Drug Catalog - Product Detail
OLOPATADINE HCL NASAL SOLN 0.6% 30.5GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0104-01 | PADAGIS | 30 | 0.6% | SOLUTION |
PACKAGE FILES
Generic Name
OLOPATADINE HYDROCHLORIDE
Substance Name
OLOPATADINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
NASAL
Application Number
ANDA202853
Description
11 DESCRIPTION Olopatadine hydrochloride nasal spray, 665 mcg is a metered-spray solution for nasal 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 g/mol, and its molecular formula is C 21 H 23 NO 3 • 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 µL of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [ see Dosage Forms and Strengths ( 3 ) ] . Olopatadine hydrochloride nasal spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride. structural
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Olopatadine Hydrochloride Nasal Spray, 665 mcg is supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator, a blue overcap and a blue clip in a box of 1 (NDC 45802- 104 -01). Each trade size bottle contains 30.5 g of clear, colorless liquid and will provide 240 metered sprays. After priming [ see Dosage and Administration ( 2.3 ) ], each spray delivers a fine mist containing 665 mcg of olopatadine hydrochloride in 100 µL of formulation through the nozzle. Net content 30.5 g, 240 sprays: NDC 45802- 104 -01 (trade size) Storage Store olopatadine hydrochloride nasal spray at room temperature between 4°C to 25°C (39°F to 77°F).
Indications & Usage
1 INDICATIONS AND USAGE Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. Olopatadine hydrochloride nasal spray is an H 1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For nasal use only. Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two sprays per nostril (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6 to 11 Years : One spray per nostril (665 mcg per spray) twice daily ( 2.2 ). • Priming Information : Prime olopatadine hydrochloride nasal spray before initial use and when olopatadine hydrochloride nasal spray has not been used for more than 7 days ( 2.3 ). 2.1 Adults and Adolescents Twelve Years of Age and Older The recommended dosage is two sprays per nostril twice daily. 2.2 Pediatric Patients Six to Eleven Years of Age The recommended dosage is one spray per nostril twice daily. 2.3 Administration Information Administer olopatadine hydrochloride nasal spray by the nasal route only. Priming : Before initial use, prime olopatadine hydrochloride nasal spray by releasing 5 sprays or until a fine mist appears. The correct amount of medication cannot be assured before the initial priming. Re-priming (as needed): 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. Discard Instructions : Discard nasal device after 240 sprays (enough for 30 days of dosing) have been used even though the bottle is not completely empty. The correct amount of medication cannot be assured after 240 sprays have been used.