VENTOLIN ROTAPACK Salbutamol / Rotahaler Device 200mcg Powder for Inhalation 1's
RXDRUG-DR-XY37089-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Salbutamol (Ventolin) is a selective beta2-adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to Salbutamol (Ventolin), treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with Salbutamol (Ventolin) may signal a need for urgent medical advice or treatment.
Nebules: Salbutamol (Ventolin Nebules) are indicated for the routine management of chronic bronchospasm (unresponsive to conventional therapy) and treatment of acute severe asthma (status asthmaticus).
Rotacap/Inhaler/Nebules: For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to Salbutamol (Ventolin), treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with Salbutamol (Ventolin) may signal a need for urgent medical advice or treatment.
Nebules: Salbutamol (Ventolin Nebules) are indicated for the routine management of chronic bronchospasm (unresponsive to conventional therapy) and treatment of acute severe asthma (status asthmaticus).
Rotacap/Inhaler/Nebules: For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger.
Dosage/Direction for Use
Salbutamol (Ventolin) 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.
Rotacaps: Salbutamol (Ventolin) Rotacaps capsules are for inhalation use only, using a VENTOLIN ROTAHALER inhaler.
Relief of Acute Bronchospasm: Adults: 200 or 400 micrograms.
Children: 200 micrograms.
Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 400 micrograms before challenge or exertion.
Children: 200 micrograms before challenge or exertion.
Chronic Therapy: Adults: 400 micrograms 3 or 4 times daily.
Children: 200 micrograms 3 or 4 times daily.
On demand use of Salbutamol (Ventolin) should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Precautions).
Inhaler: Salbutamol (Ventolin) Inhaler is administered by the inhaled route only.
In patients who find co-ordination of a pressurised metered-dose inhaler difficult a spacer may be used with Salbutamol (Ventolin) Inhaler.
Babies and young children using the Salbutamol (Ventolin) Inhaler may benefit from the use of a paediatric spacer device with a face mask (for example the BABYHALER). (Recommended statement "for example the BABYHALER" is for use only in those markets where the Babyhaler spacer device is available) (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Relief of Acute Bronchospasm: Adults: 100 or 200 micrograms.
Children: 100 micrograms. The dose may be increased to 200 micrograms if required.
Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 200 micrograms before challenge or exertion.
Children: 100 micrograms before challenge or exertion. The dose may be increased to 200 micrograms if required.
Chronic Therapy: Adults: Up to 200 micrograms 4 times daily.
Children: Up to 200 micrograms 4 times daily.
On demand use of Salbutamol (Ventolin) should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Precautions).
Nebules: Salbutamol (Ventolin Nebules) are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline as a diluent may be required.
Salbutamol (Ventolin Nebules) are to be used with a nebuliser, under the direction of a physician.
The solution must not be injected, or swallowed.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. Salbutamol (Ventolin Nebules) should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.
Adults and Children: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.
Clinical efficacy of nebulised Salbutamol (Ventolin) in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
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.
Rotacaps: Salbutamol (Ventolin) Rotacaps capsules are for inhalation use only, using a VENTOLIN ROTAHALER inhaler.
Relief of Acute Bronchospasm: Adults: 200 or 400 micrograms.
Children: 200 micrograms.
Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 400 micrograms before challenge or exertion.
Children: 200 micrograms before challenge or exertion.
Chronic Therapy: Adults: 400 micrograms 3 or 4 times daily.
Children: 200 micrograms 3 or 4 times daily.
On demand use of Salbutamol (Ventolin) should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Precautions).
Inhaler: Salbutamol (Ventolin) Inhaler is administered by the inhaled route only.
In patients who find co-ordination of a pressurised metered-dose inhaler difficult a spacer may be used with Salbutamol (Ventolin) Inhaler.
Babies and young children using the Salbutamol (Ventolin) Inhaler may benefit from the use of a paediatric spacer device with a face mask (for example the BABYHALER). (Recommended statement "for example the BABYHALER" is for use only in those markets where the Babyhaler spacer device is available) (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Relief of Acute Bronchospasm: Adults: 100 or 200 micrograms.
