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| Bronchoterol Pamphlet |
PRESENTATION
Each, 5 ml Bronchoterol syrup contains:
Active ingredient: Salbutamol (as sulfate) 2 mg
Inactive ingredients: Methyl paraben, propyl paraben, sucrose, tutti frutti flavour propylene glycol, ponceau 4R 80%, citric add anhydrous, sodium citrate dihydrate, purified water.
INDICATIONS
Salbutamol is a selective beta-2 adrenoceptor agonist providing short-acting (4-6 hours) bronchodilatation in reversible airways obstruction. Bronchoterol syrup can be used in the management of asthma, bronchospasrn and/or reversible airways obstruction.
• Relief of bronchospasm in bronchial asthma of all types.
• Bronchoterol syrup is suitable oral therapy for children and adults who are unable to use an inhaler device.
DOSAGE AND ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of β2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy Should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Adults : The usual effective dose is 4 milligrams three or four times per day.
If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8 milligrams. Some patients obtain adequate relief with 2 milligrams three or four times daily.
In the management of premature labour, after uterine contractions have been controlled by intravenous infusion of Salbutamol and the infusion has been withdrawn, maintenance therapy can be continued with oral Salbutamol. The usual dosage is 4 milligrams, three or four times daily.
Children :2- 6 years: 1 to 2 mg three or four times daily (or 2.5-5 ml of syrup)
6- 12 years: 2 mg three or four times daily. (5 ml syrup)
Over 12 years: 2-4 mg three or four times daily.
Special patient groups : In elderly patients or in those known to be unusually sensitive to β-adrenergic stimulant drugs, it is advisable to initiate treatment with 2 milligrams salbutamol three or four times per day.
CONTRAINDICATIONS
Bronchoterol is contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS AND PRECAUTIONS
• Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in those patients.
• Patients should seek medical advice if treatment with Bronchoterol syrup becomes less effective.
• The dosage or frequency of administration should only be increased on medical advice.
• Patients taking Bronchoterol syrup may also be receiving short-acting inhaled bronchodilators to relieve symptoms.
• Increasing use of bronchodilators in particular short-acting inhaled beta2-agonists to relieve symptoms indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (eg. Higher doses of inhaled corticosteroids or a course of oral corticosteroid). severe exacerbations of asthma must be treated in the normal way.
• Patients should be warned that if either the usual relief with Bronchoterol oral preparations is diminished or the usual duration of action reduced, they should not increase the dose or its Frequency of administration, but should seek medical advice.
• Bronchoterol syrup and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
- Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
• Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
• Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids. It is recommended that serum potassium levels are monitored in such situations.
In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
INTERACTIONS
• Salbutamol and non-selective β-blocking drugs, such as propranolol, should not usually be prescribed together.
• Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOls).
PREGNANCY AND LACTATION
• Administration of drugs during pregnancy should only be coisidered if the expected benefit 10 the mother is greater than any possible risk to lhe foetus. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and hmb defects have beer reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be dis emed, and basehne rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
• As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh the potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate. ABILITY TO DRIVE AND USE MACHINES : None reported.
ADVERSE REACTIONS
Adverse events are listed bekw by system organ class arid frequency Frequencies are defined as: very common
(1110), common ( 11100 and <1110), uncommon ( 1/1000 and <11100), rare ( 1/10000 and <1/1000) and very rare (<1110,000) including isolated reports. Very common and corrmon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.
• Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, ulicaria, bronctiospasm, hypotension and collapse.
• Metabolism and nutrition disorders
Rare: Hypokalaemia, potentially serious hypokalaernia may result from beta2 agonist therapy.
- Nervous system disorders : Very common: Tremor. Common: Headache. Very rare: Hyperactivity
• Cardiac disorders: Common: Tachycardia, palpitations.
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
- Vascular disorders: Rare: Peripheral vasodilatation.
• Mu5culoskeletal and connective tissue disorders:
Common: Muscle cramps. Very rare: Feeling of muscle tension.
OVERDOSE
The preferred antidote for overciosage with salbutamol is a cardioselective 13-blocking agent. However; 13-blocking drugs should be used with caution in patients with a history of bronchospasm.
Hypokalaeima may occur following overdose with saibutamol. Serum potassium levels should be monitored.
PHARMACODYNAMICS
Salbutamol is a selective 132 adrenoceptor agonist. At therapeutic doses it acts on the 132 adrenoceptors of bronchial musde, with little or no action on the 13-i adrenoceptors of cardiac muscle.
PACK
Carton box containing brown round glass bottle (Type Ill) of 120 ml with aluminum cap and inner leaflet.
STORAGE
Keep at a temperature not exceeding 30°C.
