Local treatment of antiseptic and anti-allergic rhinitis

NASAL WAY

Adult: 1 spray in each nostril 4 to 6 times a day.
Child: 1 spray in each nostril 2 to 3 times a day.
Infant: 1. Spraying in each nostril 1 to 2 times a day.

The nasal sprays are done with the bottle in a vertical position.

The duration of treatment should be short.

Class: Pharmacotherapeutic: NASAL PREPARATION FOR LOCAL USE

(R: respiratory system)

Kethexonium bromide: local antiseptic of the quaternary ammonium class.

Phenyltoloxamine: H1 antihistamine; ethanolamine in structure with the; ownership to object, by antagonism competitive more or less reversible, effects of; histamine including skin, blood vessels and, conjunctival mucosa, nasal, bronchial And intestinal infections.

Attention is drawn, in particular, for drivers of vehicles and users, machines, on the risks of somnolence attached to, the use of this drug especially early;. Treatment

This phenomenon is accentuated by the use of alcoholic beverages or medicines containing alcohol.


· Hypersensitivity to any of the components and in particular to the quaternary ammonium or antihistamine family

Due to the presence of phenyltoloxamine

· Risk of glaucoma by closure of angle

· Risk of urinary retention due to urethro-prostatic disorders

This medication is GENERALLY DISCONTINUED during the first trimester of pregnancy.
The indication does not justify treatment, prolonged.

In the case of general symptoms, general treatment should be considered.
Although administered locally, phenyltoloxamine may cause systemic effects which it is appropriate to take into account

Associations, deprecated

+ Alcohol

Enhancement by alcohol of the sedative effect of the antihistamine H1. The alteration of vigilance may render dangerous the driving of vehicles and the use of machines.

Avoid drinking alcoholic beverages and other medicines containing alcohol

Associations to be taken into account

+; Other sedative drugs (morphine derivatives; (analgesics, cough suppressants, and substitution treatment), neuroleptics, barbiturates, benzodiazepines, anxiolytics other; as benzodiazepines (eg,; meprobamate), hypnotics, antidepressants, sedatives (amitriptyline, doxepin , mianserin, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen, thalidomide)

Increased depression, central. The alteration of alertness can make dangerous the driving of vehicles and the use of machines.

+; Atropine Other drugs (tricyclic antidepressants, the, most H1 antihistamines atropine, anti-Parkinson, anticholinergics, antispasmodics atropine, disopyramide, phenothiazine neuroleptics and; clozapine)

Addition, atropine-like adverse effects to urinary retention, constipation, dryness of the mouth.

Without object.

No cases of overdose have been reported.

In the event of overdose, medical advice is required.
The presence of phenyltoloxamine conditions the course to be taken in case of pregnancy

Pregnancy

· Malformative aspect (1st quarter)

O There are no reliable data for teratogenesis in animals

o; Clinically, there is currently no data sufficiently relevant to evaluate possible, fetal malformation or toxicity of phenyltoloxamine; when administered during pregnancy
.

· Fetotoxicity (2nd and 3rd trimesters)

In newborns of mothers treated with long doses at high doses, anticholinergic drugs have rarely been described

· Digestive signs related to the properties, atropinic phenothiazines (distension, abdominal ...)

· Extrapyramidal syndromes.

Accordingly, use of this drug is discouraged during the first trimester of pregnancy. It will be prescribed only if necessary subsequently, limiting itself, in the 3rd quarter, to a punctual use.

If the administration of this medicinal product took place at the end of pregnancy, it seems justified to observe a period of surveillance of the neurological and digestive functions of the newborn.

Breastfeeding

In the absence of data on passage through breast milk, breast-feeding should be avoided during the treatment period.
· Repeated allergic sneezing with nasal discharge, local irritation

· Skin and skin allergic reactions (eczema, pruritus, purpura, urticaria).
Although nasal resorption is low, the risk of systemic effects of phenyltoloxamine can not be excluded

· Risk of drowsiness

· Strong doses or prolonged treatment

O Anticholinergic effects (dryness of the mucous membranes, constipation, visual disturbances, heart palpitations)
O, orthostatic hypotension, disorders of balance.

Hematologic effects have been noted with the use of oral antihistamines: leucopenia, neutropenia, thrombocytopenia, hemolytic anemia,
Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers, Pharmacovigilance - Website: www.ansm .sante.fr.
Local treatment of antiseptic and anti-allergic rhinitis