Propar/Propar Forte

Propar/Propar Forte

paracetamol + orphenadrine

Manufacturer:

XL Lab

Distributor:

Ambica
Full Prescribing Info
Contents
Paracetamol, orphenadrine citrate.
Description
Propar: Each film-coated tablet contains: Paracetamol BP 450 mg, Orphenadrine Citrate BP 35 mg.
Propar Forte: Each film-coated tablet contains: Paracetamol BP 650 mg, Orphenadrine Citrate BP 35 mg.
Action
Pharmacology: Paracetamol, a para-aminophenol derivative, is a peripherally acting analgesic with antipyretic and weak anti-inflammatory activity. Orphenadrine, 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.
Pharmacokinetics: Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of Paracetamol varies from about 1 to 3 hours.
Paracetamol is metabolised mainly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate after Paracetamol overdosage and cause tissue damage.
Orphenadrine is readily absorbed from the gastrointestinal tract. It is almost completely metabolised to at least 8 metabolites. It is mainly excreted in the urine as metabolites and small amount of unchanged drug. The half-life of orphenadrine has been reported to be 14 hours.
Indications/Uses
Paracetamol has analgesic and antipyretic properties and used for the short-term treatment of moderate pain, particularly after surgery, and for fever.
Orphenadrine is also used as to relieve pain due to skeletal muscle spasm and with the paracetamol used in the treatment of musculoskeletal and joint disorders.
Dosage/Direction for Use
Usual Oral Dose: Two tablets, three or four times daily.
Or as prescribed by the physician.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Paracetamol should be given with care to patients with impaired kidney or liver function. It should also be given with care to patients with alcohol dependence. Caution is advised for patients with impaired kidney or liver function, or in patients with cardiac failure, coronary insufficiency, cardiac arrhythmias and tachycardia.
Use in Pregnancy: PROPAR/PROPAR FORTE is not recommended for use during pregnancy.
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.
Use In Pregnancy & Lactation
Use in Pregnancy: PROPAR/PROPAR FORTE is not recommended for use during pregnancy.
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.
Adverse Reactions
Adverse effects of Paracetamol are rare and usually mild, although haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Skin rashes and other hypersensitivity reactions occur occasionally.
Orphenadrine adverse effects include dryness of mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilation of the pupils with loss of accommodation and photophobia, flushing and dryness of skin, transient bradycardia followed by tachycardia with palpitation and arrhythmias, and difficulty in micturition as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation.
Drug Interactions
The risk of Paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes. The absorption of Paracetamol may be accelerated by drugs such as metoclopramide. Excretion may be affected and plasma concentrations altered when given with Probenecid.
Colestyramine reduces the absorption of Paracetamol if given within 1 hour of Paracetamol.
Orphenadrine is an inhibitor of the cytochrome P450 isoenzymes CYP2B6 which is involved in the metabolism of bupropion to its major metabolites, should be used with caution in patients also receiving bupropion.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
M03BC51 - orphenadrine, combinations ; Belongs to the class of ethers. Used as centrally-acting muscle relaxants.
Presentation/Packing
Propar: FC tab 100's.
Propar Forte: FC tab 100's.
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