Retained Kenya · PPB

Unibrom

Bromfenac Ophthalmic Solution 0.09% w/v

H2017/CT4105/007/R1 Eye Drops sensory organs INN generic

What it does

Bromfenac is a medication used to help reduce inflammation and pain, especially after eye surgery.

Commonly used for: pain and inflammation after eye surgery, postoperative inflammation

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2017/CT4105/007/R1
Registration date
2026 July 13
Expiry date
2031 July 13
Status
Retained
Active ingredient
Bromfenac Ophthalmic Solution 0.09% w/v
Dosage form
Eye Drops
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
S01BC - Antiinflammatory agents, non-steroids
Drug group
SENSORY ORGANS
RxNorm RxCUI
19737
Manufacturer / MAH
Ajanta Pharma Limited
Applicant / LTR
HARLEYS LTD-NAIROBI
Country of origin
India
Manufacturer location
Gut No. 378, Plot No. 8, Waluj, Waluj, Waluj Bk., Maharashtra 431133, India

Source: Pharmacy and Poisons Board · fetched 2026-08-27 13:09:02 · updated 2026-10-20 02:06:41

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Bromfenac is a medication used to help reduce inflammation and pain, especially after eye surgery.

What it treats

  • pain and inflammation after eye surgery
  • postoperative inflammation

How it works

Bromfenac works by blocking certain chemicals in the body that cause inflammation and pain.

Who it's for

This medicine is for adults who have had eye surgery and need relief from pain and inflammation.

Cautions

  • • Avoid using with drugs that affect blood platelets.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Bromfenac

BNF-referenced

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) used primarily in ophthalmology for its anti-inflammatory properties. It is indicated for the management of postoperative inflammation following cataract surgery and for the control of inflammation in cases where corticosteroids are contraindicated. Bromfenac works by inhibiting the synthesis of prostaglandins, which are mediators of inflammation, thus providing relief from ocular inflammation and discomfort.

Indications

  • Postoperative inflammation following cataract surgery
  • Control of anterior segment inflammation when corticosteroids are contraindicated

Dosage

Children: For pediatric patients, dosage information should be obtained from the BNF for Children, as it is not provided in the general BNF.

Adults: For adult patients, the specific dosing regimen should be consulted from the product literature, as it may vary based on the formulation and clinical context.

Mechanism of action

Bromfenac exerts its effects by blocking the synthesis of prostaglandins through the inhibition of cyclooxygenase (COX) enzymes 1 and 2. Prostaglandins are known to mediate intraocular inflammation, leading to disruptions in the blood-aqueous humor barrier, vasodilation, increased vascular permeability, and leukocytosis. By inhibiting these processes, Bromfenac helps reduce inflammation and associated symptoms in the eye.

Pharmacodynamics

As a topical NSAID, Bromfenac demonstrates potent anti-inflammatory activity. It is designed for ophthalmic use, providing localized effects with reduced systemic exposure. This targeted action allows for effective management of ocular inflammation with a lower risk of systemic side effects typically seen with oral NSAIDs.

Pharmacokinetics

Bromfenac is administered topically as an eye drop formulation, leading to rapid absorption in the ocular tissues. The drug is characterized by high protein binding and undergoes metabolism primarily in the liver. The elimination half-life and specific pharmacokinetic parameters can vary based on individual patient factors and the formulation used. Generally, the pharmacokinetics of topical ophthalmic drugs like Bromfenac result in minimal systemic absorption, which is beneficial for reducing systemic side effects.

Contra-indications

  • History of hypersensitivity to aspirin
  • History of hypersensitivity to any other NSAID
  • Patients with asthma, angioedema, urticaria, or rhinitis precipitated by NSAIDs

Adverse effects

  • Eye discomfort
  • Oedema
  • Dry eye
  • Headache
  • Eye infection
  • Eye inflammation
  • Paraesthesia
  • Vision blurred
  • Retinal inflammation
  • Hypersensitivity reactions
  • Asthma exacerbation
  • Dyspnoea
  • Rhinitis
  • Vision disorders

Interactions

  • Other NSAIDs may increase the risk of adverse effects
  • Caution is advised when used with anticoagulants due to potential increased bleeding risk

Precautions

  • May mask symptoms of infection
  • Use with caution in patients with a history of asthma or respiratory conditions
  • Monitor for signs of ocular inflammation or infection

Pregnancy

Safety in pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether bromfenac is excreted in human milk. Caution is advised; use only if necessary.

Storage

Store at room temperature, protect from light, and keep out of reach of children. Once opened, use within 28 days.

Formulations

  • Bromfenac ophthalmic solution 900 micrograms/ml
  • Yellox (Bausch & Lomb UK Ltd) eye drops, 5 ml
BNF 85 (British National Formulary) p.1312 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Bromfenac

PubChem CID 60726

Molecular formula: C15H12BrNO3

Mechanism of action

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.

Pharmacodynamics

Bromfenac ophthalmic solution is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

Tanzania 1 product