BROMDAY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMDAY (BROMDAY).
Brompheniramine is a first-generation alkylamine antihistamine that competitively antagonizes histamine at H1 receptor sites, thereby suppressing histamine-mediated allergic and vasodilatory responses.
| Metabolism | Primarily hepatic via cytochrome P450 isoenzymes (CYP2D6 and CYP3A4); undergoes N-dealkylation and side-chain oxidation. |
| Excretion | Renal excretion (approximately 70%) as unchanged drug and metabolites; biliary/fecal excretion accounts for the remainder. |
| Half-life | Terminal elimination half-life is approximately 10-15 hours in adults; prolonged in hepatic impairment. |
| Protein binding | Approximately 10-15% bound to plasma albumin. |
| Volume of Distribution | Vd ~ 2-3 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Ophthalmic: ~100% locally absorbed; systemic bioavailability from ophthalmic drops is low (<1%). |
| Onset of Action | Ophthalmic administration: onset of conjunctival decongestion within minutes. |
| Duration of Action | Ophthalmic administration: duration of action is 4-8 hours for decongestant effect. |
1-2 drops in each affected eye every 4-6 hours as needed, not to exceed 4 doses per day.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established (age < 2 years). For children ≥2 years, same as adult dosing. |
| Geriatric use | No specific dosage adjustment; use with caution due to increased systemic absorption and anticholinergic effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BROMDAY (BROMDAY).
| Breastfeeding | It is unknown if bromfenac is excreted in human milk. M/P ratio not available. Because many drugs are excreted in human milk and due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | FDA Pregnancy Category C. No adequate studies in pregnant women. In animal studies, bromfenac caused embryocidal effects and increased incidence of fetal malformations at doses equivalent to the maximum recommended human ophthalmic dose. Avoid use in pregnant women, especially during the first and third trimesters, unless potential benefit outweighs risk. |
■ FDA Black Box Warning
Not applicable; no FDA black box warning has been issued for brompheniramine.
| Serious Effects |
["Hypersensitivity to brompheniramine or any component of the formulation","Simultaneous therapy with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI use","Newborn or premature infants","Nursing mothers due to potential for serious adverse effects in infants"]
| Precautions | ["May cause significant drowsiness and impair mental and physical abilities; caution when driving or operating machinery","Avoid concurrent use with alcohol or other CNS depressants","Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, urinary retention, peptic ulcer disease, pyloroduodenal obstruction, or bladder neck obstruction due to anticholinergic effects","Use with caution in patients with cardiovascular disease, hypertension, or hyperthyroidism","Elderly patients may be more sensitive to anticholinergic and hypotensive effects"] |
| Food/Dietary | No known food interactions. Avoid alcohol as it may increase the risk of gastrointestinal bleeding, though systemic absorption is minimal with ophthalmic use. |
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| Fetal Monitoring | No specific fetal monitoring required. Monitor pregnant women for potential systemic effects of bromfenac, such as gastrointestinal bleeding or renal impairment, though systemic absorption is low with ophthalmic use. |
| Fertility Effects | No studies on fertility in humans. In animal studies, bromfenac did not impair fertility at doses up to 1 mg/kg/day (approximately 370 times the human ophthalmic dose). However, NSAIDs are known to be associated with infertility in women due to effects on ovulation, which is reversible upon discontinuation. |
| Clinical Pearls | Bromday (bromfenac ophthalmic solution) is a nonsteroidal anti-inflammatory drug (NSAID) used for postoperative ocular inflammation. It is typically dosed twice daily. Due to risk of corneal adverse events, use with caution in patients with compromised corneal integrity. May increase bleeding time; avoid concurrent use with other NSAIDs or corticosteroids. |
| Patient Advice | Wash hands before and after each use. · Tilt head back, pull down lower eyelid, and instill one drop in the affected eye(s). · Avoid touching the dropper tip to any surface to prevent contamination. · Do not wear contact lenses during treatment unless directed by your doctor. · Remove contact lenses before administration and wait at least 15 minutes before reinserting. · Notify doctor if you experience eye pain, redness, vision changes, or sensitivity to light. · Use caution when driving or operating machinery if vision is blurred temporarily after instillation. |