Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)
Physicians Total Care, Inc.
DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE 22.3 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Dorzolamide HCl Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide HCl Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product. Dorzolamide HCl Ophthalmic Solution 2% INSTRUCTIONS FOR USE Please follow these instructions carefully when using Dorzolamide HCl Ophthalmic Solution 2%. Use Dorzolamide HCl Ophthalmic Solution 2% as prescribed by your doctor. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Dorzolamide HCl Ophthalmic Solution 2%. 2. Wash hands before each use. 3. To open the bottle, remove the shrink neck band and unscrew the cap by turning counter clockwise. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. 5. Instill drops as directed by your doctor. OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECO
Dorzolamide HCl Ophthalmic Solution is a slightly opalescent, nearly colorless, slightly viscous solution. Dorzolamide HCl Ophthalmic Solution is supplied in a white low-density polyethylene (LDPE) bottle with a controlled drop tip and orange polypropylene cap in the following sizes: 10 mL in a 10 mL bottle NDC 54868-6330-0
Abbreviated New Drug Application
DORZOLAMIDE HCL - DORZOLAMIDE HCL SOLUTION/ DROPS Physicians Total Care, Inc. ---------- INSTRUCTIONS FOR USE Dorzolamide HCl Ophthalmic Solution 2% INSTRUCTIONS FOR USE Please follow these instructions carefully when using Dorzolamide HCl Ophthalmic Solution 2%. Use Dorzolamide HCl Ophthalmic Solution 2% as prescribed by your doctor. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Dorzolamide HCl Ophthalmic Solution 2%. 2. Wash hands before each use. 3. To open the bottle, remove the shrink neck band and unscrew the cap by turning counter clockwise. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. 5. Instill drops as directed by your doctor. OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE. 6. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor. WARNING: Keep out of reach of children. If you have any questions about the use of Dorzolamide HCl Ophthalmic Solution 2%, please consult your doctor. Revised December 2008 Bausch & Lomb Incorporated Tampa, Florida 33637 © Bausch & Lomb Incorporated 9080602 (Folded) Revised: 3/2012 Document Id: a426eea0-b0a5-47b4-bbef-e7a99f7382ab Set id: 45a7e3c2-8527-4447-90fe-07ce688f25d3 Version: 2 Effective Time: 20120327 Physicians Total Care, Inc. read_full_document
DORZOLAMIDE HCL - DORZOLAMIDE HCL SOLUTION/ DROPS PHYSICIANS TOTAL CARE, INC. ---------- DORZOLAMIDE HCL OPHTHALMIC SOLUTION, 2% Sterile DESCRIPTION Dorzolamide HCl Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4_S-trans_)-4-(ethylamino)-5,6-dihydro-6- methyl-4_H_-thieno[2,3-_b_]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is α 25° (C=1, water) = ~ -17°. 405 Its empirical formula is C H N O S •HCl and its structural formula is Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide HCl Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of Dorzolamide HCl Ophthalmic Solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells (RBCs), but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a re read_full_document