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

Logo PHENYTOIN SODIUM 100 mg TABLETS
PHENYTOIN SODIUM CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

PHENYTOIN SODIUM 100 mg TABLETS
PHENYTOIN SODIUM CAPSULES

COMPOSITION:
TABLETS: Each tablet contains 100 mg
phenytoin sodium.
CAPSULES:        Each capsule 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:
Cardiac function impairment, such as Adams Stokes syndrome, sinoatrial block and sinus bradycardia.

WARNINGS:
Hyperglycaemia may be potentiated in patients with diabetes mellitus. Porphyria may be exacerbated.

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 few 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, and during breast-feeding. Phenytoin sodium should be prescribed with caution where ulcers or lesions of the gastro-intestinal tract exist..
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:
TABLETS:        White, shallow, biconvex, film-coated tablets.
CAPSULES:        A white No 3 opaque gelatin capsule containing a white powder.

PRESENTATION:
Packs of 84, 500, 1000 and 5000 tablets
Packs of 100 and 1000 capsules.

STORAGE DIRECTIONS:
Store below 25°C.
Store in airtight container.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
100 mg Tablet        B884 (Act 101/1965).
100 mg Capsules        B885 (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
        D170
                        A & S PRINTERS

Updated on this site: November 2000
Current: March 2005
Source: Hospital Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005