Azelastine Hydrochloride Ophthalmic Solution 0.05%

Description

DESCRIPTION Azelastine hydrochloride ophthalmic solution, USP 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: Structural formula: C 22 H 24 ClN 3 O

What Is Azelastine Hydrochloride Ophthalmic Solution 0.05% Used For?

INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

Dosage and Administration

DOSAGE & ADMINISTRATION The recommended dose is one drop instilled into each affected eye twice a day.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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 1–10% 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.

Contraindications

CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

Pregnancy and Breastfeeding

PREGNANCY Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14th rib were increased in rats. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown. There are no adequate and well-controlled studies in pregnant women. Azelastine hydrochloride ophthalmic solution 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azelastine hydrochloride ophthalmic solution 0.05% is administered to a nursing woman.

How Supplied

HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, USP 0.05% is supplied as follows: Azelastine hydrochloride ophthalmic solution, USP 0.05% 6 mL (NDC#62332-506-06) solution in a 10 mL LDPE container with LDPE nozzle and a white HDPE screw cap. Storage Azelastine hydrochloride ophthalmic solution, USP 0.05% : Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx only Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA. Made in India OR Manufactured by: Gland Pharma Limited, Hyderabad-500 043, India (IND) Revised: 01/2024