ATALINE Syrup Ref.[28137] Active ingredients: Terbutaline

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Ataline syrup is indicated for bronchodilation.

Terbutaline is a selective β2-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm is a complicating factor.

4.2. Posology and method of administration

Posology

When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists.

Terbutaline has a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours.

Adults

The starting dose should be 2 × 5ml spoonfuls 3 times in 24 hours. The dose may then be increased to 3 × 5ml spoonfuls 3 times in 24 hours if necessary to achieve adequate bronchodilation.

Elderly

Dosage as for adults.

Paediatric population

The following dosage is recommended – 0.075mg (0.25ml)/kg body weight 3 times in a 24 hour period. Not more than 15 ml 3 times in 24 hours.

Method of administration

For oral use.

4.9. Overdose

Symptoms:

Headache, anxiety, tremor, nausea, tonic muscle cramps, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs.

Laboratory Findings:

Hyperglycaemia, hypokalaemia and lactic acidosis sometimesoccur.

Treatment:

Mild and Moderate Cases: Reduce the dose. Then increase the dose more slowly if the bronchospasmolytic effect is insufficient.

Severe Cases: gastric lavage, administration of activated charcoal. Determination of the acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of the heart rate and rhythm and blood pressure. Metabolic changes should be corrected.

A cardioselective β-blocker (eg, metoprolol) is recommended for the treatment of arrhythmias causing hemodynamic deterioration. The beta-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution on patients with a history of bronchospams. If the β2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25ºC.

6.5. Nature and contents of container

Brown glass bottles containing 100ml of syrup.

6.6. Special precautions for disposal and other handling

None.

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