ASMALIN Salbutamol Sulfate 100mcg Metered-Dose Inhaler 200 doses
RXDRUG-DR-XY30395
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Features
Brand
Asmalin
Full Details
Dosage Strength
100mcg / dose
Drug Ingredients
- Salbutamol
Drug Packaging
Metered-Dose Inhaler 200 doses
Generic Name
Salbutamol Sulfate
Dosage Form
Metered-Dose Inhaler
Registration Number
DR-XY30395
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the relief of bronchospasm associated with reversible obstructive airway diseases such as bronchial asthma and chronic obstructive pulmonary disease.
For the prevention of exercise-induced bronchospasm if the drug is given before exertion
For the prevention of exercise-induced bronchospasm if the drug is given before exertion
Dosage/Direction for Use
For the relief of bronchospasm: Rapid-acting inhaled beta2-agonists, such as salbutamol, should be used only on as-needed basis at the lowest dose and frequency required.
Adults and children ≥ 4 years old: 100 or 200 mcg (1 or 2 inhalations) as needed every 4 to 6 hours, or, as prescribed by a doctor.
The bronchodilator effect of each administration of salbutamol inhaler lasts for at least 4 hours. If a previously effective fixed dosage fails to provide the usual relief, consult a physician for medical advice as this is a sign of worsening of asthma that would require reassessment of therapy.
For the prevention of exercise-induced bronchospasm: Adults: 200 mcg (2 inhalations) 15 to 30 minutes before exercise.
Children ≥ 4 years old: 100 or 200 mcg (1 or 2 inhalations) 15 to 30 minutes before exercise.
Adults and children ≥ 4 years old: 100 or 200 mcg (1 or 2 inhalations) as needed every 4 to 6 hours, or, as prescribed by a doctor.
The bronchodilator effect of each administration of salbutamol inhaler lasts for at least 4 hours. If a previously effective fixed dosage fails to provide the usual relief, consult a physician for medical advice as this is a sign of worsening of asthma that would require reassessment of therapy.
For the prevention of exercise-induced bronchospasm: Adults: 200 mcg (2 inhalations) 15 to 30 minutes before exercise.
Children ≥ 4 years old: 100 or 200 mcg (1 or 2 inhalations) 15 to 30 minutes before exercise.
Overdosage
Overdosage with salbutamol produces symptoms that may be expected with beta2-agonists such as tachycardia, central nervous system stimulation, tremor, hypokalemia, and hypoglycemia.
Nausea, vomiting and hyperglycemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy.
Cardiac arrest and even death may occur following excessive use of salbutamol.
Discontinue salbutamol and institute appropriate symptomatic therapy in cases of salbutamol overdosage. Administration of a beta-adrenergic blocking agent may be appropriate, but use with caution in patients with a history of bronchospasm. There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose.
Nausea, vomiting and hyperglycemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy.
Cardiac arrest and even death may occur following excessive use of salbutamol.
Discontinue salbutamol and institute appropriate symptomatic therapy in cases of salbutamol overdosage. Administration of a beta-adrenergic blocking agent may be appropriate, but use with caution in patients with a history of bronchospasm. There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose.
Contraindications
Hypersensitivity to salbutamol or other ingredients in the product.
Certain maternal or fetal conditions may contraindicate tocolytic therapy (e.g., eclampsia or severe preeclampsia, intrauterine infection, intrauterine fetal death, antepartum hemorrhage, placenta previa, cord compression, or toxemia of pregnancy); salbutamol should not be used for threatened abortion
Certain maternal or fetal conditions may contraindicate tocolytic therapy (e.g., eclampsia or severe preeclampsia, intrauterine infection, intrauterine fetal death, antepartum hemorrhage, placenta previa, cord compression, or toxemia of pregnancy); salbutamol should not be used for threatened abortion
Special Precautions
Seek medical advice if either the usual relief is diminished or the usual duration of action is reduced. Do not increase the dose or frequency of administration.
Paradoxical bronchospasm: Paradoxical bronchospasm, a potentially life-threatening event, has been observed with salbutamol. If it occurs, discontinue use of the product immediately.
Deterioration of asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. Increased use of beta2-agonists, especially daily use, is a sign of deterioration of asthma control and indicates the need to reassess treatment. Possible need for anti-inflammatory treatment (e.g., corticosteroids) should be considered.
