Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
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 vitami Read the complete document