QUALITATIVE AND QUANTITATIVE COMPOSITION
VENTOLIN ROTACAPS contain a mixture of microfine salbutamol sulphate and larger particle lactose in hard gelatin cartridges.
Each ROTACAP contains 200 micrograms or 400 micrograms of salbutamol (as sulphate).
Inhalation powder, hard capsule (ROTACAPS).
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 in the beta-1 adrenoceptors of the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in mild asthma and for the treatment of acute exacerbations in moderate and severe asthma.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and Peak Expiratory Flow (PEP) values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients mill require high dose inhaled (e.g. greater than 1 mg/day beclomethasone dipropionate) or oral corticosteroid therapy.
With this primary background corticosteroid treatment VENTOLIN provides essential rescue medication for a severe asthmatic in treating acute exacerbations. Failure to respond promptly or fully to such rescue medication, signals a need for urgent medical advice and treatment.
VENTOLIN provides short-acting (four hours) bronchodilation with fast onset (within five minutes) in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. It is suitable for long-term use in the relief and prevention of asthmatic symptoms. VENTOLIN should be used to relieve symptoms when they occur and to present them in those circumstances recognised by the patient to precipitate an asthmatic attack (e.g. before overdose or unavoidable allergen exposure).
VENTOLIN in particularly valuable as rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and axe of regular inhaled corticosteroid therapy.
Dosage and Administration
VENTOLIN has a duration of action of 4 to 6 hours in most patients. VENTOLIN inhaled formulations are administered by the inhaled route only, to be breathed in through the mouth.
Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient’s therapy plan maybe required and concomitant glucacorticosteroid 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.
VENTOLIN ROTACAPS capsules are for inhalation use only, using a VENTOLIN ROTAHALER inhaler.
RELIEF OF ACUTE BRONCHOSPASM
200 or 400 micrograms.
PREVENTION OF ALLERGEN OR EXERCISE-INDUCED BRONCHOSPASM
400 micrograms before challenge or exertion.
200 micrograms before challenge or exertion.
400 microgramn 3 or 4 times daily.
200 micrograms 3 or 4 times daily.
On demand use at VENTOLIN should not exceed four times daily.
Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Warnings and Precautions).
VENTOLIN is contraindicated in patients with a history of hypersensitivity to any of its components (see Excipients). Although i.v. salbutamol and occasionally VENTOLN tablets and VENTOLIN suppositories are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour. Salbutamol presentations should not be used for 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 bronchodilators, in particular beta-2 agonists to relieve 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.
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 in 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 the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator.
VENTOLIN ROTACAPS should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.
VENTOLIN and non-selective beta-blocking drugs, such as propranolol should not usually be prescribed together. VENTOLIN is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Pregnancy and Lactation
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible rink 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.
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
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥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 events were generally determined from clinical trial data. Rare and very rare events 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
Common: Tremor, headache.
Very rare: Hyperactivity.
Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders
Very rare: Paradoxical bronchospasm.
Uncommon: Mouth and throat irritation.
Musculoskeletal and connective tissue disorders
Uncommon: Muscle cramps.
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 overdosage with VENTOLIN.
Serum potassium levels should be monitored.
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, with little or no action on the beta-1 adrenoceptors of cardiac muscle.
After administration by the inhaled route, between 10 and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The traction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.
Salbutamol is bound to plasma proteins to the extent of 10%.
On reaching the systemic circulation, salbutamol becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate. The swallowed portion of an inhaled dose 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.
Salbutamol administered intravenously has a half-life of 4 to 6 hours and in cleared partly renally and partly by metabolism to the inactive 4’-O-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.
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 2.5 mg/kg, four times the maximum human oral done. 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, 70 times the maximum human oral dose.
List of Excipients.
Lactose (which contains milk protein).
The expiry date in indicated on the packaging.
Special Precautions for Storage
To keep the ROTACAPS in good condition it is important that they are stored in a dry place and where they will not be exposed to extremes of temperature and should be stored below 30oC.
Nature and Contents of Container
VENTOLIN inhalation powder is contained in a capsule (ROTACAPS) each containing 200 micrograms or 400 micrograms of salbutamol (as sulphate). An inspiration driven inhaler made of plastic (a ROTAHALER) is used for administration of medication.
Instructions for Use/Handling
The ROTACAPS must only be inserted into the ROTAHALER immediately prior to use.
Failure to observe this instruction will affect the delivery of the drug.
Instructions for use
Step-by-step guide to using your VENTOLIN ROTAHALER
How to prepare your VENTOLIN ROTAHALER for use
1 Check that your ROTAHALER mouthpiece is clean and dry and free from objects. Hold the white end in one hand and turn the blue end as far as it will go.
2 Insert the clear end of a ROTACAPS capsule into the raised hole at the blue end of your ROTAHALER. Push in firmly until the top of the ROTACAPS capsule is level with the top of the hole.
3 Hold your ROTAHALER horizontally with the moulded line at the top. Turn the blue end back the other way as far as it will go. This opens the capsule. Your ROTAHALER is now ready for use.
How to use your VENTOLIN ROTAHALER
4 Sit down in a comfortable position. Hold your ROTAHALER away from your mouth so you don’t blow the powder away. Breathe out fully. Place the mouthpiece (white coloured end) of your ROTAHALER in your mouth between your teeth and lips. Take one quick, deep breath through the mouthpiece. Hold this breath for a few seconds or as long as is comfortable. Remove the ROTAHALER from your mouth and exhale.
5 If your doctor has told you to take two capsules, wait about 30 seconds before you take another capsule by repeating steps 2-4 above. At Step 2, when you press the second capsule into the ROTAHALER, you will push the shell of the tint capsule into the chamber. Pull the 2 halves of the ROTAHALER apart and throw away the previously used shell.
How to clean your VENTOLIN ROTAHALER
Your ROTAHALER should be cleaned every 2 weeks.
Follow the instructions below to clean your ROTAHALER.
6 Pull the two halves apart and throw away the empty ROTACAPS shells. If your ROTAHALER needs cleaning: Wash the two halves in warm water and dry thoroughly before reassembling it.
Keep your ROTAHALER away from excessive heat.
Keep your ROTAHALER clean and dry at all times.
Not all presentations are available in every country.
GlaxoSmithKline Australia Pty Ltd.
1061 Mountain Highway
Boronia, Victoria 3155
VENTOLIN, ROTACAPS and ROTAHALER are trademarks of the GlaxoSmithKline group of companies.
© 2012 GlaxoSmithKline group of companies. All rights reserved.
Version number: GDS23/IPI05
Date of issue: 23 February 2012