Robinax Methocarbamol Tablets USP

Robinax is indicated as an adjunctive therapy for the relief of discomfort associated with acute painful musculoskeletal conditions.ROBINAX is also indicated for control of muscle spasm in tetanus.

COMPOSITION
Each uncoated tablet contains:
Methocarbamol USP 500mg

INDICATIONS
ROBINAX is indicated as an adjunctive therapy for the relief of discomfort associated with acute painful musculoskeletal conditions. Robinax is also indicated for control of muscle spasm in tetanus.

DOSAGE AND ADMINISTRATION
Oral: Initial: 1.5gm (i.e. 3 tablets) 4 times daily.
Maintenance: 1gm (2 tablets) 4 times daily.
For the first time 48 to 72 hours, 6gm/day is recommended. (For severe conditions 8 gm daily may be administered. Thereafter reduce to approximately 4gm daily.

PHARMACOLOGY
Methocarbamol is a centrally acting skeletal muscle relaxant. Its mechanism of action has not been established, but may be due to general CNS depression. The drug has no direct action on the contractile mechanism of striated muscle, motor endplate or nerve fiber, it does not directly relax tense skeletal muscles. Methocarbamol is rapidly absorbed from the gastro intestinal tract following oral administration. Methocarbamol has an onset of action of 30 minutes. Peak plasma levels occur approximately 2 hours after administration of 2gm.

The half life is from 1 to 2 hours. Methocarbamol is metabolised, probably in the liver and in urine primarily as the glucuronide and sulphate conjugates of its metabolites. A small amount is excreted in faeces.

ADVERSE REACTIONS
Oral – Lightheadedness, dizziness, drowsiness, nausea, urticaria, pruritus, rash conjunctivitis with nasal congestion, blurred vision, headache, fever.

PRECAUTIONS AND WARNINGS
a) Methocarbamol may impair concentration, patients so effected should not drive or
operate machinery.

b) Methocarbamol is not recommended during pregnancy, especially during early
pregnancy or in women who may become pregnant, unless potential benefits outweigh potential hazards.

c) It is not known whether Methocarbamcl is excreted in breast milk. Exercise caution when administering to nursing women.

d) Safety and efficacy of Methocarbamol in children below 12 years old has not been
established, except in tetanus.

OVERDOSAGE
Overdosage often in conjunction with alcohol or other CNS depressants, is marked by coma and other signs of CNS depression.

TREATMENT OF OVERDOSE
Treatment is essentially supportive. Simple isolated seizures may require only observation and supportive care, repetitive seizures or status epilepticus require therapy. Diazepam i.v. is generally the agent of choice, parenteral barbiturates have also been used.

CONTRA-INDICATIONS
Methocarbamol is contraindicated in hypersensitive patients, in coma or pre-coma states, brain damage, myasthenia gravis or in patients with a history of epilepsy.
Methocarbamol should not be administered to patients with known or suspected renal pathology.

DRUG INTERACTIONS
The CNS effects of Methocarbamol may be potentiated by concomitant administration of other CNS depressants, such as alcohol. Methocarbamol has also been stated to
potentiate the effects of anorectics, antimuscarinics and some psychotropic agents.
Methocarbamol may cause a colour interference in certain screening tests for 5 hydroxy indole acetic acid (5-HIAA) and vanillylmandelic acid (VMA).

STORAGE CONDITIONS
Store in a cool dry place.
Keep out of reach of children.

PRESENTATION
ROBINAX Tablets: A Strip of 10 tablets.

NAFDAC Reg. No. 04-6813

Manufactured in India by
Khandelwal Laboratories Pvt. Ltd
Survey No. 277/3/6, Demni Road, Dadra U.T. 396191.
Regd. Office 79/87, D.Lad Path, Mumbai-400 033

Marketed by
EDEN U-K PHARMACEUTICAL LTD
J116 Daminja Avenue Housing Estate
Fegge Onitsha, Anambra State, Nigeria

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