Salbutamol

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

salbutamol (salbutamol sulfate)

Available from:

Arpimed LLC

INN (International Name):

salbutamol (salbutamol sulfate)

Dosage:

2mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SALBUTAMOL 2 MG TABLETS
1. NAME OF THE MEDICINAL PRODUCT - Salbutamol NON-PROPRIETARY NAME – Salbutamol
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each tablet contains:
ACTIVE INGREDIENT: Salbutamol sulfate - 2 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
White, scored cylindrical tablets, the end surface of which are flat.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. For the relief of bronchospasm in bronchial asthmas of all types.
2. Chronic bronchitis.
3. Emphysema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration Oral.
_Adults: _
The usual effective dose is 4 mg three or four times per day. If
adequate bronchodilation is not
obtained each single dose may be gradually increased to as much as
8mg. However, it has been
established that some patients obtain adequate relief with 2 mg three
or four times daily. In
elderly patients or in those known to be unusually sensitive to
beta-adrenergic stimulant drugs, it
is advisable to initiate treatment with 2 mg three or four times per
day.
_Children: _
The following doses should be administered three or four times daily.
2-6 years: 1-2mg
6-12 years: 2mg
Over 12 years: 2-4mg
The product is not recommended for children under 2 years of age. The
drug is well tolerated by
children so that, if necessary, these doses may be cautiously
increased.
4.3 CONTRAINDICATIONS
1. Salbutamol should not be used for threatened abortion during the
first or second trimester of
pregnancy.
2. Salbutamol and beta-blocking drugs such as propranolol should not
usually be prescribed
together.
3. Salbutamol tablets are contraindicated in patients with a history
of hypersensitivity to any of
their components.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with rare hereditary problems of galactose intolerance, the
lapp lactase deficiency or
glucose – galactose malabsorption should not take this medicine.
Bronchodilators should not be the only or main treatment in patients
with severe or unst