Urbifen50 mg

Urbifen is a nonsteroidal anti-inflammatory drug (NSAID) used for the following indications:

Established (oral/systemic) uses

• Relief of the signs and symptoms of osteoarthritis
• Relief of the signs and symptoms of rheumatoid arthritis
• Management of mild-to-moderate acute pain
• Treatment of primary dysmenorrhea (menstrual pain)

Established (ophthalmic) use

• Ophthalmic Urbifen solution is indicated to inhibit intraoperative miosis (pupil constriction) during cataract and other ocular surgery

Use of Urbifen for indications not listed above is not established and should only be undertaken on a physician's advice.

Flurbiprofen is a propionic-acid-derivative NSAID. Oral formulations are typically supplied as immediate-release film-coated tablets for systemic use, while an ophthalmic formulation is supplied as a sterile solution (eye drops) of Flurbiprofen sodium for topical ocular use.

Urbifen is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the propionic acid class, chemically related to ibuprofen and ketoprofen. It possesses analgesic, anti-inflammatory, and antipyretic properties and is used both systemically (tablets) for musculoskeletal pain and inflammatory conditions, and topically (ophthalmic solution) to control inflammation-mediated miosis during eye surgery.

Urbifen belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) class, specifically the propionic acid derivatives, a group of non-selective cyclooxygenase (COX-1 and COX-2) inhibitors.

Flurbiprofen exerts its therapeutic effects primarily through reversible, non-selective inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins and thromboxanes from arachidonic acid. This reduction in prostaglandin synthesis underlies its analgesic, anti-inflammatory, and antipyretic effects.

When applied topically to the eye, Flurbiprofen ophthalmic solution penetrates the cornea and inhibits the miotic response caused by surgically released prostaglandins, thereby helping to maintain pupil dilation during intraocular surgery.

Pharmacokinetics (oral)

• Well absorbed after oral administration; peak plasma concentrations generally reached within 1-2 hours
• Highly protein bound (>99%)
• Hepatically metabolized; metabolites and unchanged drug excreted mainly in urine
• Elimination half-life approximately 3-6 hours

Oral Urbifen tablets should be swallowed whole with a full glass of water, preferably with food or milk to minimize stomach upset. Do not crush or chew unless instructed. For ophthalmic Urbifen, tilt the head back, instill the drop into the conjunctival sac without touching the dropper tip to the eye, and close the eye gently for 1-2 minutes; if using with other eye drops, space administrations at least 5 minutes apart.

Urbifen has clinically significant interactions with the following:

• Aspirin and other NSAIDs: concurrent use increases the risk of GI bleeding/ulceration without added benefit and may reduce aspirin's cardioprotective antiplatelet effect; avoid combination
• Anticoagulants (e.g. warfarin) and antiplatelet agents: increased risk of serious bleeding due to additive effects on platelet function and, with warfarin, potential displacement from protein binding
• Corticosteroids: increased risk of GI ulceration and bleeding
• ACE inhibitors, ARBs, and diuretics: Urbifen may reduce their antihypertensive effect and increase the risk of acute kidney injury, particularly in volume-depleted patients ("triple whammy")
• Lithium: reduced renal clearance of lithium, risking lithium toxicity; monitor lithium levels
• Methotrexate: reduced renal clearance of methotrexate leading to increased toxicity, especially at high methotrexate doses
• SSRIs: additive risk of GI bleeding

Common and serious side effects associated with Urbifen include:

Common

• Dyspepsia, nausea, abdominal pain, heartburn
• Headache, dizziness
• Fluid retention/edema

Serious (less common)

• Gastrointestinal ulceration, bleeding, or perforation
• Cardiovascular thrombotic events (myocardial infarction, stroke)
• Renal impairment/acute kidney injury
• Hepatotoxicity
• Hypersensitivity reactions including bronchospasm and anaphylaxis
• Skin reactions (rash, photosensitivity, rarely severe reactions such as Stevens-Johnson syndrome)

Ophthalmic Urbifen may cause transient burning/stinging, mild ocular irritation, and, rarely, delayed corneal healing.

Urbifen should be used during the first and second trimesters of pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use. Urbifen is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and other fetal/neonatal complications. NSAID use around 20 weeks gestation or later has also been associated with fetal renal dysfunction leading to oligohydramnios.

Small amounts of Urbifen may pass into breast milk; use during breastfeeding should only occur under medical supervision, weighing benefits against potential risk to the infant.

Urbifen, like other NSAIDs, carries important warnings:

• Cardiovascular risk: may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal; risk may increase with duration of use and in patients with existing cardiovascular disease or risk factors
• Gastrointestinal risk: increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time and without warning symptoms, particularly in the elderly
• Renal effects: may cause renal papillary necrosis or other renal injury, particularly with long-term use, dehydration, or pre-existing renal impairment
• Fluid retention/heart failure: caution in patients with fluid retention, hypertension, or heart failure
• Hematologic effects: may inhibit platelet aggregation; use with caution in patients with bleeding disorders or on anticoagulant therapy
• Hepatic effects: may cause elevated liver enzymes or, rarely, serious hepatic reactions
• Ophthalmic use: may slow or delay corneal healing; use with caution in patients with bleeding tendencies or those taking medicines that prolong bleeding time; prolonged use may increase the risk of keratitis

Use the lowest effective dose for the shortest duration necessary.

Symptoms of Urbifen overdose may include drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, headache, tinnitus, and, in severe cases, seizures, metabolic acidosis, renal failure, hypotension, respiratory depression, or coma. If overdose of Urbifen is suspected, seek immediate medical attention or contact a poison control center; treatment is supportive and symptomatic, as there is no specific antidote.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Ophthalmic Urbifen solution should be kept tightly closed when not in use and discarded per the product label after opening.

Elderly: Increased risk of GI bleeding, cardiovascular events, and renal impairment with Urbifen; use the lowest effective dose with close monitoring.

Renal impairment: Use with caution; avoid in patients with advanced renal disease; monitor renal function during prolonged use.

Hepatic impairment: Use with caution; dose reduction may be needed; avoid in severe hepatic impairment.

Pediatric: Safety and efficacy of oral Urbifen have not been established in children.

Pregnancy/Lactation: See Pregnancy and Lactation section.

Urbifen should be used at the lowest effective dose for the shortest duration consistent with individual treatment goals. For acute pain or dysmenorrhea, treatment is typically limited to a few days. For chronic conditions such as osteoarthritis or rheumatoid arthritis, longer-term use may be necessary but requires periodic reassessment of the need for continued therapy and monitoring for adverse effects. Ophthalmic use is limited to the perioperative period as directed by the surgeon.

Nonsteroidal Anti-Inflammatory Drug (NSAID); Propionic acid derivative; Non-selective COX-1/COX-2 inhibitor.

Flurbiprofen works by reversibly and non-selectively inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes responsible for converting arachidonic acid into prostaglandins and thromboxanes. By reducing prostaglandin synthesis, Flurbiprofen decreases inflammation, pain sensitization, and fever. In the eye, reduced prostaglandin synthesis helps prevent surgically induced miosis.

Category B (Category D if used in the third trimester or near term)

The safety and efficacy of oral Urbifen have not been established in pediatric patients, and it is generally not recommended for use in children outside specialist supervision. Ophthalmic Urbifen has been used perioperatively in pediatric ophthalmic surgery under specialist direction, but use in children should always be guided by a physician's judgment of benefit versus risk.