azelastine hydrochloride
Azelastine Hydrochloride is a histamine-1 receptor antagonist used to treat Allergic Conjunctivitis, Perennial Allergic Rhinitis, Vasomotor Rhinitis.
Histamine-1 Receptor Antagonist · by Gland
Generic of Astepro Allergy
Key facts
- Active ingredient
- Azelastine Hydrochloride
- Drug class
- Histamine-1 Receptor Antagonist
- Form
- Drops, Spray/Inhaler, metered
- Strength
- Azelastine Hydrochloride 0.05%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Gland
- What the pharmacy pays
- ~$0.58 per ml — not your price
- FDA application
- ANDA210092
What is Azelastine Hydrochloride?
From the FDA label:Azelastine hydrochloride ophthalmic solution, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H 1 -receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol, and glycerine. Azelastine hydrochloride is a racemic mixture with a melting point of 225°C. The chemical name for azelastine hydrochloride is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl), monohydrochloride and is represented by the following chemical structure: Empirical chemical structure: C 22 H 24 ClN 3 O.HCl Each mL of azelastine hydrochloride ophthalmic solution contains: Active: 0.5 mg azelastine hydrochloride, equivalent to 0.457 mg of azelastine base; Preservative: 0.125 mg benzalkonium chloride; Inactives: disodium edetate dihydrate, hypromellose, sorbitol solution, sodium hydroxide and water for injection. It has a pH of approximately 5.0 to 6.5 and an osmolarity of approximately 271 to 312 mOsmol/L. chemical-structure.jpg
How to use
Azelastine Hydrochloride is sold in more than one form (Drops and Spray/Inhaler, metered), and each is dosed differently. The instructions below come from the FDA label for application ANDA210092 — follow the label that came with the product you were actually prescribed.
The recommended dose is one drop instilled into each affected eye twice a day.
Side effects
In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1% to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied. To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Azelastine hydrochloride ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.
Who should not take Azelastine Hydrochloride
Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Drug class
How this class works, per Antihistamines - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Azelastine Hydrochloride ranks — best-rated histamine-1 receptor antagonist for:
Dosage forms
Drops and Spray/Inhaler, metered
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Azelastine Hydrochloride treat?
- Azelastine Hydrochloride (Azelastine Hydrochloride) may be used to treat allergic conjunctivitis, perennial allergic rhinitis, vasomotor rhinitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Azelastine Hydrochloride work?
- Azelastine Hydrochloride is a histamine-1 receptor antagonist. H1 antihistamines work by blocking histamine, the chemical released during an allergic reaction, from attaching to H1 receptors. This prevents the sneezing, itching, runny nose, watery eyes, and hives that histamine would otherwise trigger.
- How much does Azelastine Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.58 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Children's Cetirizine Hydrochloride Allergy — about $0.06 on the same basis.
- Is there a coupon or discount for Azelastine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Azelastine Hydrochloride. To pay less, Azelastine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Azelastine Hydrochloride?
- Azelastine Hydrochloride is marketed by Gland. You can see Gland's full profile, rating, and other products on pharmaranks.
- Is Azelastine Hydrochloride a brand-name or generic drug?
- Azelastine Hydrochloride is a generic medication; its active ingredient is Azelastine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Azelastine Hydrochloride available over the counter?
- No. Azelastine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Azelastine Hydrochloride come in?
- Azelastine Hydrochloride is currently marketed as drops and spray/inhaler, metered, per the FDA's National Drug Code Directory.
- What class of drug is Azelastine Hydrochloride?
- Azelastine Hydrochloride is classified as histamine-1 receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Azelastine Hydrochloride FDA-registered?
- Azelastine Hydrochloride is on record with the U.S. FDA under application number ANDA210092. You can verify this on its official FDA label.
- Is Azelastine Hydrochloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Azelastine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Azelastine Hydrochloride?
- Azelastine Hydrochloride's side effects are taken directly from its FDA label. From the label: In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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