(and dosage form):
Each 5 mL syrup contains 1,38 mg ketotifen hydrogen fumarate equivalent to 1 mg ketotifen base.
Each 5 mL syrup contains 0,016% Propylparahydroxybenzoate as preservative
Each 5 mL syrup contains 0,034% Methylparahydroxybenzoate as preservative
CONTAINS ALCOHOL 2,49% v/v
A.10.2.2 Medicines Acting on the respiratory tract other
KetoHexal syrup has anti-histaminic properties.
KetoHexal syrup exhibits H1 receptor blocking ability
The absorption of KetoHexal syrup is almost complete following oral dosing and within 48 hours approximately 60 to 70% of the medicine is excreted via the urine in the form of metabolites.
Long term prevention of asthma.
KetoHexal syrup is not effective in aborting an asthma attack.
Prevention and treatment of rhinitis and skin reactions of allergic nature.
Hypersensitivity to any of the ingredients of this formulation.
The administration ofKetoHexal syrup is contra-indicated in patients suffering from hepatic disease.
Safety in pregnancy and lactation has not been established .
KetoHexal syrup 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 against taking charge of vehicles or machinery or performing potentially hazardous tasks where the loss of concentration may lead to accidents.
DOSAGE AND DIRECTIONS FOR USE
Each 5 mL contains 1 mg ketotifen base.
Below 14kg body mass - 0,3 mg (1,5 mL) twice daily.
14 - 25kg body mass - 0,5 mg (2,5 mL) twice daily.
25kg body mass and over - 1 mg (5 mL) twice daily.
Therapeutic effect may only be achieved following several weeks of treatment, particularly in the prevention of asthma.
Should therapeutic response be inadequate following approximately 4 weeks of treatment, dose may be slowly increased, depending on body mass.
Note: Should the patient be receiving other anti-allergic agents before the initiation of ketotifen therapy, the dose of the other agent should slowly be tapered off.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Following initiation of therapy, sedation, dizziness and dry mouth may occur, however these effects usually disappear spontaneously.
Increased appetite and consequent weight gain have been reported.
KetoHexal syrup may potentiate the effects of sedatives, hypnotics, tranquilisers, narcotics, analgesics, anti-histamines, anti-cholinergics and alcohol.
Anti-asthmatic agents already being administered to the patient must never be withdrawn abruptly, on initiation of long term therapy withKetoHexal syrup.
Existing anti-asthma treatment should be continued for at least 2 weeks after starting ketotifen therapy . This is especially applicable to systemic corticosteroids and ACTH, because of possible adrenocortical insufficiency. Recovery of the normal pituitary-adrenal response to stress may take up to one year.
The combination of KetoHexal syrup and oralantidiabetic agents should be avoided, since concomitant administration may lead to a reversible fall in the platelet count.
Should an infection occur during treatment with Ketohexal syrup, specific anti-infectious therapy should be initiated.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of overdosage may include drowsiness to severe sedation, dizziness, hypotension, muscle weakness and inco-ordination. Nausea, vomiting, diarrhoea, colic, epigastric pain, dry mouth and blurred vision have been reported.
If the medicine was taken recently, the stomach may be emptied by aspiration and gastric lavage.
Treatment should be symptomatic and supportive.
Colourless to slightly straw coloured solution, clear and free from foreign particles.
The solution has a strong strawberry odour and a strong sweet taste.
The syrup is contained in an amber glass bottle, closed by a high density polyethylene cap.
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hexal Pharma (SA)(PTY) LTD
10 Fangio road
DATE OF PUBLICATION OF THIS PACKAGE INSERT
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