Salflu 50/500 mcg rotacap

Salflu 500 rotacap

USES

Salmeterol: Salmeterol is a selective b2 agonist providing long-acting (usually 12 hours) bronchodilation with a relatively slow onset (within 10-20 minutes) in reversible airways obstruction. Salmeterol can be used to treat reversible airway obstruction in-patients requiring long term regular bronchodilator therapy, including those with asthma and with chronic obstructive pulmonary disease

(COPD). Salmeterol is particularly useful in the treatment of nocturnal asthma and in the prevention of exerciseinduced symptoms. Fluticasone Propionate: Fluticasone Propionate given by inhalation offers preventive treatment for asthma. At recommended doses it has a potent antiinflammatory action within the lungs, without the adverse effects.

COMPOSITION

Salflu 100 : Each capsule contains microfine Salmeterol (as Xinafoate) BP 50 mcg and microfine Fluticasone Propionate BP 100 mcg.

Salflu 250 : Each capsule contains microfine Salmeterol (as Xinafoate) BP 50 mcg and microfine Fluticasone Propionate BP 250 mcg.

Salflu 500 : Each capsule contains microfine Salmeterol (as Xinafoate) BP 50 mcg and microfine Fluticasone Propionate BP 500 mcg.

DOSAGE AND ADMINISTRATION

The capsules are intended for use with rotahaler device.

While using with the rotahaler device, the capsule will be pierced and powder will be released on the screen of the device that is to be inhaled by the patient.

Adults and adolescents 12 years and older:

Salflu-100: One Rotacap twice daily.

Salflu-250: One Rotacap twice daily.

Salflu-500: One Rotacap twice daily.

Children 4 years and older:

Salflu-100: One Rotacap twice daily.

Children aged under 4 years:

Not recommended.

OR AS DIRECTED BY THE PHYSICIAN

CONTRAINDICATIONS

Salmeterol (as Xinafoate) and Fluticasone propionate Rotacaps are contraindicated in-patients with a history of hypersensitivity to any of the constituents.

SIDE-EFFECTS

Salmeterol: It may cause the pharmacological side effects of b2 agonist treatment, such as tremor, subjective palpitations and headache. Tachycardia may occur in some patients. Potentially serious hypokalaemia may results from b2 agonist therapy. Hypersensitivity reactions such as rash, angioedema, muscle cramps, non-specific chest pain, arthralgia, nausea, dizziness, insomnia and oropharyngeal irritation have been reported rarely.

Fluticasone Propionate: It may cause candidiasis of the mouth and throat (thrush) in some patients. Hoarseness of mouth and throat irritation may occur.

USE IN PREGNANCY AND LACTATION

Salmeterol: As with any medicine, use during pregnancy should be considered only if the expected benefit to the mother is greater than any possible risk to the fetus.

Plasma levels of salmeterol after inhaled therapeutic doses are negligible. The use of salmeterol in nursing mothers requires careful consideration.

Fluticasone Propionate: There is inadequate evidence of safety of fluticasone propionate in human pregnancy.

Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is not known whether fluticasone propionate is excreted in human breast milk, nor are any data available from animal studies. However, in view of its pharmacokinetic profile, transfer of fluticasone propionate into milk is unlikely.

PRECAUTIONS

Patients should be instructed in the proper use of rotahaler to ensure that the drug reaches the target areas within the lungs. A capsule should only be inserted into the rotahaler device immediately prior to use. It may be helpful to rinse out the mouth with water immediately after inhalation.

Salmeterol: It should not be used to treat acute asthma symptoms. Caution is advised to patients suffering from thyrotoxicosis.

Fluticasone Propionate: The transfer of oral steroiddependent patients to the Rotacaps, and their subsequent management, needs special care.

SUPPLY

Salflu 100: Plastic pot of 30 capsules for use with rotahaler device.

Salflu 250: Plastic pot of 30 capsules for use with rotahaler device.

Salflu 500: Plastic pot of 30 capsules for use with rotahaler device.