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DRUGS & SUPPLEMENTS
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Acetaminophen:
Torsilax is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis, the predominant influence on the thermoregulation center in the hypothalamus, enhances heat transfer.
Pain weak and moderate intensity of different genesis (including headache, migraine, toothache, neuralgia, myalgia, algomenorrhea; pain in trauma, burns). Fever in infectious and inflammatory diseases.
Oral or rectally adults and adolescents with a body weight over 60 kg is used in a single dose of 500 mg, the multiplicity of admission - up to 4 times / Maximum duration of treatment - 5-7 days.
Maximum dose: single - 1 g, daily - 4 g.
Single dose for oral administration for children aged 6-12 years - 250-500 mg, 1-5 years - 120-250 mg, from 3 months to 1 year - 60-120 mg, up to 3 months - 10 mg / kg. Single dose rectal in children aged 6-12 years - 250-500 mg, 1-5 years - 125-250 mg.
Multiplicity - 4 at intervals of not less than 4 h. The maximum duration of treatment - 3 days.
Maximum dose: 4 single dose per day.
Digestive system: rarely - dyspepsia; long-term use at high doses - hepatotoxic effects, methemoglobinemia, renal dysfunction and liver, hypochromic anemia. Hemopoietic system: rarely - thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis. Allergic reactions: rarely - skin rash, itching, hives.
Chronic active alcoholism, increased sensitivity to Torsilax, marked disturbances of liver function and / or kidney disease, anemia, pregnancy (I term).
Torsilax (Acetaminophen) crosses the placental barrier. So far, no observed adverse effects of Torsilax (Acetaminophen) on the fetus in humans.
Torsilax (Acetaminophen) is excreted in breast milk: the content in milk was 0.04-0.23% of the dose adopted mother.
If necessary, use of Torsilax (Acetaminophen) during pregnancy and lactation (breastfeeding) should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus or child.
In experimental studies found no embryotoxic, teratogenic and mutagenic action of Torsilax (Acetaminophen).
Torsilax is used with caution in patients with disorders of the liver and kidneys, with benign hyperbilirubinemia, as well as in elderly patients.
With prolonged use of Torsilax (Acetaminophen) is necessary to monitor patterns of peripheral blood and functional state of the liver.
Used for treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, a derivative of xanthine) and mepyramine (Histamine H1-receptors blocker).
With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic action of Torsilax (Acetaminophen).
With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.
With the simultaneous use of anticholinergics may decrease absorption of Torsilax (Acetaminophen).
With the simultaneous use of oral contraceptives accelerated excretion of Torsilax (Acetaminophen) from the body and may reduce its analgesic action.
With the simultaneous use with urological means reduced their effectiveness.
With the simultaneous use of activated charcoal reduced bioavailability of Torsilax (Acetaminophen).
When Torsilax (Acetaminophen) applied simultaneously with diazepam may decrease excretion of diazepam.
There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Torsilax (Acetaminophen). A case of severe toxic liver injury.
Described cases of toxic effects of Torsilax (Acetaminophen), while the use of isoniazid.
When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Torsilax (Acetaminophen), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Torsilax (Acetaminophen) and phenobarbital.
In applying cholestyramine a period of less than 1 h after administration of Torsilax (Acetaminophen) may decrease of its absorption.
At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.
With the simultaneous use of metoclopramide may increase absorption of Torsilax (Acetaminophen) and its increased concentration in blood plasma.
When applied simultaneously with probenecid may decrease clearance of Torsilax (Acetaminophen), with rifampicin, sulfinpyrazone - may increase clearance of Torsilax (Acetaminophen) due to increasing its metabolism in the liver.
At simultaneous application of Torsilax (Acetaminophen) with ethinylestradiol increases absorption of Torsilax (Acetaminophen) from the gut.
Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).
At a reception in toxic doses (10-15 g in adults) may develop liver necrosis.
Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms
Caffeine:
Active ingredient (in each tablet)
Torsilax (Caffeine) 200mg
Purpose
Alertness aid
Use
Warnings
For occasional use only
Do not use
When using this product limit the use of Torsilax (Caffeine) containing medications, foods, or beverages because too much Torsilax (Caffeine) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Torsilax (Caffeine) as a cup of coffee.
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide
Questions or comments?
