Azelastine-Xanthis (Spray) Instructions for Use

Marketing Authorization Holder

Xantis Pharma, Limited (Cyprus)

Manufactured By

Sag Manufacturing, S.L.U. (Spain)

ATC Code

R01AC03 (Azelastine)

Active Substance

Azelastine (Rec.INN registered by WHO)

Dosage Form

Azelastine-Xanthis

Nasal spray, metered 140 mcg/dose: bottle 10 mL

Dosage Form, Packaging, and Composition

Metered nasal spray as a clear, colorless solution.

Excipients: hypromellose 2910 – 0.14 mg, disodium edetate dihydrate – 0.07 mg, anhydrous citric acid – 0.061 mg, sodium phosphate dibasic dodecahydrate – 0.907 mg, sodium chloride – 0.962 mg, purified water – up to 0.14 ml.

10 ml (71 doses) – bottle (1) – cardboard package.

Clinical-Pharmacological Group

An antiallergic drug for topical use in ENT practice

Pharmacotherapeutic Group

H1 histamine receptor blocker

Pharmacological Action

H1 histamine receptor blocker, 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. Excreted mainly in feces.

Indications

• For the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 6 years of age and older.
• For the management of allergic rhinoconjunctivitis, addressing both nasal and ocular symptoms caused by allergens.

ICD codes

Dosage Regimen

Administer intranasally with one spray per nostril, twice daily for the management of allergic rhinitis and rhinoconjunctivitis.

For adults and children 12 years of age and older, the standard dose is one spray (140 mcg) in each nostril twice daily. For children 6 to 11 years of age, the recommended dose is one spray (140 mcg) in each nostril twice daily.

Prime the pump before first use and if not used for several days. Tilt head slightly forward and insert tip into nostril, directing spray away from nasal septum.

Adverse Reactions

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

Less frequently reported reactions include dry mouth, nausea, fatigue, dizziness, weight gain, and skin rash. Epistaxis is more commonly observed with higher doses or prolonged use.

Discontinue use and seek medical attention if severe local irritation, signs of hypersensitivity, or any other unexpected symptoms occur.

Drug Interactions

Concomitant use with central nervous system depressants, including alcohol, sedatives, and tranquilizers, may result in additive sedative effects and impaired alertness.

No clinically significant pharmacokinetic interactions with other drugs have been established; however, exercise caution when using with other medications that have anticholinergic properties.

Inform your healthcare provider about all concomitant medications, including over-the-counter products and herbal supplements.

Contraindications

• Hypersensitivity to azelastine hydrochloride or any of the excipients listed in the composition of the nasal spray formulation.
• For the treatment of allergic rhinitis and rhinoconjunctivitis, use is contraindicated in children under 6 years of age due to a lack of safety and efficacy data in this pediatric population.
• For the management of vasomotor rhinitis, use is contraindicated in children under 12 years of age as the safety and effectiveness have not been established for this indication in younger children.

Overdose

Excessive intranasal administration may lead to increased severity of adverse effects, such as severe drowsiness, dizziness, or gastrointestinal discomfort.

In case of accidental ingestion of the contents of the bottle, gastric lavage and symptomatic supportive therapy are recommended. There is no specific antidote.

Monitor vital signs and provide appropriate medical supervision. Hemodialysis is not expected to be effective due to the high protein binding and extensive metabolism of the drug.

Use in Pregnancy and Lactation

It is not recommended for use in pregnant and breastfeeding women, as 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 operate machinery

In some cases, intranasal use may cause fatigue of varying severity and weakness, which may also be caused by the underlying disease. In these cases, it is not recommended to drive a car or work with dangerous machinery. Alcohol consumption may enhance these phenomena.

Storage Conditions

Store at 2°C (36°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.