EFAMED Salbutamol Sulfate 2mg / 5mL Syrup 60mL
RXDRUG-DR-XY22431
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Efamed tablet/syrup: For the relief of bronchospasm in bronchial asthma, chronic bronchitis, emphysema, and other reversible obstructive pulmonary disease.
Efamed solution for nebulization: Indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and in the treatment of acute severe asthma. Salbutamol is a direct acting sympathomimetic with mainly beta adrenergic activity and a selective action on beta 2 (a beta 2 agonist). This results in its bronchodilating action being more prominent than its effect on the heart. Salbutamol and salbutamol sulfate are used as bronchodilators in the management of reversible airways obstruction, as in the asthma and in some patients with chronic obstructive pulmonary disease. Salbutamol also decreases uterine contractility and may be given as the sulfate to arrest premature labour. Inhalation results in the rapid onset (within 5 minutes) of bronchodilation, which lasts about 3-6 hours. After oral doses, the onset of action is within 30 minutes, with a peak effect between 2-3 hours after dose, and a duration of action of up to 6 hours; modified release preparations that have a longer duration of action are available. Salbutamol is used as the base or sulfate in aerosol inhalers and as the sulfate in other preparations. The dosage is expressed in terms of salbutamol base; salbutamol sulfate 1.2mg is equivalent to about 1mg of salbutamol.
Efamed Plus tablet/syrup: Treatment or prevention of bronchospasm. Relief of respiratory obstruction & improves pulmonary ventilation. Respiratory disorders complicated by bronchospasm & excessive secretion of tenacious mucus eg bronchial asthma, chronic bronchitis & emphysema.
Efamed solution for nebulization: Indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and in the treatment of acute severe asthma. Salbutamol is a direct acting sympathomimetic with mainly beta adrenergic activity and a selective action on beta 2 (a beta 2 agonist). This results in its bronchodilating action being more prominent than its effect on the heart. Salbutamol and salbutamol sulfate are used as bronchodilators in the management of reversible airways obstruction, as in the asthma and in some patients with chronic obstructive pulmonary disease. Salbutamol also decreases uterine contractility and may be given as the sulfate to arrest premature labour. Inhalation results in the rapid onset (within 5 minutes) of bronchodilation, which lasts about 3-6 hours. After oral doses, the onset of action is within 30 minutes, with a peak effect between 2-3 hours after dose, and a duration of action of up to 6 hours; modified release preparations that have a longer duration of action are available. Salbutamol is used as the base or sulfate in aerosol inhalers and as the sulfate in other preparations. The dosage is expressed in terms of salbutamol base; salbutamol sulfate 1.2mg is equivalent to about 1mg of salbutamol.
Efamed Plus tablet/syrup: Treatment or prevention of bronchospasm. Relief of respiratory obstruction & improves pulmonary ventilation. Respiratory disorders complicated by bronchospasm & excessive secretion of tenacious mucus eg bronchial asthma, chronic bronchitis & emphysema.
Dosage/Direction for Use
Efamed tab 1-2 tab tid-qid. Efamed syr Adult 10 mL tid-qid. Childn >12 yr 5-10 mL, 6-12 yr 5 mL, 2-6 yr 2.5-5 mL. To be taken tid-qid. Efamed soln for nebulization Adult & childn >18 mth 2.5-5 mg, repeated up to qid. Childn <18 mth 2.5 mg up to qid or more frequently in severe cases. Efamed Plus tab 1 tab every 4-6 hr. Efamed Plus syr Childn 6-12 yr 10 mL every 4 hr, 2-6 yr 5 mL every 4 hr.
Click to view Efamed/Efamed Plus detailed prescribing information
Overdosage
Efamed tablet/syrup: Tablet: The recommended oral dose is 1 to 2 tablets to be taken 3 to 4 times daily.
Or as prescribed by the physician.
Syrup: Children: 2-6 years old: ½ to 1 teaspoonful (2.5 to 5 ml).
6-12 years old: 1 teaspoonful (5 ml ).
Over 12 years: 1 to 2 teaspoonfuls (5 to 10 ml).
Adult: 2 teaspoonfuls (10 ml) three to four times a day.
Or as prescribed by the physician.
Efamed solution for nebulization: Adult and child over 18 months: 2.5 mg-5 mg. Repeated, up to 4 times daily.
Children under 18 months: (Transient hypoxaemia may occur consider supplemental oxygen) 2.5 mg up to 4 times daily or more frequently in severe cases.