Call toll-free 1-855-874-0970 weekdays
Display Panel Torsilax (Caffeine): 16 ct. Package
Torsilax (Caffeine)®
CAFFEINE ALERTNESS AID
16 TABLETS
200mg each
FUNCTIONAL Torsilax (Caffeine)® for Mental Alertness
SAFE & EFFECTIVE
One tablet is equal to about a cup of coffee
Torsilax (Caffeine)®
Making the Most of Every Day.®
Tamper Evident Feature: individually sealed in foil for your protection. Do not
use if foil or plastic bubble is torn or punctured.
Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL
CAFFEINE® are registered trademarks of Meda AB.
Distributed by:
Meda Consumer Healthcare Inc.
Marietta, GA 30062 ©2011 Meda AB
www.vivarin.com
16 ct. Package
Display Panel Torsilax (Caffeine): 40 ct. Package
SAFE & EFFECTIVE
FUNCTIONAL Torsilax (Caffeine)® for Mental Alertness
Torsilax (Caffeine)®
Torsilax (Caffeine) ALERTNESS AID
40 Tablets
200mg each
FUNCTIONAL Torsilax (Caffeine)® for Mental Alertness
Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.
VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.
Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL
CAFFEINE® are registered trademarks of Meda AB.
Made in the U.S.A.
Torsilax (Caffeine)®
Making the Most of Every Day.®
Distributed by:
Meda Consumer Healthcare Inc.
Marietta, GA 30062 ©2013 Meda AB
www.vivarin.com
40 ct. Package
Carisoprodol:
Torsilax (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Torsilax (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) ].
Torsilax (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
The recommended dose of Torsilax (Carisoprodol) is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Torsilax (Carisoprodol) use is up to two or three weeks.
350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side.
Tablets: 350 mg (3)
Torsilax (Carisoprodol) Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Torsilax (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 Torsilax (Carisoprodol).
Since the sedative effects of Torsilax (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.
In the postmarketing experience with Torsilax, 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 Torsilax (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 Torsilax (Carisoprodol) dependence, withdrawal, or abuse, Torsilax (Carisoprodol) should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Torsilax (Carisoprodol) should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.
Torsilax (Carisoprodol), and one of its metabolites, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3) ].
There have been postmarketing reports of seizures in patients who received Torsilax (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) ].
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.
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 Torsilax (Carisoprodol), 350 mg of Torsilax (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 Torsilax (Carisoprodol), and 350 mg of Torsilax (Carisoprodol), respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Torsilax (Carisoprodol), and 350 mg of Torsilax (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 Torsilax (Carisoprodol) in the two trials described above.
Adverse Reaction | Placebo (n=560) n (%) | Torsilax (Carisoprodol) 250 mg (n=548) n (%) | Torsilax (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) |
The following events have been reported during postapproval use of Torsilax (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.
The sedative effects of Torsilax (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 Torsilax (Carisoprodol) and meprobamate, a metabolite of Torsilax (Carisoprodol), is not recommended [see Warnings and Precautions (5.1) ].
Torsilax (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 Torsilax (Carisoprodol) could result in increased exposure of Torsilax (Carisoprodol) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Torsilax (Carisoprodol) could result in decreased exposure of Torsilax (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 Torsilax (Carisoprodol) is unknown.
Pregnancy Category C. There are no data on the use of Torsilax during human pregnancy. Animal studies indicate that Torsilax (Carisoprodol) crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Torsilax (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 Torsilax (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, Torsilax (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. Torsilax (Carisoprodol) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
There is no information about the effects of Torsilax (Carisoprodol) on the mother and the fetus during labor and delivery.
Very limited data in humans show that Torsilax 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 Torsilax (Carisoprodol) may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Torsilax (Carisoprodol) is administered to a nursing woman.
The efficacy, safety, and pharmacokinetics of Torsilax (Carisoprodol) in pediatric patients less than 16 years of age have not been established.
The efficacy, safety, and pharmacokinetics of Torsilax in patients over 65 years old have not been established.
The safety and pharmacokinetics of Torsilax (Carisoprodol) in patients with renal impairment have not been evaluated. Since Torsilax (Carisoprodol) is excreted by the kidney, caution should be exercised if Torsilax (Carisoprodol) is administered to patients with impaired renal function. Torsilax (Carisoprodol) is dialyzable by hemodialysis and peritoneal dialysis.
The safety and pharmacokinetics of Torsilax in patients with hepatic impairment have not been evaluated. Since Torsilax (Carisoprodol) is metabolized in the liver, caution should be exercised if Torsilax (Carisoprodol) is administered to patients with impaired hepatic function.
Patients with reduced CYP2C19 activity have higher exposure to Torsilax (Carisoprodol). Therefore, caution should be exercised in administration of Torsilax (Carisoprodol) to these patients [see Clinical Pharmacology (12.3) ].
