Active ingredients: Salbutamol
VENTOLIN 2 mg Effervescent tablets
Ventolin package inserts are available for pack sizes:- VENTOLIN 2 mg Effervescent tablets
- VENTOLIN 2 mg / 10 ml Syrup
- VENTOLIN 100 mcg / 5 ml Solution for injection, VENTOLIN 500 mcg / 1 ml Solution for injection
- VENTOLIN 100 mcg Pressurized suspension for inhalation
Why is Ventolin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Anti-asthmatics - adrenergics for systemic use - selective beta2-adrenergic receptor agonists
THERAPEUTIC INDICATIONS
Treatment of bronchial asthma, obstructive bronchopathy with asthmatic component.
Salbutamol is a selective beta2-receptor agonist.
At therapeutic doses it acts on the beta2-receptors of the bronchial muscles and has little or no action on the beta1-receptors of the cardiac muscles. It is indicated for the treatment of asthma attacks.
In patients with severe or unstable asthma, bronchodilators should not be the only or main therapeutic treatment. Such patients require regular medical care as severe asthma can cause death.
Patients with severe asthma present with constant symptoms and frequent exacerbations; their lung function is reduced, they have PEF values lower than 60% of normal with variability even higher than 30%.
Normally these values do not completely normalize after taking a bronchodilator. Such patients therefore require high-dose inhaled or oral steroid therapy.
A sudden worsening of symptoms may require an increase in the dosage of steroids which must be administered urgently under medical supervision.
Contraindications When Ventolin should not be used
Hypersensitivity to the active substance or to any of the excipients.
Salbutamol formulations must not be employed in the threat of abortion.
Although a percentage of congenital anomalies comparable to that reported in the population not exposed to the drug has been reported among patients who took salbutamol during pregnancy, its use in pregnancy is not recommended except in cases where the benefit for the mother is greater than the possible risk to the fetus.
Precautions for use What you need to know before taking Ventolin
Patients with severe asthma present with constant symptoms and frequent exacerbations; their lung function is reduced, they have PEF values lower than 60% of normal with variability even higher than 30%.
Normally these values do not completely normalize after taking a bronchodilator. Such patients therefore require high-dose inhaled steroid therapy (eg> 1 mg per day of Beclometasone dipropionate) or oral.
A sudden worsening of symptoms may require an increase in the dosage of steroids which must be administered urgently under medical supervision.
The treatment of asthma must normally be performed within the framework of a therapeutic plan adapted to the severity of the disease; the patient's response to therapy should be verified both clinically and by pulmonary function tests.
The need to resort to short-acting inhaled beta2-agonists more frequently for symptomatology control indicates worsening of asthma control; in this circumstance the patient's treatment plan must be modified.
Sudden and progressive aggravation of asthma is potentially life-threatening, and consideration should be given to initiating therapy with corticosteroids or increasing their dosage.
In patients considered to be at risk, daily peak flow monitoring may be recommended by the physician.
It is necessary to consult the physician whenever the usual efficacy or duration of action is decreased and not to increase the dose or the frequency of administration.
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
Even severe hypokalaemia may follow therapy with beta2-agonists, especially in case of parenteral administration and by nebulization.
Particular caution is required 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 be checked regularly in such situations.
Tell your doctor if you have heart disease or angina before starting therapy with salbutamol.
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, thyrotoxicosis, pheochromocytoma, diabetes and prostatic hypertrophy, the product should be used only in case of absolute necessity.
Since maternal pulmonary edema and myocardial ischaemia have been reported during or following treatment of premature birth with beta2-agonists, special attention should be paid to fluid balance and cardio-respiratory function, including ECG, should be monitored.If signs of pulmonary edema or myocardial ischaemia develop, treatment discontinuation should be considered.
VENTOLIN, like other beta-agonists, can cause reversible metabolic alterations such as hyperglycemia that diabetic patients are not always able to balance and cases of ketoacidosis have been reported.
Co-administration of glucocorticoids can aggravate this effect.
It is necessary to consult your doctor whenever the effectiveness of the short-acting bronchodilator is diminished or it is necessary to increase its doses.
