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

Logo ADCO-PHENOBARBITONE VITALET® Elixir

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ADCO-PHENOBARBITONE VITALET® Elixir

COMPOSITION:
Each 5 mL contains:-

Phenobarbitone         16 mg
Thiamine Hydrochloride         3 mg
Riboflavine         1 mg
Pyridoxine Hydrochloride         0,25 mg
Nicotinamide         10 mg
Preservatives:-
Methyl Hydroxybenzoate 0,09% m/v
Propyl Hydroxybenzoate 0,01% m/v
Alcohol 14,4% v/v

PHARMACOLOGICAL CLASSIFICATION:
A. 2.3. Barbiturates

PHARMACOLOGICAL ACTION:
ADCO-PHENOBARBITONE VITALET® Elixir
is a depressant of the central nervous system and has a sedative-hypnotic action. ADCO-PHENOBARBITONE VITALET® Elixir, being one of the long-acting barbiturates, has a slow onset of action and duration from six to ten hours. ADCO-PHENOBARBITONE VITALET® Elixir is largely excreted by the kidneys.

INDICATIONS:
ADCO-PHENOBARBITONE VITALET® Elixir
is used as a sedative and hypnotic in nervous insomnia and as an anticonvulsant in the treatment of epilepsy. It is especially of value in the treatment of patients with grand mal seizures or psychomotor attacks. ADCO-PHENOBARBITONE VITALET® Elixir is also used as a sedative in anxiety.

CONTRA-INDICATIONS:
ADCO-PHENOBARBITONE VITALET® Elixir
should be administered cautiously to the elderly; reduced dosage should be employed until tolerance is assessed. It should be used with care in patients with impaired hepatic or renal function and is contra-indicated when the impairment is severe. It is also contra-indicated in patients with acute intermittent porphyria and in hyperkinetic children.
Care is needed when giving the syrup to patients with severe respiratory insufficiency. The quantity prescribed at any one time should be limited, particularly in patients of unbalanced personality, as ADCO-PHENOBARBITONE VITALET® Elixir is frequently used in suicidal attempts.
In the presence of severe pain, barbiturates may fail to exert their hypnotic action and may cause wakefulness, excitement, and delirium unless accompanied by an analgesic such as aspirin.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to take charge of vehicles or machinery where loss of concentration could cause accidents.

DOSAGE AND DIRECTIONS FOR USE:
Infants: Half to one medicine measureful (2,5 mL to 5 mL)
Children: One to two medicine measuresful (5 mL to 10 mL)
Adults: Two medicine measuresful (10 mL)
To be taken with water, repeated two or three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In therapeutic doses, the side effects of ADCO-PHENOBARBITONE VITALET® Elixir include respiratory depression, sedation and allergic reactions, particularly affecting the skin. The skin rashes are most commonly of maculopapular type. Fixed-drug eruptions are associated with barbiturates, and photosensitivity may occur. Purpura, exfoliative dermatitis, erythema multiforme (the Stevens-Johnson Syndrome) and toxic epidermal necrolysis have been reported.
Nystagmus and ataxia may occur with excessive doses and "hang-over" with impaired judgement. Paradoxical excitement, restlessness and confusion may occur in the elderly or in the presence of pain - irritability and hyperexcitability may occur in children. Folate deficiency has developed during chronic administration for epilepsy, and hypoprothrombinaemia has occurred in infants of mothers who have received phenobarbitone during pregnancy. Hepatitis and cholestasis have occurred.
The chronic effects of phenobarbitone may include disorientation, mental confusion, ataxia, dizziness, depression and skin rashes, and dependence may result. In such cases withdrawal should be gradual and cautious. (Continued use of phenobarbitone, even in therapeutic doses, may result in psychic or physical dependence).

INTERACTIONS:-
The effects of ADCO-PHENOBARBITONE VITALET® Elixir and other barbiturates are enhanced by the concurrent administration of other sedatives, monoamine oxidase inhibitors and some tranquillisers, and may be enhanced by anti-cholinesterases, sodium valproate, sulphonylurea antidiabetics and tricyclic anti-depressants.
ADCO-PHENOBARBITONE VITALET® Elixir may also enhance the activity of methotrexate, cyclophosphamide, and sulphonylureas, as well as the toxic effects of tricyclic anti-depressants. The concomitant administration of ADCO-PHENOBARBITONE VITALET® Elixir and alcohol may produce very serious respiratory depression and a lowering of the lethal dose of the syrup. The effects of other central nervous system depressants e.g. anaesthetics, antihistamines and narcotic analgesics may also be enhanced.
Phenobarbitone increases the rate of metabolism of many drugs by induction of drug-metabolising enzymes in liver microsomes. This may result in a reduction in activity. Drugs affected include carbamazepine, coumarin anticoagulants, doxycycline, folic acid, phenylbutazone, phenazone, phenytoin, corticosteroids and other steroid hormones. The activity of griseofulvin may be reduced if it is given by mouth with phenobarbitone.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic effects include prolonged coma, respiratory and cardiovascular depression, with hypotension and shock leading to renal failure. Absent bowel sounds indicate severe poisoning. Hypothermia is common with associated pyrexia during recovery. Erythematous or haemorrhagic blisters may occur.
Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
Yellow-coloured elixir.

PRESENTATION:
Amber glass bottles of 100 mL elixir.

STORAGE INSTRUCTIONS:
Keep the bottle tightly closed. Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
B1492 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 January 1988

® Registered Trademark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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