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

Logo KETOHEXAL syrup

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

KETOHEXAL syrup

COMPOSITION
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

PHARMACOLOGICAL CLASSIFICATION
A.10.2.2 Medicines Acting on the respiratory tract –other

PHARMACOLOGICAL ACTION
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.

INDICATIONS
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.

CONTRA-INDICATIONS
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 .

WARNINGS
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
Side Effects
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.
Special Precautions
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.

IDENTIFICATION
Colourless to slightly straw coloured solution, clear and free from foreign particles.
The solution has a strong strawberry odour and a strong sweet taste.

PRESENTATION
The syrup is contained in an amber glass bottle, closed by a high density polyethylene cap.

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

REGISTRATION NUMBER
31/10.2.2/0639

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hexal Pharma (SA)(PTY) LTD
10 Fangio road
Mahogany Ridge
Westmead, Pinetown

DATE OF PUBLICATION OF THIS PACKAGE INSERT
15/10/2001

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000