Somaflam

Carisoprodol:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Drug abuse and dependence
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Somaflam (Carisoprodol) reviews

1 INDICATIONS AND USAGE

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

Somaflam (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) ].

Somaflam (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 Somaflam (Carisoprodol) is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Somaflam (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)

4 CONTRAINDICATIONS

Somaflam (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 Somaflam (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 Somaflam (Carisoprodol).

Since the sedative effects of Somaflam (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 Somaflam, 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 Somaflam (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 Somaflam (Carisoprodol) dependence, withdrawal, or abuse, Somaflam (Carisoprodol) should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Somaflam (Carisoprodol) should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

Somaflam (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 Somaflam (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) ].

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 Somaflam (Carisoprodol), 350 mg of Somaflam (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 Somaflam (Carisoprodol), and 350 mg of Somaflam (Carisoprodol), respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Somaflam (Carisoprodol), and 350 mg of Somaflam (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 Somaflam (Carisoprodol) in the two trials described above.

6.2 Postmarketing Experience

The following events have been reported during postapproval use of Somaflam (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.

7 DRUG INTERACTIONS

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

7.1 CNS Depressants

The sedative effects of Somaflam (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 Somaflam (Carisoprodol) and meprobamate, a metabolite of Somaflam (Carisoprodol), is not recommended [see Warnings and Precautions (5.1) ].

7.2 CYP2C19 Inhibitors and Inducers

Somaflam (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 Somaflam (Carisoprodol) could result in increased exposure of Somaflam (Carisoprodol) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Somaflam (Carisoprodol) could result in decreased exposure of Somaflam (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 Somaflam (Carisoprodol) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. There are no data on the use of Somaflam during human pregnancy. Animal studies indicate that Somaflam (Carisoprodol) crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Somaflam (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 Somaflam (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, Somaflam (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. Somaflam (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 Somaflam (Carisoprodol) on the mother and the fetus during labor and delivery.

8.3 Nursing Mothers

Very limited data in humans show that Somaflam 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 Somaflam (Carisoprodol) may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Somaflam (Carisoprodol) is administered to a nursing woman.

8.4 Pediatric Use

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

8.5 Geriatric Use

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

8.6 Renal Impairment

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

8.7 Hepatic Impairment

The safety and pharmacokinetics of Somaflam in patients with hepatic impairment have not been evaluated. Since Somaflam (Carisoprodol) is metabolized in the liver, caution should be exercised if Somaflam (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 Somaflam (Carisoprodol). Therefore, caution should be exercised in administration of Somaflam (Carisoprodol) to these patients [see Clinical Pharmacology (12.3) ].

9 DRUG ABUSE AND DEPENDENCE

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

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

10 OVERDOSAGE

Overdosage of Somaflam (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 Somaflam (Carisoprodol) overdosage. Many of the Somaflam (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 Somaflam (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 Somaflam (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 Somaflam (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 Somaflam (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 Somaflam (Carisoprodol), contact a Poison Control Center.

11 DESCRIPTION

Somaflam (Carisoprodol) Tablets, USP are available as 350 mg round, white tablets for oral administration. Somaflam (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. Somaflam (Carisoprodol) is present as a racemic mixture. Chemically, Somaflam (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 Somaflam (Carisoprodol) Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.

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

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

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

12.2 Pharmacodynamics

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

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

12.3 Pharmacokinetics

The pharmacokinetics of Somaflam (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 Somaflam (Carisoprodol). The exposure of Somaflam (Carisoprodol) and meprobamate was dose proportional between the 250 mg and 350 mg doses. The C_max of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of Somaflam (Carisoprodol), which is approximately 30% of the C_max of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.

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

Metabolism: The major pathway of Somaflam (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 Somaflam (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 Somaflam (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 Somaflam (Carisoprodol).

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

Somaflam (Carisoprodol) was not formally evaluated for effects on fertility. Published reproductive studies of Somaflam (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 Somaflam (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 Somaflam (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., Somaflam (Carisoprodol) 250 mg, Somaflam (Carisoprodol) 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Somaflam (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 Somaflam (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.

^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 Somaflam (Carisoprodol) 250 mg and placebo groups.

Patients treated with Somaflam (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 Somaflam tablets.

17.1 Sedation

Patients should be advised that Somaflam (Carisoprodol) tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Somaflam (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 Somaflam 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 Somaflam (Carisoprodol) Tablets Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with Somaflam (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 Somaflam (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

Ibuprofen:

• Pharmacological action
• Pharmacokinetics
• Why is Somaflam prescribed?
• Dosage and administration
• Somaflam side effects
• Contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Somaflam drug interactions
• Somaflam in case of emergency / overdose
• Storage conditions
• Somaflam (Ibuprofen) reviews

Pharmacological action

NSAIDs, a derivative of phenylpropionic acid, Somaflam has anti-inflammatory, analgesic and 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 both peripheral (indirectly, through suppression of prostaglandin synthesis), and a central mechanism (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system). Inhibits platelet aggregation.

For topical use anti-inflammatory and analgesic action. Reduces morning stiffness, increased the amount of motion in joints.

