No Information Provided
OPTIVAR® is contraindicated in persons with known or suspected hypersensitivity to any of its components.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800- 526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
OPTIVAR® is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
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. OPTIVAR® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is supplied as follows:
OPTIVAR® 6 mL (NDC#0037-7025-60) solution in a translucent 10 mL HDPE container with a LDPE dropper tip and a white HDPE screw cap.
StorageStore UPRIGHT between 2° and 25°C (36° and 77°F).
Distributed by: MEDA Pharmaceuticals Meda Pharmaceuticals Inc. Somers et, New Jers ey 08873-4120. Revised: April 2014
OPTIVAR® is for ocular use only and not for injection or oral use.
PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment Of FertilityAzelastine hydrochloride administered orally for 24 months was not carcinogenic in rats and mice at doses up to 30 mg/kg/day and 25 mg/kg/day, respectively. Based on a 30 ìL drop size, these doses were approximately 25,000 and 21,000 times higher than the maximum recommended ocular human use level of 0.001 mg/kg/day for a 50 kg adult.
Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow. Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 25,000 times the maximum recommended ocular human use level. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level), the duration of the estrous cycle was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, the implantation ratio was not affected.
Pregnancy Teratogenic EffectsPregnancy 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. OPTIVAR® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing MothersIt is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OPTIVAR® is administered to a nursing woman.
Pediatric UseSafety and effectiveness in pediatric patients below the age of 3 have not been established.
Geriatric UseNo overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
The recommended dose is one drop instilled into each affected eye twice a day.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800- 526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
DRUG INTERACTIONSNo Information Provided
