Mionevrix

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Mionevrix uses

Mionevrix consists of Carisoprodol, Metamizole, Vitamin B.

Carisoprodol:


1 INDICATIONS AND USAGE

Mionevrix (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Mionevrix (Carisoprodol) Tablets 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 Dosage and Administration (2) ].

Mionevrix (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)

Important Limitations:

  • Should only be used for acute treatment periods up to two or three weeks (1)
  • Not recommended in pediatric patients less than 16 years of age (8.4)

2 DOSAGE AND ADMINISTRATION

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

  • Recommended dose is 250 mg to 350 mg three times a day and at bedtime. (2)

3 DOSAGE FORMS AND STRENGTHS

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side.

Tablets: 350 mg (3)

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4 CONTRAINDICATIONS

Mionevrix (Carisoprodol) Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

  • Acute intermittent porphyria (4)
  • Hypersensitivity reactions to a carbamate such as meprobamate (4)

5 WARNINGS AND PRECAUTIONS

  • Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery
  • Additive sedative effects when used with other CNS depressants including alcohol (5.1)
  • Cases of Drug Dependence, Withdrawal, and Abuse (5.2)
  • Seizures (5.3)

5.1 Sedation

Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Mionevrix (Carisoprodol) experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1) ] 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. There have been post-marketing reports of motor vehicle accidents associated with the use of Mionevrix (Carisoprodol).

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

5.2 Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with Mionevrix, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Mionevrix (Carisoprodol) in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of carisoprodol-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Mionevrix (Carisoprodol) dependence, withdrawal, or abuse, Mionevrix (Carisoprodol) should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Mionevrix (Carisoprodol) should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

Mionevrix (Carisoprodol), and one of its metabolites, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3) ].

5.3 Seizures

There have been postmarketing reports of seizures in patients who received Mionevrix (Carisoprodol). Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10) ].

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6 ADVERSE REACTIONS

Most common adverse reactions are drowsiness, dizziness, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1‑800‑444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14) ]. In these studies, patients were treated with 250 mg of Mionevrix (Carisoprodol), 350 mg of Mionevrix (Carisoprodol), or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4% of patients treated with placebo, 250 mg of Mionevrix (Carisoprodol), and 350 mg of Mionevrix (Carisoprodol), respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Mionevrix (Carisoprodol), and 350 mg of Mionevrix (Carisoprodol), respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Mionevrix (Carisoprodol) in the two trials described above.

Adverse

Reaction

Placebo

(n=560)

n (%)


Mionevrix (Carisoprodol) 250 mg

(n=548)

n (%)

Mionevrix (Carisoprodol) 350 mg

(n=279)

n (%)

Drowsiness 31 (6)

73 (13)

47 (17)
Dizziness 11 (2) 43 (8) 19 (7)
Headache 11 (2) 26 (5) 9 (3)

6.2 Postmarketing Experience

The following events have been reported during postapproval use of Mionevrix (Carisoprodol). 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.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see Overdosage (10) ].

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10) ].

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

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7 DRUG INTERACTIONS

  • CNS depressants - additive sedative effects (5.1 and 7.1)

7.1 CNS Depressants

The sedative effects of Mionevrix (Carisoprodol) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Mionevrix (Carisoprodol) and meprobamate, a metabolite of Mionevrix (Carisoprodol), is not recommended [see Warnings and Precautions (5.1) ].

7.2 CYP2C19 Inhibitors and Inducers

Mionevrix (Carisoprodol) is metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Mionevrix (Carisoprodol) could result in increased exposure of Mionevrix (Carisoprodol) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Mionevrix (Carisoprodol) could result in decreased exposure of Mionevrix (Carisoprodol) and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Mionevrix (Carisoprodol) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. There are no data on the use of Mionevrix during human pregnancy. Animal studies indicate that Mionevrix (Carisoprodol) crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Mionevrix (Carisoprodol), meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of Mionevrix (Carisoprodol). There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, Mionevrix (Carisoprodol) reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1–1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Mionevrix (Carisoprodol) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

8.2 Labor and Delivery

There is no information about the effects of Mionevrix (Carisoprodol) on the mother and the fetus during labor and delivery.

