Fartolin

Salbutamol.

Each mL inhalation solution contains: Salbutamol Sulfate equivalent to Salbutamol 1 mg.

Pharmacology: Salbutamol BP is selective beta-2-adrenoceptor agonist. At therapeutic doses it acts on the beta-2-adrenoceptor of bronchial muscle with little or no action on the beta-1-adrenoceptor of cardiac muscle.

Routine management of chronic bronchospasm-unresponsive to conventional therapy. Treatment of acute attack of bronchospasm (status asthmaticus).

Posology and method of administration: Adults and children: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams, administered 3-4 times daily by nebulisation.
However, in domiciliary practice the benefit increasing the dose of nebulised salbutamol should be weighed against the risk that a deterioration in the patient's underlying conditions may be masked. In such circumstances, a medical assessment should be considered since alternative therapy may be indicated. Treatment may be repeated four times daily. Salbutamol inhalation solution are intended to be used undiluted. However, if prolonged delivery times is desirable, (more than 10 minutes) dilution using normal saline for injection as a diluent may be required.
Salbutamol inhalation solution are to be used with a nebulizer, under the direction of a physician. The solution must not be injected. Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
DIRECTION FOR USE: ONCE A NEBULE HAS BEEN FROM THE PLASTIC BAR, IT IS OPEN AND SHOULD BE USED IMMEDIATELY.
1. Prepare Fartolin nebule.
2. Separate one Fartolin nebule and detach by twisting it firmly.
3. Nebule is open now. Take care not to spill the contents.
4 . Squeeze the contents of the nebule into the reservoir of the nebulizer. Do not dilute the contents unless instructed to do so by the doctor.
5. Assemble the nebulizer and use it as directed.
6. After use, discard any remaining solution and clean the nebulizer in the usual way.

The preferred antidote for overdosage with salbutamol is a cardio selective beta-blocking agent. Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Salbutamol inhalation solution are contraindicated in patients with history of hypersensitivity to any of their components.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of premature labour, uncomplicated by conditions such as placenta praevia, ante partum haemorrhage or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour.
Salbutamol presentation should not used for threatened abortion during the first or second trimesters of pregnancy.

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically by lung function tests.
Increasing use of short-acting inhaled beta-2-agonists to control symptoms indicates deterioration of asthma control. Under these conditions the patient's therapy plan should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients receiving treatment at home with salbutamol inhalation solution must be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol inhalation solution should be used with caution in patients known to have received large doses of other sympathomimetic drugs.
Salbutamol should be administered cautiously to patients with thyrotoxicosis. A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol with nebulised salbutamol and ipratropium Bromide. A combination of nebulised salbutamol with nebullsed anticholinergics should be used cautiously. Patients should receive adequate instruction in correct administration and be warned to let the solution or mist enter the eye.
Potentially serious hypokalaemia may results from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia.
It is recommended that serum potassium levels are monitored in such situations.

PREGNANCY: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Salbutamol has been in widespread use for many years in human beings without apparent ill consequence; this includes its well established use in the management of premature labour. However, as with the majority of drugs, there is little published evidence of its safety in the early stage of human pregnancy, but in animal studies there was evidence of some harmful effect on the foetus at very high dose levels.
LACTATION: As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.

Salbutamol inhalation solution may cause a fine tremor of skeletal muscle in some patients, usually the hands are most obviously affected. This effect is common to all beta-adrenergic stimulants.
In patients who are unusually sensitive to beta-adrenergic stimulants, peripheral vasodilatation and a compensatory small increase in heart rate may occur. There have been very rare reports of transient muscle cramps.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
As with other inhalation therapy, the potential for paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast acting inhaled bronchodilator. Salbutamol inhalation solution should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.
Potentially serious hypokalaemia may result from beta-2-agonist therapy. As with other beta-2 agonists hyperactivity has been reported rarely in children. Mouth and throat irritation may occur with inhaled salbutamol.

Salbutamol is not contraindicated in patients under treatment with MAO inhibitors.
Effect of Salbutamol inhibited by β2-antagonist.
The concurrent administration with MAO group may increase heavy Hypertension.
Salbutamol and non selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.

Store below 30°C. Protect from light.

Antiasthmatic & COPD Preparations

R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

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