INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PHENYTOIN SODIUM 50 mg TABLETS
PHENYTOIN SODIUM 100 mg TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

PHENYTOIN SODIUM 50 mg TABLETS
PHENYTOIN SODIUM 100 mg TABLETS

COMPOSITION:
50 mg: Each tablet contains 50 mg
phenytoin sodium
100 mg: Each tablet contains 100 mg phenytoin sodium.

PHARMACOLOGICAL CLASSIFICATION:
A 2.5 Anticonvulsants, including anti-epileptics.

PHARMACOLOGICAL ACTION:
Phenytoin sodium exerts an anti-epileptic action without causing general depression of the CNS. It is believed to stabilise rather than elevate the seizure threshold and to limit the spread of seizure activity.

INDICATIONS :
Grand mal and psychomotor epilepsy.

CONTRA-INDICATIONS:
None.

DOSAGE AND DIRECTIONS FOR USE:
50 -100 mg thrice daily increasing to 200 mg thrice daily according to the patient's needs. To be taken with half a glassful of water after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects are of fairly frequent occurrence, and include nausea, vomiting, constipation, ataxia slurred speech, blurred vision, nystagmus, mental confusion, and hallucinations, together with headache, dizziness, tremor, and insomnia. Some of these effects may disappear with continued treatment at reduced dosage.
Tenderness and hyperplasia of the gums is a frequent occurrence particularly in younger patients. Hirsutism is a less frequent effect but is most noticeable in young females. There have been a number of reports of rickets, reduced bone density, and osteomalacia in patients taking phenytoin, probably due to the induction, by phenytoin of liver enzymes involved in the metabolism of vitamin D. Lupus erythematosus and lymphadenopathy have occasionally occurred.
Leucopenia, thrombocytopenia, pancytopenia, granulocytopenia and agranulocytosis occur rarely and demand immediate withdrawal of the drug. Megaloblastic anaemia following prolonged use usually responds to treatment with folic acid.
Skin rashes have occurred; an incidence of 5 to 10% has been reported; the occurrence of bullous, exfoliative, or purpuric rash is an indication for withdrawing phenytoin. Phenytoin sodium should be administered with caution to patients receiving thyroid replacement therapy. It is suggested that caution be exercised in its use during early pregnancy.
It is suggested that patients on long-term treatment receive not less then 100 µg of vitamin D as calciferol per week.
The effects of phenytoin are enhanced by concomitant administration of dicoumarol, disulfiram, and (in slow activators) isoniazid, and may be enhanced by chloramphenicol, halothane, phenyramidol, sulthiame, thyroid preparations, and viloxazine. The effects of phenytoin may be diminished by alcohol and by phenobarbitone. Phenytoin may interfere with blood-calcium and blood-sugar estimations, with protein-bound iodine estimations, and with dexamethasone and metyrapone tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypotension, coma and respiratory depression.
The stomach should be emptied by aspiration and lavage. Treatment is mainly supportive and symptomatic.

IDENTIFICATION:
White film-coated tablets.

PRESENTATION:
Packs of 100 and 500.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBERS:
50 mg: B883 (Act 101/1965).
100 mg: B884 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited,
7 Fairclough Road,
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28.11.1969
        G670A
        KOHLER C&P P.E.

Updated on this site: May 2000

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