8.3 Nursing Mothers

Very limited data in humans show that Mionevrix is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4–6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of Mionevrix (Carisoprodol) may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Mionevrix (Carisoprodol) is administered to a nursing woman.

8.4 Pediatric Use

The efficacy, safety, and pharmacokinetics of Mionevrix (Carisoprodol) in pediatric patients less than 16 years of age have not been established.

8.5 Geriatric Use

The efficacy, safety, and pharmacokinetics of Mionevrix in patients over 65 years old have not been established.

8.6 Renal Impairment

The safety and pharmacokinetics of Mionevrix (Carisoprodol) in patients with renal impairment have not been evaluated. Since Mionevrix (Carisoprodol) is excreted by the kidney, caution should be exercised if Mionevrix (Carisoprodol) is administered to patients with impaired renal function. Mionevrix (Carisoprodol) is dialyzable by hemodialysis and peritoneal dialysis.

8.7 Hepatic Impairment

The safety and pharmacokinetics of Mionevrix in patients with hepatic impairment have not been evaluated. Since Mionevrix (Carisoprodol) is metabolized in the liver, caution should be exercised if Mionevrix (Carisoprodol) is administered to patients with impaired hepatic function.

8.8 Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to Mionevrix (Carisoprodol). Therefore, caution should be exercised in administration of Mionevrix (Carisoprodol) to these patients [see Clinical Pharmacology (12.3) ].

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9 DRUG ABUSE AND DEPENDENCE

Mionevrix (Carisoprodol) is not a controlled substance [see Warnings and Precautions (5.2) ]. Discontinuation of Mionevrix (Carisoprodol) in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human Mionevrix (Carisoprodol) dependence.

In vitro studies demonstrate that Mionevrix (Carisoprodol) elicits barbiturate-like effects. Animal behavioral studies indicate that Mionevrix (Carisoprodol) produces rewarding effects. Monkeys self administer Mionevrix (Carisoprodol). Drug discrimination studies using rats indicate that Mionevrix (Carisoprodol) has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.

10 OVERDOSAGE

Overdosage of Mionevrix (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 Mionevrix (Carisoprodol) overdosage. Many of the Mionevrix (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 Mionevrix (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 Mionevrix (Carisoprodol) 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 Mionevrix (Carisoprodol) overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). 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.

The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of Mionevrix (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 Mionevrix (Carisoprodol), contact a Poison Control Center.

11 DESCRIPTION

Mionevrix (Carisoprodol) Tablets, USP are available as 350 mg round, white tablets for oral administration. Mionevrix (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. Mionevrix (Carisoprodol) is present as a racemic mixture. Chemically, Mionevrix (Carisoprodol) is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:

Other ingredients in Mionevrix (Carisoprodol) Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.

This in an image of the structural formula of Mionevrix (Carisoprodol).

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of Mionevrix in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.

In animal studies, muscle relaxation induced by Mionevrix (Carisoprodol) is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

12.2 Pharmacodynamics

Mionevrix (Carisoprodol) is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.

A metabolite of Mionevrix (Carisoprodol), meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Mionevrix (Carisoprodol) is unknown.

12.3 Pharmacokinetics

The pharmacokinetics of Mionevrix (Carisoprodol) and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg Mionevrix (Carisoprodol). The exposure of Mionevrix (Carisoprodol) and meprobamate was dose proportional between the 250 mg and 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of Mionevrix (Carisoprodol), which is approximately 30% of the Cmax of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.

