Mastodon

Allergodil® (Spray, Drops) Instructions for Use

ATC Code

R01AC03 (Azelastine)

Active Substance

Azelastine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

An antiallergic drug for topical use in ENT practice

Pharmacotherapeutic Group

Antiallergic agent – H1-histamine receptor blocker

Pharmacological Action

Blocker of histamine H1-receptors, a phthalazinone derivative. It has a pronounced antiallergic effect.

In addition, it inhibits the release of inflammatory mediators from mast cells.

Pharmacokinetics

After intranasal application, about 40% reaches the systemic circulation.

It is metabolized in the liver.

It is excreted mainly with feces.

Indications

  • Seasonal allergic rhinitis for the relief of symptoms such as sneezing, rhinorrhea, and nasal pruritus.
  • Perennial allergic rhinitis for the management of chronic nasal symptoms associated with persistent allergens.
  • Allergic rhinoconjunctivitis for the treatment of nasal and ocular symptoms caused by allergens.

ICD codes

ICD-10 code Indication
H10.1 Acute atopic (allergic) conjunctivitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
ICD-11 code Indication
9A60.01 Acute atopic conjunctivitis
9A60.02 Allergic conjunctivitis
9A60.0Y Other specified papillary conjunctivitis
9A60.0Z Papillary conjunctivitis, unspecified
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the nasal spray twice daily. For adults and children 6 years and older, use one spray per nostril. For children under 6 years, consult a physician.

Apply eye drops twice daily. Instill one drop into each affected eye. Increase frequency to up to four times daily if symptoms are severe, as directed by a physician.

Adverse Reactions

Common adverse reactions include bitter taste, headache, nasal burning, paroxysmal sneezing, and epistaxis.

Less frequently reported reactions include fatigue, dry mouth, nausea, weight gain, and skin rash. Discontinue use if severe local irritation or signs of systemic hypersensitivity occur.

Contraindications

  • Hypersensitivity to azelastine hydrochloride or any excipient of the formulation.
  • Do not use the nasal spray for the treatment of allergic rhinitis in children under 6 years of age.
  • Avoid use of the eye drops while wearing soft contact lenses.

Drug Interactions

Concomitant use with central nervous system depressants, including alcohol, may potentiate sedative effects. Exercise caution when operating vehicles or machinery.

No clinically significant pharmacokinetic interactions with other drugs have been established. However, the potential for additive effects with other antihistamines exists.

Overdose

Symptoms of overdose may include severe sedation. No specific antidote exists. Provide symptomatic and supportive care.

Gastric lavage may be considered if ingestion occurred recently. Monitor vital signs and cardiac function. Treatment should be directed at the clinical presentation.

Use in Pregnancy and Lactation

It is not recommended for use in pregnant and breastfeeding women, since there is no experience with the use of azelastine during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in allergic rhinitis and rhinoconjunctivitis – children under 6 years of age; for vasomotor rhinitis – children under 12 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

In some cases, with intranasal use, fatigue of varying severity and weakness are detected, which can also be caused by the underlying disease.

In these cases, it is not recommended to drive a car and work with dangerous machinery.

Alcohol consumption may enhance these phenomena.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

Dosage Form

Bottle OTC Icon Allergodil® Metered-dose nasal spray 140 mcg/1 dose: 10 ml bottle with spray-dispenser

Dosage Form, Packaging, and Composition

Metered-dose nasal spray in the form of a transparent, colorless or almost colorless solution.

1 dose
Azelastine hydrochloride 0.14 mg

Excipients : hypromellose – 0.14 mg, disodium edetate dihydrate – 0.07 mg, citric acid – 0.061 mg, sodium phosphate dibasic dodecahydrate – 0.907 mg, sodium chloride – 0.961 mg, purified water – 138.419 mg.

10 ml (60 doses) – dark glass bottles (1) with a spray dispenser – cardboard packs.

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Tubilix Pharma, S.p.A. (Italy)

Dosage Form

Bottle OTC Icon Allergodil® Eye drops 0.05%: 6 ml bottle with dropper

Dosage Form, Packaging, and Composition

Eye drops in the form of a colorless, transparent or almost transparent solution.

1 ml 1 bottle
Azelastine hydrochloride 0.5 mg 3 mg

Excipients : hypromellose – 6 mg, disodium edetate – 3 mg, benzalkonium chloride – 0.75 mg, sorbitol – 399.996 mg, sodium hydroxide – to pH 6.0, water for injections – up to 6 ml (6.09 g).

6 ml – polyethylene bottles (1) with a dropper – cardboard packs.

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Meda Pharmaceuticals Inc. (USA)

Dosage Form

Bottle OTC Icon Allergodil® C Dosed nasal spray 0.14 mg/dose: 4 or 30 ml bottle with dispenser

Dosage Form, Packaging, and Composition

Metered-dose nasal spray 1 dose
Azelastine hydrochloride 140 mcg

4 ml – polyethylene bottles (1) with a dispenser – cardboard packs.
30 ml – polyethylene bottles (1) with a dispenser – cardboard packs.

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