Children: 100 micrograms. The dose may be increased to 200 micrograms if required.
Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 200 micrograms before challenge or exertion.
Children: 100 micrograms before challenge or exertion. The dose may be increased to 200 micrograms if required.
Chronic Therapy: Adults: Up to 200 micrograms 4 times daily.
Children: Up to 200 micrograms 4 times daily.
On demand use of Salbutamol (Ventolin) should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Precautions).
Nebules: Salbutamol (Ventolin Nebules) are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline as a diluent may be required.
Salbutamol (Ventolin Nebules) are to be used with a nebuliser, under the direction of a physician.
The solution must not be injected, or swallowed.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. Salbutamol (Ventolin Nebules) should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.
Adults and Children: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.
Clinical efficacy of nebulised Salbutamol (Ventolin) in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
Overdosage
The most common signs and symptoms of overdose with Salbutamol (Ventolin) are transient beta agonist pharmacologically mediated events (see Precautions and Adverse Reactions).
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin). Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin). Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Administration
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.
Contraindications
Salbutamol (Ventolin) is contraindicated in patients with a history of hypersensitivity to any its components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
Rotacap: Salbutamol (Ventolin) dry powder inhaler formulations are contraindicated in patients with severe milk-protein allergy or who have a history of hypersensitivity to salbutamol or any of its formulation components (see Description).
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
Rotacap: Salbutamol (Ventolin) dry powder inhaler formulations are contraindicated in patients with severe milk-protein allergy or who have a history of hypersensitivity to salbutamol or any of its formulation components (see Description).
Special Precautions
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Increasing use of short-acting inhaled beta2-agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that if either the usual relief 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.
Salbutamol (Ventolin) should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
Rotacap/Inhaler: As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
Nebules: Salbutamol (Ventolin Nebules) must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.
Patients receiving treatment at home with Salbutamol (Ventolin Nebules) must be warned that if either the usual relief 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.
Salbutamol (Ventolin Nebules) should be used with caution in patients known to have received large doses of other sympathomimetic drugs.
Salbutamol (Ventolin) should be administered cautiously to patients with thyrotoxicosis.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised Salbutamol (Ventolin) and ipratropium bromide. A combination of nebulised Salbutamol (Ventolin) with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
Potentially serious hypokalaemia may result from beta2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. Salbutamol (Ventolin Nebules) should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin) can induce reversible metabolic changes, for example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reactions). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
Effects on Ability to Drive and Use Machines: None reported.
Increasing use of short-acting inhaled beta2-agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients should be warned that if either the usual relief 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.
Salbutamol (Ventolin) should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from beta2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
Rotacap/Inhaler: As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
Nebules: Salbutamol (Ventolin Nebules) must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.
Patients receiving treatment at home with Salbutamol (Ventolin Nebules) must be warned that if either the usual relief 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.
Salbutamol (Ventolin Nebules) should be used with caution in patients known to have received large doses of other sympathomimetic drugs.
Salbutamol (Ventolin) should be administered cautiously to patients with thyrotoxicosis.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised Salbutamol (Ventolin) and ipratropium bromide. A combination of nebulised Salbutamol (Ventolin) with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
Potentially serious hypokalaemia may result from beta2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. Salbutamol (Ventolin Nebules) should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin) can induce reversible metabolic changes, for example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reactions). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
Effects on Ability to Drive and Use Machines: None reported.
Use In Pregnancy & Lactation
Fertility: There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Use in Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with Salbutamol (Ventolin). Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with Salbutamol (Ventolin) use cannot be established.
Use in Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Use in Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with Salbutamol (Ventolin). Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with Salbutamol (Ventolin) use cannot be established.
Use in Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Adverse Reactions
Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.
Rotacap/Inhaler: Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and Nutrition Disorders: Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta2 agonist therapy.
Nervous System Disorders: Common: Tremor, headache. Very Rare: Hyperactivity.
Cardiac Disorders: Common: Tachycardia. Uncommon: Palpitations. Very Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular Disorders: Rare: Peripheral vasodilatation.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.
Gastrointestinal Disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps.
