Azelastine Hydrochloride Ophthalmic Solution 0.05%
Generic Name: azelastine hydrochloride ophthalmic solution 0.05%
Brand Names:
Azelastine Hydrochloride Ophthalmic Solution 0.05%
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.
Overview
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.
Uses
INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Dosage
DOSAGE & ADMINISTRATION The recommended dose is one drop instilled into each affected eye twice a day.
Side Effects
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.
Warnings
WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use. CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Pregnancy
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.
Storage
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).
Frequently Asked Questions
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.
What are the side effects of Azelastine Hydrochloride Ophthalmic Solution 0.05%?▼
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.
Can I take Azelastine Hydrochloride Ophthalmic Solution 0.05% during pregnancy?▼
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.
What are the important warnings for Azelastine Hydrochloride Ophthalmic Solution 0.05%?▼
WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use. CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.