Allergodil nasal spray 1mg/ml 10ml (bottle)

Allergodil nasal spray 10 ml

Name: Allergodil
Form: nasal spray
Dose: 1 mg/ml
Package: 10 ml (bottle)

Allergodil Description and indications

Symptomatic treatment of seasonal allergic rhinosinusitis (hay fever). Symptomatic treatment of non-seasonal (year-round) allergic rhinosinusitis.

Action

Action: antihistamine drug, H1 receptor antagonist. After intranasal administration, it exerts mainly local effects, reaching blood concentrations about 8 times lower than after oral administration. The onset of action after intranasal administration occurs already after 15 min and persists for about 12 h.

Azelastine hydrochloride is an antagonist of histamine _H1 receptors and thus has an anti-allergic effect. It is characterized by a long half-life ( t0_.5 ≈ 20 h. ).In vivo studies in guinea pigs have shown that azelastine at doses equivalent to those used in humans inhibits bronchoconstriction induced by leukotrienes and PAF (platelet-activating factor). The results of animal studies have shown that azelastine inhibits airway inflammation, causing airway hypersensitivity. However, the relevance of these results obtained in animals, to the therapeutic use of azelastine in humans, has not been fully clarified.

Composition - what ingredients the drug Allergodil contains

1 ml of Allergodil solution contains 1 mg of azelastine hydrochloride. 10 ml of solution (10.05 g) contains 10 mg of azelastine hydrochloride. 1 dose, i.e. 0.14 ml (a single press of the applicator) contains 0.14 mg of azelastine hydrochloride.

Dosage - how to use the drug Allergodil

Dosage: Adults and children 7 years of age and older 2 times a day 1 dose of Allergodil aerosol into each nostril, i.e. 0.56 mg per day.
Notes: The maximum duration of use is 6 months.

Contraindications

Hypersensitivity to azelastine hydrochloride or any of the excipients. Do not use in children under 6 years of age.

Notes and warnings about the drug Allergodil

This is a medication. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Special warnings / Precautions

Allergodil product contains disodium edetate, which may cause allergic reactions in hypersensitive patients.

Interactions

There are no known interactions of azelastine with other medicinal products.

Pregnancy and lactation

Although doses much higher than therapeutic doses have not shown teratogenic effects in animal studies, the product is not recommended for use during the first trimester of pregnancy. The product should not be used during lactation, due to insufficient data on the safety of use during this period.

Side effects

Immune system disorders: (very rarely) hypersensitivity. Nervous system disorders: (common) bitter taste sensation in mouth (often caused by improper position during aerosol administration, such as head tilted back; (rare) may cause nausea; (very rare) dizziness. Respiratory, thoracic and mediastinal disorders: (uncommon) irritation of inflamed nasal mucous membranes with symptoms such as tingling, burning sensation, itching, sneezing, nose bleeding. Gastrointestinal disorders: (rarely) nausea. General disorders: (very rarely) fatigue, exhaustion, weakness. Skin and subcutaneous tissue disorders: (very rarely) rash, pruritus, urticaria.

Overdose

No cases of overdose of azelastine hydrochloride in humans have been reported. Central nervous system disorders (somnolence, disorientation, coma, tachycardia, hypotension) can be expected after overdose or in case of accidental oral ingestion, analogous to those found in animal studies. In such cases, symptomatic treatment should be administered. A specific antidote for azelastine is not known.

Responsible Entity
Meda Pharma GmbH & Co. KG