Torsilax (Carisoprodol) is not a controlled substance [see Warnings and Precautions (5.2) ]. Discontinuation of Torsilax (Carisoprodol) in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human Torsilax (Carisoprodol) dependence.
In vitro studies demonstrate that Torsilax (Carisoprodol) elicits barbiturate-like effects. Animal behavioral studies indicate that Torsilax (Carisoprodol) produces rewarding effects. Monkeys self administer Torsilax (Carisoprodol). Drug discrimination studies using rats indicate that Torsilax (Carisoprodol) has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.
Overdosage of Torsilax (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 Torsilax (Carisoprodol) overdosage. Many of the Torsilax (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 Torsilax (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 Torsilax (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 Torsilax (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 Torsilax (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 Torsilax (Carisoprodol), contact a Poison Control Center.
Torsilax (Carisoprodol) Tablets, USP are available as 350 mg round, white tablets for oral administration. Torsilax (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. Torsilax (Carisoprodol) is present as a racemic mixture. Chemically, Torsilax (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 Torsilax (Carisoprodol) Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.
This in an image of the structural formula of Torsilax (Carisoprodol).
The mechanism of action of Torsilax in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.
In animal studies, muscle relaxation induced by Torsilax (Carisoprodol) is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.
Torsilax (Carisoprodol) is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.
A metabolite of Torsilax (Carisoprodol), meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Torsilax (Carisoprodol) is unknown.
The pharmacokinetics of Torsilax (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 Torsilax (Carisoprodol). The exposure of Torsilax (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 Torsilax (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 Torsilax (Carisoprodol) | 350 mg Torsilax (Carisoprodol) | |
Torsilax (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 Torsilax (Carisoprodol) has not been determined. The mean time to peak plasma concentrations (Tmax) of Torsilax (Carisoprodol) was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Torsilax (Carisoprodol) (350 mg tablet) had no effect on the pharmacokinetics of Torsilax (Carisoprodol). Therefore, Torsilax (Carisoprodol) may be administered with or without food.
Metabolism: The major pathway of Torsilax (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 Torsilax (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 Torsilax (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%.
Long term studies in animals have not been performed to evaluate the carcinogenic potential of Torsilax (Carisoprodol).
Torsilax (Carisoprodol) was not formally evaluated for genotoxicity. In published studies, Torsilax (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. Torsilax (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. Torsilax (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.
Torsilax (Carisoprodol) was not formally evaluated for effects on fertility. Published reproductive studies of Torsilax (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 Torsilax (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 Torsilax (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., Torsilax (Carisoprodol) 250 mg, Torsilax (Carisoprodol) 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Torsilax (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 Torsilax (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 Torsilax (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 Torsilax (Carisoprodol) and Placebo, Mean (SE)b (95% CI) | 0.5 (0.4, 0.7) | |||
Study | Parameter | Placebo | Torsilax (Carisoprodol) 250 mg | Torsilax (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 Torsilax (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 Torsilax (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 Torsilax (Carisoprodol) 250 mg and placebo groups.
Patients treated with Torsilax (Carisoprodol) experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.
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).
Patients should be advised to contact their physician if they experience any adverse reactions to Torsilax tablets.
Patients should be advised that Torsilax (Carisoprodol) tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Torsilax (Carisoprodol) before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].
Patients should be advised to avoid alcoholic beverages while taking Torsilax 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) ].
Patients should be advised that treatment with Torsilax (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 Torsilax (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
Diclofenac Sodium:
NSAIDs, a derivative of phenylacetic acid, Torsilax has a pronounced anti-inflammatory, analgesic and mild antipyretic effect. The mechanism of action is associated with inhibition of COX activity - the main enzyme metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. Analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).
Inhibits synthesis of proteoglycan in cartilage.
In rheumatic diseases, Torsilax (Diclofenac Sodium) reduces joint pain at rest and in motion, as well as morning stiffness and swelling of the joints, helps to increase range of motion; reduces post-traumatic and postoperative pain, and inflammatory edema.
Inhibits platelet aggregation. With prolonged use has a desensitizing effect.
When used topically in ophthalmology reduces swelling and pain in inflammatory processes non-infectious etiology.
After intake is absorbed from the gastrointestinal tract. Eating slows down the rate of absorption, extent of absorption is not changed. About 50% of the active substance is metabolized in the "first passage" through the liver. When used rectally absorption is slower. Time to reach Cmax in plasma after oral administration is 2-4 hours depending on the used dosage form, after rectal - 1 h, I.M. administration - 20 min. The concentration of active substance in plasma is a linear function of the applied dose.
