DORZOLAMIDE HCL solution/ drops

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

DORZOLAMIDE HYDROCHLORIDE

Composição:

DORZOLAMIDE 22.3 mg in 1 mL

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

DORZOLAMIDE HCL - DORZOLAMIDE HCL SOLUTION/ DROPS
Physicians Total Care, Inc.
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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.

Características técnicas

DORZOLAMIDE HCL - DORZOLAMIDE HCL SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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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