Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
NORSTAN-PHENYTOIN SODIUM TABLETS SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): NORSTAN-PHENYTOIN SODIUM TABLETS COMPOSITION: Per tablet: Phenytoin sodium 100 mg PHARMACOLOGICAL CLASSIFICATION: A 2.5 Anticonvulsants, including anti-epileptics. PHARMACOLOGICAL ACTION: Norstan-Phenytoin sodium exerts anti-epileptic activity without causing general depression of the central nervous system. INDICATIONS: Norstan-Phenytoin sodium is an anticonvulsant used to control tonic-clonic (grand mal) seizures, and psychomotor (partial or focal) seizures. CONTRA-INDICATIONS: Known hypersensitivity to the drug. DOSAGE AND DIRECTIONS FOR USE: Adults: Initial dosage: one tablet (100 mg) three times daily, progressively increased at intervals of a few days to a maximum of 600 mg daily. Usual maintenance dosage: 300-400 mg daily. Children: Initial dosage: 5 mg per kg body mass daily n two or three divided doses. Maintenance dosage: 4 to 8 mg per kg body mass daily. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Norstan-Phenytoin sodium should be used with caution in pregnancy and lactating mothers, and its use in early pregnancy should be avoided unless the benefits outweigh the risks. It should also be given with caution in patients with hepatic disease. Nausea, vomiting, ataxia, nystagmus, mental confusion together with headache, dizziness, hallucinations, tenderness and hyperplasia of the gums, constipation, slurred speech, diplopia, transient nervousness and insomnia occur fairly frequently. Some of these effects may disappear with continued treatment at reduced dosage. A less frequent side-effect is hirsuitism, which is more noticeable in young females. Due to reports of rickets, reduced bone density and osteomalacia developing, vitamin D supplements may be necessary for some patients on lo Read the complete document