LEVOREACT SPRAY NAS 10ML 0.5MG

LEVOREACT 0.5 MG/ML NASAL SPRAY, SOSPENSION

active ingredients

A ml of nasal spray, suspension contains: levocabastina hydrochloride 0.54 mg (equal to 0.5 mg of levocabastina) Eccipients: propylene glycol, sodium phosphate monohydrate, disodium phosphate anidro, hydroxypropylmethylcellulose, polysorbate 80, benzalconio chloride, disodium edetate, purified water. For the full list of excipients, see paragraph 6.1

Excellent

Propylene glycol, sodium phosphate monohydrate, disodium phosphate anidro, hydroxypropylmethylcellulose, polysorbate 80, benzalconio chloruro, disodium edetate, purified water.

Therapeutic indications

Syntomatic treatment of allergic rhinitis

Contraindications

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

Population

Because 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 per nostril, 2 times a day. In case of need the dose can be repeated up to 3-4 times a day. Treatment should be continued for the period necessary for the disappearance of symptoms. The patient must be instructed to blow the nose well before the use of LEVOREACT nasal spray, suspension. Before using the preparation for the first time remove the cap and press two or three times empty until you get a regular dispensing.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

Since levocabasin is excreted mainly by renal way, LEVOREACT nasal spray, suspension should be given with caution in patients with kidney failure. Like all nasal preparations containing benzalconio chloride, propilen glycol and esters, Levoreact can cause skin irritation.

Interactions

Drug interactions During clinical studies, interactions of levocabastina with alcohol or other drugs have never been reported. In specially designed studies there has been no evidence of strengthening the effects of alcohol or diazepam by LEVOREACT nasal spray, suspension used to normal dosages. Drug interaction Oxytazoline decongestant can temporarily reduce the absorption of nasal spray levocabastine. Co-administration of CYP3A4 ketoconazole or erythromycin inhibitors has not produced effects on pharmacokinetic properties of levocabastine intranasal. The intranasal levocabastina has not modified the pharmacokinetic properties of loratadine.

Effects

Adverse drug reactions (ADRs) identified during clinical, epidemiological studies and during post-marketing experience with LEVOREACT nasal spray, are included in table 1, the frequencies are reported according to the following classification:

Very common	≥1/10
Town	≥1/100 and
Not common	≥1/1000 and
Rare	≥1/10,000 and
Very rare

Table 1: Adverse reactions detected during clinical studies and postmarketing experience with LEVOREACT nasal spray
Heart disease
Rare	Tachycardia
Pathologies of the eye
Not common	Eyebrow Edema
Gastrointestinal diseases
Town	Nausea
Systemic pathologies and conditions for the administration site
Town	Fatigue, pain
Not common	Malessere, irritation of the application site, pain of the application site, dryness of the application site
Rare	Burning the application site, annoying the application site
Immune system disorders
Not common	Hypersensitivity
Infections	Sinu
Disorders of the nervous system
Very common	Cefa
Town	Vertigo, drowsiness
Respiratory, chest and mediastinic pathologies
Town	Faringolaryean pain, epistassi, cough
Not common	Dispnea, Nasal Fastidium, nasal congestion, Broncospasmo
Rare	Nasal edema

Overdosing

Synonyms No overdose cases have ever been reported with levocabastine. However, it cannot be excluded the occurrence of sedation after accidental ingestion of the content of the bottle.Treatment In case of accidental ingestion, advise the patient to drink many non-alcoholic liquids in order to accelerate the renal elimination of levocabastine.

Pregnancy In mice, rats and rabbits, the product, administered to systemic doses up to 1250 times (mg/kg) the recommended maximum clinical nasal dose, has not revealed any embryotoxic or teratogenic effect. In rodents, teratogenicity and/or increased embryonic reabsorptions were observed at levocabastine doses over 2500 times (mg/kg) the maximum nasal dose. There are limited data about the use of LEVOREACT nasal spray, suspension in pregnant women; The risk for man is not known, therefore the drug should not be used during pregnancy, except for cases where the expected benefit for the woman warrants the potential fetal risk. Breasting Depending on the concentration of levocabasin in saliva and milk of a nursing woman, to which a single oral dose of 0.5 mg of levocabasin was given, it is expected that approximately 0.6 % of the total dose of levocabasin administered nasally can be transferred to the newborn. However, as clinical studies and experimental data are limited, caution is recommended in administering LEVOREACT to the nursing women.

Source: Farmadati