Hypokalemia: Therapy with salbutamol and other beta2-agonists may produce decrease in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular undesirable effects. Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; potassium concentrations should be monitored in severe asthma.
Metabolic Effects: As with other beta2-agonists, salbutamol can induce reversible metabolic changes (e.g., increased blood sugar levels). The diabetic patient may be unable to compensate for this; and thus, result in the development of ketoacidosis. Concomitant administration of corticosteroids can exaggerate this effect.
Coexisting Conditions: Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, or hypertension: Salbutamol, like all other beta2-agonists, can produce clinically significant cardiovascular effects such as changes in pulse rate or blood pressure.
Convulsive disorders.
Hyperthyroidism.
Diabetes mellitus.
In patients who are unusually responsive to sympathomimetic amines.
Use in Children: The safety and efficacy of orally inhaled salbutamol aerosol with hydrofluoroalkane (HFA) propellant have not been established in children younger than 4 years old.
Use in Elderly: Data on the use of salbutamol inhalation aerosol in patients 65 years and older are limited and are insufficient to determine whether the efficacy and safety are similar to those of younger patients. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in elderly patients, salbutamol should be used with caution, starting at the lower end of the usual dosing range.
Paradoxical bronchospasm: Paradoxical bronchospasm, a potentially life-threatening event, has been observed with salbutamol. If it occurs, discontinue use of the product immediately.
Deterioration of asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. Increased use of beta2-agonists, especially daily use, is a sign of deterioration of asthma control and indicates the need to reassess treatment. Possible need for anti-inflammatory treatment (e.g., corticosteroids) should be considered.
Hypokalemia: Therapy with salbutamol and other beta2-agonists may produce decrease in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular undesirable effects. Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; potassium concentrations should be monitored in severe asthma.
Metabolic Effects: As with other beta2-agonists, salbutamol can induce reversible metabolic changes (e.g., increased blood sugar levels). The diabetic patient may be unable to compensate for this; and thus, result in the development of ketoacidosis. Concomitant administration of corticosteroids can exaggerate this effect.
Coexisting Conditions: Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, or hypertension: Salbutamol, like all other beta2-agonists, can produce clinically significant cardiovascular effects such as changes in pulse rate or blood pressure.
Convulsive disorders.
Hyperthyroidism.
Diabetes mellitus.
In patients who are unusually responsive to sympathomimetic amines.
Use in Children: The safety and efficacy of orally inhaled salbutamol aerosol with hydrofluoroalkane (HFA) propellant have not been established in children younger than 4 years old.
Use in Elderly: Data on the use of salbutamol inhalation aerosol in patients 65 years and older are limited and are insufficient to determine whether the efficacy and safety are similar to those of younger patients. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in elderly patients, salbutamol should be used with caution, starting at the lower end of the usual dosing range.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C. There have been reports of congenital anomalies (e.g., cleft palate and limb defects) in children of patients treated with salbutamol. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship between the use of salbutamol and the development of congenital anomalies cannot be established. Therefore, salbutamol should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: Since beta2-agonists may interfere with uterine contraction, salbutamol should be used in labor only if the potential benefit justifies the potential risk.
Lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefit of the drug justifies the potential risk.
Labor and Delivery: Since beta2-agonists may interfere with uterine contraction, salbutamol should be used in labor only if the potential benefit justifies the potential risk.
Lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefit of the drug justifies the potential risk.
Adverse Reactions
Infections and infestations: Urinary tract infection.
Immune system disorders: Hypersensitivity (anaphylaxis, angioedema, bronchospasm, collapse, hypotension, rash, urticaria).
Metabolism and nutrition disorders: Diabetes mellitus, edema, hypokalemia, metabolic acidosis.
Psychiatric disorders: Aggressive behavior, anxiety, depression, dysphonia/voice alteration, hyperactivity, insomnia, nervousness, nightmare, somnolence.
Nervous system disorders: Agitation, altered taste, central nervous stimulation, dizziness, headache, hyperkinesia, inhalation site/taste sensation, lightheadedness, tremor, vertigo.
Ear and labyrinth disorders: Ear disorder, ear pain, tinnitus.
Cardiac disorders: Angina, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), dyspnea, myocardial ischemia, palpitations, tachycardia.
