| COMPOSITION |
Each Orphilexa tablet contains:
Orphenadrine Citrate 35 mg and Paracetamol 450 mg.
|
| Exipients |
Magnesium stearate, Collodial anhydrous sillica (Aerosil 200), Microcrystalline cellulose, Starch.
|
| DESCRIPTION |
It is an analgesic and muscle relaxant effective in the relief of acute
musculoskeletal pain of mild to moderate intensity.
|
| PHARMACOKINETICS |
Orphilexa is well absorbed from the gastrointestinal tract. Orphenadrine is rapidly distributed in the body tissues; most of the dose is metabolized and excreted in the urine. Paracetamol is readily absorbed from the gastrointestinal tract. It diffuses throughout body tissues, and is excreted in the urine.
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| MECHANISM OF ACTION |
Orphenadrine acts centrally by blocking reticular facilitation i.e. it blocks
preferentially those pathways whose hyperactivity leads to exaggeration of motor function as it happens spasticity or rigidity.
Paracetamol is a well-tolerated analgesic and antipyretic. Its analgesic
action is rapid in onset (within 30 minutes) and lasts for 3-4 hours.
|
| INDICATIONS |
Orphilexa is indicated for the symptomatic relief of acute painful musculoskeletal conditions such as low back pain, lumbago, acute strains, neck pain, myalgia and post-surgical pain.
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| CONTRAINDICATIONS |
Due to the mild anticholinergic effect. Orphilexa should not be used in
patients with glaucoma, prostatic hypertrophy or obstructions at the
bladder neck, myasthenia, pyloric or duodenal obstruction, achalasia
and in patients with previous hypersensitivity to any of the product
ingredients.
|
| SIDE EFFECT |
Dry mouth, blurring vision, dizziness and restlessness may occur in
some patients susceptible to the anti cholinergic action of
Orphenadrine. These symptoms rapidly disappear following a reduction
of dosage or cessation of treatment.
|
| PREGNANCY & LACTATION |
Pregnancy: Pregnancy Category C
There is no evidence of the drug safety during pregnancy. Pregnant
women should use this product only if the potential benefit outweighs
the risk to the fetus.
Nursing Mothers:
Orphenadrine and paracetamol are excreted in breast milk and therefore, Orphilexa is contraindicated in lactating mothers. |
| WARNINGS & Precautions |
Orphilexa should be used with caution in patients with tachycardia. if
pain persists more than 10 days consult a physician immediately.
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 values is recommended.
|
| EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES |
Reaction speed may be lowered during Orphilexa treatment. This must
be considered in situations requiring care as driving a vehicle.
|
| Drug Interactions |
Side effects may be intensified by other drugs with anticholinergic or sympathomimetic effects. Alcohol should not be consumed with orphilexa.
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| DOSAGE & ADMINISTRATION |
Two tablets three times daily as needed.
|
| OVER DOSE AND ITS MANAGEMENT |
Symptoms: Excitation, confusion and delirium leading to coma.
Convulsions, tachycardia, dilated pupils and urinary retention may
occur. Overdose with paracetamol is known to be associated with gastro gastrointestinal upset, diarrhea, loss of appetite, nausea or vomiting
stomach cramps or pain and increased sweating.
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.
|
| Storage |
Store below 25°C.
|
| Packaging |
Orphilexa: A pack of 20 tablets.
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