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VERSION: GDS22/IPI06

VENTOLIN - Syrup - GDS22-IPI06 -Eng_GSKDC-PT-CRM-2016-13424_D1.indd 1 1/7/2017 2:48:51 AM

 Vascular disorders
Rare: Peripheral vasodilatation.
Musculoskeletal and Connective Tissue Disorders
SYRUP Common: Muscle cramps.
Salbutamol sulphate Very rare: Feeling of muscle tension.
Qualitative and Quantitative Composition Overdose
VENTOLIN ® Syrup contains 2 mg salbutamol, as sulphate, in each 5 ml of syrup. The most common signs and symptoms of overdose with VENTOLIN ® are transient beta agonist pharmacologically
Pharmaceutical Form mediated events (see Warnings and Precautions and Adverse Reactions).
Syrup. Hypokalaemia may occur following overdose with VENTOLIN ®. Serum potassium levels should be monitored.
Clinical Particulars Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting
Indications beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly
VENTOLIN ® is a selective beta-2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing)
It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and may be indicated in the setting of overdose.
emphysema. Nausea, vomiting and hyperglycemia have been reported, predominantly in children and when VENTOLIN ® overdose
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent has been taken via the oral route.
asthma unresponsive to VENTOLIN ®, treatment with inhaled corticosteroids is recommended to achieve and maintain Treatment
control. Failing to respond to treatment with VENTOLIN ® may signal a need for urgent medical advice or treatment. Further management should be as clinically indicated or as recommended by the national poisons centre, where
VENTOLIN ® syrup is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and available.
emphysema. Pharmacological Properties
VENTOLIN ® Syrup is suitable oral therapy for children or those adults who prefer liquid medicines. Pharmacodynamics
Dosage and Administration Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of
VENTOLIN ® has a duration of action of 4 to 6 hours in most patients. bronchial muscle providing short acting (4 to 6 hour) bronchodilation in reversible airways obstruction.
Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the Pharmacokinetics
patient’s therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should metabolism to the inactive 4’-0- sulphate (phenolic sulphate) which is also excreted primarily in the urine.
only be increased on medical advice. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by
Adults inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
The usual effective dose is 10 ml salbutamol (4 mg of salbutamol) 3 or 4 times per day. If adequate bronchodilation is After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass
not obtained each single dose may be gradually increased to as much as 20 ml of syrup (8 mg salbutamol). metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine. The
Some patients obtain adequate relief with 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily). bioavailability of orally administered salbutamol is about 50%.
Children Pre-clinical Safety Data
2-6 years 2.5 to 5 ml of syrup (1 to 2 mg salbutamol) 3 or 4 times daily. In common with other potent selective beta-2 receptor agonists, salbutamol has been shown to be teratogenic in mice
6-12 years 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily. when given subcutaneously. In a reproductive study, 9.3% of fetuses are found to have cleft palate, at 2.5 mg/kg,
Over 12 years 5 to 10 ml of syrup (2 to 4 mg salbutamol) 3 or 4 times daily. 4 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
Special Patient Groups throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal
In elderly patients or in those known to be unusually sensitive to beta- adrenergic stimulant drugs, it is advisable to mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial
initiate treatment with 5 ml of syrup (2 mg salbutamol) 3 or 4 times per day. malformations in 37% of fetuses at 50 mg/kg/day, 78 times the maximum human oral dose.
Contraindications Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of VENTOLIN ® up to
VENTOLIN ® Syrup is contra-indicated in patients with a history of hypersensitivity to any of its components. 50 mg/kg.
Non-i.v. formulations of VENTOLIN ® must not be used to arrest uncomplicated premature labour or threatened abortion. Pharmaceutical Particulars
Warnings and Precautions List of Excipients
The management of asthma should normally follow a stepwise programme, and patient response should be monitored Syrup (sugar-free formulation)
clinically and by lung function tests. Sodium Citrate
Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Citric Acid Monohydrate
Under these conditions, the patient’s therapy plan should be reassessed. Sudden and progressive deterioration in Hydroxypropyl Methylcellulose 2910
asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid Sodium Benzoate
therapy. In patients considered at risk, daily peak flow monitoring may be instituted. Saccharin Sodium
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they Orange Flavour
should not increase the dose or its frequency of administration, but should seek medical advice. Sodium Chloride
VENTOLIN ® should be administered cautiously to patients with thyrotoxicosis. Purified Water
Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulizer Syrup (sugar-containing formulation)
administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant As registered locally
treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels Incompatibilities
are monitored in such situations. Sugar-free formulation
In common with other beta-adrenoceptor agonists, VENTOLIN ® can induce reversible metabolic changes, for example Dilution of VENTOLIN ® Syrup with Syrup BP or Sorbitol solution is not recommended as this may result in precipitation
increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of of the cellulose thickening agent.
ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect. Shelf Life
Long term treatment with VENTOLIN ® Syrup (Sugar-containing formulation) increases the risk of dental caries. It is 3 years (sugar-free formulation)
important that adequate dental hygiene is maintained. The expiry date is indicated on the packaging (sugar-containing formulation).
Interactions Special Precautions for Storage
VENTOLIN ® and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together. Store at a temperature not exceeding 30°C. (Sugar-free formulation).
VENTOLIN ® is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs). Store at a temperature not exceeding 25°C. (Sugar-containing formulation).
Pregnancy and Lactation Protect from light.
Fertility Nature and Contents of Container
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in Amber glass bottles with metal (aluminium) caps or plastic (polypropylene/high density polyethylene [PP/HDPE]) child
animals (see Pre-clinical Safety Data). resistant caps
Pregnancy Or
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater As registered locally
than any possible risk to the fetus. Instructions for Use/Handling
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb Dilution
defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking Sugar-free formulation
multiple medications during their pregnancies. VENTOLIN ® Syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from
As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a light and used within 28 days.
relationship with salbutamol use cannot be established. A 50% v/v dilution of VENTOLIN ® Syrup has been shown to be adequately preserved against microbial contamination.
Lactation However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected should be recently prepared or alternatively it should be boiled and cooled immediately before use.
benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the Admixture of VENTOLIN ® Syrup with other liquid preparation is not recommended.
neonate. Sugar-containing formulation
Effects on Ability to Drive and Use Machines VENTOLIN ® Syrup may be diluted with Unpreserved Syrup BP. The resulting mixture should be protected from light
None Reported. and will keep for 14 days.
Adverse Reactions Not all presentations are available in every country.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common Version: GDS22/IPI06
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare Date of issue: 29th April 2016
®
(<1/10000) including isolated reports. VENTOLIN is a trademark of the GlaxoSmithKline group of companies
Very common and common reactions were generally determined from clinical trial data.
Rare and very rare reactions were generally determined from spontaneous data.
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 beta-2 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 extra systoles.

VENTOLIN - Syrup - GDS22-IPI06 -Eng_GSKDC-PT-CRM-2016-13424_D1.indd 1 1/7/2017 2:48:51 AM