ASMACAIRE Salbutamol Sulfate 1mg / mL Solution for Inhalation 2.5mL 1's
RXDRUG-DRP-630-05-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Salbutamol (ASMACAIRE) is used as bronchodilators in the management of reversible airways obstruction, as in asthma and in some patients with chronic obstructive pulmonary disease.
Salbutamol sulfate is indicated in the treatment of acute severe asthma and in routine management of chronic bronchospasm unresponsive to conventional therapy. Its main clinical use is in asthma. Itmay be used for the symptomatic relief of an acute attack, as part of the emergency treatment of acute severe asthma, and as part of the long-term chronic therapy of asthma.
Salbutamol sulfate is indicated in the treatment of acute severe asthma and in routine management of chronic bronchospasm unresponsive to conventional therapy. Its main clinical use is in asthma. Itmay be used for the symptomatic relief of an acute attack, as part of the emergency treatment of acute severe asthma, and as part of the long-term chronic therapy of asthma.
Dosage/Direction for Use
For preventing or treating bronchospasm: Per 2.5 mL of Solution for Inhalation contains 2.5 mg of Salbutamol: This medicine is used with a nebulizer and is taken by inhalation over five (5) to fifteen (15) minutes. Salbutamol (ASMACAIRE) Solution must not be injected.
Adults and children 12 years of age and older: The usual dose is 50 drops (2.5 mL) to 100 drops (5 mL) 4 times daily.
A suitable starting dose of Salbutamol by wet aerosol is 2.5 mg (one nebule) but this may be increased to 5 mg. Treatment may be repeated up to four times daily by means of a nebulizer. Delivery of the aerosol may be by face mask of "T" piece. Salbutamol sulfate 2.5 mg are intended to be used undiluted. However of prolonged delivery time is desirable (more than ten times) dilution with sterile distilled water or normal saline for injection may be required.
Or as prescribed by the physician.
Children up to 12 years of age: The usual dose is 25 drops (1.25 mL) to 50 drops (2.5 mL) every 4 to 6 hours if needed.
In adults, a maximum dose of 40 mg per day for the treatment of severe airways obstruction may be given under strict medical supervision in the hospital.
Dosage and frequency of administration should only be increased upon advice of the physician.
Beta2 agonists are not appropriate for use alone in the treatment of more than mild asthma. Increasing need for, or decreased duration of effect of, inhaled salbutamol and other short-acting beta2 agonists indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.
Direction for use: Nebules: The product should be used with a respirator or nebulizer only, under the direction of a physician. It is not to be injected or administered orally.
To open the nebules, twist off the cap.
Squeeze the content into the reservoir of the nebulising chamber.
Discard the nebules after use.
Adults and children 12 years of age and older: The usual dose is 50 drops (2.5 mL) to 100 drops (5 mL) 4 times daily.
A suitable starting dose of Salbutamol by wet aerosol is 2.5 mg (one nebule) but this may be increased to 5 mg. Treatment may be repeated up to four times daily by means of a nebulizer. Delivery of the aerosol may be by face mask of "T" piece. Salbutamol sulfate 2.5 mg are intended to be used undiluted. However of prolonged delivery time is desirable (more than ten times) dilution with sterile distilled water or normal saline for injection may be required.
Or as prescribed by the physician.
Children up to 12 years of age: The usual dose is 25 drops (1.25 mL) to 50 drops (2.5 mL) every 4 to 6 hours if needed.
In adults, a maximum dose of 40 mg per day for the treatment of severe airways obstruction may be given under strict medical supervision in the hospital.
Dosage and frequency of administration should only be increased upon advice of the physician.
Beta2 agonists are not appropriate for use alone in the treatment of more than mild asthma. Increasing need for, or decreased duration of effect of, inhaled salbutamol and other short-acting beta2 agonists indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.
Direction for use: Nebules: The product should be used with a respirator or nebulizer only, under the direction of a physician. It is not to be injected or administered orally.
To open the nebules, twist off the cap.
Squeeze the content into the reservoir of the nebulising chamber.
Discard the nebules after use.
Overdosage
The preferred antidote to overdosage with Salbutamol sulfate is cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with history of bronchospasm.
