Orphenadrine citrate, paracetamol.
Each tablet contains Paracetamol B.P. 450mg, Orphenadrine citrate B.P. 35mg.
Orphenadrine citrate acts centrally, blocking facilitatory functions of the reticular formation, thus relaxing and inhibiting spasm of the striated muscle. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating centre.
Relaxes and inhibits striated muscle spasm. Analgesia and antipyresis.
Adults: The usual dose is one to two tablets three to four times a day.
Because of the mild anti-cholinergic effect of orphenadrine, this preparation should not be used in patients with glaucoma, achalasia, prostatic hypertrophy, or obstruction of the bladder neck. It is also contraindicated in patients with myasthenia gravis and in patients known to be hypersensitive to orphenadrine or paracetamol.
Special senses: Dryness of mouth, blurred vision, dilatation of the pupils, increased intra-ocular pressure.
Central nervous system: Weakness, headache, dizziness, and rarely confusion (in elderly patients), hallucinations. Drowsiness has occurred rarely.
Cardiovascular: Tachycardia, palpitations, transient syncope.
Gastrointestinal: Nausea, vomiting, constipation, gastric irritation.
Urinary: Hesitancy, retention.
Immunogenic: Urticaria, and other dermatoses.
Serious Skin Reactions: Rarely, paracetamol may cause serious skin reactions such as acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reaction, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Adverse effects are mainly to the mild anti-cholinergic action of orphenadrine, and are usually associated with higher dosage.
Phenobarbitone and alcohol potentiate hepatotoxicity of paracetamol. Bioavailability of paracetamol is decreased in epileptic patients on anticonvulsants possibly because of first pass metabolism secondary to enzyme induction. Despiramine may delay and reduce the peak concentration of paracetamol in blood. There may be an increased risk of liver damage when doxorubicin and paracetamol are used together. Paracetamol has also been reported to increase the half-life of chloramphenicol. Orphenadrine citrate has been shown to induce enzymatic systems involving the metabolism of aminopyrine, steroidal contraceptives, griseofulvin, hexobarbital, and phenylbutazone. Orphenadrine will potentiate other anticholinergic agents.
Incompatibilities: Aspirin acetylate paracetamol to diacetyl p-aminophenol. Magnesium stearate accelerate the reactions. In solution, paracetamol degradation is catalysed by acids and alkalis.
Blister pack: Store at or below 30°C.
Bottle pack: Store at or below 25°C.
M03BC51 - orphenadrine, combinations ; Belongs to the class of ethers. Used as centrally-acting muscle relaxants.