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. |
| Molecular Weight | 278.35 |
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 | Avoid during first trimester unless potential benefit outweighs risk; fetal risk cannot be ruled out. |
| 2nd trimester | Avoid during second trimester; may cause fetal miosis and respiratory depression if used near term. |
| 3rd trimester | Avoid during third trimester; may cause neonatal respiratory depression and withdrawal symptoms. |
Clinical note
Comprehensive clinical and safety monograph for BROMDAY (BROMDAY).
| Placental transfer | Crosses placenta; detected in fetal plasma and amniotic fluid. Degree of transfer is moderate to high (fetal-to-maternal ratio ~0.5-1.0). |
| Breastfeeding | BROMDAY is excreted in breast milk in small amounts; monitor infant for sedation, poor feeding, and respiratory depression. Use caution in breastfeeding women, especially with prolonged use. |
■ FDA Black Box Warning
Not applicable; no FDA black box warning has been issued for brompheniramine.
| Serious Effects |
Hypersensitivity to BROMDAY or any componentAcute narrow-angle glaucomaSevere hepatic impairmentBreastfeeding infants with known sensitivity to opioids
| 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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| Lactation Rating |
| L3 (Moderately Safe) – limited data, but likely safe with monitoring. |
| 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. |
| 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. |