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

Logo 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 long-term therapy.
Blood disorders such as leucopenia, thrombocytopenia, pancytopenia, granulocytopenia and agranulocytosis have been reported. Megaloblastic anaemia following prolonged use usually responds to treatment with folic acid.
Skin rashes, sometimes with fever, are common. Particularly in children. More serious skin reactions include lupus erythematosus and erythema multiforme, and the occurrence of bullous, exfoliative or purpuric rash is an indication for withdrawing phenytoin sodium.
Drug Interactions:
1. Rugs which may increase phenytoin sodium levels include:
  tolbutamide, chloramphenicol, dicoumarol, disulfiram, isoniazid, phenylbutazone, acute alcohol intake, aminosalicylic acid, chlordiazepoxide HCl, chlorpromazine, diazepam, oestrogens, ethosuximide, halothane, methylphenidate, prochlorperazine.
2. Drugs which may decrease phenytoin serum levels include:
  Carbamazepine, chronic alcohol abuse, reserpine. Molidone hydrochloride contains calcium ions which interfere with the absorption of phenytoin.
3. Drugs which may either increase or decrease phenytoin serum levels include:
  phenobarbitone, valproic acid and sodium valproate. Similarly, the effect of phenytoin on phenobarbitone, valproic acid and sodium valproate serum levels is unpredictable.
4. Although not a true drug interaction, tricyclic antidepressants may precipitate seizures in susceptible patients and phenytoin dosage may need to be adjusted.
5. Drugs whose efficacy is impaired by phenytoin include:
  corticosteroids, coumarin anticoagulants, oral contraceptives, quinidine and vitamin D. Serum levels determinations are especially helpful when possible drug interactions are suspected.
Drug/Laboratory Test Interactions:
  phenytoin may cause decreased serum levels of protein-bound iodine (PBI). It may also produce lower than normal values for dexamethasone or metyrapone tests. Phenytoin may cause raised serum levels of glucose.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may lead to hypotension, coma and respiratory depression. Treatment of acute poisoning includes emptying the stomach by aspiration and lavage, followed by symptomatic treatment.

IDENTIFICATION:
White, sugar-coated tablet

PRESENTATION:
Tablets:        100', 500', 1 000' and 5 000'
        56's/84's (tender packs sizes)

STORAGE INSTRUCTIONS:
Store below 25°C and keep well closed.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
B1366 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 November 1969

D522
Pro-Print

Updated on this site: May 2003
Source: Community Pharmacy

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