Drug Catalog - Product Detail
OLOPATADINE HCL OPTH SOL SOL 0.001 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0757-05 | AUROBINDO PHARMA | 5 | 0.1% | SOLUTION |
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Description
DESCRIPTION Olopatadine hydrochloride ophthalmic solution USP 0.1 % is a sterile ophthalmic solution containing olopatadine, a relatively selective H 1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride USP is a white to off-white crystalline powder, odorless with a molecular weight of 373.88. The chemical structure is presented below: Chemical Name 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP contains: Active : 1.11 mg olopatadine hydrochloride USP equivalent to 1 mg olopatadine. Preservative: benzalkonium chloride 0.01 %. Inactives: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and water for injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg. Chemical Structure
How Supplied
HOW SUPPLIED Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% is a clear, colorless solution. Practically free from visible particles packed in 5 mL opaque LDPE container with LDPE nozzle and white colored HDPE cap. 5 mL: NDC 65862-757-05 Storage Store at 39°F to 77°F (4°C to 25°C). Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised : June 2018
Indications & Usage
INDICATIONS AND USAGE Olopatadine hydrochloride ophthalmic solution USP 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.