Generic

Indications

Bronchospasm: Salbutamol Inhaler is used to treat or prevent bronchospasm in people with bronchial asthma, as well as to treat reversible airway obstruction caused by bronchitis and emphysema.

Exercise-Induced Bronchospasm: Salbutamol Inhaler can be used to treat acute dyspnea episodes as well as prophylactically before exertion or to avoid exercise-induced asthma.

Pharmacology

Salbutamol is a 2-adrenoceptor agonist that is selective. It operates on the 2-adrenoceptors of bronchial smooth muscle at therapeutic dosages but has little or no effect on the 1-adrenoceptors of cardiac muscle. In reversible airway blockage, salbutamol offers short-acting (4-6 hours) bronchodilation with a rapid start (within 5 minutes). It also inhibits the production of bronchoconstrictor mediators such as histamine, neutrophil chemotactic factor (NCF), and prostaglandin D2 from mast cells, resulting in anti-inflammatory action.

Dosage

Administer Salbutamol Inhaler by oral inhalation only. Shake Salbutamol Inhaler well before each spray.

For relief of acute episodes of bronchospasm:

• Adults: 1 or 2 puffs as necessary. The maximum dose is up to 8 puffs in 24 hours.
• Children: Half the adult dose.

To prevent allergen-or exercise-induced bronchospasm:

• Adults: 2 puffs 15 minutes prior to exercise or exposure to the allergen. The maximum dose is 2 puffs, up to 4 times a day.
• Children: Half the adult dose.

Chronic therapy:

• Adults: Up to 200 mcg (2 puffs) four times daily.
• Children: Up to 200 mcg (2 puffs) four times daily.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to “National Asthma Guidelines for Medical Practitioners” published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as fully as comfortably possible & hold the inhaler upright.
• Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly and add fully to the canister to release medicine.
• Remove the inhaler from the mouth. Continue holding your breath for at least for 10 seconds or as long as it is comfortable.
• If the doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse your mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around the mouthpiece, or you may not be breathing in as you press the can. This indicates a failure of the technique. If this happens, repeat the procedure from step 4 carefully.
• Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove the canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Interaction

Salbutamol and non-selective beta-blocking medications like propranolol should not be taken simultaneously. 2-agonist treatment may result in potentially fatal hypokalaemia. Concomitant therapy with xanthine derivatives, steroids, diuretics, and hypoxia may increase this impact, therefore use with care in acute severe asthma. In such cases, it is suggested that serum potassium levels be monitored.

Contraindications

A Salbutamol inhaler is not recommended for people who have a history of hypersensitivity to salbutamol or any of its components.

Side Effects

In general, salbutamol is well tolerated. During inhalation, just a few adverse effects have been reported. Tremors, anxiety, muscular cramps, headache, palpitation, a compensatory slight rise in heart rate, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), tachycardia, and extrasystoles may occur in certain people. Inhaled salbutamol may cause mouth and throat discomfort.

Pregnancy & Lactation

Pregnancy Type C. There has been no appropriate and well-controlled research on the use of salbutamol inhalers or salbutamol sulfate in pregnant women. During pregnancy, this inhaler should be used only if the possible benefit outweighs the potential danger to the fetus. It is unknown whether the Salbutamol inhaler components are excreted in human milk. When using this inhaler on a breastfeeding woman, proceed with caution.

Precautions & Warnings

Paradoxical Bronchospasm: Inhaled salbutamol sulfate can cause life-threatening paradoxical bronchospasm. If paradoxical bronchospasm occurs, stop the Salbutamol inhaler immediately and seek alternate treatment. It should be noted that paradoxical bronchospasm is common with the initial usage of a new canister when using inhaled formulations.

Cardiovascular Effects: Like all other 2-adrenergic agonists, a salbutamol inhaler might cause clinically significant cardiovascular effects in certain people, such as changes in pulse rate or blood pressure. If such side effects develop, the Salbutamol inhaler may need to be stopped. Furthermore, beta-agonists have been linked to ECG alterations such as flattening of the T wave, lengthening of the QTc interval, and ST-segment depression. These results have little clinical significance. As a result, as with other sympathomimetic amines, the Salbutamol inhaler should be used with caution in individuals with underlying cardiovascular diseases, including coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate Hypersensitivity Reactions: Urticaria, angioedema, dermatitis, bronchospasm, anaphylaxis, and oropharyngeal edema have all been reported following the administration of salbutamol sulfate inhalation aerosol. If you experience acute hypersensitivity responses, stop using the Salbutamol inhaler.

Coexisting Conditions: As with other sympathomimetic amines, salbutamol inhalers should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, as well as those who are especially susceptible to sympathomimetic amines. Large intravenous salbutamol dosages have been observed to exacerbate underlying diabetes and ketoacidosis.

Therapeutic Class

Short-acting selective & β2-adrenoceptor stimulants

Storage Conditions

Canister under pressure. Even if the bottle seems to be empty, do not puncture, shatter, or burn it. Keep away from direct sunshine and heat. Store at or below 30°C. Do not go into a frenzy. Keep your eyes away from the screen. Keep away from minors. To be supplied only on or with the prescription of a qualified physician.

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.