Vascular disorders: Epistaxis, hypertension, peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders: Asthma exacerbation, cough, flu syndrome, paradoxical bronchospasm, pharyngitis, rhinitis, upper respiratory tract infection.
Gastrointestinal disorders: Constipation, diarrhea, dry mouth, eructation, flatulence, gagging, gastroenteritis, glossitis, heartburn, mouth and throat irritation, nausea, tongue ulceration, vomiting.
Musculoskeletal and connective tissue disorders: Back pain, muscle cramps.
General disorders and administration site conditions: Ataxia, increased sweating.
Injury, poisoning and procedural complications: Accidental injur
Immune system disorders: Hypersensitivity (anaphylaxis, angioedema, bronchospasm, collapse, hypotension, rash, urticaria).
Metabolism and nutrition disorders: Diabetes mellitus, edema, hypokalemia, metabolic acidosis.
Psychiatric disorders: Aggressive behavior, anxiety, depression, dysphonia/voice alteration, hyperactivity, insomnia, nervousness, nightmare, somnolence.
Nervous system disorders: Agitation, altered taste, central nervous stimulation, dizziness, headache, hyperkinesia, inhalation site/taste sensation, lightheadedness, tremor, vertigo.
Ear and labyrinth disorders: Ear disorder, ear pain, tinnitus.
Cardiac disorders: Angina, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), dyspnea, myocardial ischemia, palpitations, tachycardia.
Vascular disorders: Epistaxis, hypertension, peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders: Asthma exacerbation, cough, flu syndrome, paradoxical bronchospasm, pharyngitis, rhinitis, upper respiratory tract infection.
Gastrointestinal disorders: Constipation, diarrhea, dry mouth, eructation, flatulence, gagging, gastroenteritis, glossitis, heartburn, mouth and throat irritation, nausea, tongue ulceration, vomiting.
Musculoskeletal and connective tissue disorders: Back pain, muscle cramps.
General disorders and administration site conditions: Ataxia, increased sweating.
Injury, poisoning and procedural complications: Accidental injur
Drug Interactions
Sympathomimetic agents: Salbutamol should not be administered concomitantly with other sympathomimetic agents or epinephrine since serious adverse cardiovascular effects may occur.
Beta-adrenergic blocking agents (e.g., propranolol): Beta-adrenergic blocking agents may inhibit the effect of beta-agonists such as salbutamol. It may also produce severe bronchospasm in asthmatic patients.
Diuretics: Administration of nonpotassium-sparing diuretics (e.g., loop or thiazide diuretics) may result in electrocardiographic changes/and or hypokalemia and can be acutely worsened by administration of beta2-agonists such as salbutamol, especially when the recommended dose of the beta2-agonist is exceeded.
Digoxin: Following administration of single-dose intravenous or oral salbutamol to healthy individuals who had received digoxin for 10 days, a 16% to 22% decrease in serum digoxin concentration was observed. Although the clinical importance of these findings for patients who are receiving inhaled salbutamol and digoxin on a chronic basis is unclear, patients receiving such concomitant therapy should have their serum digoxin concentration carefully evaluated.
Monoamine oxidase inhibitors (MAOIs) or Tricyclic antidepressants (TCAs): Salbutamol should be used with caution in patients receiving MAOIs or TCAs, or within 2 weeks of discontinuation of such agents, because the effect of salbutamol on the vascular system may be potentiated. Alternative therapy should be considered in patients taking MAOIs or TCAs.
Beta-adrenergic blocking agents (e.g., propranolol): Beta-adrenergic blocking agents may inhibit the effect of beta-agonists such as salbutamol. It may also produce severe bronchospasm in asthmatic patients.
Diuretics: Administration of nonpotassium-sparing diuretics (e.g., loop or thiazide diuretics) may result in electrocardiographic changes/and or hypokalemia and can be acutely worsened by administration of beta2-agonists such as salbutamol, especially when the recommended dose of the beta2-agonist is exceeded.
Digoxin: Following administration of single-dose intravenous or oral salbutamol to healthy individuals who had received digoxin for 10 days, a 16% to 22% decrease in serum digoxin concentration was observed. Although the clinical importance of these findings for patients who are receiving inhaled salbutamol and digoxin on a chronic basis is unclear, patients receiving such concomitant therapy should have their serum digoxin concentration carefully evaluated.
