2010/09/17

Aldecin

Composition, structure and packing

Nasal spray dose 1 dose - beclomethasone (in the form dipropionate) 50 mg

200 doses (8.5 g) - spray bottles (1) with a valve dispensing action - cartons.

Clinico-pharmacological group

SCS for inhalation and intranasal application

Pharmacological action

Beclometasone dipropionate - SCS has anti-inflammatory, antiallergic and immunosuppressive effect. Hinders the release of inflammatory mediators from mast cells, increases the production lipomodulina, is an inhibitor of phospholipase A, reduces the release of arachidonic acid inhibits the synthesis of metabolic products of arachidonic acid - Cyclic endoperekisey, prostaglandins. It reduces swelling and secretion of glands of the nasal mucosa, improves mucociliary transport. Virtually has no mineralocorticoid activity and resorptive effect after inhalation.

Pharmacokinetics

Absorption - low, an inhalation route of administration in recommended doses has no clinically significant systemic activity. After inhalation may ingestion of the administered dose with saliva. Most of the drug, got into the digestive tract, is inactivated at the first passage through the liver.

Relationship to plasma proteins - 87%. T1 / 2 - 15 h. The bulk of the drug (35-76%) is displayed for 96 h with fecal masses, mainly in the form of polar metabolites, 10-15% - the kidneys.

Indications for use of the drug
allergic rhinitis (seasonal or year-round);
vasomotor rhinitis;
polyposis of the nose (in a combination therapy).

Dosage regimen

Intranasal - in the form of inhalation.

Adults and teenagers 12 years: the recommended dose - 1-2 inhalations in each nostril 4, depending on the severity of symptoms. Children from 6 to 11 years: the recommended dose - 1-2 inhalations in each nostril 2, depending on the severity of symptoms. The maximum daily dose should not exceed 16 inhalations (0.8 mg) in adult and 8 inhalations (0.4 mg) in children aged 6 to 11 years. Upon reaching the therapeutic effect of the drug abolished, gradually reducing the dose.

Side effect

Allergic reactions (urticaria, pruritus, angioedema, skin redness), nose and throat infections caused by fungal flora, rhinorrhea, nasal bleeding, burning sensation or irritation of the mucous membrane of nose, dry nose, sneezing, a violation of smell, increased intraocular pressure, glaucoma, a violation of appetite, indigestion, nausea, diarrhea, headache, dizziness, hypertension, shortness of breath.

When using nasal GCS in large doses for a long time been cases perforation of the nasal septum. Side effects typical of systemic GCS may appear in the treatment of Aldetsinom if the drug is used in doses exceeding the recommended, or the patient has an increased sensitivity to the SCS, or have recently received systemic therapy of GCS. With the development of symptoms and side effects Aldetsin should be abolished, gradually reducing the dose.

Contraindications to the use of the drug
Hypersensitivity to any component of the drug;
tuberculosis (including latent) respiratory;
systemic infection (bacterial, fungal, viral, including infection caused by Herpes simplex eye affection);
recent surgery or trauma of the nose;
bleeding diathesis;
frequent nosebleeds;
Children up to age 6 (safety and efficacy of the drug in children under 6 years are not installed).

Pregnancy and lactation

Aldetsin can be used in pregnant and lactating women only if the possible benefits of treatment for women justifies the potential risk to the fetus or newborn. Infants of women who received SCS during pregnancy, should be explored to identify a possible reduction in adrenocortical function.

Application for violations of liver function

With care use in patients with severe hepatic insufficiency.

Cautions

Do not pierce the bottle nozzle needle or wire.

Need to protect the eyes from getting the drug.

Therapeutic effect Aldetsina, unlike the local vasoconstrictor agent for the treatment of rhinitis with intranasal application of slow onset. Relief of symptoms of rhinitis usually becomes apparent within a few days of starting treatment.

Patients in whom the therapy SCS may reduce immunity, it should warn about the dangers of contact with the patients of certain infections (eg chickenpox, measles) and the need for treatment to a doctor in case of such contact. This is especially important for children.

Because the drug slows the healing of wounds, patients who had recently undergone trauma or surgery of the nose, should not apply Aldetsin nasal spray to complete healing.

A guide for patients on the correct implementation of inhalation

Before the first use of nasal spray should be his "calibrated" by pressing the dispensing device 6-7 times. After the "calibration" set stereotyped presentation of the medicinal substance. If the spray is not used within 14 days or longer, before a new application is needed to double "calibration".

Prior to the inhalation of free nasal passages. Intensively shake flask. Insert the nasal applicator by holding it upright, into the nostril - in the direction of the inner corner of eye. In this second nostril should be closed, pressing a finger, and his head slightly tilted forward. Do not spray spray directly on the nasal septum.

Make a deep breath through your nose while pressing the spray and exhale through the mouth. Inhalation into the second nostril the same way.

To receive a single dose of 100 mg patients should make an inhalation by the above method twice.

Precautions

Opportunistic infections requiring antibiotics, hypertension, recent myocardial infarction, ulceration of the nasal septum, glaucoma, amebiasis, severe hepatic insufficiency, hypothyroidism, pregnancy, lactation.

Overdose

When used in very high doses can be observed systemic effects of GCS, including adrenal suppression and Cushing's symptoms. When these symptoms the dose should be reduced.

Drug Interactions

Clinically significant interactions of inhaled GCS with other drugs have been detected.

Phenobarbital, phenytoin, rifampicin and other inducers of microsomal oxidation of reduced efficiency.

Methandrostenolone, estrogens, beta 2-adrenostimulyatorov, theophylline, and oral appointed SCS reinforcing effect. Increases the effect of beta-adrenostimulyatorov.

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Drug prescription.

Terms and Conditions of storage

Keep out of reach of children, at a temperature not above 25 ° C.

Shelf life - 3 years. Do not use the drug after the expiry date.