Pharmacokinetics

When oral administered Somaflam (Ibuprofen) almost completely absorbed from the gastrointestinal tract. Simultaneous food intake slows the rate of absorption. Metabolised in the liver (90%). T1 / 2 is 2-3 hours.

80% of the dose excreted in urine mainly as metabolites (70%), 10% - unchanged, 20% eliminated through the intestine in the form of metabolites.

Why is Somaflam prescribed?

Inflammatory, degenerative diseases of joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), articular syndrome in patients with acute gout, psoriatic arthritis, ankylosing spondylitis, tendonitis, bursitis, sciatica, traumatic inflammation of soft tissue and musculoskeletal apparatus. Neuralgia, myalgia, pain in infectious and inflammatory diseases of ENT organs, bursitis, algomenorrhea, headache and toothache. Fever in infectious and inflammatory diseases.

Dosage and administration

Setting individually, depending on etiology of disease, severity of clinical manifestations. When administered rectally or adult single dose of 200-800 mg, the frequency of reception - 3-4; for children - 20-40 mg / kg in divided doses.

Topical applied within 2-3 weeks.

The maximum daily dose for adults when administered oral or rectally or is 2.4 g.

Oral, after a meal. Rheumatoid arthritis - by 0.8 g 3 times a day in osteoarthrosis and ankylosing spondylitis - by 0.4-0.6 g 3-4 times a day, in juvenile rheumatoid arthritis - at 30-40 mg / kg / day in several stages.

When soft tissue injuries, sprains - 1.6-2.4 g / day in divided doses.

At moderate pain syndrome - 1.2 g per day.

Somaflam side effects

Digestive system: frequently - nausea, anorexia, vomiting, epigastric discomfort, diarrhea, possibly the development of erosive and ulcerative lesions of the gastrointestinal tract; rare - bleeding from the gastrointestinal tract, long-term use possible liver problems.

Central nervous system and peripheral nervous systems: frequently - headache, dizziness, sleep disturbances, agitation, visual impairment.

Hemopoietic system: long-term use may be anemia, thrombocytopenia, agranulocytosis.

Urinary tract: long-term use possible renal dysfunction.

Allergic reactions: often - skin rash, Quincke's edema, rarely - aseptic meningitis (usually in patients with autoimmune diseases), bronchospasm syndrome.

Local reactions: when topical used may be hyperemia of the skin, burning or tingling.

Contraindications

Erosive-ulcerative lesions in the gastrointestinal tract exacerbation, diseases of the optic nerve, "aspirin triad", hemodyscrasia, pronounced renal dysfunction and / or liver, children age, hypersensitivity to Somaflam (Ibuprofen).

Using during pregnancy and breastfeeding

Do not use Somaflam (Ibuprofen) in the III trimester of pregnancy. Application I and II trimesters of pregnancy is justified only in cases where the expected benefit to the mother than the possible harm to the fetus.

This medication Somaflam (Ibuprofen) in small amounts excreted in breast milk. Possible using in lactation for pain and fever. If necessary, prolonged use or use in high doses (800 mg / 24 h), should decide on the termination of breastfeeding.

Special instructions

Precautions are used with the attendant liver and kidney diseases, chronic heart failure, with dyspeptic symptoms before treatment, immediately after surgery, with indications of a history of gastrointestinal bleeding in diseases of the digestive tract, allergic reactions associated with NSAID intake.

In the course of treatment requires systematic monitoring of the liver and kidneys, peripheral blood picture.

It should not be applied externally to the damaged skin.

Somaflam drug interactions

With simultaneous use of Somaflam (Ibuprofen) reduces the effect of antihypertensive agents (ACE inhibitors, beta-blockers), diuretics (furosemide, hypothiazide).

With the simultaneous use of anticoagulants may enhance their action.

With simultaneous application of SCS increases the risk of side effects from the gastrointestinal tract.

With the simultaneous application of Somaflam (Ibuprofen) may displace from compounds with plasma proteins indirect anticoagulants (acenocoumarol), derivatives of hydantoin (phenytoin), oral hypoglycemic drugs sulfonylurea derivatives.

With the simultaneous use of amlodipine may be a slight reduction of antihypertensive action of amlodipine, with acetylsalicylic acid - decreased concentration of Somaflam (Ibuprofen) in blood plasma, with baclofen - described a case of toxic gain of baclofen.

When applied simultaneously with warfarin may increase bleeding time, were also observed microhematuria, bruises with hydrochlorothiazide - perhaps a slight reduction of antihypertensive action of hydrochlorothiazide, captopril - may reduce antihypertensive effect of captopril, with cholestyramine - moderately decrease absorption of Somaflam (Ibuprofen).

With simultaneous application of lithium carbonate increased the concentration of lithium in blood plasma.

With simultaneous application of magnesium hydroxide increases the initial absorption of Somaflam (Ibuprofen), with methotrexate - increases the toxicity of methotrexate.

Somaflam in case of emergency / overdose

In case of overdose, call your local poison control center or emergency services.

Symptoms of overdose may include: dizziness; fast eye movements that you cannot control; slow breathing or short periods of time without breathing; blue color around the lips, mouth, and nose.

Storage conditions

In a dry, protected from light place, at temperatures below 25°C.Common expiration date for Somaflam (Ibuprofen) tablets: 3 years.