20u00b0-25u00b0C (68u00b0-77u00b0F).
Meda Pharmaceuticals Inc.Somerset, NJ 08873-4120
LB-90H2-14u00a0u00a0u00a0u00a0u00a0Rev. 5/2018400940-01

NDC 0037-2001-01
100 Tablets
Soma CIVn
Rx Only
MEDA
Please see enclosed full Prescribing Information.
Dispense in tight container.Store at controlled room temperature 20u00b0-25u00b0C (68u00b0-77u00b0F).
Meda Pharmaceuticals Inc.Somerset, NJ 08873-4120
LB-90G6-05u00a0u00a0u00a0u00a0u00a0Rev. 5/2018400939-01

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Carisoprodol (Soma)

Trade Name : Soma

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Carisoprodol (Soma)

Trade Name : Soma

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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