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.
2 mg: White, round, flat tablets with bevelled edges and engraved with
4 mg: White, round, flat tablets with bevelled edges and engraved with GX/CN5.
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
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.
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.
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
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
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
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
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.
VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should
not usually be prescribed together.
Pregnancy and Lactation
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).
Administration of drugs during pregnancy should only be considered if the
expected benefit to the mother is greater than any possible risk to the
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
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
Effects on Ability to Drive and Use Machines
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
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Nervous system disorders
Very common: Tremor.
Very rare: Hyperactivity.
Common: Tachycardia, palpitations.
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular
tachycardia and extrasystoles.
Rare: Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Very rare: Feeling of muscle tension.
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.
Further management should be as clinically indicated or as recommended by
the national poisons centre, where available
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.
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
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.
List of Excipients
Lactose monohydrate, maize starch, pregelatinised starch, magnesium stearate.
The expiry date is indicated on the packaging.
Special Precautions for Storage
Store at a temperature not exceeding 25°C.
Store in a dry place and replace cap securely.
Nature and Contents of Container
Securitainers of 100s