Nedocromil Sodium
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Drug Approvals
(BANM, US Adopted Name, rINNM)
Note. Nedocromil Calcium is also USAN.
Adverse Effects and Precautions
Inhaled nedocromil sodium may cause headache, gastrointestinal disturbances (nausea, vomiting, dyspepsia, and abdominal discomfort). An unusual or unpleasant taste is reported rarely. Paradoxical bronchospasm may occur. Eye drops may cause transient burning and stinging.
It should not be used for the treatment of acute asthma attacks. The general cautions described under sodium cromoglicate also apply.
Incidence of adverse effects. A review of nedocromil sodium noted that adverse effects were infrequent, mild, and shortlived. The most common effect appeared to be an unpleasant or bitter taste, which was experienced by 12 to 13% of patients, although less than 1 % of patients stopped treatment because of it. Other adverse effects included cough (in 7%), headache (6%), sore throat (5.7%), nausea (4%), and vomiting (1.7%).
Pharmacokinetics
Nedocromil sodium is poorly absorbed from the gastrointestinal tract about 10% of the inhaled dose is absorbed from the lungs. Absorption is also poor after topical ophthalmic use, and occurs mainly through the nasal mucosa. Nedocromil sodium is excreted unchanged in the urine and faeces. The half-life is stated to range from about 1 to 3.3 hours.
The extent of absorption or bioavailability of nedocromil sodium after inhalation in healthy subjects was 7 to 9% of the dose, including 2 to 3% oral absorption and 5 to 6% absorption from the respiratory tract. After inhalation of nedocromil sodium 4 mg the mean peak plasma concentration was 3.3 nanograms/mL in healthy subjects and 2.8 nanograms/mL in asthmatic patients, with peak values being reached at about 20 and 40 minutes respectively. The mean total urinary excretion 24 hours after a single dose was 5.4% of the dose in healthy subjects and 2.3% in asthmatics.
Uses and Administration
Nedocromil sodium has a stabilising action on mast cells resembling that of sodium cromoglicate and is used similarly in the management of chronic asthma. It should not be used to treat an acute attack of asthma.
For asthma, nedocromil sodium is inhaled from a metered-dose aerosol. The usual dose for adults and children from 6 years of age is 4 mg inhaled four times daily which may be decreased to 4 mg twice daily after control of symptoms is achieved. Clinical improvement may not be obtained for 1 week or longer after beginning therapy.
Nedocromil sodium is also used topically in the treatment of allergic conjunctivitis and allergic rhinitis. For seasonal and perennial allergic conjunctivitis it is given as a 2% solution, instilled into each eye twice daily. This may be increased to 4 times daily if necessary, which is the usual dose in vernal keratoconjunctivitis. In seasonal allergic conjunctivitis, treatment is usually given for no more than 12 weeks. In allergic rhinitis nedocromil sodium is used as a 1 % nasal spray: one spray is given into each nostril 4 times daily. For details of doses in children, see Administration in Children, below.
Administration in children. Nedocromil sodium is given by metered-dose aerosol inhalation for the treatment of asthma in children from 6 years of age at the adult dose, see above. Although unlicensed in the UK for younger children, the BNFC recommends the same dose from 5 years of age. Similarly, for the topical treatment of seasonal allergic conjunctivitis and vernal keratoconjunctivitis, the adult dose may be given to children from 6 years of age, see above. Treatment of perennial allergic conjunctivitis with nedocromil sodium is not licensed in children in the UK, but the BNFC recommends adult doses from 6 years of age.
Asthma. Nedocromil sodium is generally considered to be an alternative to sodium cromoglicate in the management of asthma. Nedocromil has been shown to improve symptoms and reduce bronchodilator intake in adults and children with chronic asthma. However, a systematic review of nedocromil for chronic asthma in children subsequently found that although a number of small studies have shown that nedocromil improves airflow limitation, reduces symptoms, and reduces bronchial hyperresponsiveness, this has not been confirmed in a larger long-term study of children with milder asthma. Its place in relation to other asthma therapies for children is also unclear. It may be used before exercise to reduce exercise-induced bronchoconstriction, and appears to be as effective as sodium cromoglicate for this indication.
Cough. For references indicating a positive response to sodium cromoglicate but not to nedocromil sodium in the management of cough induced by ACE inhibitor therapy, see Cough.
Rhinitis and conjunctivitis. Nedocromil has been used in the management of allergic rhinitis and conjunctivitis. In the management of seasonal allergic rhinitis, there is some evidence that prophylactic mometasone furoate reduces symptoms more effectively than nedocromil. In vernal keratoconjunctivitis nedocromil may be more effective than cromoglicate, but is less effective than fluorometholone.
Preparations
Proprietary Preparations
Australia: Tilade
Austria: Tilade Tilarin Tilavist
Brazil: Tilade
Canada: Alocril Tilade
Czech Republic: Tilade Tilarin Tilavist
Denmark: Tilade Tilavist
Finland: Tilade Tilarin Tilavist †
France: Tilavist
Germany: Halamid † Irtan Tilade
Greece: Tilade
Hong Kong: Tilade
Hungary: Tilade
Ireland: Tilade Tilavist †
Israel: Tilade Tilavist
Italy: Kovilen Kovinal Tilade Tilarin Tilavist
Mexico: Irtan
The Netherlands: Tilade Tilavist
Norway: Tilavist
New Zealand: Tilade
Portugal: Tilavist
Russia: Tilade
Spain: Brionil Cetimil Tilad Tilavist
Sweden: Tilavist
Switzerland: Tilade Tilarin Tilavist
Turkey: Tilade
UK: Rapitil Tilade
USA: Alocril Tilade
Multi-ingredient
Italy: Zarent
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