The expected symptoms with overdose are those of excessive beta-stimulation and/or occurrence or exaggeration of any of the symptoms listed under Adverse Reactions.
Treatment consists of discontinuation of salbutamol together with appropriate symptomatic therapy.
There is insufficient evidence to determine if dialysis is beneficial for overdosage of salbutamol solution for inhalation.
The expected symptoms with overdose are those of excessive beta-stimulation and/or occurrence or exaggeration of any of the symptoms listed under Adverse Reactions.
Treatment consists of discontinuation of salbutamol together with appropriate symptomatic therapy.
There is insufficient evidence to determine if dialysis is beneficial for overdosage of salbutamol solution for inhalation.
Contraindications
Salbutamol (ASMACAIRE) Solution for inhalation is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Beta2 agonists should not be used for threatened abortion. First trimester of pregnancy, eclampsia and severe pre-eclampsia, intra-uterine infection, intra-uterine fetal death, ante-partum hemorrhage, placenta praevia and cord compression.
Beta2 agonists should not be used for threatened abortion. First trimester of pregnancy, eclampsia and severe pre-eclampsia, intra-uterine infection, intra-uterine fetal death, ante-partum hemorrhage, placenta praevia and cord compression.
Warnings
Salbutamol sulfate 2.5 mg are to be used with a nebulizer, or under the direction of a physician. The solution should not be injected or administered orally. Patients receiving treatment at home with Salbutamol sulfate 2.5 mg must be warned that if either the usual relief is diminished or the usual duration of action was reduced, they should not increase the dose or its frequency of administration, but should seek medical advices. Unnecessary administration of drugs during the first trimester of pregnancy is undesirable.
Special Precautions
Salbutamol (ASMACAIRE) Solution for Inhalation should be given with caution in hyperthyroidism, myocardial insufficiency, arrhythmias, susceptibility to QT-interval prolongation, hypertension and diabetes mellitus. Great care is also needed in patients withcardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Anginal pain may beprecipitated in patients with angina pectoris.
Excessive administration of sympathomimetic agents to the nasal mucosa may produce reboundcongestion and rhinorrhea.
Care is also required when sympathomimetic agents are given to patients with diabetes mellitus or closed-angle glaucoma.
In severe asthma, particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by concomitant administration of other anti-asthma drugs; plasma-potassium concentrations should be monitored.
Should patients with mild asthma find that more than one dose is required daily, then that should be a sign for additional treatment with anti-inflammatory drugs. Increasing need for, or decreased effect of, short-acting beta2 agonists indicates deteriorating asthma and the requirement for stepping up therapy.
Sympathomimetic agents should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinine or tricyclic antidepressants.
Salbutamol nebulas 2.5 mg should be used with care in patients known to have received large doses of other sympathomimetic drugs. They should be administered cautiously to patients from thyrotoxicosis.
Excessive administration of sympathomimetic agents to the nasal mucosa may produce reboundcongestion and rhinorrhea.
Care is also required when sympathomimetic agents are given to patients with diabetes mellitus or closed-angle glaucoma.
In severe asthma, particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by concomitant administration of other anti-asthma drugs; plasma-potassium concentrations should be monitored.
Should patients with mild asthma find that more than one dose is required daily, then that should be a sign for additional treatment with anti-inflammatory drugs. Increasing need for, or decreased effect of, short-acting beta2 agonists indicates deteriorating asthma and the requirement for stepping up therapy.
Sympathomimetic agents should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinine or tricyclic antidepressants.
Salbutamol nebulas 2.5 mg should be used with care in patients known to have received large doses of other sympathomimetic drugs. They should be administered cautiously to patients from thyrotoxicosis.
Use In Pregnancy & Lactation
There are no studies on birth defects in humans. Some studies in animals have shown that they cause birth defects when given in doses many times higher than the human dose.
The administration of any drug during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Although most drugs pass into the breast milk in small amounts, many of these drugs may be used safely while breast feeding.
The administration of any drug during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Although most drugs pass into the breast milk in small amounts, many of these drugs may be used safely while breast feeding.
