Salpium Refil

Salpium Refil

DESCRIPTION

Salpium Inhalation Aerosol is a combination of ipratropium bromide and salbutamol sulfate. Ipratropium Bromide is a anticholinergic bronchodilator and salbutamol sulfate is a short acting beta2-adrenergic bronchodilator. When used in combination ipratropium bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Salpium 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 both an anticholinergic (ipratropium bromide) and a beta2-sympathomimetic (salbutamol sulfate) is designed to benefit the patient by producing a greater bronchodilator effect than when either drug is utilized alone at its recommended dosage.

COMPOSITION

Salpium: Each actuator delivers ipratropium bromide BP 20 mcg and Salbutamol (As Sulfate) BP 100 mcg.

INDICATIONS AND USAGE

Salpium Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular Aerosol bronchodilator who continues to have evidence of bronchospasm and who require a second bronchodilator.

DOSAGE AND ADMINISTRATION

The dose of Salpium Inhalation Aerosol 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. Children under 12 years are not recommended.

OR AS DIRECTED BY THE PHYSICIANS.

CONTRAINDICATIONS

Salpium Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to Soya Lecithin or related food products such as soybean and peanut.

Salpium Inhalation Aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.

Precautions

1. Effects Seen with Anticholinergic Drugs: Salpium Inhalation Aerosol contains ipratropium bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladderneck obstruction.

2. Effects Seen with Sympathomimetic Drugs:

Preparations containing sympathomimetic amines such as salbutamol sulfate should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.

PEDIATRIC USE

Safety and effectiveness of Salpium Inhalation Aerosol in pediatric patients have not been established.

DRUGS INTERACTIONS

Salpium 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 Salpium 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. Beta2-agonist containing drugs, like Salpium should be administrated with extreme caution to patients with non potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.

USE DURING PREGNANCY AND LACTATION

Ipratropium bromide: Pregnancy category B. (studies have demonstrated no teratogenic effects as a result of ipratropium). Salbutamol: Pregnancy category C. salbutamol has been shown to be teratogenic in animals.

There are, however no adequate and well-controlled studies of Salpium inhalation Aerosol, ipratropium bromide or salbutamol sulfate in pregnant woman. Salpium inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the

Salpium inhalation Aerosol are excreted in human milk. As many drugs are excreted in human milk, Salpium should be cautiously administered to a nursing mother.

SIDE EFFECTS

Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensivity reaction including angioedema, urticaria, bronchospasm and hypotension have been reported very rarely. For the presence of Ipratropium headache, influenza, chest pain, nausea, dyspea, coughing, phoryngitis, sinusitis are rarely reported.

OVERDOSE

The effects of overdosage are expected to be related primarily to Salbuterol sulfate. Acute overdosage with ipratropium bromide is unlikely since ipratropium bromide is not well absorbed systemically after Aerosol administration. Manifestations of overdosage with

Salbutamol may include anginal pain, hypertension, hypokalaemia, and tachycardia.

SUPPLY

Salpium: Each canister of Salpium contains 200-metered doses for inhalation Aerosol with each actuation (puff) containing ipratropium bromide BP 20 mcg and

Salbutamol (As Sulfate) BP 100 mcg.