Efamed Plus tablet/syrup: Tablet: The recommended oral dose is 1 tablet every 4 to 6 hours.
Or as prescribed by the physician.
Syrup: 6-12 years old: 2 teaspoonful (10 mL) to be taken every four hours.
2-6 years old: 1 teaspoonful (5 mL) to be taken every 4 hours.
Or as prescribed by the physician.
Or as prescribed by the physician.
Syrup: Children: 2-6 years old: ½ to 1 teaspoonful (2.5 to 5 ml).
6-12 years old: 1 teaspoonful (5 ml ).
Over 12 years: 1 to 2 teaspoonfuls (5 to 10 ml).
Adult: 2 teaspoonfuls (10 ml) three to four times a day.
Or as prescribed by the physician.
Efamed solution for nebulization: Adult and child over 18 months: 2.5 mg-5 mg. Repeated, up to 4 times daily.
Children under 18 months: (Transient hypoxaemia may occur consider supplemental oxygen) 2.5 mg up to 4 times daily or more frequently in severe cases.
Efamed Plus tablet/syrup: Tablet: The recommended oral dose is 1 tablet every 4 to 6 hours.
Or as prescribed by the physician.
Syrup: 6-12 years old: 2 teaspoonful (10 mL) to be taken every four hours.
2-6 years old: 1 teaspoonful (5 mL) to be taken every 4 hours.
Or as prescribed by the physician.
Administration
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.
Contraindications
Efamed tablet/syrup: Should not be prescribed to patients under treatment with beta blockers. Also contraindicated in pregnancy, to patients suffering from thyrotoxicosis and to patients hypersensitive to Salbutamol.
Efamed Plus tablet/syrup: History of hypersensitivity to salbutamol sulfate, guaifenesin or to any of the excipients of Ventolin Expectorant.
Efamed Plus tablet/syrup: History of hypersensitivity to salbutamol sulfate, guaifenesin or to any of the excipients of Ventolin Expectorant.
Special Precautions
Efamed tablet/syrup: Salbutamol and nonselective B-blocking drugs like propranolol should not usually be prescribed together.
Efamed solution for nebulization: Salbutamol and other beta agonists should be given with caution in hyperthyroidism, myocardial insufficiency, arrythmias, susceptibility to QT- interval prolongation, hypertension, and diabetes mellitus (especially on intravenous use-blood glucose should be monitored since ketoacidosis has been reported).
In severe asthma particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by the effect of other antiasthma drugs on potassium plasma-potassium concentrations should be monitored.
Beta 2 agonist such as salbutamol 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 beta 2 agonist indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.
In women being treated for pre-mature labour the risk of pulmonary oedema means that the patient's state of hydration and cardiac and respiratory function should be monitored very carefully; the volume of infusion fluid should be kept to the minimum (normally using glucose 5% as the diluent), and beta 2-agonist therapy should be stopped immediately and diuretic therapy started if signs of pulmonary oedema develop other risk factors for pulmonary oedema include multiple pregnancy and heart disease. Ischaemic heart disease or significant risk factors for ischaemic heart disease are specific contraindications; where heart disease is suspected assessment by a physician experienced in cardiology is needed. Eclampsia and severe preeclampsia are also contraindications, with special care needed in mild to moderate pre-eclampsia. Other placenta praevia, and cord compression, beta 2 agonists should not be used for threatened miscarriage.
Efamed Plus tablet/syrup: Sympathomimetics may produce a wide range of adverse effects most of which mimic the results of excessive stimulation of the sympathomimetic nervous system. Clinically, this is manifested by confusion, irritability, tremor, insomnia and restlessness. Appetite may be reduced and nausea and vomiting may occur.
There may also be reflex bradycardia because of the stimulation of the beta 1 receptors of the heart. But often they cause tachycardia hypotension, palpitations and sudden death due to cardiac arrhythmias.
Salbutamol also is considered to possess mucolytic property. It is believed to act in the cilia of the respiratory tract and aside from bronchodilation can produce lysis of thick mucus.
Efamed solution for nebulization: Salbutamol and other beta agonists should be given with caution in hyperthyroidism, myocardial insufficiency, arrythmias, susceptibility to QT- interval prolongation, hypertension, and diabetes mellitus (especially on intravenous use-blood glucose should be monitored since ketoacidosis has been reported).
