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

Logo ADCO-KETOTIFEN ALCOHOL AND SUGAR FREE

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-KETOTIFEN ALCOHOL AND SUGAR FREE
Syrup

COMPOSITION:
Each 5 mL contains 1 mg ketotifen base which corresponds to 1,38 mg ketotifen fumarate.
Preservative: Sodium benzoate 0,2% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.2.2 Medicines acting on the respiratory system - other.

PHARMACOLOGICAL ACTION:
Ketotifen has anti-anaphylactic properties and anti-histaminic effects. Laboratory experiments have indicated the following properties which may contribute to its activity:
• Inhibition both of the acute bronchoconstrictor response to PAF (Platelet Activating Factor) and of PAF-induced airway hyper-responsiveness.
• Inhibition of PAF-induced accumulation of eosinophils in the airways.
• Inhibition of the release of such chemical mediators as histamine and SRS-A (A slow Reacting Substance of Anaphylaxis) or leukotrines.
• Antagonism of acute bronchoconstriction due to SRS-A or leukotrines.
• Ketotifen exerts H1 receptor blocking activity which can be clearly dissociated from its anti-anaphylactic properties.
After oral administration the absorption of ketotifen is nearly complete. Bioavailability amounts to approximately 50% due to a first-pass effect of about 50% in the liver. Maximal plasma concentrations are reached within 2-4 hours. Protein binding is 75%.
Ketotifen is eliminated biphasically with a short half-life of 3-5 hours and a longer one of 21 hours. In urine about 1% of the substance is excreted unchanged within 48 hours and 60-70% as metabolites. The main metabolite in the urine is practically inactive ketotifen-N-glucuronide.

INDICATIONS:
ADCO-KETOTIFEN Alcohol and Sugar free Syrup is indicated in the long-term prevention of asthma. Ketotifen is not effective in aborting established attacks of asthma.
ADCO-KETOTIFEN Alcohol and Sugar free Syrup is also indicated in the prevention and treatment of allergic rhinitis and allergic skin reactions.       

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
ADCO-KETOTIFEN Alcohol and Sugar free Syrup should not be used in patients with hepatic disease.
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Each 5 mL of the syrup contains 1 mg ketotifen base.
Children:
Under 14 kg mass (older than 6 months of age): 1,5 mL (0,3 mg) twice daily.
14 - 25 kg mass: 2,5 mL (0,5 mg) twice daily.
Over 25 kg mass: 5 mL (1 mg) twice daily.
In the prevention of asthma it may take several weeks of treatment to achieve full therapeutic effect. If the therapeutic response after four weeks of treatment is insufficient, the doses may be increased gradually depending on body mass. In introducing ketotifen therapy to patients, care must be taken to slowly taper off the dose of other anti-allergic substances that the patient may be receiving.

SIDE-EFFECTS:
Sedation, dry mouth and dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days. On the first few days of treatment with ketotifen, the patient's reactions may be impaired.
Care should therefore be exercised when driving a vehicle, operating machinery etc. The preparation may cause drowsiness which will be aggravated by the simultaneous intake of alcohol.
ADCO-KETOTIFEN Alcohol and Sugar free Syrup may potentiate the effects of sedatives, hypnotics, tranquilizers, narcotic analgesics, antihistamines, anticholinergics and alcohol. If intercurrent infection occurs, treatment must be supplemented by specific anti-infectious therapy.
Anti-asthmatic agents already in use should never be withdrawn abruptly when long term treatment with ADCO-KETOTIFEN Alcohol and Sugar free Syrup is begun.
This applies especially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid-dependent patients, in such cases recovery of a normal pituitary-adrenal response to stress may take up to one year.
A reversible fall in the thrombocyte count in patients receiving ketotifen concomitantly with oral anti-diabetic agents has been observed in a few cases. This combination of medicines should therefore be avoided.
Increases in appetite and weight gain have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage would include drowsiness to severe sedation, dizziness, hypotension, muscular weakness and inco-ordination, confusion, dyspnoea, bradycardia, or tachycardia, disorientation, convulsions. Other symptoms may include nausea, vomiting, diarrhoea, colic, epigastric pain, dryness of the mouth and blurred vision.
The most serious symptoms are unconsciousness, convulsions, bradycardia and tachycardia, and severe hypotension. If the medicine has been taken recently, the stomach should be emptied by aspiration and lavage. Treatment should be symptomatic and supportive.

IDENTIFICATION:
A clear, colourless to pale yellow liquid with a strawberry flavour.

PRESENTATION:
ADCO-KETOTIFEN Alcohol and Sugar free Syrup (1 mg/5 mL): 200 mL bottles.

STORAGE INSTRUCTIONS:
Store in a well closed container below 25°C, protected from direct light.
Keep out of reach of children.

REGISTRATION NUMBER:
33/10.2.2/0431

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

DATE AND PUBLICATION OF THIS PACKAGE INSERT:
26 November 1999

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

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