Orphenadrine citrate, paracetamol.
White, scored, biconvex tablet marked: Upper Face: N/C, Lower Face has no markings.
Each tablet contains orphenadrine citrate 35 mg and paracetamol 450 mg.
Pharmacology: Pharmacodynamics: Orphenadrine is a skeletal muscle relaxant.
Paracetamol is an analgesic and antipyretic.
Pharmacokinetics: Orphenadrine is readily absorbed from the gastrointestinal tract and is almost completely metabolised to at least eight metabolites. Orphenadrine and its metabolites are excreted from the body in the urine, with a half life of 14 hours.
Paracetamol is also readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. It has a half life of between 1 to 3 hours.
Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.
2 tablets three times daily.
Route of Administration: Oral.
Symptoms: Symptoms of orphenadrine overdosage are excitement, confusion, delirium leading to coma. Convulsions and tachycardia with dilated pupils and urinary retention may occur.
Paracetamol overdosage may cause acute liver damage, but symptoms may not appear for up to several days after ingestion.
Treatment: Gastric lavage should be carried out immediately, regardless of the estimated ingested dose. Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important. It is recommended that the patient be referred to a hospital where early and regular monitoring of plasma paracetamol levels can be carried out. If instituted sufficiently early, treatment with N-acetylcysteine, L-methionine or L-cysteamine will minimise liver damage.
Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis.
This preparation contains PARACETAMOL.
Do not take any other paracetamol containing medicines at the same time.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition.
If these reactions occur, stop use and seek medical assistance right away.
Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias.
Safety of continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended.
Effects on the Ability to Drive or Operate Machinery: Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.
Use in Pregnancy: Safe use in pregnancy has not been established, therefore the drug should not be used in pregnant women or those likely to become pregnant unless the expected benefits outweigh the potential risks.
Use in lactation: It is unknown whether orphenadrine is excreted during lactation. However it is established that paracetamol is excreted into the breast milk, one to two hours after oral administration.
Side effects rarely occur at the recommended dosage. Those encountered are associated with anticholinergic activity and may include nausea, dry mouth, blurring of vision. Rarely, rash or drowsiness may occur. These symptoms disappear rapidly with a reduction in dosage or cessation of medication. No toxic effects have been observed.
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
The effects of antimuscarinic agents such as orphenadrine maybe enhanced by other drugs with antimuscarinic properties such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants. The reduction in gastric motility caused by antimuscarinic agents may affect the absorption of other drugs.
M03BC51 - orphenadrine, combinations ; Belongs to the class of ethers. Used as centrally-acting muscle relaxants.
Norgesic tab
1 × 12's;50 × 12's
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