ATALINE Tablet Ref.[28136] Active ingredients: Terbutaline

Source: Υπουργείο Υγείας (CY)  Revision Year: 2013  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

  • Bronchial asthma.
  • Chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor.

4.2. Posology and method of administration

Posology

Adults

During the first 1–2 weeks, 2.5 mg 3 times in a 24-hours period is recommended. The dose may then, if necessary, be increased to 5mg 3 times in 24 hours.

Elderly

Dosage as for adults

Paediatric population

Children (7–15 years)

The starting dose should normally be 2.5 mg 2 times in 24 hours. However, in some patients, the dose may need to be increased to 2.5 mg 3 times in 24 hours.

Renal impairment

Not applicable.

Hepatic impairment

Not applicable.

Method of administration

The tablet should be swallowed whole with a little fluid on an empty stomach. The duration of treatment is determined by the doctor. Dosage should be individualized.

4.9. Overdose

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

Laboratory findings: Hyperglycaemia and lactacidosis sometime occur. β2-agonists may cause hypokalemia as a result of re-distribution of potassium, but this requires usually no treatment.

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. Determine the acid-base balance, blood glucose and electrolytes. Monitor heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardio-selective β-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing a hemodynamic deterioration. Beta-blockers should be used with care because of the possibility of inducing inducing bronchial obstruction (bronchoconstricion). 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

30 months.

6.4. Special precautions for storage

Store below 25°C, in the original package, in order to protect from moisture and light.

6.5. Nature and contents of container

PVC-Al blisters packed in cartons with 20, 50, 100 tablets and hospital packs of 500 and 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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