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VENTOLIN NEBULES : SALBUTAMOL SULPHATE

1/ PRESENTATION

VENTOLIN Nebules 2.5 mg contain concentration of salbutamol of 0.1% (1 mg salbutamol,as the sulphate, in 1 ml). Each Nebule contains 2.5 ml of solution equivalent to 2.5 mg salbutamol.

VENTOLIN Nebules 50 mg: contain a concentration of salbutamol of 0.2% (2 mg salbutamol. as the sulphate,in 1 ml) Each Nebule contains 2.5 ml of solution equivalent to 5.0 mg salbutamol.

Excipients: sodium,dilute sulphuric acid and water for injection

Pharmaceutical form: Nebules solution

pack size: box of 6 blisters x 5 nebules of 2.5ml

ventolin-2.5mg

 2/ INDICATION

Salbutamol is a selective beta, adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting (toot hours) bronctroOHatron In reversible airways obstruction due to asthma, chronic bronchitis and emphysema For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a Known trigger

Bronchodilators should not be the only or main treatment in patients with persistent asihma. In patients with persistent asthma unresponsive to VENTOLIN, treatmenl with inhaled corticosteroids is recommended to achieve and maintain control, Failing to respond to treatment with VENTOLIN may signal a need for urgent medical advice or treatment

VENTOLIN Nebules are indicated for:

– routine management of chronic bronchospasm – unresponsive to conventional therapy

– treatment of acute severe asthma (status asthmaticus)

Dosage and Administration

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

VENTOLIN Nebules are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline as a diluent may be required.

VENTOLIN Nebules are to be used with a nebuliser. under the direction of a physician

The solution must not be injected, or swallowed.

Increasing use of beta-2agonists 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.

Delivery of the aerosol may be by facemask, ‘T’ piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. VENTOLIN Nebules should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.

Adults and Children

A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams. This may be increased to 5 milligrams.

Treatment may be repeated four times daily.  In adults higher dosing up to 40 miligrams per day, can be give under strict medical supervision in hospital for the treatment of severe airways obstruction.

Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

3/ CONTRA-INDICATIONS

VENTOLIN Nebules 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

VENTOLIN Nebules must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.

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 PEF values below 60% predicted at baseline with grealer than 30% variabiliti,usually not returning entirety to normal after a bronchodilator. These patients will require high dose inhaled (e.g >1 mg/day beclomethasone dipropionate)) or oral corticosteroid therapy.Sudden worsening of

symptoms  may require increased corticosteroid dossage which should be administered under urgent medical supervision.

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-2agonists 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 receiving treatment at home with VENTOLIN Nebules must 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 Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs.

VENTOLIN should be administered cautiously to patients with thyrotoxicosis.

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 ischaermc heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pam 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

A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised VENTOLIN and ipratropium bromide. A combination of nebulised VENTOLIN with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

Potentially serious hypokalaemia may result from beta-2agonist 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.

As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. VENTOLIN nebules should be discontinued, and if necessary a different fastacting  bronchodilator instituted for ongoing use.

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.

Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Adverse Reaction section).  Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment.  It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

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).

Pregnancy and Lactation

Fertility

There is no information on the effects of VENTOLIN 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 delects have been reported in the offspnng ol patients being treated with salbutamol Some of the mothers were taking multiple medications during their pregnancies.

As no consistent pattern ol delects can be discerned, and baseline rale for congenital anomalies is 2-3%, 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 events 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 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

Rare:   Hypokalaemia.

Potentially serious hypokalaemia may result from beta-2-agonist therapy.

Very rare: Lactic acidosis

Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.

Nervous system disorders

Common: Tremor, headache.

Very rare: Hyperactivity.

Cardiac disorders

Common: Tachycardia.

Uncommon: Palpitations

Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Vascular disorders

Rare: Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders

Very rare:  Paradoxical bronchospasm.

Gastrointestinal disorders

Uncommon: Mouth and throat irritation.

Musculoskeletal and connective tissue disorders

Uncommon:  Muscle cramps.

4/ 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 overdosage 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.

PHARMACOLOGICAL PROPERTIES

5/ Pharmacodynamics

Salbutamol is a selective beta2-adrenoceptor agonist. At therapeutic doses it acts on the beta2-adrenoceptors of bronchial muscle providing short acting (4 to 6 hour) bronchodilation with a fast onset (within 5 minutes) in reverse airways obstruction.

6/ Pharmacokinetics

Absorption

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 fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.

Distribution

Salbutamol is bound to plasma proteins to the extent of 10%.

Metabolism

On reaching the systemic circulation it 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.

Elimination

Salbutamol administered intravenously has a half-life of four to six hours and is 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 beta2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of fetuses were found to have cleft palate, at 2.5 mg/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 fetuses 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

SHELF LIFE

36 months from the manufacturing date

Special Precautions for Storage

VENTOLIN Nebules should be stored at a temperature below 30ºC and protected from light. Unused Nebules be discarded three months opening of the foil.

Instructions for Use/Handling

Dilution:

VENTOLIN Nebules may be diluted with sterile normal saline. Any unused solution in the chamber of the nebuliser must be discarded.

Before using your Ventolin Nebules, Pleae read this leaflet carefullt and follow these instructions.

An aqueous preservative-free solution for inhalation made isotonic with sodium chloride.

FOR INHALATION ONLY NOT FOR INJECTION

Method of Administration

Do not open the foil pack until the Nebutes are required

The contents of ventolin Nebules are to be inhaled from a nebuliser

Prepare the nebultset (or Wmg (accordng to the manufacturers’ instructions)

-Toopen the foil pack, lift the red arrow (Diagram 1).

-Do not peefthe lid oft completely. Remove the Nebutes (Diagram 2f

-To detach one Ventofin Nebules push the Nebule downwards and away while holding the other Nebutesseu diagram 3). Return the remaining Nebules to the fod tray, cover the tray with the foil fid and place the tray back into the box

-Holding the top of the Nebule securely, twist the body to open (Diagram 4)

-Place the open end the nebule well into the nebuliser bowl and squeeze slowly , (Dragram 5) Ensure the contents are empbed into the nebuliser bowl

-Assemble the nebuliser and use it as directed.

-After use discard any solution remaining in the nebuliser bowl. Clean your nebuliser in the recommended way

Make sure the mist does not get into your eyes.

General Instruction

Open only one foil pack at a time, and use all 5 Nebules before opening the next foil pack. Always place foil tray (covered with lid) in box after use.

Diluting your Nebules

-Do not dilute the contents of a Nebule unless you are told to by your doctor

-If your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl

-Add the amount of sterile normal saline your doctor has told you to use

-Put the top on the nebuliser bowl and shake gently          to mix the contents.

After opening pack please:

1. Note date of opening.

2.Add 3 months to this date which win be the ‘discard after’ date.

3.Wnte the ‘discard after’ date on the fofl pack lid in the space provided

4. All unused Nebules remaining m the tray after the ‘discard after’ date should be discarded

5.Clean your nebuliser in the recommended way

IMPORTANT:

IF A PREVIOUS EFFECTIVE DOSE FALLS TO GIVE ADEQUATE RELIEF WHICH LAST FOR AT LEAST THREE HOURS, SEEK MEDICAL ADVICE IMMEDIATELY

Storage

Should not be stored above 30°C. Nebules must be protected from light (store the Nebules in the foil tray inside the box). Unused Nebules should be discarded three months after opening of the foil pack.

Further information

Consult your doctor if further information is required on Ventolin Nebules a nebulisabon

Ventolin sprays :

ventolin-sprays

3 Comments

  1. http://www./ says:

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