Azelone spray

Azelone

  • Active Ingredient: Azelastine
  • 10ml
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What is Azelone?

The active ingredient of Azelone brand is azelastine. Azelastine HCl nasal spray, 0.1% contains 0.1% Azelastine HCl, USP in an aqueous solution at pH 6.8 В± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of Azelastine HCl, USP (equivalent to 125 mcg of Azelastine base). The bottle can deliver 200 metered sprays.

Used for

Azelone is used to treat diseases such as: Allergic Rhinitis.

Side Effect

Possible side effects of Azelone include: eye redness; hives, itching, or skin rash; headache; troubled breathing; dryness of the mouth.

How to Buy Azelone spray online?

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Postmarketing Experience

During the post approval use of Azelone HCl nasal solution (nasal spray), 0.1% and 0.15%, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include: abdominal pain, nasal burning, nausea, sweet taste, and throat irritation.

Additionally, the following adverse reactions have been identified during the post approval use of the Azelone HCl nasal solution (nasal spray) without sweetener brand of Azelone hydrochloride 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of smell and/or taste, tachycardia, tolerance, urinary retention, and xerophthalmia.

Before using Azelone eye drops,

  • tell your doctor and pharmacist if you are allergic to Azelone or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Azelone, call your doctor.
  • you should know that you should not wear contact lenses if your eye(s) is/are red. If your eye is not red and you wear contact lenses, you should know that Azelone solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling Azelone and put them back in 10 minutes later.

How should this medicine be used?

Azelone comes as a nasal spray. Azelone usually is sprayed in each nostril two times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Azelone exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Before using Azelone for the first time, remove the child-resistant screw cap and replace with the pump unit. Prime the delivery system (pump unit) with four sprays or until a fine mist appears. If 3 days or more have elapsed since your last use of the nasal spray, reprime the pump with two sprays or until a fine mist appears.

Patients should be informed that the treatment with Azelone HCl Nasal Solution (Nasal Spray), 0.15% may lead to adverse reactions, most common of which include bitter taste, nasal discomfort, epistaxis, headache, sneezing, fatigue, and somnolence .

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ Azelone hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.

The efficacy and safety of Azelone HCl nasal solution (nasal spray), 0.15% in perennial allergic rhinitis was evaluated in one randomized, multicenter, double-blind, placebo-controlled clinical trial in 578 adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis. The population of the trial was 12 to 84 years of age (68% female, 32% male; 85% white, 11% black, 1% Asian, 3% other; 17% Hispanic, 83% non-Hispanic).

Assessment of efficacy was based on the 12-hour reflective total nasal symptom score (rTNSS) assessed daily in the morning and evening, the instantaneous total nasal symptom score (iTNSS), and other supportive secondary efficacy variables. The primary efficacy endpoint was the mean change from baseline rTNSS over 4 weeks. The one 4-week perennial allergic rhinitis trial evaluated the efficacy of Azelone HCl nasal solution (nasal spray), 0.15%, Azelone HCl nasal solution (nasal spray), 0.1%, and vehicle placebo dosed at 2 sprays per nostril twice daily. In this trial, Azelone HCl nasal solution (nasal spray), 0.15% demonstrated a greater decrease in rTNSS than placebo and the difference was statistically significant (Table 5).

Table 4: Mean Change from Baseline in Reflective TNSS over 4 Weeks* in Adults and Children ≥ 12 years with Perennial Allergic Rhinitis

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ Azelone hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.

COMMON BRAND(S): Astelin, Astepro

GENERIC NAME(S): Azelone

OTHER NAME(S): Azelone Aerosol, Spray

This medication is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. Azelone belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for nasal symptoms.


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