Dorbaxin Methocarbamol Tablets USP 500mg.

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.

COMPOSITION
Each film coated tablet contains:
Methocarbamol USP 500mg
Excipients q.s.

DESCRIPTION
Methocarbamol tablets, a carbamate derivative of guaifenesin, are a central nervous
system (CNS) depressant with sedative and musculoskeletal relaxant properties.

INDICATIONS AND USAGE
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.

DOSAGE AND ADMINISTRATION
Methocarbamol Tablets, 500 mg – Adults: Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Methocarbamol Tablets, 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.

CONTRAINDICATIONS
Methocarbamol tablets, USP are 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 methocarbamol tablets, should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of methocarbamol tablets, has not been established with regard to possible
adverse effects upon fatal development. There have been reports of fatal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol tablets, 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.

Use In Activities Requiring Mental Alertness
Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

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

Drug interactions
See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.
Methocarbamol may inhibit the effect of pyridostigmine bromice. Therefore methocarbamol shoud be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

Pregnancy: Methocarbamol tablets, should be given to e pregnant woman only if clearly needed.

Nursing Mothers: Caution should be exercised when methocarbamol tablets, are administered to a nursing woman.

Pediatric Use: Safety and effectiveness of methocarbamol tablets, in pediatric patients below the age of 16 have not been established.

ADVERSE REACTIONS
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 grandmal), vertigo.

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

OVERDOSAGE
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.

Treatment: Management of overdose includes symptomatic and supportive treatment.
Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

STORAGE CONDITION
Store in a cool (between 10 oC and 25 oC) dry and dark place.

PRESENTATION: 10 x 1 x 10 Tablets in Blister Pack.

Marketed ByXCEL PHARMACEUTICAL LTD
No 8 Obokun Street off Coker Road,
Ilupeju, Lagos, Nigeria.

Manufacture By
Stalllion LABORATORIES PVT. LTD
C-1B, 305/2 & 3, G.I.D.C. Kerala (Bavia)
Dist: Ahmedabad-382 220, Gujarat India.