Not cumulative. Plasma protein binding is 99.7% (predominantly albumin). Penetrates into synovial fluid, Cmax is achieved in 2-4 hours later than in plasma.
To a large extent metabolized to form several metabolites, among which two pharmacologically active, but to a lesser extent than Torsilax (Diclofenac Sodium).
Systemic clearance of the active substance is about 263 ml / min. T1/2 from plasma is 1-2 h, from synovial fluid - 3-6 h. Approximately 60% of the dose was excreted as metabolites by the kidneys, less than 1% excreted in the urine as unchanged, while the rest is displayed in the form of metabolites with bile.
Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of musculoskeletal system (osteochondrosis, osteoarthritis, periartropatii), post-traumatic inflammation of soft tissue and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after surgery or injury, pain in gout, migraine, algomenorrhea, pain with Bursitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.
For local use: the inhibition of miosis during surgery for cataract prevention of cystoid macular edema associated with removal and lens implantation, inflammatory eye non-infectious nature, post-traumatic inflammation in penetrating and nonpenetrating wound of the eyeball.
For oral use for adult single dose is 25-50 mg 2-3 times / 24 h. Frequency of admission depends on the dosage form employed, the severity of the disease and is 1-3 times / 24 h, rectally - 1 times / 24 h, for the treatment of acute conditions or the exacerbation of chronic edema use intramuscular in dose of 75 mg.
For children older than 6 years and adolescents daily dose is 2 mg / kg.
Topical applied at a dose of 2-4 g on the affected area 3-4 times / 24 h.
When used in ophthalmology frequency and duration of administration are determined individually.
The maximum oral daily dose for adults is 150 mg.
Digestive system: nausea, vomiting, anorexia, abdominal pain and discomfort in the epigastrium, flatulence, constipation, diarrhea, and in some cases - erosive-ulcerative lesions, gastrointestinal bleeding and perforation; rarely - abnormal liver function. When rectal administration - in isolated cases were observed inflammation of the colon bleeding, exacerbation of ulcerative colitis.
From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, fatigue, rarely - paresthesia, visual disturbances (blurred, double vision), tinnitus, insomnia, cramps, irritability, tremors, mental disorders, depression.
Hemopoietic system: rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.
Urinary system: rarely - renal failure; in predisposed patients may be swelling.
Dermatological reactions: rarely - hair loss.
Allergic reactions: skin rash, itching, when used in the form of eye drops - itching, redness, photosensitivity.
Local reactions: in the place of I.M. introducing possible burning, in some cases - the formation of infiltration, abscess, necrosis of adipose tissue in the rectal administration may be local irritation, the appearance of mucous discharge mixed with blood, painful defecation, when used externally, in rare cases - itching, redness, rash, burning sensation, when applied topically in ophthalmology may be a transient burning sensation and / or temporary blurred vision immediately after instillation.
With long-term topical use and / or drawing on a vast surface of body are possible systemic side effects due to resorptive action of Torsilax (Diclofenac Sodium).
known hypersensitivity to Torsilax sodium or to any accessory ingredient that is part of the drug Torsilax (Diclofenac Sodium);
anamnestic information about the attacks of bronchial asthma, urticaria, acute rhinitis associated with the use of aspirin or other NSAIDs;
hemodyscrasia unknown origin;
children under 6 years
pregnancy (III trimester);
lactation
increased sensitivity to sulfite (for injection solution).
children under age 15 - tablets of 50 mg to 18 years - injection.
Use during pregnancy and lactation is possible in cases where the potential benefits for the mother exceeds than the potential risk to the fetus or newborn.
With extreme caution is used in diseases of liver, kidney, gastrointestinal history, dyspepsia, asthma, hypertension, heart failure, after major surgery, as well as elderly patients.
When referring to a history of allergic reactions to NSAIDs Torsilax and sulfites are used only in urgent cases. In the course of treatment requires systematic monitoring of liver function and kidney picture of peripheral blood.
Do not recommended the use for rectal patients with diseases of anorectal region or anorectal bleeding in history. Topical should be applied only to intact skin areas.
Avoid contact with Torsilax (Diclofenac Sodium) in the eye (except for eye drops), or on mucous membranes. Patients who use contact lenses, eye drops should be applied no earlier than 5 minutes after removing the lenses.
