Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Micro Labs Limited

SOLUTION

Strength 0.5 mg/mL

KETOROLAC TROMETHAMINE Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]

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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 Ketorolac Tromethamine (Ketorolac Tromethamine) which is also known as Ketorolac Tromethamine and Manufactured by Micro Labs Limited. It is available in strength of 0.5 mg/mL per ml. Read more

Ketorolac Tromethamine (Ketorolac Tromethamine) 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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No data

Ketorolac tromethamine ophthalmic solution 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution 0.5% ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
Ketorolac tromethamine ophthalmic solution 0.5% is a nonsteroidal, anti- inflammatory indicated for:

The treatment of inflammation following cataract surgery. (n n n )n n n
The temporary relief of ocular itching due to seasonal allergic conjunctivitis. (n n n )n n n

One drop of ketorolac tromethamine ophthalmic solution 0.5%should be applied to the affected eye(s) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.
For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution 0.5%should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. (n n n )n nn

5 mL size bottle filled with 3 mL, 5 mL size bottle filled with 5 mL and 10 mL size bottle filled with 10 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL)
Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. (n n n )n nn

5 mL size bottle filled with 3 mL, 5 mL size bottle filled with 5 mL and 10 mL size bottle filled with 10 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL)

Ketorolac tromethamine ophthalmic solution 0.5%n n n solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.n nn
Hypersensitivity to any component of this product. (n n n )n nn

No data

Delayed healing (n n n )n n n
Cross-sensitivity or hypersensitivity (n n n )n n n
Increased bleeding time due to interference with thrombocyte aggregation (n n n )n n n
Corneal effects including keratitis (n n n )n n n

The most frequent adverse reactions reported by up to 40% of
patients participating in clinical trials have been transient stinging and burning on instillation. (n n n )n nn
www.fda.gov/medwatch
u00a0

No data

Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-u00adpyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (u00b1)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure:n n n n n
Ketorolac tromethamine ophthalmic solution 0.5% is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution 0.5% is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution 0.5% is 290 mOsmol/kg.
Each mL of ketorolac tromethamine ophthalmic solution contains: n n n ketorolac tromethamine 0.5%. n n n : benzalkonium chloride 0.01%. n n n : edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.n nn

No data

Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 125 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis.
Ketorolac tromethamine was not mutagenic n n n in the Ames assay or in forward mutation assays. Similarly, it did not result in an n n n increase in unscheduled DNA synthesis or an n n n increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.n nn
Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.

Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.
Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

Ketorolac Tromethamine Ophthalmic solution 0.5% is supplied sterile, in white opaque LDPE bottles with white opaque LDPE Nozzles with HDPE grey caps as follows.
3 mL in 5 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n 42571-137-31n nn
5 mL in 5 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n 42571-137-25n nn
10 mL in 10 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n 42571-137-26n nn
Storage:

No data

Before you use Ketorolac Tromethamine Ophthalmic solution 0.5% for the first time:
1.Check to make sure that the tamper evident ring between the bottle and the cap is not broken (n n n ). If the tamper evident ring is broken or missing, contact your pharmacist.n nn
u00a0n n n n
2.Tear off the tamper evident ring (n n n ).n nn
u00a0n n n n
3.To open the bottle, remove the cap by turning it in the counterclockwise direction (n n n ).n nn
u00a0n n n n
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Rx Onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC-42571-137-31n n n Ketorolacn n n Tromethaminen n n Ophthalmicn n n Solutionn n n 0.5%u00a0u00a0 3mLn n n MICRO LABSu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0FOR USE IN THE EYES ONLYn n n n n n n NDC-42571-137-31u00a0u00a0u00a0u00a0u00a0u00a0 Rx Onlyn n n Ketorolac Tromethaminen n n Ophthalmic Solutionn n n 0.5%n n n FOR USE IN EYES ONLYn n n 3mLn n n MICRO LABSn n n n n n n

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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

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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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

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?

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QUICK LINKS

CONTACT US

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