Nebules: Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and Nutrition Disorders: Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta2 agonist therapy.
Very Rare: Lactic acidosis.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.
Nervous System Disorders: Common: Tremor, headache. Very Rare: Hyperactivity.
Cardiac Disorders: Common: Tachycardia. Uncommon: Palpitations. Very Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular Disorders: Rare: Peripheral vasodilatation.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.
Gastrointestinal Disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps.
Rotacap/Inhaler: Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and Nutrition Disorders: Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta2 agonist therapy.
Nervous System Disorders: Common: Tremor, headache. Very Rare: Hyperactivity.
Cardiac Disorders: Common: Tachycardia. Uncommon: Palpitations. Very Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular Disorders: Rare: Peripheral vasodilatation.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.
Gastrointestinal Disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps.
Nebules: Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and Nutrition Disorders: Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta2 agonist therapy.
Very Rare: Lactic acidosis.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.
Nervous System Disorders: Common: Tremor, headache. Very Rare: Hyperactivity.
Cardiac Disorders: Common: Tachycardia. Uncommon: Palpitations. Very Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular Disorders: Rare: Peripheral vasodilatation.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.
Gastrointestinal Disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps.
Drug Interactions
Salbutamol (Ventolin) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol (Ventolin) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Salbutamol (Ventolin) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Caution For Usage
Instructions for Use and Handling: Syrup: Dilution: May be diluted with purified water (50% v/v). The resulting mixture should be protected from light and used within 28 days.
A 50% v/v dilution of Ventolin syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the purified water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.
Admixture of Ventolin syrup with other liquid preparation is not recommended.
Rotacap: The Rotacap must only be inserted in to the Rotahaler immediately prior to use. Failure to observe this instruction will affect the delivery of the drug.
Inhaler: Testing the Inhaler: Before using for the first time, remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release two puffs into the air to make sure that it works. If it has not been used for 5 days or more, shake it well and release 2 puffs into the air to make sure that it works.
Using the Inhaler: 1. Remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
3. Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright between fingers and thumb with thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable and then place the mouthpiece in the mouth between the teeth and close the lips around it but do not bite it.
6. Just after starting to breathe in through the mouth press down on the top of the inhaler to release Salbutamol (Ventolin) while still breathing in steadily and deeply.
7. While holding breath, take the inhaler from the mouth and take the finger from the top of the inhaler. Continue holding breath for as long as is comfortable.
8. If the patient is to take further puffs, keep the inhaler upright and wait about half a minute before repeating steps three to seven.
9. Replace the mouthpiece cover by firmly pushing and snapping the cap into position.
Important: Do not rush Stages 5, 6 and 7. It is important that the patients starts to breathe in as slowly as possible just before operating the Inhaler.
Practise in front of a mirror for the first few times. If the patient sees the 'mist' coming from the top of the inhaler or the sides of the mouth the patient should start again from stage two.
If the physician has given the patient different instructions for using the inhaler, follow them carefully. Tell the physician if the patient has any difficulties.
Cleaning: The inhaler should be cleaned at least once a week.
Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
Rinse the actuator thoroughly under warm running water.
Dry the actuator thoroughly inside and out.
Replace the metal canister and mouthpiece cover.
Do not put the metal canister into water.
Nebules: Dilution: Salbutamol (Ventolin Nebules) may be diluted with sterile normal saline.
Any unused solution in the chamber of the nebuliser must be discarded.
A 50% v/v dilution of Ventolin syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the purified water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.
Admixture of Ventolin syrup with other liquid preparation is not recommended.
Rotacap: The Rotacap must only be inserted in to the Rotahaler immediately prior to use. Failure to observe this instruction will affect the delivery of the drug.
Inhaler: Testing the Inhaler: Before using for the first time, remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release two puffs into the air to make sure that it works. If it has not been used for 5 days or more, shake it well and release 2 puffs into the air to make sure that it works.
Using the Inhaler: 1. Remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
3. Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright between fingers and thumb with thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable and then place the mouthpiece in the mouth between the teeth and close the lips around it but do not bite it.
