Dorzolamide Hydrochloride (Trusopt)

Trade Name : TRUSOPT

Merck Sharp & Dohme Corp.

SOLUTION

Strength 20 mg/mL

DORZOLAMIDE HYDROCHLORIDE Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dorzolamide Hydrochloride (Trusopt) which is also known as TRUSOPT and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 20 mg/mL per ml. Read more

Dorzolamide Hydrochloride (Trusopt) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

TRUSOPT Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
TRUSOPT is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ()

The dose is one drop of TRUSOPT Ophthalmic Solution in the affected eye(s) three times daily.
TRUSOPT may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
The dose is one drop of TRUSOPT in the affected eye(s) three times daily. TRUSOPT may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. ()

Solution containing 20 mg/mL dorzolamide (22.3 mg of dorzolamide hydrochloride).
Solution containing 20 mg/mL dorzolamide. ()

TRUSOPT is contraindicated in patients who are hypersensitive to any component of this product n
TRUSOPT is contraindicated in patients who are hypersensitive to any component of this product. (, )

No data

Sulfonamide Hypersensitivity ()
Bacterial Keratitis ()
Corneal Endothelium ()
Allergic Reactions ()
Acute Angle-Closure Glaucoma ()

The most frequently reported adverse reactions associated with TRUSOPT were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. ()n n n

No data

Potential additive effect of oral carbonic anhydrase inhibitor with TRUSOPT. ()
Potential acid-base and electrolyte disturbances. ()

No data

Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

TRUSOPT (dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.
Dorzolamide hydrochloride is described chemically as: (4)-4-(ethylamino)-5,6-dihydro-6-methyl-4-thieno[2,3-]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is
Its empirical formula is CHNOSu2219HCl and its structural formula is:
Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264u00b0C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.
TRUSOPT Sterile 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 TRUSOPT 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.

No data

In a two-year study of dorzolamide hydrochloride administered orally to male and female Sprague-Dawley rats, urinary bladder papillomas were seen in male rats in the highest dosage group of 20 mg/kg/day. Papillomas were not seen in rats given oral doses of 1 mg/kg/day. These doses represent estimated plasma C levels in rats, 138 and 7 times higher than the lower limit of detection in human plasma following ocular administration, respectively.
No treatment-related tumors were seen in a 21-month study in female and male mice given oral doses up to 75 mg/kg/day. This dose represents an estimated plasma C level in mice, 582 times higher than the lower limit of detection in human plasma following ocular administration.
The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class-effect of carbonic anhydrase inhibitors in rats. Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria, and diverse sodium salts.
No changes in bladder urothelium were seen in dogs given oral dorzolamide hydrochloride for one year at 2 mg/kg/day or monkeys dosed topically to the eye for one year. An oral dose of 2 mg/kg/day in dogs represents an estimated plasma C level, 137 times higher than the lower limit of detection in human plasma following ocular administration. The topical ophthalmic dose in monkeys was approximately equivalent to the human topical ophthalmic dose.
The following tests for mutagenic potential were negative: (1) (mouse) cytogenetic assay; (2) chromosomal aberration assay; (3) alkaline elution assay; (4) V-79 assay; and (5) Ames test.
In reproduction studies of dorzolamide hydrochloride in rats, there were no adverse effects on the reproductive capacity of males or females at doses of 15 and 7.5 mg/kg/day, respectively. These doses represent estimated plasma C levels in rats, 104 and 52 times higher than the lower limit of detection in human plasma following ocular administration, respectively.

The efficacy of TRUSOPT was demonstrated in clinical studies in the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension (baseline IOP u2265 23 mmHg). The IOP-lowering effect of TRUSOPT was approximately 3 to 5 mmHg throughout the day and this was consistent in clinical studies of up to one year duration.
The efficacy of TRUSOPT when dosed less frequently than three times a day (alone or in combination with other products) has not been established.
In a one year clinical study, the effect of TRUSOPT 2% three times daily on the corneal endothelium was compared to that of betaxolol ophthalmic solution twice daily and timolol maleate ophthalmic solution 0.5% twice daily. There were no statistically significant differences between groups in corneal endothelial cell counts or in corneal thickness measurements. There was a mean loss of approximately 4% in the endothelial cell counts for each group over the one year period.

TRUSOPT is supplied in an OCUMETER PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with orange label as follows:
NDC
Storage
Store TRUSOPT Ophthalmic Solution at 15-30u00b0C (59-86u00b0F). Protect from light.

See FDA-approved patient labeling ().

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
By: Laboratoires Merck Sharp & Dohme-ChibretClermont Ferrand Cedex 9, 63963, France
Copyright u00a9 1994, 2014 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 02/2014
uspi-mk0507-os-1402r013

INSTRUCTIONS FOR USEn- TRU-sopt
Before using your TRUSOPT
Before using your TRUSOPT for the first time, make sure the safety strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle. (See ).
Step 1.
Step 2.
Step 3.n- Do not
Giving your TRUSOPT drops
Step 4.
Step 5.n- Do not
Step 6.n- Do notn- Do not
Step 7.
After using your TRUSOPT
Step 8.n- Do not
After you have used all of your TRUSOPT doses, there will be some TRUSOPT medicine left in the dispenser. try to remove the extra medicine from the TRUSOPT dispenser. Throw away your TRUSOPT dispenser in your household trash.
How should I store TRUSOPT?
Keep TRUSOPT and all medicines out of the reach of children.
Important information about using TRUSOPT
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of n Whitehouse Station, NJ 08889, USA
By: Laboratoires Merck Sharp & Dohme-Chibret Clermont Ferrand Cedex 9, 63963, France
Copyright u00a9 2000, 2014 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 02/2014
ifu-mk0507-os-1402r013

NDC
10 mLOCUMETERn- PLUS OPHTHALMIC DISPENSERSTERILE OPHTHALMIC SOLUTION
TRUSOPTn- (DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION)
2%
Rx only

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Dorzolamide Hydrochloride (Trusopt)

Trade Name : TRUSOPT

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Dorzolamide Hydrochloride (Trusopt)

Trade Name : TRUSOPT

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?