Nedocromil Sodium

Nedocromil inhaler is indicated for maintenance therapy in the management of adult and pediatric patients 6 years and older with mild to moderate asthma. Nedocromil inhaler is not indicated for the reversal of acute bronchospasm.

Nedocromil is a mast-cell stabiliser. It inhibits mediator release and bronchoconstriction induced by various stimuli and affects various inflammatory cells.

The recommended dosage for adult and pediatric patients 6 years of age and older is two inhalations four times a day at regular intervals, which provides a dose of 14 mg per day. In patients whose asthma is well controlled on this dosage (e.g., patients who only need occasional inhaled or oral beta2-agonists and who are not experiencing serious exacerbations), less frequent administration may be effective.

Each Nedocromil Inhaler canister must be primed with 3 actuations prior to the first use. If a canister remains unused for more than 7 days, then it should be reprimed with 3 actuations. Nedocromil Inhaler may be added to the patient's existing treatment regimen (e.g., bronchodilators). When a clinical response to Nedocromil Inhaler is evident and if the patient's asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually. Proper inhalational technique is essential (see Patient Instructions for Use). Patients should be advised that the optimal effect of Nedocromil  therapy depends upon its administration at regular intervals, even during symptom-free periods.

In clinical studies, Nedocromil inhalation aerosol has been co-administered with other anti-asthma medications, including inhaled and oral bronchodilators, and inhaled corticosteroids, with no evidence of increased frequency of adverse events or laboratory abnormalities. No formal drug-drug interaction studies, however, have been conducted.

Nedocromil inhalation aerosol inhaler is contraindicated in patients who have shown hypersensitivity to nedocromil sodium or other ingredients in this preparation.

Unpleasant taste, headache, fatigue, nausea, vomiting, dyspepsia, diarrhoea, abdominal pain, conjunctivitis, cough, pharyngitis, rhinitis, upper respiratory infection.

Pregnancy Category B. Reproduction studies performed in mice, rats, and rabbits using a subcutaneous dose of 100 mg/kg/day (approximately 30 times, 60 times, and 116 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2 basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nedocromil inhalation aerosol is administered to a nursing woman.

Pregnancy and lactation. Not for use in acute asthma attacks; acute bronchospasm. Children <6 yr; monitor closely.

Cromoglycate & related drugs

Pediatric Use: The safety and effectiveness of Nedocromil inhalation aerosol in patients below the age of 6 years have not been established.

Geriatric Use: Clinical studies of Nedocromil inhalation aerosol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Store at 2-30° C. Do not freeze.