Aldecin^® (Spray) Instructions for Use

Marketing Authorization Holder

Schering-Plough Labo N.V. (Belgium)

ATC Code

R01AD01 (Beclomethasone)

Active Substance

Beclometasone (Rec.INN registered by WHO)

Dosage Form

Aldecin®

Nasal spray 50 mcg/1 dose: canister 200 doses (8.5 g) with dosing device and mouthpiece

Dosage Form, Packaging, and Composition

200 doses (8.5 g) – aerosol canisters (1) with a metering valve – cardboard boxes.

Clinical-Pharmacological Group

Intranasal corticosteroids

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Beclomethasone dipropionate is a glucocorticosteroid (GCS) that has anti-inflammatory, anti-allergic, and immunosuppressive effects.

It inhibits the release of inflammatory mediators from mast cells, increases the production of lipomodulin, which is a phospholipase A inhibitor, reduces the release of arachidonic acid, and suppresses the synthesis of arachidonic acid metabolites – cyclic endoperoxides, prostaglandins.

It reduces swelling and secretion of the nasal mucosa glands, improves mucociliary transport.

It has practically no mineralocorticoid activity and no resorptive effect after inhalation administration.

Pharmacokinetics

Absorption is low; when administered by inhalation in recommended doses, it does not possess clinically significant systemic activity.

After inhalation, part of the administered dose may be swallowed with saliva.

The majority of the drug that enters the gastrointestinal tract is inactivated during the first pass through the liver.

Plasma protein binding is 87%.

The half-life (T_1/2) is 15 hours.

The main part of the drug (35-76%) is excreted within 96 hours in feces, predominantly in the form of polar metabolites, and 10-15% is excreted by the kidneys.

Indications

• Allergic rhinitis (seasonal or perennial);
• Vasomotor rhinitis;
• Nasal polyposis (as part of combination therapy).

ICD codes

Dosage Regimen

Intranasally – as an inhalation.

Adults and adolescents from 12 years of age: the recommended dose is 1-2 inhalations into each nostril 4 times/day, depending on the severity of symptoms.

Children from 6 to 11 years: the recommended dose is 1-2 inhalations into each nostril 2 times/day, depending on the severity of symptoms.

The maximum daily dose should not exceed 16 inhalations (0.8 mg) in adults and 8 inhalations (0.4 mg) in children aged 6 to 11 years.

Upon achieving the therapeutic effect, the drug should be discontinued, gradually reducing the dose.

Adverse Reactions

Allergic reactions (urticaria, itching, angioedema, skin redness), nasopharyngeal infections caused by fungal flora, rhinorrhea, nosebleed, sensation of burning or irritation of the nasal mucosa, nasal dryness, sneezing, impaired sense of smell, increased intraocular pressure, glaucoma, appetite disturbance, dyspepsia, nausea, diarrhea, headache, dizziness, arterial hypertension, difficulty breathing.

When using nasal GCS in high doses for a long time, cases of nasal septum perforation have been noted.

Side effects characteristic of systemic GCS may also appear during treatment with Aldecin^® if the drug is used in doses exceeding the recommended ones, or if the patient has increased sensitivity to GCS, or has recently received therapy with systemic GCS.

If such symptoms and side effects develop, Aldecin^® should be discontinued, gradually reducing the dose.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Respiratory tuberculosis (including latent);
• Systemic infections (bacterial, fungal, viral, including infection caused by Herpes simplex with eye involvement);
• Recent nasal surgery or trauma;
• Hemorrhagic diathesis;
• Frequent nosebleeds;
• Children under 6 years of age (safety and efficacy of the drug in children under 6 years of age have not been established).

Use in Pregnancy and Lactation

Aldecin^® can be used in pregnant and lactating women only if the potential benefit of treatment for the woman justifies the potential risk to the fetus or newborn.

Newborns of women who received GCS during pregnancy should be examined to identify possible hypoadrenalism.

Use in Hepatic Impairment

Use with caution in severe hepatic insufficiency.

Pediatric Use

Contraindication — children under 6 years of age (safety and efficacy of the drug in children under 6 years of age have not been established).

Children from 6 to 11 years the recommended dose is 1-2 inhalations into each nostril 2 times/day, depending on the severity of symptoms.

Special Precautions

Do not pierce the bottle nozzle with a needle or wire.

It is necessary to protect the eyes from contact with the drug.

The therapeutic effect of Aldecin^®, unlike topical vasoconstrictors for the treatment of rhinitis, does not appear immediately with intranasal use.

Relief of rhinitis symptoms usually becomes noticeable within a few days after the start of treatment.

Patients in whom GCS therapy may lead to reduced immunity should be warned about the danger of contact with patients with certain infections (e.g., chickenpox, measles) and the need to consult a doctor in case of such contact.

This is especially important for children.

Since the drug slows down wound healing, patients who have recently suffered nasal trauma or surgery should not use Aldecin^® nasal spray until the wounds are completely healed.

Patient guide for correct inhalation technique

Before the first use of the nasal spray, it is necessary to “calibrate” it by pressing the dosing device 6-7 times.

After “calibration”, a standard delivery of the medicinal substance is established.

If the spray has not been used for 14 days or longer, then a repeated “calibration” is necessary before new use.

Before inhalation, clear the nasal passages.

Shake the bottle vigorously.

Insert the nasal applicator, holding it vertically, into the nostril – towards the inner corner of the eye.

At the same time, the second nostril should be closed by pressing with a finger, and the head should be slightly tilted forward.

Do not spray the spray directly onto the nasal septum.

Take a deep breath through the nose while simultaneously pressing the spray and exhale through the mouth.

Perform inhalation into the second nostril in a similar manner.

To receive a single dose of 100 mcg, patients should perform inhalation using the method described above twice.

Use with caution

Concomitant infectious disease requiring antibiotic therapy, arterial hypertension, recent myocardial infarction, ulceration of the nasal septum, glaucoma, amoebiasis, severe hepatic insufficiency, hypothyroidism, pregnancy, lactation period.

Overdose

When used in very high doses, systemic effects of GCS may be observed, including suppression of adrenal function and symptoms of hypercortisolism.

If such symptoms appear, the dose should be reduced.

Drug Interactions

No clinically significant types of interaction of inhaled GCS with other medicinal products have been identified.

Phenobarbital, phenytoin, rifampicin and other inducers of microsomal oxidation reduce the effectiveness.

Methandrostenolone, estrogens, beta₂-adrenergic agonists, theophylline and orally administered GCS enhance the action.

It enhances the effect of beta-adrenergic agonists.

Storage Conditions

Store in a place inaccessible to children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.