ASMALIN Salbutamol 1mg / mL Solution for Nebulization 2.5mL 5's
RXDRUG-DRP-3528-02
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Features
Brand
Asmalin
Full Details
Dosage Strength
1mg / mL
Drug Ingredients
- Salbutamol
Drug Packaging
Solution for Nebulization 5's
Generic Name
Salbutamol
Dosage Form
Solution for Nebulization
Registration Number
DRP-3528-02
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the prevention and relief of bronchospasm associated with reversible obstructive airway diseases eg, bronchial asthma.
Pulmoneb: For the treatment of acute exacerbations of asthma.
Pulmoneb: For the treatment of acute exacerbations of asthma.
Dosage/Direction for Use
Syrup: Orally, every 6 to 8 hours, or, as prescribed by a physician.
Adults and children over 12 years: 5 to 10 mL (1 to 2 teaspoonfuls).
Children: 7 to 12 years: 5 mL (1 teaspoonful);
2 to 6 years: 2.5 to 5 mL (1/2 to 1 teaspoonful);
Under 2 years: as prescribed by a physician;
Pulmoneb: To be administered via a nebulizer.
Children and Adults: 2.5 to 5 mg as needed every 6 to 8 hours, or, as prescribed by a physician.
Adults and children over 12 years: 5 to 10 mL (1 to 2 teaspoonfuls).
Children: 7 to 12 years: 5 mL (1 teaspoonful);
2 to 6 years: 2.5 to 5 mL (1/2 to 1 teaspoonful);
Under 2 years: as prescribed by a physician;
Pulmoneb: To be administered via a nebulizer.
Children and Adults: 2.5 to 5 mg as needed every 6 to 8 hours, or, as prescribed by a physician.
Overdosage
Symptoms of Salbutamol overdose include extensions of the common undesirable effects (e.g. angina, arrhythmias, palpitation, tachycardia, nervousness, dizziness, tremor, seizures, insomnia/sleeplessness, headache, fatigue, malaise, dry mouth, and nausea). Hypokalemia has also been reported; thus, plasma potassium concentrations should be monitored.
Discontinue Salbutamol and institute appropriate symptomatic therapy in cases of Salbutamol overdosage. Administration of a β-adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic.
Pulmoneb: Symptoms include hypertension or hypotension. Excessive use of oral sympathomimetic inhalations may result in cardiac arrest and even fatalities.
There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose.
Discontinue Salbutamol and institute appropriate symptomatic therapy in cases of Salbutamol overdosage. Administration of a β-adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic.
Pulmoneb: Symptoms include hypertension or hypotension. Excessive use of oral sympathomimetic inhalations may result in cardiac arrest and even fatalities.
There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose.
Administration
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.
Contraindications
Hypersensitivity to any ingredient in the formulation.
Warnings
Syrup: The bronchodilator effect of each administration of Salbutamol syrup lasts for at least 6 hours. If a previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a physician for medical advice as this is a sign of worsening of asthma that would require reassessment of therapy.
Pulmoneb: If a previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a physician for medical advice as this is a sign of worsening of asthma that would require re-assessment of therapy.
Excessive use of sympathomimetic oral inhalations has been associated with fatalities in asthmatic patients. The exact cause of death is unknown but cardiac arrest following severe, acute asthmatic crisis and hypoxia is suspected.
Paradoxical bronchospasm, a potentially life-threatening event, may occur with the first use of a new ampule. If it occurs, discontinue Salbutamol immediately and institute alternative therapy.
Immediate hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema may occur rarely after administration of the product.
Pulmoneb: If a previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a physician for medical advice as this is a sign of worsening of asthma that would require re-assessment of therapy.
Excessive use of sympathomimetic oral inhalations has been associated with fatalities in asthmatic patients. The exact cause of death is unknown but cardiac arrest following severe, acute asthmatic crisis and hypoxia is suspected.
