ILEVRO Ophthalmic suspension (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Alcon Laboratories, Inc.

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1. Indications and Usage

ILEVRO 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.

2. Dosage and Administration

2.1 Recommended Dosing One drop of ILEVRO 0.3% should be applied to the affected eye one time daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks ...

3. Dosage Forms and Strengths

Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle.

4. Contraindications

ILEVRO 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

5. Warnings and Precautions

5.1 Increased Bleeding Time With some NSAIDS including ILEVRO 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ...

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 ...

8.1. Pregnancy

Teratogenic Effects Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, ...

8.3. Nursing Mothers

Nepafenac is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ILEVRO ...

8.4. Pediatric Use

The safety and effectiveness of ILEVRO 0.3% in pediatric patients below the age of 10 years have not been established.

8.5. Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

11. Description

ILEVRO 0.3% is a sterile, topical, NSAID prodrug for ophthalmic use. Each mL of ILEVRO 0.3% contains 3 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical ...

12.1. Mechanism of Action

After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a NSAID. Nepafenac and amfenac are thought to inhibit the action of prostaglandin H ...

12.3. Pharmacokinetics

Following bilateral topical ocular once-daily dosing of ILEVRO 0.3%, the concentrations of nepafenac and amfenac peaked at a median time of 0.5 hour and 0.75 hour, respectively on both Day 1 and Day 4. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. ...

14. Clinical Studies

In two double masked, randomized clinical trials in which patients were dosed daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first two weeks of the postoperative ...

16.1. How Supplied

ILEVRO 0.3% is supplied in a white, oval, low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented ...

16.2. Storage and Handling

Store at 2°C-25°C (36°F-77°F). Protect from light.

17. Patient Counseling Information

Slow or Delayed Healing Inform the patient of the possibility that slow or delayed healing may occur while using NSAIDs [see Warnings and Precaution (5.2)]. Avoiding Contamination of the Product ...