Nedocromil Other names: Nedocromil sodium

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

Studies in pregnant have failed to reveal a hazard with nedocromil sodium. However, as with all new medicines, caution should be exercised during pregnancy (especially during the first trimester).

There is no information on the use of nedocromil sodium formulated with propellant HFA-227 or with propellant HFA-227 alone in human pregnancy. However studies of HFA-227 administered to pregnant and lactating animals have not revealed any special risk and cumulative clinical experience with nedocromil sodium formulated with CFC propellants would suggest that nedocromil sodium has no adverse effects on fetal development. Nedocromil sodium formulated with propellant HFA-227 should only be used in pregnancy where there is a clear need.

Studies in lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all new medicines, caution should be exercised while breast feeding.

On the basis of animal studies and its physicochemical properties it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no evidence to suggest that the use of nedocromil sodium during breast-feeding has any undesirable effects on the baby. However there is no experience to date with nedocromil sodium formulated with propellant HFA-227 or with propellant HFA-227 alone during lactation in female patients with asthma. Nedocromil sodium formulated with propellant HFA-227 should only be used in lactation where there is a clear need and its use should be restricted to those situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Nedocromil has no or negligible influence on the ability to drive and use machines.

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1% and <10%; Uncommon ≥0.1% and <1%; Rare ≥0.01% and <0.1%; Very rare <0.01%; Unknown (cannot be estimated from available data).

In clinical studies conducted in patients treated with nedocromil metered dose inhaler, the following adverse events have been reported at the corresponding frequencies:

Gastrointestinal disorders

Very common: Abdominal pain, vomiting, nausea

Common: Dyspepsia

Respiratory, thoracic and mediastinal disorders

Very common: Cough, bronchospasm

Frequency not known: Throat irritation, pharyngitis

Nervous system disorders

Very common: Headache

Common: Dysgeusia

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, dyspnoea and/or tightness in the chest following administration. This requires immediate treatment with a fast-acting inhaled bronchodilator and immediate medical attention must be sought straightaway. Therapy with nedocromil pressurised inhalation suspension CFC-Free should be discontinued immediately and alternative treatment instituted.