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What is Soma?

Soma is a tradition drug used to treat the symptoms of musculoskeletal pain. Soma may be used alone or with other specifics.

Soma belongs to a class of medicines called Cadaverous Muscle Relaxants.

It isn't known if Soma is safe and effective in children youngish than 16 times old. Soma isn't recommended for senior cases.

What are the possible side goods of Soma?

Soma may beget serious side goods including

· seizure ( storms),

. · agitation,

. · visions,

. · fever,

. · sweating,

. · shivering,

. · fast heart rate,

. · muscle stiffness,

. · shuddering,

. · loss of collaboration,

. · nausea,

. · vomiting, and

. · diarrhea

The most common side goods of Soma include

· doziness,

. · dizziness, and

. · headache

Tell the croaker if you have any side effect that bothers you or that doesn't go down.

These aren't all the possible side goods of Soma. For further information, ask your croaker or druggist.

DESCRIPTION

SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, liquid greasepaint, having a mild, characteristic odor and a bitter taste.

Other constituents in the SOMA medicine product include alginic acid, magnesium stearate, potassium sorbate, bounce, and tribasic calcium phosphate.

Suggestions & Lozenge

Suggestions

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in grown-ups.

Limitation Of Use

SOMA should only be used for shortages (up to two or three weeks) because acceptable substantiation of effectiveness for further dragged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. ( see DOSAGE AND ADMINISTRATION.

Lozenge AND ADMINISTRATION

The recommended cure of SOMA is 250 mg to 350 mg three times a day and at bedtime. The recommended outside duration of SOMA use is over to two or three weeks.

250 mg Tablets round, convex, white tablets, inscribed with SOMA 250

.350 mg Tablets round, convex, white tablets, inscribed with SOMA 350

Storage And Handling

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).

SIDE EFFECTS

Clinical Studies Witness

Because clinical studies are conducted under extensively varying conditions, adverse response rates observed in clinical studies of a medicine can not be directly compared to rates in the clinical studies of another medicine and may not reflect rates observed in practice.

The data described below are grounded on 1387 cases pooled from two double-eyeless, randomized, multicenter, placebo-controlled, one-week trials in adult cases with acute, mechanical, lower aft pain ( see Clinical Studies). In these studies, cases were treated with 250 mg of SOMA, 350 mg of SOMA, or placebo three times a day and at bedtime for seven days. The mean age was about 41 times old with 54 ladies and 46 males and 74 Caucasian, 16 Black, 9 Asian, and 2 other.

There were no deaths and there were no serious adverse responses in these two trials. In these two studies,2.7, 2, and5.4, of cases treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, independently, discontinued due to adverse events; and0.5,0.5, and1.8 of cases treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, independently, discontinued due to central nervous system adverse responses.

Table 1 displays adverse responses reported with frequentness lesser than 2 and further constantly than placebo in cases treated with SOMA in the two trials described over.

Central Nervous System

Doziness, dizziness, vertigo, ataxia, earthquake, agitation, perversity, headache, depressive responses, blackout, wakefulness, and seizures.

Gastrointestinal

Nausea, puking, and epigastric discomfort.

Hematologic

Leukopenia, pancytopenia

Dependence

Forbearance is when a case's response to a specific lozenge and attention is precipitously reduced in the absence of complaint progression, taking an increase in the lozenge to maintain the same. Physical dependence is characterized by pullout symptoms after abrupt termination or a significant cure reduction of a medicine. Both forbearance and physical dependence have been reported with the dragged use of SOMA. Reported pullout symptoms with SOMA include wakefulness, puking, abdominal cramps, headache, temblors, muscle shuddering, anxiety, ataxia, visions, and psychosis. Instruct cases taking large boluses of SOMA or those taking the medicine for a prolonged time to not suddenly stop SOMA.

Warnings & Preventives

WARNINGS

Included as part of the Preventives section.