Adverse Reactions
Salbutamol and other beta agonists may cause fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tension, headaches, peripheral vasodilation, and rarely muscle cramps.
Potentially serious hypokalaemia has been reported after large doses. Hypersensitivity reactions have occurred including paradoxical bronchospasm, angioedema, urticaria, hypotension and collapse.
Potentially serious hypokalaemia has been reported after large doses. Hypersensitivity reactions have occurred including paradoxical bronchospasm, angioedema, urticaria, hypotension and collapse.
Drug Interactions
Concomitant administration of salbutamol and other beta2 agonists, corticosteroids, diuretics or xanthines increases the risk of hypokalemia and monitoring of potassium concentrations is recommended in severe asthma, where such combination therapy is the rule.
Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with Salbutamol sulfate. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Beta-adrenergic blocking agents (e.g. acebutolol, atenolol, labetalol, metoprolol, nadolol, pindolol, propranolol, timolol) may prevent the adrenergic bronchodilators from working properly.
Disopyramide, quinidine, phenothiazines or procainamide may increase the risk of heart problems.
Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with Salbutamol sulfate. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Beta-adrenergic blocking agents (e.g. acebutolol, atenolol, labetalol, metoprolol, nadolol, pindolol, propranolol, timolol) may prevent the adrenergic bronchodilators from working properly.
Disopyramide, quinidine, phenothiazines or procainamide may increase the risk of heart problems.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Salbutamol is a direct-acting sympathomimetic with predominantly beta-adrenergic activity and a selective action on beta2 receptors (a beta2 agonist). This results in its bronchodilating action being more prominent than its cardiovascular effect.
Administration by inhalation results in the rapid onset (within 5 to 15 minutes) of bronchodilation which lasts for about 3 to 6 hours.
Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract. It is subject to first-pass metabolism in the liver and possibly in the gut wall: the main metabolite is an inactive sulfate conjugate.
Salbutamol is rapidly excreted in the urine as metabolites and unchanged drug; there is some excretion in the faeces. It does not appear to be metabolized in the lung, therefore its ultimate metabolism and excretion following inhalation depends upon the delivery method used, which determines the proportion of inhaled salbutamol relative to the proportion inadvertently swallowed. It has been suggested that the majority of an inhaled dose is swallowed and absorbed from the gut.
The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours.
Following inhalation, salbutamol sulfate acts topically in bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours low concentrations are seen, due presumably tothe portion of the dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol sulfate is between 2.7 and 5 hours.
Salbutamol sulfate is not metabolized in the lung but is converted to the 4'-0 - sulphate ester in the liver. Salbutamol sulfate is excreted in the urine as free drug and as the metabolite. After oral administration 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites, a small fraction is excreted in the feces.
Administration by inhalation results in the rapid onset (within 5 to 15 minutes) of bronchodilation which lasts for about 3 to 6 hours.
Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract. It is subject to first-pass metabolism in the liver and possibly in the gut wall: the main metabolite is an inactive sulfate conjugate.
Salbutamol is rapidly excreted in the urine as metabolites and unchanged drug; there is some excretion in the faeces. It does not appear to be metabolized in the lung, therefore its ultimate metabolism and excretion following inhalation depends upon the delivery method used, which determines the proportion of inhaled salbutamol relative to the proportion inadvertently swallowed. It has been suggested that the majority of an inhaled dose is swallowed and absorbed from the gut.
The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours.
Following inhalation, salbutamol sulfate acts topically in bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours low concentrations are seen, due presumably tothe portion of the dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol sulfate is between 2.7 and 5 hours.
Salbutamol sulfate is not metabolized in the lung but is converted to the 4'-0 - sulphate ester in the liver. Salbutamol sulfate is excreted in the urine as free drug and as the metabolite. After oral administration 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites, a small fraction is excreted in the feces.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
ASMACAIRE
Full Details
Dosage Strength
1mg / mL
Drug Ingredients
- Salbutamol
Drug Packaging
Solution for Inhalation 2.5ml x 1's
Generic Name
Salbutamol Sulfate
Dosage Form
Solution for Inhalation
Registration Number
DRP-630-05
Drug Classification
Prescription Drug (RX)
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