In severe asthma particular caution is also required to avoid inducing hypokalemia as this effect may be potentiated by hypoxia or by the effect of other antiasthma drugs on potassium plasma-potassium concentrations should be monitored.
Beta 2 agonist such as salbutamol 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 beta 2 agonist indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.
In women being treated for pre-mature labour the risk of pulmonary oedema means that the patient's state of hydration and cardiac and respiratory function should be monitored very carefully; the volume of infusion fluid should be kept to the minimum (normally using glucose 5% as the diluent), and beta 2-agonist therapy should be stopped immediately and diuretic therapy started if signs of pulmonary oedema develop other risk factors for pulmonary oedema include multiple pregnancy and heart disease. Ischaemic heart disease or significant risk factors for ischaemic heart disease are specific contraindications; where heart disease is suspected assessment by a physician experienced in cardiology is needed. Eclampsia and severe preeclampsia are also contraindications, with special care needed in mild to moderate pre-eclampsia. Other placenta praevia, and cord compression, beta 2 agonists should not be used for threatened miscarriage.
Efamed Plus tablet/syrup: Sympathomimetics may produce a wide range of adverse effects most of which mimic the results of excessive stimulation of the sympathomimetic nervous system. Clinically, this is manifested by confusion, irritability, tremor, insomnia and restlessness. Appetite may be reduced and nausea and vomiting may occur.
There may also be reflex bradycardia because of the stimulation of the beta 1 receptors of the heart. But often they cause tachycardia hypotension, palpitations and sudden death due to cardiac arrhythmias.
Salbutamol also is considered to possess mucolytic property. It is believed to act in the cilia of the respiratory tract and aside from bronchodilation can produce lysis of thick mucus.
Use In Pregnancy & Lactation
Efamed tablet/syrup: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefit outweighs any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Efamed Plus tablet/syrup: Guaifenesin has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Guaifenesin is only recommend for use during pregnancy when benefit outweighs risk.
There are no data on the excretion of guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Efamed Plus tablet/syrup: Guaifenesin has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Guaifenesin is only recommend for use during pregnancy when benefit outweighs risk.
There are no data on the excretion of guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Efamed tablet/syrup: Salbutamol may cause tremor of skeletal muscle in some patients; usually the hands are most obviously affected. A few patients experience feeling of tension, this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Hypersensitivity reactions including angioedema, urticarial, bronchospasm, hypertension and collapse have been reported very rarely.
Efamed Plus tablet/syrup: Fine tremor of skeletal muscle, feeling of tension, peripheral vasodilation, a compensatory small increase in heart rate, headache, transient muscle cramps, hypersensitivity reactions, hyperactivity in children. Risk of dental caries.
Efamed Plus tablet/syrup: Fine tremor of skeletal muscle, feeling of tension, peripheral vasodilation, a compensatory small increase in heart rate, headache, transient muscle cramps, hypersensitivity reactions, hyperactivity in children. Risk of dental caries.
Drug Interactions
Efamed tablet/syrup: Use of salbutamol and other beta 2 agonist with corticosteroids, diuretics, or xanthines increases the risk of hypokalaemia, and monitoring of potassium concentrations is recommended in severe asthma, where such combination therapy is common.
Efamed Plus tablet/syrup: Salbutamol and nonselective β-blocking drugs eg, propranolol, should not usually be prescribed together. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Efamed Plus tablet/syrup: Salbutamol and nonselective β-blocking drugs eg, propranolol, should not usually be prescribed together. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Storage
Store at temperatures not exceeding 30°C.
Action
Efamed tablet/syrup: Pharmacologic Classification: Antiasthma.
Pharmacology: Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract. When given by inhalation, 10 to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is swallowed and absorbed from the gut. Salbutamol is subject to first pass metabolism in the liver and possibly in the gut wall but does not appear to be metabolized in the lung; the main metabolite is the inactive sulfate conjugate. Salbutamol is rapidly excreted mainly in the urine, as metabolites and unchanged drug; a smaller proportion is excreted in the feces. The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours.
Efamed solution for nebulization: Pharmacologic Classification: Bronchodilator.
Pharmacology: Pharmacokinetics: Salbutamol is readily absorbed from the gastro intestinal tract. When given by inhalation, 10-20% of the dose reaches the lower airways. The remainder is retained in the delivery in the delivery system or is swallowed and absorbed from the gut. Salbutamol is subject to first-pass metabolism in the liver and possibly in the gut wall but does not appear to be metabolized in the lungs; the main metabolite is the inactive sulfate conjugate. Salbutamol is rapidly excreted, mainly in the urine, as metabolites and unchanged drug: a smaller proportions excreted in the faeces. The plasma half-life of salbutamol has been estimated to range from 4-6 hours.
