Ventolin Tablet/Sirup

Ventolin Tablet/Sirup

salbutamol

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Contents
Salbutamol sulfate.
Description
VENTOLIN Tablets 2 mg each contain 2 mg salbutamol, as sulphate.
VENTOLIN Syrup contains 2 mg salbutamol, as sulphate, in each 5 ml of syrup.
Action
VENTOLIN is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle, with little or no action on the beta-1 adrenoceptors of the heart.
Indications/Uses
Relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. VENTOLIN Syrup is suitable oral therapy for children or those adults who prefer liquid medicines.
Dosage/Direction for Use
Salbutamol has a duration of action of 4-6 hrs in most patients.
Increasing use of beta2-agonists may be a sign of worsening asthma. Under these conditions, a re-assessment 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.
Tablet/Syrup: Adults: The usual effective dose is 4 mg (two 2-mg tabs or 10 mL of syrup) 3 or 4 times/day. If adequate bronchodilation is not obtained, each single dose may be gradually increased to as much as 8 mg or 20 mL of syrup.
Some patients obtain adequate relief with 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily.
Children >12 years: 2-4 mg as one to two 2-mg tab or 5-10 mL of syrup; 6-12 years: 2 mg as one 2-mg tab or 5 mL of syrup; 2-6 years: 1-2 mg as half to one 2-mg tab or 2.5-5 mL of syrup. All doses should be administered 3 or 4 times daily.
Special patient groups: In elderly patients or in those known to be unusually sensitive to beta- adrenergic stimulant drugs, it is advisable to initiate treatment with 5 ml of syrup (2 mg salbutamol) 3 or 4 times per day.
Overdosage
The most common signs and symptoms of overdose with VENTOLIN are transient beta agonist pharmacologically mediated events. Hypokalaemia may occur following overdose with 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.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Contraindications
VENTOLIN Oral Preparations are contraindicated in patients with a history of hypersensitivity to any of its components. Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
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 beta-2 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. VENTOLIN should be administered cautiously to patients with 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 concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
In common with other beta-adrenoceptor agonists, 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.
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.
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. 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 use cannot be established.
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 & Lactation
Fertility: There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals.
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. 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 use cannot be established.
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.
Side Effects
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 extrasystoles.
Vascular disorders: Rare: Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps. Very rare: Feeling of muscle tension.
Drug Interactions
VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
VENTOLIN is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Caution For Usage
Dilution: Sugar-free formulation: VENTOLIN Syrup may be diluted with Purified Water BP (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.
Storage
Ventolin tablet and syrup should be stored at a temperature not exceeding 30°C. Protect from light.
ATC Classification
R03CC02 - salbutamol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Tab 2 mg (white) x 3 x 10's. Syr 2 mg/5 mL (fruit-flavored, sugar-free) x 100 mL x 1's.
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