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Ventolin

Salbutamol

QUALITATIVE AND QUANTITATIVE COMPOSITION
VENTOLIN Tablets 2 mg each contain 2 mg salbutamol, as sulphate.
VENTOLIN Tablets 4 mg each contain 4 mg salbutamol, as sulphate.

PHARMACEUTICAL FORM
2 mg: White, round, flat tablets with bevelled edges and engraved with GX/CN3.
4 mg: White, round, flat tablets with bevelled edges and engraved with GX/CN5.

CLINICAL PARTICULARS

Indications
Relief of bronchial asthma of all types, chronic bronchitis and emphysema.

Dosage and Administration
VENTOLIN has a duration of action of 4 to 6 hours in most patients.

Increasing use of beta-2 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 3 or 4 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 3 or 4 times daily.

Children
2 - 6 years - 1 to 2 mg 3 or 4 times daily. If a dose of 1 mg is required, the use of salbutamol syrup should be considered.
6 - 12 years - 2 mg (1 tablet of 2 milligrams) 3 or 4 times daily.
Over 12 years - 2 to 4 milligrams (1 tablet of 2 milligrams or 1 tablet of 4 milligrams) 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 2 milligrams salbutamol 3 or 4 times per day.

Contraindications
VENTOLIN Tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.

Warnings and 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
ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

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.

Interactions
VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.

Pregnancy and Lactation

Fertility
There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in
animals (see Pre-clinical Safety Data).

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.

Effects on Ability to Drive and Use Machines
None reported

Adverse Reactions
Adverse reactions are listed below 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 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 extrasystoles.

Vascular disorders
Rare: Peripheral vasodilatation.

Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Very rare: Feeling of muscle tension.

Overdose
The most common signs and symptoms of overdose with VENTOLIN are transient beta agonist pharmacologically mediated events (see Warnings and Precautions and Adverse Reactions).

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

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic doses it acts on the beta-2 adrenoceptors of bronchial muscle providing short acting (4 to 6 hours) bronchodilation in reversible airways obstruction.

Pharmacokinetics
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-0-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. Salbutamol is bound to plasma proteins to the extent of 10%.

After oral administration, salbutamol 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. The bioavailability of orally administered salbutamol is about 50%.

Pre-clinical Safety Data
In common with other potent selective beta-2 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 2.5mg/kg, 4 times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/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 50mg/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.

PHARMACEUTICAL PARTICULARS

List of Excipients
Lactose monohydrate, maize starch, pregelatinised starch, magnesium stearate.

Incompatibilities
None reported.

Shelf Life
The expiry date is indicated on the packaging.

Special Precautions for Storage
Store at a temperature not exceeding 25C.
Store in a dry place and replace cap securely.

Nature and Contents of Container
Securitainers of 100s

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Tongue
 
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