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

Logo DOVAL TABLETS 2 mg.
DOVAL TABLETS 5 mg.

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

DOVAL TABLETS 2 mg.
DOVAL TABLETS 5 mg.

COMPOSITION:
Each Doval Tablet 2 mg contains 2 mg
diazepam.
Each Doval Tablet 5 mg contains 5 mg diazepam.

PHARMACOLOGICAL CLASSIFICATION:
Category A:2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
It has been found that the major locus of CNS depressant action of Doval on spinal reflexes is the brain stem reticular system. After oral administration peak plasma concentrations are reached in 1 to 4 hours. Drug elimination follows a biphasic pattern with a rapid phase (halflife = 2 to 3 hours) followed by a slow decay with a halflife of 2 to 8 days. Doval is metabolized to active products including oxazepam. One third is excreted as oxazepam and 70% of the metabolites appears in the urine. Metabolites have been found in the urine and in the plasma 14 days after a 10 mg dose.

INDICATIONS:
Doval is used in the treatment of anxiety in neurotic patients, agitated depression and for pre-operative medication. It may be effective in relieving the acute symptoms of the alcohol withdrawal syndrome, but has no specific usefulness in the treatment of psychotic patients.

CONTRA-INDICATIONS:
Doval is contra-indicated in infants and in patients with known hypersensitivity to diazepam. Caution should be observed when giving Doval to patients with impaired hepatic or renal function.

In elderly or debilitated patients and patients with obstructive airways disease large doses may produce syncope. The effects of Doval may be enhanced by alcohol, barbiturates, narcotics, MAO inhibitors and other depressants of the central nervous system. The response to treatment with oral anti-coagulants may be variable in patients taking diazepam.

WARNINGS:
Elderly or debilitated patients and patients with obstructive airways disease should be given one-half the usual adult dose. Acute narrow angle glaucoma requires caution.

DOSAGE AND DIRECTIONS FOR USE:
The usual dosage for mild anxiety states in ambulant patients is 2 mg thrice daily and in severe anxiety and other psychiatric disorders 15 mg to 30 mg daily in divided doses.

For sleep disturbances 5 mg to 30 mg should be given in the evening.

Elderly or debilitated patients and patients with obstructive airways disease should be given one-half the usual adult dose.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The toxic effects most frequently encountered with Doval are drowsiness, dizziness, fatigue, apathy, constipation, irritability and ataxia; less frequently, depression, diarrhoea, indigestion, impairment of sexual, function may occur. Large doses may produce Syncope. Other side-effects occasionally reported are skin rashes, headaches, nausea, frequency of urination and menstrual irregularities. Blood dyscrasias and hepatic dysfunction have occasionally been reported. Care should be taken when administered in obstetrics during labour because of the possible effect of central respiratory depression, hypothermia and hypotonia and an increase in foetal heart rate in the infant.

In severely disturbed patients treatment with Doval may result in paradoxical reactions provoking excitement instead of sedation. There is a risk of dependence of the barbiturate-alcohol type and withdrawal reactions including convulsions have been observed in patients receiving large doses for prolonged periods when the drug was stopped abruptly.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
Sedation is the most prominent symptom of overdosage. This usually follows symptoms of dizziness, fatigue, apathy or irritability. Large doses may produce syncope.

Treatment:
In severe overdosage the stomach should be emptied by aspiration or lavage. There is no specific treatment and recovery usually follows symptomatic treatment.

CONDITIONS OF REGISTRATION:
Advertising to the medical professions only.

IDENTIFICATION:
2 mg –White tablets with scoremark on the one side.
5 mg –Yellow tablets with scoremark on the one side.

PRESENTATION:
Containers with 10, 30 or 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NO.:
K/2.6/116.

NAME AND BUSINESS ADDRESS:
Ormed Limited,
Howard Studios,
Howard Drive,
Pinelands 7405.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1988
        RSA Litho

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998