MEDOLIN Tablet Ref.[28250] Active ingredients: Salbutamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Salbutamol tablets are indicated in the treatment of:

  1. Reversible airways obstruction, as in asthma (used as bronchodilators)
  2. Chronic obstructive pulmonary disease

4.2. Posology and method of administration

Posology

Adult dosage

The usual initial adult dosage for treatment of asthma is 2 to 4 milligrams (mg) three to four times a day. If the patient fails to respond to the upper limit of this range, doses may be cautiously increased to a maximum of 8 mg four times a day.

Dosage in geriatric patients

In general, no dose reduction is necessary for geriatric patients treated with salbutamol. Geriatric patients and patients who are unusually sensitive to beta-adrenergic stimulators should begin salbutamol therapy with 2 milligrams orally three or four times a day. If adequate bronchodilatation is not achieved, the salbutamol doses may be gradually increased to a maximum of 8 milligrams four times a day.

Paediatric population

Children aged 3-6 years: A dose of 1 mg to 2 mg, administered three or four times daily.

Children aged 6-12 years: A dose of 2 mg, administered three or four times daily.

Children aged over 12 years: A dose of 2 to 4 mg administered three of four times daily. If the child does not respond the dose can be increased gradually.

Method of administration

Salbutamol tablets are for oral administration.

4.9. Overdose

In case of over dosage the preferred antidote is a cardio selective beta blocking agent but care should be taken when employing such agents in patients with bronchospasm.

Over dosage may result in hypokalaemia and hence serum potassium levels should be monitored. Symptomatic treatment of other side effects has proven beneficial.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

Primary packaging: PVC – Aluminium foil blisters.

Secondary packaging: Cast coated Carton boxes with information leaflet.

Pack sizes available: Boxes of 50, 100, 1000 tablets in blisters.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

For oral administration only.

No special requirements for disposal.

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