Rinoklenil
Producer: Chiesi Farmaceutici S.p.A. (Kyezi Pharmatsevtichi S. Square) Italy
Code of automatic telephone exchange: R01AD01
Release form: Liquid dosage forms. The aerosol is nasal.
General characteristics. Structure:
Active agent: beclomethasone Dipropionas of 0,770 mg
Excipients: Polysorbate 20, microcrystallic cellulose and karmelloza of sodium, benzalkoniya chloride, фенилэтанол, Dextrosums monohydrate, water.
Pharmacological properties:
Beclomethasone – the synthetic glucocorticosteroid for topical administration possessing antiinflammatory and antiallergic action.
Reduces formation of substance of a chemotaxis, slows down development of "immediate" allergic reaction (it is caused by braking of products of metabolites of arachidonic acid and decrease in release from mast cells of mediators of an inflammation) and improves mukotsiliarny transport. Under the influence of beclomethasone the quantity of mast cells in a mucous membrane of a nasal cavity and adnexal bosoms decreases, hypostasis, slime secretion, regional accumulation of neutrophils, inflammatory exudate and products of cytokines decrease, migration of macrophages is slowed down, intensity of processes of infiltration and granulation decreases.
Has no mineralokortikoidny activity. The therapeutic effect develops gradually that demands use of drug within several days.
Pharmacokinetics. At intranasal use in the recommended doses, Rinoklenil has no system activity. It is quickly soaked up in a mucous membrane of a nose. A part of a dose which is unintentionally swallowed, inactivated at "the first passing" through a liver. In a liver there is Dipropionas beclomethasone transformation process into beclomethasone monopropionate and then – in polar metabolites. Linkng with proteins of plasma of the active agent which is in a system blood-groove makes 87%. The main part of drug (35-76%) is removed during 96 h through intestines, 10-15% - kidneys are preferential in the form of polar metabolites.
Indications to use:
Prevention and treatment of seasonal and year-round allergic rhinitis, vasculomotor rhinitis.
Route of administration and doses:
Intranazalno.
Adults and children are more senior than 6 years: on 2 doses (200 mkg) in each nasal course once a day.
At children, if necessary, use on 1 dose (100 mkg) in each nasal course 2 times a day is possible.
The maximum daily dose – 400 mkg.
Instructions to the correct use.
Shake up a bottle before each use. Before the first use or after a long break remove a protective cap (2), remove a safety ring (3) and make spraying once in air.
Before use remove a protective cap (2), a safety ring (3) and make several sprayings in air before emergence of an aerosol.
At use:
Carefully clear nasal passes.
Remove a protective cap.
Remove a safety ring.
Make spraying in air before emergence of an aerosol.
Place a doser tip in a nasal opening as shown in the drawing. Clamp other nasal opening a finger, inhale, having at the same time pressed the doser. Repeat the procedure with other nasal pass.
Place a safety ring and a protective cap into place.
Features of use:
Rinoklenil's use for a long time, can result in the classical system effects typical for this drug in exceptional cases. In this case it is necessary to suspend treatment and to appoint the corresponding therapy.
There is a risk of deterioration in function of adrenal glands at Rinoklenil's use for patients after prolonged system treatment by glucocorticosteroids. At children, receiving prolonged treatment by glucocorticosteroids intranazalno, regular control of growth is shown.
It is necessary to consider that in certain cases at treatment of allergic rhinitis additional therapy for elimination of eye symptoms can be required.
To attention of athletes: use of drug in other purposes, except therapeutic, is regarded as dope; even when using in therapeutic doses it can cause doping effect and answer in the affirmative at a doping test.
Side effects:
At use in therapeutic doses side effects occur seldom, among them: change of taste and sense of smell, allergic reactions (rash, urticaria, a Quincke's disease), a rhinorrhea, a krnjyuktiva hyperemia, cough, sneezing, irritation, burning in a nose, dryness in a nose, nasal bleeding, a headache, a nose mucosal atrophy. Extremely seldom – perforation of a nasal partition and increase in intraocular pressure. At development of the infections caused by fungal microflora the corresponding treatment has to be appointed.
Interaction with other medicines:
Now interactions with other medicines are not revealed.
Contraindications:
Hypersensitivity, tuberculosis infection, children's age up to 6 years.
With care
Pregnancy, the lactation period, system and local infections (fungal, bacterial, virus), herpes of eyes, glaucoma, ulcerations of a nasal partition, recent surgical interventions in a nasal cavity.
Pregnancy and lactation
Use at pregnancy is allowed only if the expected advantage for mother exceeds potential risk for a fruit.
At the recommended doses hit of drug in maternal milk is improbable. Nevertheless, Rinoklenil's use in the period of a lactation is allowed only if the expected advantage for mother exceeds potential risk for the child.
Overdose:
At one-time use of high doses of beclomethasone function suppression гипоталамо - pituitary and adrenal system is possible. In this case the dose of drug has to be lowered to recommended.
Storage conditions:
List B. At a temperature not above 25 °C. Not to freeze.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Spray nasal dosed 100 mkg / a dose. On 120 or 200 doses of drug in 35 ml the plastic bottle with the dosing sprayer closed by a protective cap and a safety ring. On 1 bottle with the instruction place in a cardboard pack.