KETOROLAC TROMETHAMINE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)

Disponibil de la:

Sandoz Inc

INN (nume internaţional):

KETOROLAC TROMETHAMINE

Compoziție:

KETOROLAC 5 mg in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily d

Rezumat produs:

Ketorolac tromethamine ophthalmic solution, 0.5% is supplied sterile in a white LDPE plastic bottle, a natural dropper tip and a gray polypropylene cap as follows: 5 mL in 8 mL bottle NDC 61314-126-05 10 mL in 10 mL bottle NDC 61314-126-10 Storage: Store at 15° to 30°C (59° to 86°F). Protect from light. FOR TOPICAL OPHTHALMIC USE ONLY

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE SOLUTION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETOROLAC
TROMETHAMINE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION.
KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is a nonsteroidal,
anti-inflammatory indicated for:
•
•
DOSAGE AND ADMINISTRATION
One drop of ketorolac tromethamine ophthalmic solution 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 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. (2.1)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. (3)
•
•
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most frequent adverse reactions reported by up to 40% of patients
participating in clinical trials have
been transient stinging and burning on instillation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC., AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Use with Other Topical Ophthalmic Medications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
The treatment of inflammation following cataract surgery. (1)
The temporary relief of ocular itching due to seasonal allergic
conjunctivitis. (1)
8 mL size bottle filled with 5 mL of