Paradoxical bronchospasm, a potentially life-threatening event, may occur with the first use of a new ampule. If it occurs, discontinue Salbutamol immediately and institute alternative therapy.
Immediate hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema may occur rarely after administration of the product.
Special Precautions
Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias or hypertension; Convulsive disorders; Hyperthyroidism; Diabetes mellitus; In patients who are unusually responsive to sympathomimetic amines.
Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; plasma potassium concentrations should be monitored in severe asthma.
Pulmoneb: Patients should be advised that increased blood glucose has occurred after inhalation of Salbutamol via nebulization of higher than recommended doses of the drug. Therapy with Salbutamol and other beta2-agonists may decrease plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular adverse effects such as palpitation.
Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; plasma potassium concentrations should be monitored in severe asthma.
Pulmoneb: Patients should be advised that increased blood glucose has occurred after inhalation of Salbutamol via nebulization of higher than recommended doses of the drug. Therapy with Salbutamol and other beta2-agonists may decrease plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular adverse effects such as palpitation.
Use In Pregnancy & Lactation
Pregnancy: There have been reports of congenital anomalies (e.g., deft 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.
Lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefits of the drug justify the possible 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 benefits of the drug justify the possible risk.
Adverse Reactions
Syrup: The most frequent adverse reactions of Salbutamol in adults and older children are tremors (particularly the hands), nervousness and shakiness. Other reported reactions are headache, dizziness, hyperactivity and excitement, tachycardia, palpitation, peripheral vasodilation, epistaxis, cough, increased appetite, epigastric pain or stomachache, insomnia/sleeplessness, weakness, and rarely muscle cramps.
The following side effects are noted in young children: excitement, nervousness, hyperkinesia, sleeplessness, emotional lability, fatigue, tachycardia, pallor, gastrointestinal symptoms, and conjunctivitis. Erythema multiforme or Stevens-Johnson syndrome has been reported rarely with administration of oral Salbutamol in children.
Potentially serious hypokalemia has also been reported.
Cases of urticaria, angioedema, rash, anaphylaxis, paradoxical bronchospasm, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been noted after the use of oral Salbutamol.
Salbutamol, like other sympathomimetic agents, can also cause central nervous system stimulation, angina, nausea, unusual taste, and drying or irritation of the oropharynx.
Pulmoneb: Tremors (particularly the hands), nervousness, dizziness, headache, sleeplessness/insomnia, tachycardia, palpitations, chest pain, hypertension, peripheral vasodilation, increased coughing, wheezing, asthma exacerbation, bronchitis, nasal congestion, rhinitis, pharyngitis, sinusitis, viral infection, increased hemoptysis in patients with pre-existing hemoptysis, hoarseness, otitis media, nausea, vomiting, diarrhea, hypertonia, asthenia, back pain, fever, lymphadenopathy, and rarely, muscle cramps have been observed after administration of nebulized Salbutamol. Potentially serious hypokalemia has also been reported.
Hypersensitivity reactions (such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, oropharyngeal edema, hypotension, and collapse) and arrhythmias (such as atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been noted after the use of orally inhaled Salbutamol.
Salbutamol, like other sympathomimetic agents, can also cause angina, vertigo, central nervous system stimulation, paradoxical bronchospasm, and dry mouth.
The following side effects are noted in young children: excitement, nervousness, hyperkinesia, sleeplessness, emotional lability, fatigue, tachycardia, pallor, gastrointestinal symptoms, and conjunctivitis. Erythema multiforme or Stevens-Johnson syndrome has been reported rarely with administration of oral Salbutamol in children.
Potentially serious hypokalemia has also been reported.
Cases of urticaria, angioedema, rash, anaphylaxis, paradoxical bronchospasm, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been noted after the use of oral Salbutamol.
Salbutamol, like other sympathomimetic agents, can also cause central nervous system stimulation, angina, nausea, unusual taste, and drying or irritation of the oropharynx.
