PROLENSA Ophthalmic solution (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch & Lomb Incorporated

Λέξεις κλειδιά

24208-602

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

PROLENSA (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

2. Dosage and Administration

2.1 Recommended Dosing One drop of PROLENSA ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through ...

3. Dosage Forms and Strengths

<u>Topical ophthalmic solution:</u> bromfenac 0.07%.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Sulfite Allergic Reactions PROLENSA ophthalmic solution contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

8.1. Pregnancy

Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration ...

8.3. Nursing Mothers

Caution should be exercised when PROLENSA ophthalmic solution is administered to a nursing woman.

8.4. Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 years have not been established.

8.5. Geriatric Use

There is no evidence that the efficacy or safety profiles for PROLENSA differ in patients 70 years of age and older compared to younger adult patients.

11. Description

PROLENSA (bromfenac ophthalmic solution) 0.07% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of PROLENSA contains 0.805 mg bromfenac sodium sesquihydrate ...

12.1. Mechanism of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting ...

12.3. Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of PROLENSA (bromfenac ophthalmic solution) 0.07% in humans is unknown. Based on the maximum proposed dose of one drop to each eye ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from the recommended human ophthalmic dose ...

14. Clinical Studies

14.1 Ocular Inflammation and Pain Bromfenac 0.07% QD for the treatment of postoperative inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallel-group, ...

16.1. How Supplied

PROLENSA (bromfenac ophthalmic solution) 0.07% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper tip and 15 mm polypropylene gray cap as follows: 3 mL in a 7.5 mL container ...

16.2. Storage and Handling

Store at 15º to 25ºC (59º to 77ºF).

17. Patient Counseling Information

Slowed or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Sterility of Dropper Tip Advise patients to replace bottle cap after using and to ...