In patients with severe or unstable asthma, bronchodilators should not be the only or primary therapeutic treatment.
Severe asthma requires regular medical testing, including pulmonary function tests, as such patients are at risk of severe attacks and even death.
Physicians should consider the need for the maximum recommended doses of inhaled and / or oral steroids.
Interactions Which drugs or foods can modify the effect of Ventolin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
As a rule, VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should not be prescribed at the same time.
Salbutamol is not contraindicated in patients being treated with monoamine oxidase inhibitors (anti-MAO drugs).
Warnings It is important to know that:
Pregnancy
Although a percentage of congenital anomalies comparable to that reported in the population not exposed to the drug has been reported among patients who took salbutamol during pregnancy, its use in pregnancy is not recommended, except in cases where the benefit for the mother is greater than the possible risk to the fetus.
Pregnancy
Because salbutamol is probably secreted into breast milk it is not recommended for use in nursing mothers unless the foreseeable benefits outweigh the potential risks. It is not known whether salbutamol in breast milk can cause harmful effects on the infant.
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been reported.
For those who carry out sports activities
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Ventolin: Dosage
The duration of action of salbutamol in most patients is 4-6 hours.
An increased need for beta2-agonists may indicate deterioration in asthma conditions. If this occurs, a review of the patient's treatment plan may be required and the need for concomitant corticosteroid therapy should be considered.
Since undesirable effects may appear at high doses, the dosage and frequency of administration should only be changed on the advice of the physician.
Adults:
The usual effective dose is:
1-2 tablets (2-4 mg) for 3-4 times a day.
Children:
3-6 years: ½-1 tablet (1-2 mg) 3-4 times a day;
6-12 years: 1 tablet (2 mg) 3-4 times a day.
Over 12 years: as for adults.
In elderly patients or in patients hypersensitive to beta-adrenergic agonists, it is advisable to start treatment with 1 tablet (2 mg) of salbutamol 3 or 4 times a day. The optimal dosage depends on a precise clinical assessment of individual needs.
The effervescent tablet allows an instant solubilization of the product in a little water and consequently greater practicality in administration, especially in infancy and the elderly.
In addition, the tablet, equipped with a fracture line, allows the dosage to be adjusted to the clinical needs of individual patients.
Overdose What to do if you have taken too much Ventolin
The most common signs and symptoms of salbutamol overdose are transient events related to the pharmacological action on beta agonist receptors (see sections Precautions for use and Undesirable effects).
Hypokalaemia may occur following salbutamol overdose. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, particularly in children and when salbutamol overdose has occurred following oral administration.
Treatment
In patients experiencing cardiac symptoms (eg, tachycardia, palpitations), discontinuation of treatment and the adoption of appropriate symptom control measures, such as the use of cardio-selective beta-blockers, should be considered.
Beta-blocking drugs should be used with caution in patients with a history of bronchospasm. In case of accidental ingestion / intake of an excessive dose of VENTOLIN, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT USING VENTOLIN, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Ventolin
Like all medicines, VENTOLIN can cause side effects, although not everybody gets them.
Adverse events are listed below by organ, organ / system and frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100,
Disorders of the immune system
Very rare: hypersensitivity reactions including: angioedema, urticaria, bronchospasm, hypotension and collapse
Metabolism and nutrition disorders
Rare: hypokalaemia
Potentially severe hypokalaemia may be associated with beta2-agonist therapy.
Nervous system disorders
Common: headache
Very rare: hyperactivity
Cardiac pathologies
Common: tachycardia, palpitations
Rare: cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and ectopic beats
Very rarely, some patients may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible, avoiding stopping therapy unless advised to do so.
Vascular pathologies
Rare: peripheral vasodilation
Musculoskeletal and connective tissue disorders
Common: muscle cramps
Very rare: sensations of muscle tension
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Storage rules The product is hygroscopic, therefore it must be protected from humidity.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you are not using. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
One effervescent tablet contains:
active ingredient: salbutamol sulfate 2.4 mg
equal to salbutamol 2.0 mg
Excipients: dibasic sodium citrate, sodium bicarbonate, povidone, sodium benzoate.
