Methocarbamol Tablets USP Revised: September 2008 Rx only 173752

Rx only

Methocarbamol, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.

The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate. The structural formula is shown below:

                                                                                        C₁₁H₁₅NO₅         M.W. 241.24

Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

Methocarbamol Tablets USP 500 mg and 750 mg, contain the follwing inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and stearic acid.

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Methocarbamol tablets are 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. Methocarbamol does not directly relax tense skeletal muscles in man.

Methocarbamol tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

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

Safe use of methocarbamol 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, methocarbamol 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 (seePRECAUTIONS, Pregnancy).

Adverse reactions reported coincident with the administration of methocarbamol include:

Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache

Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and lymphatic system: Leukopenia

Immune system: Hypersensitivity reactions

Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

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: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

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.

500 mg - Adults:
      initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.

750 mg - Adults:
      initial dosage, 2 tablets q.i.d.; maintenance dosage 1 tablet q.4h or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

Methocarbamol Tablets USP 500 mg are scored, round, white tablets imprinted DAN DAN and 5381 supplied in bottles of 30, 40, 60, 90, 120 and 180.

Methocarbamol Tablets USP 750 mg are scored, capsule shaped, white tablets imprinted DAN DAN and 5382 supplied in bottles of 30, 40, 60, 90, 120 and 180.

Dispense in a tight container with a child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Manufactured by:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA

Distributed By:
Watson Pharma Inc.
Corona, CA 92880 USA

Revised : September 2008       
0908B            173752     

Methocarbamol  500mg  tablet (s)

PRINCIPAL DISPLAY PANEL 500mg

Methocarbamol   750mg   tablet (s)

PRINCIPAL DISPLAY PANEL 750 mg