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Salbutamol

Structure

Salbutamol SA-4 Tablets
Each uncoated sustained-release tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 4 .

Salbutamol SA-8 Tablets Each uncoated sustained-release tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 8 .

Salbutamol-AX Respules
Each 2.5 ml respule contains Salbutamol Sulphate IP equivalent to Salbutamol IP 2.5 , Ambroxol hydrochloride Ph. Eur 15 mg, In an isotonic solution q.s.

Salbutamol Inhaler
Each actuation delivers Salbutamol IP 100 micro gms, inert aerosol propellants q.s.

Salbutamol Rotacaps
Each capsule contains Salbutamol Sulphate IP equivalent to Salbutamol IP 200 micro gms

Salbutamol Ecopack Inhaler
Each actuation delivers Salbutamol IP 100 micro gms, inert aerosol propellants q.s.

Salbutamol HFA Inhaler
Each actuation delivers Salbutamol IP 100 micro gms, suspended in CFC-free propellant - HFA.

Salbutamol Respules
Each 2.5 ml contains Salbutamol Sulphate IP equivalent to Salbutamol IP 2.5 in Normal Saline Solution IP q.s.

Salbutamol Respirator Solution
Each ml contains Salbutamol Sulphate IP equivalent to Salbutamol IP 5

Salbutamol Expectorant
Each 5 ml contains Salbutamol Sulphate IP equivalent to Salbutamol IP 1 and Guaiphenesin BP 50 mg

Salbutamol-2 Tablets
Each tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 2

Salbutamol-4 Tablets
Each tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 4

Salbutamol SA-4 Tablets
Each uncoated sustained-release tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 4

Salbutamol SA-8 Tablets
Each uncoated sustained-release tablet contains Salbutamol Sulphate IP equivalent to Salbutamol IP 8

Salbutamol Syrup
Each 5 ml contains Salbutamol Sulphate IP equivalent to Salbutamol IP 2

Indications

Salbutamol is indicated for the relief of bronchospasm in asthma, chronic bronchitis and emphysema, and other conditions associated with airways obstruction.
Salbutamol is indicated to prevent symptoms in circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise, unavoidable allergic exposure).
Salbutamol-AX Respules are indicated for the treatment of secretion disorders in acute and chronic bronchopulmonary infections associated with bronchospasm.
Salbutamol Respirator Solution is indicated for the treatment of acute, severe asthma (status asthmaticus) and other forms of bronchospasm.
Salbutamol Respules are indicated for use in the routine management of chronic bron-chospasm unresponsive to conventional therapy and in the treatment of acute severe asthma.
Salbutamol Inhalers and Rotacaps are indicated in the treatment and prophylaxis of bron-chospasm in bronchial asthma, chronic bronchitis and emphysema.
Salbutamol Inhalers is indicated with a Cipla Spacer/Zerostat Spacer device in patients who find it difficult to synchronise aerosol actuation with inspiration of breath.
The Cipla BabyMask device may be used to facilitate administration t children under 5 years of age.
Salbutamol is indicated for the relief of bronchospasm in asthma, chronic bronchitis and emphysema, and other conditions associated with airways obstruction and for prevention of asthma attack triggered by allergic exposure or exercise.
Salbutamol Expectorant is indicated for clinical relief of cough associated with bronchitis, bronchial asthma, emphysema and other broncho-pulmonary disorders where bronchospasm, mucous plugging and problems of expectoration co-exist.

Dosage

Salbutamol SA Tablets
The tablets must be swallowed whole with a glass of water and not chewed or crushed.
Adults: 4 or 8 tablets twice daily.
Children (3-12 years): 4 twice daily.

Adults and children > 5 years: 1 respule two times a day
Children < 5 years: ? respule two times a day
Salbutamol-AX Solution for nebulisation is inhaled with the aid of a nebuliser.
It can be diluted with normal saline in the ratio of 1:1.

