Salmolin 4

Generic

Salbutamol

 

Indications

Salbutamol is indicated as a bronchodilator for use in-

• Emphysema and
• Asthma
• Chronic Bronchitis
• Other conditions associated with airways obstruction.

 

Pharmacology

Salbutamol is a synthetic sympathomimetic that predominates in beta-2 adrenergic activity. Salbutamol causes bronchodilation and relaxes bronchial muscle fibers via beta 2 adrenergic receptor stimulation of bronchial smooth muscle. This effect appears in improving lung function, as evidenced by spirometry.

 

Dosage & Administration

Salbutamol tablet or syrup-
Children:

• 2-6 years: 2.5 ml syrup, 3-4 times daily
• 6-12 years: 5 ml syrup, 3-4 times daily
• Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)

Adults: 2-4 mg tablet, 3-4 times daily. Maximum single dose is 8 mg tablet.

Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.

Method-1 (Intermittent Administration):

• Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
• Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
• Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.

Method-2 (Continuous administration): 1-2 ml solution is diluted to make up to 100 ml with normal saline solution. The diluted solution is administered by a suitable nebulizer devise. When there is risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.

• Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
• Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.

Salbutamol injection:
Adults:

• Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
• The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
• Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
• As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
• All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.

Children and Adolescents (<18 years of age): The dosage of Salbutamol infusion solution in the pediatric age group has not been established. At present, there are insufficient data to recommend a dosage regimen for children.

Salbutamol Inhalation Capsule:

• Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
• Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.

Excercise-induced Asthma:

• Adults: 400 microgram
• Child: 200 microgram, 15-30 minutes prior to any physical exertion.

 

Interactions

Care should be taken while using with the same anesthetics as chloroform, cyclopropane, halothane, and other halogenating agents.

The effects of this product may be altered by guanettideen, reserpine, methyl waveguides, and tricyclic antidepressants. Oral

Salbutamol and non-selective beta-blockers such as propranolol should generally not be prescribed together.

Salbutamol has no contraindications for patients being treated with monoamine oxidase inhibitors (MAOIs).

 

Contraindications

Contraindicated in patients with high blood pressure during pregnancy, uterine infection, miscarriage, heart disease, hypersensitivity.

 

Side Effects

Salbutamol may cause slight tremors of skeletal muscles (especially of the hands), palpitations and muscle spasticity. Tachycardia, nervousness, headache, and peripheral vasodilation have been reported following high doses.

 

Pregnancy & Lactation

The drug should be used during pregnancy only if possible benefit to the fetus. It is not known whether this medicine is excreted in human milk. Because of the demonstrated tumorigenic potential for salbutamol in several animal studies, a decision must be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

Precautions & Warnings

Caution should be exercised when administering salbutamol to patients with hyperthyroidism, cardiovascular disease, thromboembolic disorders, hypertension, and aneurysms. Hypokalemia with high doses of salbutamol may increase susceptibility to digitalis-induced arrhythmias. Rapid anaphylaxis may occur with prolonged use of high doses. Caution should be exercised when treating patients with diabetes or narrow-angle glaucoma and those on treatment with antihypertensive drugs.

 

Therapeutic Class

Short-acting selective & β2-adrenoceptor stimulants

 

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name

ACME Laboratories Ltd.