Pulmoneb: Tremors (particularly the hands), nervousness, dizziness, headache, sleeplessness/insomnia, tachycardia, palpitations, chest pain, hypertension, peripheral vasodilation, increased coughing, wheezing, asthma exacerbation, bronchitis, nasal congestion, rhinitis, pharyngitis, sinusitis, viral infection, increased hemoptysis in patients with pre-existing hemoptysis, hoarseness, otitis media, nausea, vomiting, diarrhea, hypertonia, asthenia, back pain, fever, lymphadenopathy, and rarely, muscle cramps have been observed after administration of nebulized Salbutamol. Potentially serious hypokalemia has also been reported.
Hypersensitivity reactions (such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, oropharyngeal edema, hypotension, and collapse) and arrhythmias (such as atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been noted after the use of orally inhaled Salbutamol.
Salbutamol, like other sympathomimetic agents, can also cause angina, vertigo, central nervous system stimulation, paradoxical bronchospasm, and dry mouth.
Drug Interactions
Do not use with other sympathomimetic aerosol bronchodilators or epinephrine. Administer with caution additional sympathomimetic agents by any route to patients using Salbutamol aerosol to avoid deleterious cardiovascular effects.
Concurrent administration with monoamine oxidase (MAO) inhibitors (e.g., Phenelzine) or tricyclic antidepressants (e.g., Amitriptyline, Imipramine, Nortriptyline, Doxepin) may increase the risk for cardiac arrhythmia, tachycardia, and increased or decreased blood pressure.
Do not administer Salbutamol and beta-receptor blockers (e.g., Propranolol, Atenolol, Metoprolol) at the same time since they inhibit each other's effect.
Pulmoneb: The combination of nebulized Salbutamol and nebulized anticholinergic has been reported to precipitate acute angle-closure glaucoma and therefore should be used with caution in patients with actual or potential glaucoma.
Concurrent administration with monoamine oxidase (MAO) inhibitors (e.g., Phenelzine) or tricyclic antidepressants (e.g., Amitriptyline, Imipramine, Nortriptyline, Doxepin) may increase the risk for cardiac arrhythmia, tachycardia, and increased or decreased blood pressure.
Do not administer Salbutamol and beta-receptor blockers (e.g., Propranolol, Atenolol, Metoprolol) at the same time since they inhibit each other's effect.
Pulmoneb: The combination of nebulized Salbutamol and nebulized anticholinergic has been reported to precipitate acute angle-closure glaucoma and therefore should be used with caution in patients with actual or potential glaucoma.
Caution For Usage
Pulmoneb: Directions for Use: Salbutamol (Asmalin) PulmoNeb must only be used in a nebulizer for inhalation.
1. Prepare your nebulizer for use.
2. Remove the PulmoNeb from the labeled strip by twisting and pulling.
3. Hold the PulmoNeb upright and twist off the cap. Transfer the content to the reservoir of your nebulizer. If dilution is required, use only sterile normal saline as directed by the physician.
4. Use the nebulizer, as instructed by the manufacturer.
5. After use, discard any remaining solution. Thoroughly clean your nebulizer.
Patient Information: Administer in a well-ventilated area.
Do not mix the solution with other medicines, unless instructed to do so by the physician.
Do not allow the solution for nebulization or the mist to come into contact with the eyes.
If a dose was missed, do not take a double dose.
1. Prepare your nebulizer for use.
2. Remove the PulmoNeb from the labeled strip by twisting and pulling.
3. Hold the PulmoNeb upright and twist off the cap. Transfer the content to the reservoir of your nebulizer. If dilution is required, use only sterile normal saline as directed by the physician.
4. Use the nebulizer, as instructed by the manufacturer.
5. After use, discard any remaining solution. Thoroughly clean your nebulizer.
Patient Information: Administer in a well-ventilated area.
