Levoreact 0.5 mg nasal spray - treatment of allergic rhinitis 10 ml

Product Description

Levoreact

Treatment of Symptomatic Allergic Rhinitis

Composition

One ml of nasal spray, suspension contains: levocabastine hydrochloride 0.54 mg (equivalent to 0.5 mg of levocabastine). Excipients: propylene glycol, sodium phosphate monohydrate, anhydrous disodium phosphate, hydroxypropyl methylcellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.

Excipients

Propylene glycol, sodium phosphate monohydrate, anhydrous disodium phosphate, hydroxypropyl methylcellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.

Therapeutic indications

Symptomatic treatment of allergic rhinitis

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Generally contraindicated in pregnancy (see 4.6).

Dosage

Since LEVOREACT nasal spray, suspension is available as a microsuspension, the bottle must be shaken before each application. Adults and children over 3 years: the usual dose is 2 sprays in each nostril, 2 times a day. If necessary, the dose can be repeated up to 3-4 times a day. Treatment should be continued for the period necessary for the symptoms to disappear. The patient must be instructed to blow their nose thoroughly before using LEVOREACT nasal spray, suspension. Before using the preparation for the first time, remove the cap and press two or three times until a regular spray is obtained.

Warnings and precautions

Since levocabastine is excreted mainly by the kidneys, LEVOREACT nasal spray, suspension should be administered with caution in patients with renal insufficiency. Like all nasal preparations containing benzalkonium chloride, propylene glycol, and esters, Levoreact may cause skin irritation.

Interactions

Pharmacodynamic interactions In clinical studies, no interactions of levocabastine with alcohol or other drugs have ever been reported. In specially designed studies, there was no evidence of potentiation of the effects of alcohol or diazepam by LEVOREACT nasal spray, suspension used at normal doses. Pharmacokinetic interactions: The decongestant oxymetazoline may temporarily reduce the absorption of levocabastine nasal spray. Co-administration of the CYP3A4 inhibitors ketoconazole or erythromycin had no effect on the pharmacokinetic properties of intranasal levocabastine. Intranasal levocabastine did not alter the pharmacokinetic properties of loratadine.

Undesirable effects

Consult the package leaflet.

Pregnancy and lactation

Pregnancy In mice, rats, and rabbits, the product, administered at systemic doses up to 1250 times (mg/kg) the maximum recommended clinical nasal dose, did not reveal any embryotoxic or teratogenic effects. In rodents, teratogenicity and/or increased embryonic resorptions were observed at levocabastine doses exceeding 2500 times (mg/kg) the maximum nasal dose. There are limited data regarding the use of LEVOREACT nasal spray, suspension in pregnant women; the risk for humans is unknown, therefore the drug should not be used during pregnancy, except in cases where the expected benefit to the woman justifies the potential risk to the fetus. Breastfeeding: Based on determinations of levocabastine concentrations in saliva and milk of a breastfeeding woman administered a single oral dose of 0.5 mg of levocabastine, it is expected that approximately 0.6% of the total nasal levocabastine dose may be transferred to the infant. However, since clinical studies and experimental data are limited, caution is recommended when administering LEVOREACT to breastfeeding women.