6. Just after starting to breathe in through the mouth press down on the top of the inhaler to release Salbutamol (Ventolin) while still breathing in steadily and deeply.
7. While holding breath, take the inhaler from the mouth and take the finger from the top of the inhaler. Continue holding breath for as long as is comfortable.
8. If the patient is to take further puffs, keep the inhaler upright and wait about half a minute before repeating steps three to seven.
9. Replace the mouthpiece cover by firmly pushing and snapping the cap into position.
Important: Do not rush Stages 5, 6 and 7. It is important that the patients starts to breathe in as slowly as possible just before operating the Inhaler.
Practise in front of a mirror for the first few times. If the patient sees the 'mist' coming from the top of the inhaler or the sides of the mouth the patient should start again from stage two.
If the physician has given the patient different instructions for using the inhaler, follow them carefully. Tell the physician if the patient has any difficulties.
Cleaning: The inhaler should be cleaned at least once a week.
Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
Rinse the actuator thoroughly under warm running water.
Dry the actuator thoroughly inside and out.
Replace the metal canister and mouthpiece cover.
Do not put the metal canister into water.
Nebules: Dilution: Salbutamol (Ventolin Nebules) may be diluted with sterile normal saline.
Any unused solution in the chamber of the nebuliser must be discarded.
Storage
Rotacap: To keep the Rotacap in good condition it is important that it is stored in a dry place and where it will not be exposed to extremes of temperature and should be stored below 30°C.
Inhaler: Replace the mouthpiece cover firmly and snap it into position.
Store below 30°C. Protect from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold.
The canister should not be broken, punctured or burnt, even when apparently empty.
Inhaler: Replace the mouthpiece cover firmly and snap it into position.
Store below 30°C. Protect from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold.
The canister should not be broken, punctured or burnt, even when apparently empty.
Action
Pharmacology: Pharmacodynamics: Salbutamol is a selective beta2-adrenoceptor agonist. At therapeutic doses it acts on the beta2-adrenoceptors of bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction.
Clinical Studies: Inhaler: Special Patient Populations: Children <4 Years of Age: Paediatric clinical studies conducted at the recommended dose (SB020001, SB030001, SB030002), in patients <4 years with bronchospasm associated with reversible obstructive airways disease, show that the Inhaler has a safety profile comparable to that in children ≥4 years, adolescents and adults.
Pharmacokinetics: Absorption: After administration by the inhaled route, between 10 and 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. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Distribution: Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism: On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
Elimination: Salbutamol administered intravenously has a half-life of four to six hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours.
Toxicology: Pre-clinical Safety Data: In common with other potent selective beta2-receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, four times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50 mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50 mg/kg/day, 78 times the maximum human oral dose.
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on fertility, embryofetal development, litter size, birth weight or growth rate.
Inhaler: HFA 134a has been shown to be non-toxic at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
Clinical Studies: Inhaler: Special Patient Populations: Children <4 Years of Age: Paediatric clinical studies conducted at the recommended dose (SB020001, SB030001, SB030002), in patients <4 years with bronchospasm associated with reversible obstructive airways disease, show that the Inhaler has a safety profile comparable to that in children ≥4 years, adolescents and adults.
Pharmacokinetics: Absorption: After administration by the inhaled route, between 10 and 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. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Distribution: Salbutamol is bound to plasma proteins to the extent of 10%.
Metabolism: On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
Elimination: Salbutamol administered intravenously has a half-life of four to six hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours.
Toxicology: Pre-clinical Safety Data: In common with other potent selective beta2-receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, four times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50 mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50 mg/kg/day, 78 times the maximum human oral dose.
In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on fertility, embryofetal development, litter size, birth weight or growth rate.
Inhaler: HFA 134a has been shown to be non-toxic at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Ventolin Rotapack
Full Details
Dosage Strength
200mcg
Drug Ingredients
- Salbutamol
Drug Packaging
Powder for Inhalation 1's
Generic Name
Salbutamol Sulfate with Rotahaler Device
Dosage Form
Powder for Inhalation
Registration Number
DR-XY37089
Drug Classification
Prescription Drug (RX)
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