Paracetamol 450mg&Orphenadrine citrate 35mg

 

Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice.

Høivik HO, Moe N.

Abstract

The clinical efficacy and tolerability of a combination preparation ('Norgesic') of 35 mg orphenadrine plus 450 mg paracetamol was compared with that of placebo in a controlled double-blind, parallel group, 7-day study comprising 44 patients suffering from pain due to tension of the cervical and upper thoracic musculature. The patients were allocated at random into two homogeneous groups, stratified by sex and initial pain intensity. One group received the combination, the other placebo. The dosage used was 1 tablet 3-times daily. The effect of treatment of pain was assessed daily using a visual analogue scale. Despite the low dosage used, orphenadrine/paracetamol produced statistically significant pain relief from initial levels by and from the second day of the study. Comparison between the groups showed that the analgesic efficacy of the combination was significantly superior to that of placebo from the third day of treatment. These results confirm the efficacy of a combination of orphenadrine/paracetamol in patients suffering from myalgia nuchae.
https://www.ncbi.nlm.nih.gov/pubmed/6653131

• Concise Info

Paracetamol + Orphenadrine
> Indications > Dosage > Dosage Details > Administration > Contraindications > Special Precaution > Adverse Drug Reactions > Overdosage > Drug Interactions > Mechanism of Action > Storage > MIMS Class		Available Brands Camgesic Norgesic Suniton Other Known Brands Anarex Cetagesic Norphen Orphenadol

Indications	Pain and muscular spasms in musculoskeletal disorders.
Dosage	Adult : PO Per tab contains paracetamol 450 mg and orphenadrine citrate 35 mg: 2 tab 3 times/day.
Dosage Details	Oral Pain and muscular spasms in musculoskeletal disorders Adult: Each tablet containing paracetamol 450 mg and orphenadrine citrate 35 mg: 2 tablets tid.
Administration	May be taken with or without food. May be taken w/ meals if GI discomfort occurs.
Contraindications	Bladder neck or prostate obstruction or hypertrophy, glaucoma, myasthenia gravis, oesophageal spasm, pyloric or duodenal obstruction, porphyria.
Special Precautions	Impaired kidney or liver function, or in patients with cardiac failure, coronary insufficiency, cardiac arrhythmias and tachycardia. Alcohol dependence. Pregnancy and lactation. In prolonged therapy, monitor blood, urine, and LFTs periodically. May affect ability to drive or operate machinery.
Adverse Drug Reactions	Dry mouth, nausea, constipation, tachycardia, palpitation, urinary hesitancy or retention, blurred vision, mydriasis, increased ocular tension, weakness, headache, dizziness and drowsiness. Potentially Fatal: Blood dyscrasias (rare).
Overdosage	Paracetamol: Symptoms: Paleness, nausea, vomiting, anorexia, abdominal pain, metabolic acidosis and glucose metabolism disturbances. Liver damage may surface 12-48 hr after overdose. In severe cases, encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, acute renal failure and death. Management: Immediate medical treatment even if there are no symptoms. If presented within 1 hr of poisoning, admin activated charcoal. If needed, admin IV N-acetylcysteine or oral methionine. Orphenadrine: Symptoms: 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. Management: Treatment is symptomatic and supportive.
Drug Interactions	Increased paracetamol absorption with metoclopramide and domperidone. Decreased paracetamol absorption with cholestyramine. May increase risk of bleeding with warfarin and coumarins. Increased anticholinergic side effects with other anticholinergic drugs. Additive CNS effects with propoxyphene. Increased bupropion levels with concurrent use. May antagonise actions of centrally acting anticholinesterases e.g. donepezil, galantamine, rivastigmine, tacrine. May decrease levodopa absorption with concurrent use. Potentially Fatal: Increased risk of liver damage with alcohol.
Mechanism of Action	Description: Paracetamol, a para-aminophenol derivative, is a peripherally acting analgesic with antipyretic and weak anti-inflammatory activity. Orphenadrine, an analog of diphenhydramine, is a skeletal muscle relaxant and is postulated to act on cerebral motor center or on the medulla through an atropine-like central action. It has anticholinergic, local anaesthetic effects and some antihistaminic effects. Orphenadrine is used either as the hydrochloride or the citrate and doses are expressed in terms of the relevant salt. Pharmacokinetics: Absorption: Paracetamol: Absorbed readily from GI tract; time to peak plasma concentrations: 10-60 minutes. Orphenadrine: Absorbed readily from GI tract and after IM inj. Distribution: Paracetamol: Distributed into most body tissues including breast milk, crosses the placenta; plasma-protein binding: negligible (but dose dependent). Orphenadrine: May cross placenta. Metabolism: Paracetamol: Undergoes hepatic metabolism; a minor metabolite, produced in minute amounts by cytochrome P450 isoenzymes in the liver and kidney, is usually removed by conjugation with glutathione, but may accumulate and cause tissue damage in paracetamol overdosage. Orphenadrine: Metabolised to ≥8 metabolites. Excretion: Paracetamol: Excreted in the urine mainly as the glucuronide and sulfate conjugates with <5% excreted unchanged; elimination half-life: 1-3 hr. Orphenadrine: Excreted mainly in urine and unchanged drug (small amounts); half-life: 14 hr.
Storage	Store below 25°C.
MIMS Class	Muscle Relaxants / Analgesics (Non-Opioid) & Antipyretics

http://www.mims.com/singapore/drug/info/paracetamol%20%2B%20orphenadrine/