Salbutamol Respirator Solution
By intermittent administration
Adults
0.5-1 ml (2.5-5 of salbutamol up to 4 times daily) should be diluted to a final volume of 2 to 4 ml with normal saline (used for injection).
The resulting solution is inhaled from a suit-ably driven nebuliser until aerosol gene-ration ceases.
Using a correctly matched nebuliser and driving source, this should take about ten minutes.
Salbutamol Respirator Solution may be used undiluted for intermittent administration.
For this, 2 ml of the solution (10 sal-butamol) is placed in the nebuliser and the patient is allowed to inhale the solution until bronchodilation is achieved.
This usually takes 3-5 minutes.
Some adult patients may require higher doses of salbutamol, up to 10 , in which case the nebulisation of the undiluted solution may continue until aerosol generation ceases.
Children
The same mode of administration for intermittent administration is also applic-able to children.
The usual dosage for children under the age of twelve years is 0.5 ml (2.5 salbutamol up to 4 times daily) diluted to 2 to 4 ml with normal saline for injection.
Some children may however require doses of salbutamol up to 5 , up to 4 times daily.

By continuous administration
Salbutamol Respirator Solution is diluted with normal saline (used for injection) to contain 50100 salbutamol per ml (1-2 ml solution made up to 100 ml with diluent).
The diluted solution is administered as an aerosol by a suitably driven nebuliser.
The usual rate of administration is 1-2 per hour.
Delivery of the aerosol may be done by a suitable facemask, a T piece or via an endotracheal tube.
Intermittent positive pressure ventilation may be used but is rarely necessary.
When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

Salbutamol Respules
Salbutamol Respules are to be used with a nebuliser only under the direction of a physician.
The solution should not be in-jected or administered orally.
Adults and children
Start with a dose of 2.5 (one Respule) which may be increased up to 5 mg.
In infants up to18 months old the clinical efficacy of nebulised salbutamol is uncertain.
Treatment should be repeated up to four times daily by means of a nebuliser.
Up to 40 /day can be given under strict medical supervision in hospital.
Delivery of the aerosol may be by face mask or T piece.
Salbutamol Respules should be used undiluted.
However, if delivery time is prolonged (more than 10 minutes), dilution with normal saline (used for injection) may be required.

Salbutamol Inhalers
Adults
For the relief of acute episodes of broncho-spasm: 1 or 2 puffs as necessary.
On demand, maximum 8 puffs in 24 hours.
To prevent allergen or exercise-induced broncho-spasm: Two inhalations 15 minutes prior to exercise, or exposure to allergen.
Children
Half the adult dose.
For chronic maintenance or prophylactic therapy: Adults: 1 or 2 puffs 4 times daily.
Children: Half the adult dose.

Salbutamol Rotacaps
Salbutamol Rotacaps should only be used for inhalation through the Cipla Rotahaler.
Adults
For the relief of acute bronchospasm and for managing intermittent episodes of asthma: The contents of one or two capsules (200400 micro gms) may be administered as a single dose.
On demand, maximum 400 micro gms four times daily.
For chronic maintenance or prophylactic therapy: Two capsules (400 micro gms) three or four times daily.
To prevent exercise-induced broncho-spasm: Two capsules (400 micro gms) should be taken 15 minutes before exercise.
Children
For the relief of acute bronchospasm, in the management of episodic asthma or before exercise One capsule (200 micro gms) as a single dose.
On demand, maximum 200 micro gms four times daily.
For chronic maintenance or prophylactic therapy:One capsule (200 micro gms) three or four times daily.

Salbutamol-2/4 Tablets
Adults: 2-4 three or four times daily.
Children (7-12 years): 2 three or four times daily.
Children (2-6 years): 1-2 three or four times daily.

Salbutamol Syrup
Adults: 5-20 ml three or four times daily.
Children: Under 2 years : Not recommended.
2-6 years : 2.5-5 ml three or four times daily.
6-12 years : 5 ml three or four times daily.
> 12 years : 5-10 ml three or four times daily.

Salbutamol SA Tablets
The tablets must be swallowed whole with a glass of water and not chewed or crushed.
Adults 4 or 8 tablets twice daily.
Children (3-12 years)
4 twice daily.
Children under 3 years
Not recommended.

Adults: 10-20 ml thrice daily.
Children (6-12 years): 10 ml thrice daily.
Children (under 6 years): 5-10 ml thrice daily.

Contraindications

Pre-existing cardiac tachyarrhythmias and in patients with known hypersensitivity to salbutamol.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of premature labour, ante-partum haemorrhage or toxaemia of pregnancy are contraindications.
Hypersensitivity to the components of the formulation and those with epilepsy.
Hypersensitivity to components of the formulation.

Package

- 200 metered doses;
- 200 metered doses;
- 30 capsules;
- 400 metered doses;
- Blister pack of 10 tablets;
- Bottle of 100 ml;
- Bottle of 15 ml;
- Respules of 2.5 ml;