BROMFENAC- bromfenac sodium solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Bromfenac sodium (UNII: 8ECV571Y37) (Bromfenac - UNII:864P0921DW)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Bromfenac sodium

Composition:

Bromfenac sodium 1.035 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bromfenac ophthalmic solution is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction. Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

Product summary:

Bromfenac ophthalmic solution 0.09% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. Store at 20ºC to 25°C (68ºF to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMFENAC - BROMFENAC SODIUM SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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BROMFENAC OPHTHLAMIC SOLUTION
STERILE
DESCRIPTION
Bromfenac ophthalmic solution 0.09% is a sterile, topical,
nonsteroidal anti-inflammatory drug
(NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution
contains 1.035 mg bromfenac
sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is
designated chemically as
sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an
empirical formula of
C
H BrNNaO • 1 1/2 H O. The structural formula of bromfenac sodium is:
Bromfenac sodium is a yellow to orange crystalline powder. The
molecular weight of bromfenac
sodium is 383.17. Bromfenac ophthalmic solution is supplied as a
sterile aqueous 0.09% solution, with
a pH of 8.3. The osmolality of bromfenac ophthalmic solution is
approximately 300 mOsmol/kg. Each
mL of bromfenac ophthalmic solution contains: ACTIVE: bromfenac sodium
hydrate 0.1035%. INACTIVES:
benzalkonium chloride (0.05 mg/mL), boric acid, disodium edetate (0.2
mg/mL), polysorbate 80 (1.5
mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous
(2 mg/mL), sodium hydroxide
to adjust the pH, and water for injection, USP.
CLINICAL PHARMACOLOGY
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
cyclooxygenase 1 and 2.
Prostaglandins have been shown in many animal models to be mediators
of certain kinds of intraocular
inflammation. In studies performed in animal eyes, prostaglandins have
been shown to produce
disruption of the blood-aqueous humor barrier, vasodilation, increased
vascular permeability,
leukocytosis, and increased intraocular pressure.
PHARMACOKINETICS
The plasma concentration of bromfenac following ocular administration
of bromfenac ophthalmic
solution 0.09% in humans is unknown. Based on the maximum proposed
dose of one drop to each eye
(0.09mg)