Dorzolamide

Treatment of elevated intraocular pressure in ocular hypertension or open-angle glaucoma. It may be combined with other separately prescribed topical IOP-lowering products. Acute angle-closure glaucoma requires interventions beyond ocular hypotensive drops; this is not a standalone acute-angle-closure treatment or a demonstrated cure for optic-nerve damage.

Not recommended with severe renal impairment, CrCl <30 mL/min; no validated reduced-drop regimen substitutes for this restriction. Hepatic impairment is unstudied: use caution. Pediatric safety/effectiveness are supported by a three-month trial; the label supplies no age-specific titration or weight-based formula. No dedicated geriatric adjustment is specified. Dorzolamide/timolol is a distinct product with beta-blocker contraindications and a different regimen; it is excluded here. No swallowed/oral dorzolamide treatment regimen inferred from PK studies.

Hypersensitivity to any product component. The sulfonamide warning requires clinical allergy assessment; the label does not create a blanket formal contraindication to every unrelated sulfur-containing compound.

The selected standalone dorzolamide label has no boxed warning. Serious sulfonamide-type reactions, eye contamination risks and the severe-renal-impairment restriction still apply.

Common trial effects include immediate burning/stinging/discomfort and bitter taste; superficial punctate keratitis, ocular allergy, redness, blurred vision, tearing/dryness and photophobia may occur. Uncommon systemic reports include fatigue, headache, nausea, rash and stones. Postmarketing reports include angioedema/bronchospasm, severe skin reactions, choroidal detachment after filtration surgery and dyspnea; frequencies are uncertain. Overdose may cause electrolyte imbalance, acidosis and CNS effects: seek emergency/Poison Help (1-800-222-1222). Professionals monitor electrolytes, particularly potassium, and blood pH; no home neutralization or invented antidote.

Concomitant oral carbonic anhydrase inhibitors, such as acetazolamide, are not recommended because systemic carbonic anhydrase effects can add. Review all glaucoma medicines; separately prescribed topical products require ≥5-minute spacing.

Oral carbonic anhydrase inhibitors have caused acid-base/electrolyte disturbances and toxicity interactions with high-dose salicylates. Such disturbances were not reported in dorzolamide trials, but the label advises considering the potential interaction. No unsupported low-dose-aspirin prohibition or dose-adjustment formula supplied.

CrCl <30 mL/min: not studied and not recommended because parent/metabolite are primarily renally excreted. Hepatic impairment: unstudied, use caution. No validated dialysis clearance, dialysis supplement or renal reduced-frequency regimen is supplied.

Pediatric efficacy and safety demonstrated in a three-month active-controlled trial; no exact pediatric minimum-age boundary is stated in the selected section, so none is invented. No overall safety/effectiveness differences were observed between older and younger patients; individual eye and organ comorbidities still matter.

Adequate controlled pregnancy studies are absent; animal studies found developmental toxicity at higher systemic exposures. Individualize benefit/risk without asserting human teratogenicity or zero risk. Human-milk presence, infant effects and milk-production effects are unknown; consider maternal need and feeding benefits/risks. Rat milk data do not prove human transfer magnitude or a required milk-discard interval.

Inhibits carbonic anhydrase II in the ciliary processes, reducing bicarbonate formation and associated sodium/fluid transport, thereby decreasing aqueous-humor secretion and intraocular pressure. Elevated pressure is a risk factor for optic-nerve damage and visual-field loss.

Ocular doses enter systemic circulation. Parent binds CA-II and accumulates in RBCs; N-desethyl metabolite accumulates mainly through CA-I binding. Plasma concentrations are generally very low, protein binding about 33%. Parent and metabolite are excreted in urine. After stopping, RBC washout is nonlinear, with a slow terminal phase of about four months; this is not a dosing interval or guaranteed duration of clinical IOP lowering.

Assess IOP response, prescribed frequency, adherence, corneal disease/endothelial concerns, allergy symptoms, renal suitability and interacting oral drugs. Follow the ophthalmologist’s glaucoma/ocular-hypertension examination plan; no universal IOP target, visit interval or routine laboratory schedule inferred from trials.

Use only in the prescribed eye(s), never share drops, keep tip away from eye/lids/surfaces and do not enlarge its opening. Remove soft contact lenses, observe 15-minute reinsertion and 5-minute other-drop spacing. Stop and report conjunctivitis/eyelid reactions; seek prompt advice after eye surgery, injury or infection about continued container use. Severe skin or systemic allergy symptoms need immediate assessment.

Strength / route

Sterile 2% ophthalmic solution, 20 mg/mL dorzolamide equivalent.

Selected bottle

10 mL, NDC 24208-485-10; white LDPE bottle with controlled drop tip and orange cap.

Status

Prescription standalone product, ANDA090143; label listing does not prove current stock.

Salt distinction

20 mg/mL dorzolamide equals 22.3 mg/mL dorzolamide hydrochloride.

Preservative

Benzalkonium chloride 0.0075% in this selected product; do not infer preservative-free status.

Package scope

Full PI also lists 5 mL fill in 7.5 mL bottle, NDC 24208-485-05; current SPL product panel focuses on 10 mL. No stock inference.

Excluded combinations

Dorzolamide/timolol and compounded combinations require their own dosing, contraindications and regulatory review.

Store at 20–25°C and protect from light. Selected Bausch & Lomb IFU permits use after opening until the bottle expiration date; do not substitute an invented universal 28-day rule or transplant this to every manufacturer. Safely discard expired/unneeded product and protect the sterile drop tip.