Do not mix the solution with other medicines, unless instructed to do so by the physician.
Do not allow the solution for nebulization or the mist to come into contact with the eyes.
If a dose was missed, do not take a double dose.
Storage
Syrup: Store at temperatures not exceeding 30°C.
Always keep the container tightly closed.
Pulmoneb: Store below 25°C.
Protect from light.
Always keep the container tightly closed.
Pulmoneb: Store below 25°C.
Protect from light.
Action
Pharmacology: Pharmacodynamics: Salbutamol is a selective short-acting beta2-adrenergic agonist with preferential effect on beta2-adrenergic 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:Syrup:Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. Salbutamol's onset of action is within 30 minutes, peaks in 2-3 hours after the dose, and persists for 6 hours. The plasma half-life of salbutamol is from 4-6 hours. It is extensively metabolized in the liver, being converted to salbutamol 4'O-sulfate. Salbutamol and its metabolites are rapidly excreted in urine and feces. After an oral administration of salbutamol to healthy individuals, about 75% of a single dose is excreted in urine within 72 hours, mainly as the major metabolite; about 4% of the dose is excreted in feces.
Pulmoneb: Onset of bronchodilation is within 5 minutes after nebulization with Salbutamol, peaks in 1 to 2 hours, and persists for 3 to 4 hours. Bronchodilation generally persist up to 6 hours or longer. After inhalation of nebulized salbutamol, less than 20% of the drug is absorbed in the lungs. The remaining amount is retained in the nebulizer and recovered in expired air. Much of the salbutamol dose delivered by oral inhalation is deposited on the buccal mucosa and subsequently swallowed and absorbed from the gastrointestinal tract.
Salbutamol is metabolized in the liver, being converted to salbutamol 4'-O-sulfate. This is then excreted in the urine and feces. In patients with asthma, about 70% of the inhaled dose is excreted in urine as unchanged drug and metabolites within 24 hours, and 80 to 100% within 72 hours. About 30% of the inhaled dose is excreted unchanged in the urine in 24 hours. About 10% of the inhaled dose may be excreted in the feces.
Animal studies show that salbutamol can cross the blood-brain barrier and the placenta. It may be secreted in breast milk but the concentrations are not known.
Pharmacokinetics:Syrup:Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. Salbutamol's onset of action is within 30 minutes, peaks in 2-3 hours after the dose, and persists for 6 hours. The plasma half-life of salbutamol is from 4-6 hours. It is extensively metabolized in the liver, being converted to salbutamol 4'O-sulfate. Salbutamol and its metabolites are rapidly excreted in urine and feces. After an oral administration of salbutamol to healthy individuals, about 75% of a single dose is excreted in urine within 72 hours, mainly as the major metabolite; about 4% of the dose is excreted in feces.
Pulmoneb: Onset of bronchodilation is within 5 minutes after nebulization with Salbutamol, peaks in 1 to 2 hours, and persists for 3 to 4 hours. Bronchodilation generally persist up to 6 hours or longer. After inhalation of nebulized salbutamol, less than 20% of the drug is absorbed in the lungs. The remaining amount is retained in the nebulizer and recovered in expired air. Much of the salbutamol dose delivered by oral inhalation is deposited on the buccal mucosa and subsequently swallowed and absorbed from the gastrointestinal tract.
Salbutamol is metabolized in the liver, being converted to salbutamol 4'-O-sulfate. This is then excreted in the urine and feces. In patients with asthma, about 70% of the inhaled dose is excreted in urine as unchanged drug and metabolites within 24 hours, and 80 to 100% within 72 hours. About 30% of the inhaled dose is excreted unchanged in the urine in 24 hours. About 10% of the inhaled dose may be excreted in the feces.
Animal studies show that salbutamol can cross the blood-brain barrier and the placenta. It may be secreted in breast milk but the concentrations are not known.
MedsGo Class
Antiasthmatic & COPD Preparations
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