Not recommended for children under 6 years.
During the period of treatment drugs for systemic use is not recommended alcohol consumption.
During the period of treatment may decrease the speed of psychomotor reactions. With worsening blurred vision after application of eye drops should not be driving and doing other potentially danger activities.
At simultaneous application with Torsilax (Diclofenac Sodium) antihypertensive drugs may be weakening their actions.
There are few reports on the occurrence of seizures in patients taking both NSAIDs and antibacterial drugs quinolic series.
At simultaneous application with GCS and increased risk of side effects from the digestive system.
With simultaneous use of diuretics may decrease diuretic effect. With the simultaneous use of potassium-sparing diuretics may increase the concentration of potassium in the blood.
With simultaneous use with other NSAIDs may increase the risk of side effects.
There are reports of hypoglycemia or hyperglycemia in patients with diabetes who engaged in Torsilax (Diclofenac Sodium) together with hypoglycemic drugs.
When applied simultaneously with acetylsalicylic acid may decrease the concentration of Torsilax (Diclofenac Sodium) in plasma.
Although clinical studies have not found the influence of Torsilax (Diclofenac Sodium) on the action of anticoagulants, describes the individual cases of bleeding when used with Torsilax (Diclofenac Sodium) and warfarin.
With simultaneous use may increase digoxin, lithium, and phenytoin in blood plasma.
The absorption of Torsilax (Diclofenac Sodium) from the gastrointestinal tract is reduced by simultaneous application with kolestiraminom, to a lesser extent - with colestipol.
With simultaneous use may increase the concentration of methotrexate in plasma and increased its toxicity.
With simultaneous application of Torsilax (Diclofenac Sodium) could not affect the bioavailability of morphine, but the concentration of the active metabolite of morphine may be enhanced in the presence of Torsilax (Diclofenac Sodium), which increases the risk of side effects metabolites of morphine, including respiratory depression.
When applied simultaneously with pentazocine described a case of great convulsions, and rifampicin - may decrease the concentration of Torsilax (Diclofenac Sodium) in plasma, with ceftriaxone - increases excretion of ceftriaxone in bile; with cyclosporine - may increase cyclosporine nephrotoxicity.
Symptoms: may cause hypotension, renal failure, convulsions, gastrointestinal irritation or respiratory depression. Treatment: There is no specific antidote. In acute poisoning as soon as possible to stop drug absorption from the gastrointestinal tract. There is indicated gastric lavage, activated charcoal appointment and conduct of other symptomatic and supportive therapy. The use of forced diuresis, dialysis or blood transfusion is not justified because NSAIDs largely associated with serum proteins and possess extensive metabolism.
In a dry, protected from light place, at temperature not above 25°C.Common expiration date for Torsilax (Diclofenac Sodium) tablets: 3 years.
Depending on the reaction of the Torsilax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Torsilax 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 Torsilax 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.
Visitors | % | ||
---|---|---|---|
Useful | 1 | 50.0% | |
Not useful | 1 | 50.0% |
Visitors | % | ||
---|---|---|---|
It has side effects | 2 | 66.7% | |
No side effects | 1 | 33.3% |
Visitors | % | ||
---|---|---|---|
Expensive | 1 | 100.0% |
Visitors | % | ||
---|---|---|---|
Once in a day | 6 | 66.7% | |
4 times in a day | 1 | 11.1% | |
Twice in a day | 1 | 11.1% | |
3 times in a day | 1 | 11.1% |
Visitors | % | ||
---|---|---|---|
201-500mg | 3 | 23.1% | |
11-50mg | 2 | 15.4% | |
101-200mg | 2 | 15.4% | |
6-10mg | 2 | 15.4% | |
501mg-1g | 2 | 15.4% | |
51-100mg | 1 | 7.7% | |
1-5mg | 1 | 7.7% |
Visitors | % | ||
---|---|---|---|
> 3 month | 2 | 25.0% | |
3 days | 2 | 25.0% | |
1 day | 2 | 25.0% | |
1 month | 1 | 12.5% | |
2 days | 1 | 12.5% |
Visitors | % | ||
---|---|---|---|
After food | 2 | 66.7% | |
With a meal | 1 | 33.3% |
Visitors | % | ||
---|---|---|---|
46-60 | 9 | 40.9% | |
> 60 | 6 | 27.3% | |
30-45 | 5 | 22.7% | |
16-29 | 1 | 4.5% | |
1-5 | 1 | 4.5% |
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The information was verified by Dr. Rachana Salvi, MD Pharmacology