Orcigesic

Orcigesic

Manufacturer:

Sunward

Distributor:

Apex Pharma Marketing
Full Prescribing Info
Contents
Mefenamic acid, orphenadrine citrate.
Description
Orcigesic Tablet: Each tablet contains Mefenamic acid 250mg, Orphenadrine citrate 35mg.
Excipients/Inactive Ingredients: Calcium Phosphate Dibasic, Ethylene Glycol Monoethyl Ether, HPMC, Isopropyl Alcohol, Magnesium Stearate, Methylene Chloride, PVP, Starch, Sunset Yellow FCF, TALC, Titanium Dioxide.
Action
Therapeutic Properties: Mefenamic acid is a non steroidal agent with demonstrated anti-inflammatory, analgesic and anti-pyretic activity. It inhibits prostaglandin synthesis and compete for binding at the prostaglandin site.
Orphenadrine citrate acts centrally, blocking facilitatory functions of the reticular formation, this relaxing and inhibiting spasm of the striated muscle.
Dosage/Direction for Use
Route of administration: Oral.
Dosage: Administration is by the oral route, preferably with food. The recommended regimen for adults and children over 14 years of age is two tablets as an initial dose followed by one tablet every six hours as needed, usually not to exceed one week.
Contraindications
Mefenamic acid should not be used in patients who have exhibited hypersensitivity to it. Because potential exists for cross-sensitivity to aspirin or other non-steroidal anti-inflammatory drugs, it should not be given to patients in whom these drugs induce symptoms of bronchospasm, allergic rhinitis or urticaria. Mefenamic acid is contraindicated in patients with active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract. Mefenamic acid should be avoided in patients with pre-existing renal disease. Safety and effectiveness in children below the age of 14 have not been established.
This preparation should not be used in patients with glaucoma, achalasia, prostatic hypertrophy, obstruction of the bladder neck or myasthenia gravis.
Warnings
This product contains tartrazine which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.
Use In Pregnancy & Lactation
Usage during pregnancy: In pregnant women, this drug should be used only if clearly needed. The use of this drug in late pregnancy is not recommended because of the effects on the foetal cardiovascular system.
Use of NSAIDs at about 20 weeks gestation or later in pregnancy may cause foetal renal dysfuction leading to oligohydramnios and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Adverse Reactions
Gastrointestinal: More frequently reported are diarrhoea, nausea with or without vomiting and abdominal pain. Less frequently reported are anorexia, pyrosis, flatulence and constipation. Gastrointestinal ulceration with or without haemorrage has also been reported.
Haematopoietic: Cases of auto-immune hemolytic anaemia have been associated with the continuous administration of Mefenamic acid for 12 months or longer, leukopenia, eosinophilia, pancytopenia, thrombocytopenic purpura, agranulocytosis and bone marrow hypoplasia.
Nervous System: Drowsiness, dizziness, nervousness, headache, blurred vision and insomnia.
Integumentary: Urticaria, rash, and facial oedema.
Renal: Papillary necrosis, renal failure, haematuria and dysuria.
Other: Eye irritation, ear pain, perspiration and mild hepatic toxicity, dryness of mouth with difficulty in swallowing, thirst, dilatation of pupil with loss of accommodation and photophobia, increased intra ocular pressure, flushing of the skin, transient bradycardia followed by tachycardia with palpitations and arrhythmias, difficult micturition and constipation.
Drug Interactions
Mefenamic acid may prolong prothrombin time. Therefore, when the drug is administered to patients receiving oral anti-coagulant drugs, frequent monitoring of prothrombin time is necessary.
Orphenadrine has been shown to induce enzymatic systems involving the metabolism of aminopyrine, steroidal contraceptives, griseofulvin, hexobarbital and phenylbutazone. Orphenadrine will potentiate other anticholinergic agents.
Caution For Usage
Incompatibilities: Reports of incompatibilities are not available.
Storage
Store at or below 25°C.
Shelf life: 4 Years.
MIMS Class
Muscle Relaxants
ATC Classification
M03BC51 - orphenadrine, combinations ; Belongs to the class of ethers. Used as centrally-acting muscle relaxants.
Presentation/Packing
Form
Orcigesic tab
Packing/Price
10 × 10 × 10's
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