Each, 5 ml Bronchoterol syrup contains:
Active ingredient: Salbutamol (as sulfate) 2 mg
Inactive ingredients: Methyl paraben, propyl paraben, sucrose, tutti frutti flavour propylene glycol, ponceau 4R 80%, citric add anhydrous, sodium citrate dihydrate, purified water.
INDICATIONS
Salbutamol is a selective beta-2 adrenoceptor agonist providing short-acting (4-6 hours) bronchodilatation in reversible airways obstruction. Bronchoterol syrup can be used in the management of asthma, bronchospasrn and/or reversible airways obstruction.
• Relief of bronchospasm in bronchial asthma of all types.
• Bronchoterol syrup is suitable oral therapy for children and adults who are unable to use an inhaler device.
DOSAGE AND ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of β2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy Should be considered.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Adults : The usual effective dose is 4 milligrams three or four times per day.
If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8 milligrams. Some patients obtain adequate relief with 2 milligrams three or four times daily.
In the management of premature labour, after uterine contractions have been controlled by intravenous infusion of Salbutamol and the infusion has been withdrawn, maintenance therapy can be continued with oral Salbutamol. The usual dosage is 4 milligrams, three or four times daily.
Children :2- 6 years: 1 to 2 mg three or four times daily (or 2.5-5 ml of syrup)
6- 12 years: 2 mg three or four times daily. (5 ml syrup)
Over 12 years: 2-4 mg three or four times daily.
Special patient groups : In elderly patients or in those known to be unusually sensitive to β-adrenergic stimulant drugs, it is advisable to initiate treatment with 2 milligrams salbutamol three or four times per day.
CONTRAINDICATIONS
Bronchoterol is contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS AND PRECAUTIONS
• Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in those patients.
• Patients should seek medical advice if treatment with Bronchoterol syrup becomes less effective.
• The dosage or frequency of administration should only be increased on medical advice.
• Patients taking Bronchoterol syrup may also be receiving short-acting inhaled bronchodilators to relieve symptoms.
• Increasing use of bronchodilators in particular short-acting inhaled beta2-agonists to relieve symptoms indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (eg. Higher doses of inhaled corticosteroids or a course of oral corticosteroid). severe exacerbations of asthma must be treated in the normal way.
• Patients should be warned that if either the usual relief with Bronchoterol oral preparations is diminished or the usual duration of action reduced, they should not increase the dose or its Frequency of administration, but should seek medical advice.
• Bronchoterol syrup and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
- Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
• Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
• Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids. It is recommended that serum potassium levels are monitored in such situations.
In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
INTERACTIONS
• Salbutamol and non-selective β-blocking drugs, such as propranolol, should not usually be prescribed together.
• Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOls).
PREGNANCY AND LACTATION
• Administration of drugs during pregnancy should only be coisidered if the expected benefit 10 the mother is greater than any possible risk to lhe foetus. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and hmb defects have beer reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be dis emed, and basehne rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
• As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh the potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate. ABILITY TO DRIVE AND USE MACHINES : None reported.
ADVERSE REACTIONS
Adverse events are listed bekw by system organ class arid frequency Frequencies are defined as: very common
(1110), common ( 11100 and <1110), uncommon ( 1/1000 and <11100), rare ( 1/10000 and <1/1000) and very rare (<1110,000) including isolated reports. Very common and corrmon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.
• Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, ulicaria, bronctiospasm, hypotension and collapse.
• Metabolism and nutrition disorders
Rare: Hypokalaemia, potentially serious hypokalaernia may result from beta2 agonist therapy.
- Nervous system disorders : Very common: Tremor. Common: Headache. Very rare: Hyperactivity
• Cardiac disorders: Common: Tachycardia, palpitations.
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
- Vascular disorders: Rare: Peripheral vasodilatation.
• Mu5culoskeletal and connective tissue disorders:
Common: Muscle cramps. Very rare: Feeling of muscle tension.
OVERDOSE
The preferred antidote for overciosage with salbutamol is a cardioselective 13-blocking agent. However; 13-blocking drugs should be used with caution in patients with a history of bronchospasm.
Hypokalaeima may occur following overdose with saibutamol. Serum potassium levels should be monitored.
PHARMACODYNAMICS
Salbutamol is a selective 132 adrenoceptor agonist. At therapeutic doses it acts on the 132 adrenoceptors of bronchial musde, with little or no action on the 13-i adrenoceptors of cardiac muscle.
PACK
Carton box containing brown round glass bottle (Type Ill) of 120 ml with aluminum cap and inner leaflet.
STORAGE
Keep at a temperature not exceeding 30°C.
Keep all medications out of reach of children.
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