FDA records indicate that there are no current recalls for this drug.
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Olopatadine Hydrochloride Spray Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Olopatadine Hydrochloride Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 • HCl with the following chemical structure:
Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage and Administration (2)]. Olopatadine Hydrochloride Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.
Sources
Olopatadine Hydrochloride Spray Manufacturers
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Falcon Pharmaceuticals, Ltd.
Olopatadine Hydrochloride Spray | Falcon Pharmaceuticals, Ltd.
Administer Olopatadine Hydrochloride Nasal Spray by the intranasal route only.
2.1 Adults and Adolescents 12 years of age and older:The recommended dosage is two sprays per nostril twice daily.
2.2 Children 6 to 11 years of age:The recommended dosage is one spray per nostril twice daily.
2.3 Administration InformationPriming: Before initial use, prime Olopatadine Hydrochloride Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Hydrochloride Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Hydrochloride Nasal Spray into the eyes.
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