Monoamine oxidase inhibitors (MAOIs) or Tricyclic antidepressants (TCAs): Salbutamol should be used with caution in patients receiving MAOIs or TCAs, or within 2 weeks of discontinuation of such agents, because the effect of salbutamol on the vascular system may be potentiated. Alternative therapy should be considered in patients taking MAOIs or TCAs.
Caution For Usage
Directions for use: Before initial use and if the product has not been used for several days, remove the cap from the mouthpiece and shake the inhaler well, then release 4 puffs into the air (away from the face).
Using the inhaler: 1. Remove the cap from the mouthpiece and hold inhaler upright.
2. Shake the inhaler well.
3. Breathe out fully, then place the mouthpiece into the mouth and close lips firmly around it.
4. Press down the inhaler to release the medicine, while breathing in slowly (3 to 5 seconds) and deeply at the same time. Synchronize inhaler actuation and inhalation for optimum drug delivery to the lungs.
5. Remove inhaler from the mouth, hold breath for 10 seconds or as long as possible, and breathe out slowly.
6. Repeat puff as directed. Wait one minute between puffs for better lung penetration.
7. Replace the cap.
Cleaning instructions: 1. Remove the metal aerosol canister containing the drug from the inhaler.
2. Wash the plastic case and cap regularly in warm running water.
3. Allow plastic parts to dry completely.
4. Replace the aerosol container and mouthpiece cap.
Using the inhaler: 1. Remove the cap from the mouthpiece and hold inhaler upright.
2. Shake the inhaler well.
3. Breathe out fully, then place the mouthpiece into the mouth and close lips firmly around it.
4. Press down the inhaler to release the medicine, while breathing in slowly (3 to 5 seconds) and deeply at the same time. Synchronize inhaler actuation and inhalation for optimum drug delivery to the lungs.
5. Remove inhaler from the mouth, hold breath for 10 seconds or as long as possible, and breathe out slowly.
6. Repeat puff as directed. Wait one minute between puffs for better lung penetration.
7. Replace the cap.
Cleaning instructions: 1. Remove the metal aerosol canister containing the drug from the inhaler.
2. Wash the plastic case and cap regularly in warm running water.
3. Allow plastic parts to dry completely.
4. Replace the aerosol container and mouthpiece cap.
Storage
Store at temperatures not exceeding 30°C.
Protect from direct sunlight or heat.
Do not freeze or refrigerate.
The efficacy of this medicine may decrease when the metal aerosol canister is cold.
Do not break, puncture or burn the canister even when apparently empty.
Protect from direct sunlight or heat.
Do not freeze or refrigerate.
The efficacy of this medicine may decrease when the metal aerosol canister is cold.
Do not break, puncture or burn the canister even when apparently empty.
Action
Pharmacology: Pharmacodynamics: Salbutamol is a selective short-acting beta2-agonist with a preferential effect on beta2-receptors found in the respiratory tract. It stimulates adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). cAMP mediates cellular responses such as bronchial smooth muscle relaxation resulting in bronchodilation.
Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. When given by inhalation, 10% to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. Plasma protein binding is around 10%.
Salbutamol undergoes first-pass metabolism in the liver, being converted to salbutamol 4'-O-sulfate. The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours. Salbutamol is rapidly excreted, mainly in the urine, as metabolites and unchanged drug; a smaller proportion is excreted in the feces. Majority of a salbutamol dose given orally or by inhalation is excreted within 72 hours.
Bronchodilation begins within 5 to 15 minutes after oral inhalation of salbutamol, peaks in 0.5 to 3 hours, and persists 2 to 5 hours. In some patients, bronchodilation may persist up to 6 hours.
Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. When given by inhalation, 10% to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. Plasma protein binding is around 10%.
Salbutamol undergoes first-pass metabolism in the liver, being converted to salbutamol 4'-O-sulfate. The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours. Salbutamol is rapidly excreted, mainly in the urine, as metabolites and unchanged drug; a smaller proportion is excreted in the feces. Majority of a salbutamol dose given orally or by inhalation is excreted within 72 hours.
Bronchodilation begins within 5 to 15 minutes after oral inhalation of salbutamol, peaks in 0.5 to 3 hours, and persists 2 to 5 hours. In some patients, bronchodilation may persist up to 6 hours.
MedsGo Class
Antiasthmatic & COPD Preparations
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