PHARMACEUTICAL FORM AND CONTENT
30 effervescent tablets of 2 mg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
VENTOLIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
VENTOLIN 500 mcg / 1 ml Solution for injection
One vial contains:
active ingredient: salbutamol sulfate 0.6 mg
equal to salbutamol 0.5 mg
VENTOLIN 100 mcg / 5 ml Solution for injection
One vial contains:
active ingredient: salbutamol sulfate 0.12 mg
equal to salbutamol 0.1 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution for injection for intramuscular, intravenous and infusional use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
VENTOLIN Solution for injection is indicated for the resolution of severe bronchospasm associated with asthma or obstructive bronchopathy with asthmatic component as well as for the treatment of asthmatic disease.
04.2 Posology and method of administration
The duration of action of salbutamol in most patients is 4-6 hours.
An increased need for beta2-agonists may indicate deterioration in asthma conditions. If this occurs, a review of the patient's treatment plan may be required and the need for concomitant corticosteroid therapy should be considered.
VENTOLIN Solution for injection must be administered intramuscularly, intravenously and infusion, under medical supervision.
Adults
Intramuscular route
500 mcg (8 mcg / kg of body weight) to be repeated, if necessary, every 4 hours.
Intravenous route
100 mcg to 250 mcg (4 mcg / kg body weight) administered slowly (3-5 minutes). If necessary, this dose can be repeated. For convenience of administration, VENTOLIN Solution for injection can be diluted with water for injections F.U.
Infusion route
In the state of asthmatic disease and in other forms of severe bronchospasm, the recommended dosage of VENTOLIN Solution for injection is equal to 10 mcg / ml of solution.
The rate of infusion may vary from 3 to 20 micrograms per minute, however higher rates of administration can be used successfully in patients with respiratory failure.
An initial dose of 5 mcg / min is recommended. with appropriate dose adjustments based on the patient's clinical response.
The solution for infusion can be prepared by diluting 2 vials of 0.5 mg in 100 ml of physiological saline.
Children
There are currently insufficient data to recommend a routine dosing regimen for use in children.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Salbutamol formulations must not be employed in the threat of abortion.
Although a percentage of congenital anomalies comparable to that reported in the population not exposed to the drug has been reported among patients who took salbutamol during pregnancy, its use in pregnancy is not recommended except in cases where the benefit for the mother is greater than the possible risk to the fetus.
04.4 Special warnings and appropriate precautions for use
In patients with severe or unstable asthma, bronchodilators should not be the only or main therapeutic treatment. Such patients require regular medical care as severe asthma can cause death.
Patients with severe asthma present with constant symptoms and frequent exacerbations; their lung function is reduced, they have PEF values lower than 60% of normal with variability even higher than 30%.
Normally these values do not completely normalize after taking a bronchodilator. Such patients therefore require high-dose inhaled or oral steroid therapy. A sudden worsening of symptoms may require an increase in the dosage of steroids which must be administered urgently under the doctor's check.
The treatment of asthma must normally be performed within the framework of a therapeutic plan adapted to the severity of the disease; the patient's response to therapy should be verified both clinically and by pulmonary function tests.
The need to resort to short-acting inhaled beta2-agonists more frequently for symptomatology control indicates worsening of asthma control; in this circumstance the patient's treatment plan must be modified.
Sudden and progressive aggravation of asthma is potentially life-threatening, and consideration should be given to initiating therapy with corticosteroids or increasing their dosage.
In patients considered to be at risk, daily peak flow monitoring may be recommended by the physician.
Even severe hypokalaemia may follow therapy with beta2-agonists, especially in case of parenteral administration and by nebulization.
Particular caution is required in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended, in such situations, to regularly check serum potassium levels.
There is evidence from post-marketing data and published literature of rare cases of myocardial ischaemia associated with the use of salbutamol. Patients with pre-existing severe heart disease (eg, ischemic heart disease, tachyarrhythmia, or severe heart failure) who receive salbutamol for respiratory disease , they should be advised to tell their doctor if chest pain or symptoms of worsening heart disease occur.
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, thyrotoxicosis, pheochromocytoma and diabetes, the product should only be used in case of absolute necessity.
