Generic

Salbutamol + Ipratropium

Indications

This Inhaler is indicated for patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Pharmacology

This inhalation aerosol is a combination of Salbutamol (as Sulphate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment-friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as a propellant which is one of the main reasons for ozone layer depletion.

Salbutamol is a short-acting beta2-adrenergic bronchodilator and Ipratropium Bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium Bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which is caused by the interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. This inhalation aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium Bromide) and a beta 2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.

Dosage & Administration

The recommended dose of this inhaler is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Or, as directed by the registered physician.

Interaction

This inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with this inhalation aerosol and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase the risk of adverse cardiovascular effects. Beta-2-agonist-containing drugs, like this inhalation aerosol, should be administrated with extreme caution in patients with non-potassium-sparing diuretics, monoamine oxidase inhibitors, or tricyclic antidepressants.

Contraindications

Ventil Plus HFA Inhaler is contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut. Ventil Plus HFA Inhaler is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.

Side Effects

Due to the presence of Salbutamol, mild tremors, and headaches have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments for muscle cramps, and hypersensitivity reactions including angioedema, urticaria, bronchospasm, and hypotension.

The presence of Ipratropium Bromide headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, and sinusitis are rarely reported.

Pregnancy & Lactation

There are no adequate and well-controlled studies of Ventil Plus in pregnant women. This Inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether the components of Ventil Plus are excreted in human milk, caution should be exercised when this Inhaler is administered to a nursing mother.

Precautions & Warnings

This Inhaler can produce paradoxical bronchospasm that can be life-threatening. if it occurs, therapy with this Inhaler should be discontinued immediately and alternative therapy instituted. The Ventil Plus, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients. If these symptoms occur, Ventil Plus may need to be discontinued.

Therapeutic Class

Combined bronchodilators

Storage Conditions

Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight or heat. Store in a cool and dry place. Keep away from children. Keep away from eyes.

Pharmaceutical Name

Drug International Ltd.