The Facts Of Robaxin

BRAND NAME: Robaxin GENERIC DRUG NAME: Methocarbamol

INDICATIONS AND USAGE:

Robaxin (Methocarbamol) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Robaxin does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS:

Robaxin is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

WARNINGS:

Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxin should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Robaxin has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards.

Robaxin may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

PRECAUTIONS:

Patients should be cautioned that Robaxin may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because Robaxin may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

ADVERSE REACTIONS:

Adverse reactions reported coincident with the administration of methocarbamol include:

Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headacheCardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitisDigestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomitingHemic and lymphatic system: LeukopeniaImmune system: Hypersensitivity reactionsNervous system: Amnesia, confusion, Diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigoSkin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

DRUG INTERACTIONS:

Robaxin may inhibit the effect of pyridostigmine bromide. Therefore, Robaxin should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

DRUG / LABORATORY TEST INTERACTIONS:

Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Long-term studies to evaluate the carcinogenic potential of Robaxin have not been performed. No studies have been conducted to assess the effect of Robaxin on mutagenesis or its potential to impair fertility.

PREGNANCY:

Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Robaxin should be given to a pregnant woman only if clearly needed.

Safe use of Robaxin has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards.

NURSING MOTHERS:

Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Robaxin is administered to a nursing woman.

PEDIATRIC USE:

Safety and effectiveness of Robaxin in pediatric patients below the age of 16 have not been established.

OVERDOSAGE:

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms:

nauseadrowsinessblurred visionhypotensionseizurescoma

In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs. Management of overdose includes symptomatic and supportive treatment.

Store Robaxin at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

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Source: U.S. Food and Drug Administration, NDA 11-011/S-070/071

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