Sanofi, Tilarin 1% 30 ml Sanofi

“Directions
Tilarin 1% nasal spray is used to treat allergic rhinitis.

Composition
Active ingredient: nedocromil sodium 300 mg.
Excipients: benzalkonium chloride USNF; disodium edetate FE; sodium chloride FE; purified water.

Method of administration and dosage
Adults and children: one spray in each nostril 2-4 times a day. The drug should be used regularly to achieve the best symptom control. Most patients who respond to therapy with the product will notice an improvement within the first 48 hours of use; however, some patients (less than 10% of cases studied) may need to wait up to 7 days for complete symptom control. The duration of treatment should not exceed eight weeks.

Warnings
Safety and efficacy in children under 12 years of age have not been established. Experience in clinical studies of the drug in the elderly is limited. However, based on the available data, it has the same spectrum of efficacy and safety in such patients.

Interactions
No harmful interactions with other medicinal products have been described in humans or animals. In particular, no interactions have been reported with other ophthalmic or nasal medications, oral antihistamine therapy, or inhaled or oral asthma treatments.

Adverse reactions
When applicable, the following frequency scale has been used: very common (>=1/10), common (>=1/100, <1/10), uncommon (>=1/1,000, <1/100), rare (>=1/10,000, <1/1,000), very rare (<1/10,000), unknown. The following adverse reactions have been reported in clinical studies in patients receiving nedocromil sodium nasal solution 1%. Respiratory, thoracic and mediastinal disorders. Common: burning sensation in the nose, irritation in the nose; uncommon: burning pain in the nose, soreness of the nose. Nervous system disorders. Common: dysgeusia.

Pregnancy
Animal studies during pregnancy and lactation have not revealed any harmful effects of nedocromil sodium. However, as with all drugs, caution should be exercised during pregnancy (especially in the first trimester) and during breastfeeding. Based on animal studies and the chemical and physical properties of nedocromil sodium, it is believed that only minimal amounts penetrate into human breast milk. There is no data to suggest that the use of nedocromil sodium by women who are breastfeeding could have an adverse effect on the child.”