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Cetagesic


DESCRIPTION:
An oblong , scored tablet, green in colour with markings 'dp 500' and 'duo / duo'.

COMPOSITION:
Each tablet contains:
Paracetamol ..................................500 mg
Orphenadrine Citrate .......................25 mg

ACTIONS AND MODE OR MECHANISMS OF ACTIONS
Orphenadrine is a skeletal muscle relaxant. Paracetamol is an analgesic and antipyretic.

PHARMACOLOGY
Orphenadrine is readily absorbed from the gastrointestinal tract and is almost completely metabolized to at least 8 metabolites. It is mainly excreted in the urine as metabolites and small amounts of unchanged drug.


Paracetamol is readily absorbed from the gastro intestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. 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 metabolized predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine) which is usually produced in very small amounts by mixed-function oxidases in the liver and kidney and which is usually detoxified by conjugation with glutathione may accumulate following paracetamol overdosage and cause tissue damage.

INDICATIONS
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.

CONTRAINDICATIONS
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.

ADVERSE REACTIONS
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.


This preparation contains PARACETAMOL. Do not take any other PARACETAMOL containing medicines at the same time.

PRECAUTIONS
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. Orphenadrine 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 values is recommended.

Use in pregnancy
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.

DRUG INTERACTIONS
Orphenadrine with alcohol - Anticholinergic intoxication potentiated by alcohol.
Orphenadrine with Amantadine - Amantadine may enhance effects of orphenadrine.
Orphenadrine with Amitriptyline, Cyproheptadine, Desipramine, Dibenzepin, Diphenydramine, Doxepin, Furazolidone, Imipramine, Iproniazid, Isocarboxazid, Meclozine, Nortiptyline, Opipramol, Phenelzine, Phenindamine , Promethazine, Protriptyline, Tranylcypromine, Trimipramine - The anticholinergic activity of orphenadrine is increased.
Orphenadrine with Chlorpromazine, Fluphenazine, Pericyazine, Perphenazine, Promazine, Thiopropazate, Thioridazine, Trifluoperazine - Plasma levels and effects of phenothiazines may be reduced by orphenadrine.
Paracetamol with metoclopramide - Absorption rate of paracetamol increased.
Paracetamol with pethidine - Absorption rate of paracetamol delayed significantly.
Paracetamol with propantheline - Rate of absorption of paracetamol retarded.
Paracetamol with warfarin - Activity of anticoagulants possibly potentiated.

RECOMMENDED DOSAGE, DOSAGE SCHEDULE & ROUTE OF ADMINISTRATION

Two tablets three times daily.

SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE
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, 1-methionine or 1-cysteamine will minimize liver damage.


PACKING/PACK SIZES

Bottles of 30's, 60's, 90's and 120's.

Containers of 500 & 1000 (For Export Only).

Blister pack of 3 x 10's, 5 x 10's, 10 x10's, 50 x 10's and 100 x 10's.

STORAGE
Store below 25C.

Protect from light.

Keep out of reach of children.

SHELF LIFE

Please refer to outer package.

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