250 mg

Mionevrix (Carisoprodol)

350 mg

Mionevrix (Carisoprodol)

Mionevrix (Carisoprodol)
Cmax (μg/mL)

1.2 ± 0.5

1.8 ± 1.0
AUCinf (μg*hr/mL)

4.5 ± 3.1

7.0 ± 5.0
Tmax (hr)

1.5 ± 0.8

1.7 ± 0.8
T½ (hr)

1.7 ± 0.5

2.0 ± 0.5
Meprobamate
Cmax (μg/mL)

1.8 ± 0.3

2.5 ± 0.5
AUCinf (μg*hr/mL)

32 ± 6.2

46 ± 9.0
Tmax (hr) 3.6 ± 1.7 4.5 ± 1.9
T½ (hr)

9.7 ± 1.7

9.6 ± 1.5

Absorption: Absolute bioavailability of Mionevrix (Carisoprodol) has not been determined. The mean time to peak plasma concentrations (Tmax) of Mionevrix (Carisoprodol) was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Mionevrix (Carisoprodol) (350 mg tablet) had no effect on the pharmacokinetics of Mionevrix (Carisoprodol). Therefore, Mionevrix (Carisoprodol) may be administered with or without food.

Metabolism: The major pathway of Mionevrix (Carisoprodol) metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism.

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.

Gender: Exposure of Mionevrix (Carisoprodol) is higher in female than in male subjects (approximately 30–50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to Mionevrix (Carisoprodol), and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3–5% and in Asians is approximately 15–20%.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of Mionevrix (Carisoprodol).

Mionevrix (Carisoprodol) was not formally evaluated for genotoxicity. In published studies, Mionevrix (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. Mionevrix (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. Mionevrix (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.

Mionevrix (Carisoprodol) was not formally evaluated for effects on fertility. Published reproductive studies of Mionevrix (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 Mionevrix (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.

14 CLINICAL STUDIES

The safety and efficacy of Mionevrix (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 three treatment groups (i.e., Mionevrix (Carisoprodol) 250 mg, Mionevrix (Carisoprodol) 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Mionevrix (Carisoprodol) 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 Mionevrix (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.


Number of Patients


n=278

n=269

Relief from Starting Backache, Mean (SE)b


1.1 (0.1)


1.8 (0.1)


2


Difference between Mionevrix (Carisoprodol) and Placebo, Mean (SE)b (95% CI)


0.7 (0.5, 0.9)


Global Impression of Change, Mean (SE)b


1.7 (0.1)


2.2 (0.1)

Difference between Mionevrix (Carisoprodol) and Placebo, Mean (SE)b (95% CI) 0.5 (0.4, 0.7)
Study Parameter Placebo

Mionevrix (Carisoprodol) 250 mg

Mionevrix (Carisoprodol)

350 mg

Number of Patients n=269

n=264

n=273
Relief from Starting Backache, Mean (SE)b 1.4 (0.1)

1.8 (0.1)

1.8 (0.1)
1 Difference between Mionevrix (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.4 (0.2, 0.5)

0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE)b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1)
Difference between Mionevrix (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.2 (0.1, 0.4)

0.3 (0.1, 0.4)

aThe primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).

b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the Mionevrix (Carisoprodol) 250 mg and placebo groups.

Patients treated with Mionevrix (Carisoprodol) experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

16 HOW SUPPLIED/STORAGE AND HANDLING

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side

49999-064-01

Storage:

Store at 20°-25°C (68°-77°F).

17 PATIENT COUNSELING INFORMATION

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

17.1 Sedation

Patients should be advised that Mionevrix (Carisoprodol) tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Mionevrix (Carisoprodol) before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking Mionevrix tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1) ].

17.3 Mionevrix (Carisoprodol) Tablets Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with Mionevrix (Carisoprodol) tablets 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 Mionevrix (Carisoprodol) tablets, 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.

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181281

Revised: 10/2010

R5

image of label

Mionevrix pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Mionevrix available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Mionevrix destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Mionevrix Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Mionevrix pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CARISOPRODOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ASPIRIN; CARISOPRODOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "carisoprodol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mionevrix?

Depending on the reaction of the Mionevrix after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mionevrix not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mionevrix addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Mionevrix, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mionevrix consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Mionevrix drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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