The use of VENTOLIN Solution for injection in the treatment of severe bronchospasm and asthmatic disease should not replace therapy with glucocorticoids, if necessary.
Where possible, it is recommended that oxygen be administered concomitantly with VENTOLIN Solution for Injection, especially when the latter is used by infusion in hypoxic patients.
VENTOLIN Solution for injection, like other beta-agonists, can cause reversible metabolic alterations such as hypokalaemia and hyperglycemia. Diabetics are not always able to balance the latter and cases of ketoacidosis have been reported.
Co-administration of glucocorticoids can aggravate this effect.
In diabetic patients and in patients already on glucocorticoid therapy, careful medical supervision is necessary during the infusion of VENTOLIN Solution for injection in order to gradually address (eg by increasing the insulin dosage) any metabolic alterations that may occur. In these patients, VENTOLIN solution for injection must be diluted with physiological FU solution instead of with a sodium chloride and dextrose solution.
Lactic acidosis has been reported very rarely in conjunction with the administration of high therapeutic doses of short-acting beta agonists intravenously or by nebulisation, particularly in patients being treated for acute worsening of asthma (see section Undesirable effects. ). The increase in lactate levels may lead to dyspnoea and compensatory hyperventilation which could be misinterpreted as signs of asthma therapy failure and could lead to an inappropriate increase in short-acting beta agonist treatment. It is recommended. therefore to carefully observe patients to prevent the development of elevated serum lactate levels and the consequent metabolic acidosis in this therapeutic setting.
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
VENTOLIN Solution for injection, being also equipped with tocolytic activity as a beta2-stimulant, inhibits uterine contractions. This effect can be neutralized by administering oxytocic drugs.
Since maternal pulmonary edema and myocardial ischaemia have been reported during or following treatment of premature birth with beta2-agonists, special attention should be paid to fluid balance and cardio-respiratory function, including ECG, should be monitored. If they develop. signs of pulmonary edema or myocardial ischaemia should be considered upon discontinuation of treatment.
04.5 Interactions with other medicinal products and other forms of interaction
As a rule, VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should not be prescribed at the same time.
VENTOLIN is not contraindicated in patients receiving monoamine oxidase inhibitors (anti-MAO drugs).
04.6 Pregnancy and breastfeeding
Although a percentage of congenital anomalies similar to that reported in the population not exposed to the drug has been reported among the patients who took salbutamol during pregnancy, its use in pregnancy is not recommended except in cases where the benefit for the mother is greater than the possible risk to the fetus.
Because salbutamol is likely secreted into breast milk it is not recommended for use in nursing mothers unless the foreseeable benefits outweigh the potential risks.
It is not known whether salbutamol present in breast milk can cause harmful effects on the newborn.
04.7 Effects on ability to drive and use machines
No effects on ability to drive and use machines have been reported.
04.8 Undesirable effects
Adverse events are listed below by organ, organ / system and frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100,
Disorders of the immune system
Very rare: hypersensitivity reactions including: angioedema, urticaria, bronchospasm, hypotension and collapse
Metabolism and nutrition disorders
Rare: hypokalaemia
Potentially severe hypokalaemia may be associated with beta2-agonist therapy.
Very rare: lactic acidosis
Lactic acidosis has been reported very rarely in patients receiving intravenous or nebulised salbutamol for the treatment of acute worsening of asthma.
Nervous system disorders
Very common: tremor
Common: headache
Very rare: hyperactivity
Cardiac pathologies
Very common: tachycardia, palpitations
Uncommon: myocardial ischaemia *
* in the treatment of pre-term birth with salbutamol by injection
Rare: cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and ectopic beats
Very rare: myocardial ischaemia
Vascular pathologies
Rare: peripheral vasodilation
Respiratory, thoracic and mediastinal disorders
Uncommon: pulmonary edema
In the treatment of preterm labor, injected salbutamol has been associated with pulmonary edema with an "uncommon" frequency. Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia, may have an increased risk of developing pulmonary edema.
Gastrointestinal disorders
Very rare: nausea, vomiting
In the treatment of premature birth, intravenous infusion of salbutamol has been associated very rarely with nausea and vomiting.