Preventives

Sedation

SOMA has dreamy parcels (in the low reverse pain trials, 13 to 17 of cases who entered SOMA endured sedation compared to 6 of cases who entered placebo) ( see ADVERSE Responses) and may vitiate the internal and/ or physical capacities needed for the performance of potentially dangerous tasks similar as driving a motor vehicle or operating ministry. There have been post-marketing reports of motor vehicle accidents associated with the use of SOMA.

Since the dreamy goods of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be cumulative, applicable caution should be exercised with cases that take further than one of these CNS depressants contemporaneously.

Abuse, Dependence, And Withdrawal

.

Carisoprodol, the active component in SOMA, has been subject to abuse, dependence, pullout, abuse, and felonious diversion. ( see Medicine Abuse And Dependence). Abuse of SOMA poses a threat of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other diseases.

Post-marketing experience cases of carisoprodol abuse and dependence have been reported in cases with dragged use and a history of medicine abuse. Although utmost of these cases took other medicines of abuse, some cases solely abused carisoprodol. Pullout symptoms have been reported following the abrupt conclusion of SOMA after prolonged use. Reported pullout symptoms included wakefulness, puking, abdominal cramps, headache, temblors, muscle shuddering, ataxia, visions, and psychosis. One of the carisoprodol’s metabolites, meprobamate (a controlled substance), may also beget dependence ( see How to order soma).

To reduce the threat of SOMA abuse assess the threat of abuse before defining. After defining, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful traditional records, cover for signs of abuse and overdose, and educate cases and their families about abuse and on proper storehouse and disposal.

Seizures

There have been post-marketing reports of seizures in cases who entered SOMA. Utmost of these cases have passed in the setting of multiple medicine overdoses ( including medicines of abuse, illegal medicines, and alcohol).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

. Carcinogenesis

Long-term studies in creatures haven't been performed to estimate the carcinogenic eventuality of carisoprodol.

Mutagenesis

SOMA wasn't formally estimated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse carcinoma cell assay in the absence of metabolizing enzymes but wasn't 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 redounded in negative findings. Carisoprodol wasn't mutagenic in the Ames rear mutation assay usingS. Typhimurium strains with or without metabolizing enzymes weren't clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Impairment Of Fertility

SOMA wasn't formally estimated for goods on fertility. A published reproductive study in which womanish mice entered carisoprodol orally at boluses of 300, 750, or 1200 mg/ kg/ day ( roughly 1,2.6, and4.1 times the MRHD of 1400 mg per day (350 mg QID) grounded on body face area (BSA) comparison) from 1-week before lovemaking, to 27-weeks post-mating, plant no revision infertility although a revision in reproductive cycles characterized by a lesser time spent in estrus was observed at a carisoprodol cure of 1200 mg/ kg/ day. In a 13week toxicology study that didn't determine fertility, mouse testis' weight and sperm motility were reduced at a cure of 1200 mg/ kg/ day ( motherly boluses original to4.2- times the MRHD grounded on BSA comparison). In both studies, the no-effect position was 750 mg/ kg/ day, corresponding to roughly2.6- times the MRHD grounded on a BSA comparison. The significance of these findings for mortal fertility isn't known.

Use In Specific Populations

Data over numerous decades of carisoprodol use in gestation haven't linked a medicine-associated threat of major birth blights, confinement, or other adverse motherly or fetal issues. Data on meprobamate, the primary metabolite of carisoprodol, also don't show a harmonious association between motherly use of meprobamate and an increased threat of major birth blights.

In a published beast reduplication study, pregnant mice administered carisoprodol orally at2.6 and4.1- times the outside recommended mortal cure ( (MRHD) of 1400 mg per day (350 mg QID) grounded on body face area (BSA) comparison) from gravidity through weaning redounded in reduced fetal weights, postnatal weight gain, and postnatal survival.

The estimated background threat of major birth blights and confinement for the indicated population is unknown. All gravidity has a background threat of birth disfigurement, loss, or other adverse issues. In theU.S. general population, the estimated background threat of major birth blights and confinement in clinically honored gravidity is 2 to 4 and 15 to 20, independently ( go to Website Visit )

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