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

Logo DEGRANOL® TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DEGRANOL® TABLETS

COMPOSITION:
Each tablet contains 200 mg
carbamazepine.

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

PHARMACOLOGICAL ACTION:
Degranol possesses both anticonvulsant and psychotropic properties.

INDICATIONS:
Epilepsy with motor and psychic manifestations:
- psychomotor and temporal-lobe epilepsy
- grand mal
- mixed forms
- focal seizures
Carbamazepine is also used in the treatment of trigeminal neuralgia.

CONTRA-INDICATIONS:
Hypersensitivity to carbamazepine. Carbamazepine is contra-indicated for expectant or nursing mothers or patients with liver disease.
Not to be used in patients with heartblock.
It should not be given to patients taking a mono-amine oxidase inhibitor or within 2 weeks of stopping such treatment.
Not to be used in patients with porphyria.

WARNING:
In rats treated with carbamazepine for two years, the incidence of tumours of the liver was found to be increased. There is, however, no evidence to indicate that this observation has any significance relative to the therapeutic use of the drug.

DOSAGE AND DIRECTIONS FOR USE:
Trigeminal Neuralgia
An initial dose of 200 mg twice daily gradually increasing until a suitable response is obtained.
The usual dosage required is one tablet three or four times daily.
In elderly or hypersensitive patients an initial dose of half a tablet daily is recommended.
Adults: Initially 100 mg to 200 mg once or twice a day, followed by a slow increase until usually at a level of 400 mg twice or three times a day, the best response is obtained. In some instances 1600 mg in 3 to 4 divided doses may be necessary.
Children: Administered in several fractional doses –usually 10 to 20 mg/kg per day.
  Age up to 1 year:        100 mg to 200 mg (½ to 1 tablet ) per day.
1 to 5 years:        200 mg to 400 mg (1 to 2 tablets) per day.
5 to 10 years:        400 mg to 600 mg (2 to 3 tablets) per day.
10 to 15 years:        600 mg to 1 000 mg (3 to 5 tablets) per day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Medical supervision during treatment is essential.
The level of serum folic acid should be observed during anticonvulsant therapy since Degranol may enhance the metabolism of folic acid.
Abnormalities of liver function and jaundice have been associated with long-term treatment.
Blood counts and liver function tests should be performed before commencing treatment.
Blood counts should then be repeated at weekly intervals during the first month of treatment and subsequently at monthly intervals; liver function tests should also be undertaken periodically, if allergic skin reactions occur, if the leucocyte and/or platelet count diminish, if tests reveal a deterioration in liver function, or if any serious adverse symptoms develop, Degranol should be withdrawn.
Reaction-time may be increased by Degranol. The patient's safety as a road-user or operator of machines may be impaired in consequence.
Unwanted effects - i.e. loss of appetite, dryness of the mouth, retching, diarrhoea or constipation, headache, drowsiness, dizziness, somnolence, ataxia, disorders of visual accommodation, diplopia, or, in elderly patients, states of confusion and agitation - may occur, particularly at the start of treatment. These effects may require temporary reduction in the dosage.
Hyponatraemia due to the antidiuretic effect of Degranol and possibly accompanied by vomiting, headache, and mental confusion has been observed.
Allergic skin reactions, as well as occurrences of exfoliative dermatitis, paraesthesia, systemic lupus erythematosus, Steven's-Johnson syndrome, photosensitivity, altered skin pigmentation, leucopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, thrombo-embolism, left ventricular failure, disturbances of cardiac impulse conduction, hepatocellular and cholestatic hepatitis, acute oliguria with hypertension and proteinuria have been reported.
A wide variety of other central nervous system, gastro-intestinal, cardiovascular and dermatological effects have also been reported.
In patients with cardiovascular diseases, or with hepatic or renal disorders, glaucoma and in elderly subjects, Degranol should be administered with caution.
Tolerance may develop to some of the untoward effects of carbamazepine and they can be minimized by gradual increase in dosage and adjustment of maintenance dosage.
If treatment with Degranol is withdrawn abruptly, the change-over to another anti-epileptic should be effected under cover of diazepam or a barbiturate.
INTERACTIONS:
Degranol may reduce the patient's alcohol tolerance, it is therefore advisable to abstain from alcohol during treatment.
Induction of hepatic enzymes in response to Degranol may have the effect of diminishing the activity of certain drugs that are metabolized in the liver. This should be borne in mind when administering Degranol concomitantly with other anti-epileptic agents, e.g. phenytoin and the tetracycline, doxycycline. Similarly, in patients receiving oral anticoagulant medication, the dosage of the anticoagulant should be readapted to clinical requirements whenever treatment with Degranol is initiated or withdrawn. Degranol may adversely affect the reliability of oral contraceptives.
Pregnancy and Lactation:
Safety of Degranol in pregnancy has not been demonstrated conclusively.
If pregnancy occurs in a woman receiving Degranol or if the problem of initiating treatment with Degranol rises during pregnancy, the drug's potential benefits must be carefully weighed against its possible hazards, particularly in the first three months of pregnancy. The active substance of Degranol passes into the breast milk.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Agitation, tremor, abnormal reflexes, convulsions, impairment of consciousness, hypertension or hypotension, nausea, vomiting, renal insufficiency, deep sleep, coma, EEG and ECG changes.
No specific antidote.
The stomach should be emptied by aspiration and lavage.
Ensure clear airway and maintain respiration.
Treatment is mainly supportive and symptomatic. Measures to monitor and safeguard vital functions.
Administration of diazepam where necessary.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
Flat, white bisected tablets with bevelled edges, engraved with a mortar and pestle on one side.

PRESENTATION :
Packs of 100 and 500 tablets.

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

REGISTRATION NUMBER:
G/2.5/220

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19./3/1985.

Information for the Patient:
If the treatment is to prove successful, it is essential that the doctors instructions be carried out exactly.
It is advisable to refrain from alcohol during treatment with Degranol. In addition, caution should be exercised when driving a vehicle. If a skin rash, fever, sore throat, or any other symptoms develop, the doctor should be informed without delay.
You should also consult your doctor at once should you become pregnant.

        G941
        A&S PRINTERS

Updated on this site: October 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