Musculoskeletal and connective tissue disorders
Common: muscle cramps
Injury, poisoning and complications from therapeutic procedures
Very rare: slight pain or burning following intramuscular injection of undiluted solution.
04.9 Overdose
The most common signs and symptoms of salbutamol overdose are transient events related to the pharmacological action on beta agonist receptors (see sections 4.4 and 4.8).
Hypokalaemia may occur following salbutamol overdose. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, particularly in children and when salbutamol overdose has occurred following oral administration.
Treatment
In patients experiencing cardiac symptoms (eg, tachycardia, palpitations), discontinuation of treatment and the adoption of appropriate symptom control measures, such as the use of cardio-selective beta-blockers, should be considered.
Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drugs for obstructive respiratory tract syndromes - selective beta2-adrenergic receptor agonists.
ATC code: R03CC02
Salbutamol is a selective beta2-receptor agonist.
At therapeutic doses it acts on the beta2-receptors of the bronchial muscles and has little or no action on the beta1-receptors of the cardiac muscles.
05.2 Pharmacokinetic properties
Salbutamol, administered intravenously, has a "half-life of 4-6 hours and is eliminated partly by the kidney and partly by metabolism in the form of the inactive metabolite 4" -O-sulphate (phenolic sulphate), also " mainly excreted via the urine.
Stool constitutes a minor route of excretion.
Most of a dose of salbutamol, administered intravenously, orally, or by inhalation, is eliminated within 72 hours. Salbutamol binds to plasma proteins in the measure of 10%.
05.3 Preclinical safety data
As with other selective high-potency beta2-receptor agonists, salbutamol, administered subcutaneously, has been shown to be teratogenic in mice. In a reproductive study, 9.3% of fetuses had cleft palate at doses of 2.5 mg / kg, which is 4 times the maximum oral dose in humans.
Treatments in doses of 0.5; 2.32; 10.75 and 50 mg / kg / day orally in rats during the period of pregnancy did not result in significant onset of fetal abnormality. The only toxic effect found was an increase in neonatal mortality, at higher doses, as a result of no maternal care. A reproductive study in rabbits found cranial malformations in 37% of fetuses at doses of 50 mg / Kg / day equal to 78 times the maximum oral dose in man.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
VENTOLIN 500 mcg / 1 ml Solution for injection
Sodium chloride
Sulfuric acid to taste at pH 3.5
Water for injections q.s. to 1 ml
VENTOLIN 100 mcg / 5 ml Solution for injection
Sodium chloride
Sulfuric acid to taste at pH 3.5
Water for injections q.s. to 5 ml
06.2 Incompatibility
Like any other injectable preparation, VENTOLIN Solution for injection should not be mixed in the same syringe or infusion solution with other drugs.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Keep away from light.
It is recommended to discard any unused solutions obtained by diluting VENTOLIN Solution for injection in infusion liquids within 24 hours of preparation.
Compatibility
The diluents recommended for VENTOLIN Solution for injection are water for injections F.U., physiological solution F.U., sodium chloride and dextrose solution, dextrose solution.
06.5 Nature of the immediate packaging and contents of the package
Type I white glass vials; the package consists of a cardboard box containing 10 ampoules.
VENTOLIN 500 mcg Solution for injection - 10 ampoules of 0.5 mg
VENTOLIN 100 mcg Solution for injection - 10 ampoules of 0.1 mg
06.6 Instructions for use and handling
The vials are equipped with a safety pre-opening and must be opened as follows:
- hold the lower part of the vial with one hand
- place the other hand on the upper part, placing the thumb over the COLORED DOT and exert pressure
07.0 MARKETING AUTHORIZATION HOLDER
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona.
08.0 MARKETING AUTHORIZATION NUMBER
VENTOLIN 500 mcg / 1 ml Solution for injection - 10 ampoules of 0.5 mg - A.I.C .: 022984126
VENTOLIN 100 mcg / 5 ml Solution for injection - 10 ampoules of 0.1 mg - A.I.C .: 022984114
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
19.01.1998 / May 2005
10.0 DATE OF REVISION OF THE TEXT
March 2009