Efamed Plus tablet/syrup: Pharmacologic Classification: Expectorant/Bronchodilator.
Pharmacology: Pharmacodynamics: Mechanism of Action: Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial muscle, with little or no action on the β1-adrenoceptors of cardiac muscle.
Guaifenesin can make the viscous mucus of the respiratory pathway more fluid and therefore expectoration and reduces cough.
Pharmacodynamic Effects: Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle providing short-acting (4-6 hours) bronchodilation in reversible airways obstruction.
Pharmacokinetics: Absorption: After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine. Guaifenesin is well-absorbed after oral administration. After the administration of guaifenesin 600 mg in healthy adult volunteers the maximum peak plasma concentration (Cmax) was approximately 1.4 mcg/mL with Tmax about 15 minutes after drug administration.
Distribution: The bioavailability of orally administered salbutamol is about 50%. Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism: Salbutamol administered IV has a half-life (t1/2) of 4-6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. Guaifenesin has a plasma t1/2 of approximately 1 hour and was not detectable in the blood after 8 hrs. Guaifenesin appears to undergo both oxidation and demethylation.
Elimination: The majority of a dose of salbutamol given IV, orally or by inhalation is excreted within 72 hrs. The feces are a minor route of excretion. Guaifenesin is excreted in urine.
Pharmacology: Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract. When given by inhalation, 10 to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is swallowed and absorbed from the gut. Salbutamol is subject to first pass metabolism in the liver and possibly in the gut wall but does not appear to be metabolized in the lung; the main metabolite is the inactive sulfate conjugate. Salbutamol is rapidly excreted mainly in the urine, as metabolites and unchanged drug; a smaller proportion is excreted in the feces. The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours.
Efamed solution for nebulization: Pharmacologic Classification: Bronchodilator.
Pharmacology: Pharmacokinetics: Salbutamol is readily absorbed from the gastro intestinal tract. When given by inhalation, 10-20% of the dose reaches the lower airways. The remainder is retained in the delivery in the delivery system or is swallowed and absorbed from the gut. Salbutamol is subject to first-pass metabolism in the liver and possibly in the gut wall but does not appear to be metabolized in the lungs; the main metabolite is the inactive sulfate conjugate. Salbutamol is rapidly excreted, mainly in the urine, as metabolites and unchanged drug: a smaller proportions excreted in the faeces. The plasma half-life of salbutamol has been estimated to range from 4-6 hours.
Efamed Plus tablet/syrup: Pharmacologic Classification: Expectorant/Bronchodilator.
Pharmacology: Pharmacodynamics: Mechanism of Action: Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial muscle, with little or no action on the β1-adrenoceptors of cardiac muscle.
Guaifenesin can make the viscous mucus of the respiratory pathway more fluid and therefore expectoration and reduces cough.
Pharmacodynamic Effects: Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle providing short-acting (4-6 hours) bronchodilation in reversible airways obstruction.
Pharmacokinetics: Absorption: After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine. Guaifenesin is well-absorbed after oral administration. After the administration of guaifenesin 600 mg in healthy adult volunteers the maximum peak plasma concentration (Cmax) was approximately 1.4 mcg/mL with Tmax about 15 minutes after drug administration.
Distribution: The bioavailability of orally administered salbutamol is about 50%. Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism: Salbutamol administered IV has a half-life (t1/2) of 4-6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. Guaifenesin has a plasma t1/2 of approximately 1 hour and was not detectable in the blood after 8 hrs. Guaifenesin appears to undergo both oxidation and demethylation.
Elimination: The majority of a dose of salbutamol given IV, orally or by inhalation is excreted within 72 hrs. The feces are a minor route of excretion. Guaifenesin is excreted in urine.
MedsGo Class
Antiasthmatic & COPD Preparations / Cough & Cold Preparations
Features
Brand
EFAMED
Full Details
Dosage Strength
2 mg / 5 mL
Drug Ingredients
- Salbutamol
Drug Packaging
Syrup 60ml
Generic Name
Salbutamol Sulfate
Dosage Form
Syrup
Registration Number
DR-XY22431
Drug Classification
Prescription Drug (RX)
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