ACUVAIL Ophthalmic solution (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Allergan, Inc.
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1. Indications and Usage
ACUVAIL ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.
2. Dosage and Administration
2.1 Recommended Dosing Patient Dosing One drop of ACUVAIL should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first ...
3. Dosage Forms and Strengths
4.5 mg/mL ketorolac tromethamine solution (0.45%) in a single-use vial.
4. Contraindications
ACUVAIL solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
5. Warnings and Precautions
5.1 Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and ...
6. Adverse Reactions
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies ...
6.1. Clinical Trials Experience
The most common adverse reactions were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of ketorolac tromethamine ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population ...
8.1. Pregnancy
Teratogenic Effects <u>Pregnancy Category C:</u> 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. ...
8.3. Nursing Mothers
Because many drugs are excreted in human milk, caution should be exercised when ACUVAIL is administered to a nursing woman.
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
11. Description
ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 ...
12.1. Mechanism of Action
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action ...
12.3. Pharmacokinetics
Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
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 900 times and 300 ...
14. Clinical Studies
Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of ACUVAIL on anterior chamber cell and flare, ...
16.1. How Supplied
ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is available as a sterile solution supplied in clear, LDPE, single-use vials packaged in 3 foil pouches, 10 vials per pouch: 30 Single-Use Vials ...
16.2. Storage and Handling
Store at 15º-30ºC (59º-86ºF). Store the vials in the pouch, protected from light. Fold pouch ends closed.
17. Patient Counseling Information
17.1 Slow or Delayed Healing Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs). 17.2 Avoiding Contamination ...