Parashin Relax
Paracetamol and Orphenadrine
Indication
PARASHIN - Relax is used for the treatment, control, prevention & improvement of the following conditions:
-Acute painful musculoskeletal conditions
-Headache
-Toothache
-Ear pain
-Joint pain
-Periods pain
-Fever
-Cold.
PARASHIN - Relax may be also used for purposes not listed here.
Dosage and Administration
Adults: 1 to 2 tablets 3 to 4 times daily. Elderly: the dosage should be reduced.
Or as recommended by Healthcare Professionals.
Composition
Each tablet contains:
Paracetamol B.P ... 450 mg
Orphenadrine Citrate B.P ... 35 mg.
Description
Paracetamol is N-acetyl para-amino phenol derivatives. It is non-steroidal anti-inflammatory drug and it has analgesic, antipyretic and weak anti-inflammatory activity. Chemical formula is C8H9NO2 and its molecular weight is 151.2.
Orphenadrine citrate, an analog of diphenhydramine, is a skeletal muscle relaxant. Chemically, it is(RS)-N, N-Dimethyl-2-[(2-methylphenyl)phenylmethoxy] ethanamine dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate.The molecular formula is C24H31NO8. The molecular weight is 461.5.
Clinical Pharmacology
Paracetamol is also known as acetaminophen. It is inhibitor of the enzyme cyclo-oxygenase and inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Therefore...
Orphenadrine citrate is centrally acting potent skeletal muscle relaxant by blocking reticular facilitation whose hyperactivity leads to spasticity, rigidity and muscle spasm. It does not affect normal muscle tone and voluntary movement. Action is rapid in onset relatively prolonged. It also possess...
Pharmacokinetics
Paracetamol is readily absorbed from the GI tract. Peak plasma concentration occurs at 10 - 60 minutes after oral dose. It is distributed into most body tissues. It crosses the placenta and present in breast milk. Plasma protein binding is negligible at usual therapeutic concentration but increase ...
Orphenadrine is readily absorbed from the GI tract and has bioavailability of 90%. The half-life is approximately 13 - 20 hrs and it is metabolized in the liver by hepatic demethylation.
Excretion is via renal and bilary tracts.
Contraindication
It is contraindicated in patients who have hypersensitivity to acetaminophen or orphenadrine and patients with known G6PD deficiency. Repeated administration is contraindicated in patient with anaemia, cardiac, pulmonary, renal and hepatic disease. Orphenadrine shows some anticholinergic act...
Precaution
It should be given with care to patients with impaired liver or kidney functions, in patients with cardiac failure, coronary insufficiency, cardiac arrhythmia, tachycardia, alcohol dependence, pregnancy and lactation. The hazards of overdose are greater in those with non-cirrhotic alcoholic liv...
Adverse Effects
Adverse effects of this combinations are mostly dry mouth, nausea, constipation, tachycardia, palpitation, urinary hestiancy or retention, blurred vision, mydriasis, increased ocular tension, weakness, headache, dizziness and drowsiness.
Overdose
Paracetamol: Acute overdose whether accidental or deliberate, is relatively common and can be extremely serious because of the narrow margin between therapeutic and toxic dose. Ingestion of as little as 10 - 15g of paracetamol by adults may cause severe hepatocellular necrosis and less often, renal ...
Activated charcoal and N-acetylcysteine are used as antidote for paracetamol poisoning.
Orphenadrine: Overdose symptoms are vomiting, gastric irritation, dilated pupils, pruritus, urinary retention, tachycardia, hyperpyrexia, euphoria, hallucinations, agitation, paranoid reactions, tremor, excitement, confusion, delirium, circulatory and respiratory failure, coma and convulsions.
Drug Interaction
Interactions have been reported between orphenadrine and phenothiazines and other drugs with anti-muscarinic properties. Concomitant use with alcohol or other CNS depressants should be avoided.
Anticoagulant dosage may require reduction if paracetamol medication is prolonged.
Paracetamol absorption is increased by medicines that increase gastric emptying, e.g. metoclopramide and decreased by medicines that decrease gastric emptying, e.g. propantheline, anti- depressants with anticholinergic properties and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol or anticonvulsant medicines.
Storage
Store below 30°C in cool and dry place. Protect from light and moisture. Keep out of reach and sight of children.
Presentation
10 x 10’s Blisters.