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Dorzolamide and timolol

Cosopt · Cosopt PF · Carbonic-anhydrase inhibitor / beta blocker

Product-specific glaucoma pressure control, systemic beta-blocker safety and preserved versus single-use handling.

Concentration
Dorzolamide 2% / timolol 0.5%
Schedule
One drop in affected eye(s) twice daily
PF handling
Immediate single use; opened pouch 15 days
Essential safety

Eye drops can cause systemic beta-blocker effects.

Avoid with asthma/history, severe COPD or specified bradycardia/heart disease. Urgently assess breathing trouble, fainting or severe hypersensitivity.

Warnings and precautions
01

Indications

Dorzolamide/timolol lowers intraocular pressure in selected open-angle glaucoma or ocular hypertension.

Labeled use

The fixed combination reduces elevated IOP in open-angle glaucoma or ocular hypertension insufficiently responsive to beta blockers, with target pressure assessed over multiple measurements. It is not an emergency acute-angle-closure regimen. Twice-daily combination pressure reduction was slightly less than separate dorzolamide three times daily plus timolol twice daily in label comparisons; do not present these schedules as identically effective.

Formulation and pediatric scope

Cosopt is a preserved multidose ophthalmic solution; Cosopt PF is preservative-free in single-dose containers. Both are prescription products. Label pediatric evidence establishes the individual components from age two; it does not supply a separately tested universal infant combination schedule. Use below two is not established. Preservative-free packaging does not remove systemic beta-blocker contraindications.

02

Dosage and administration

Instill one drop in each prescribed affected eye twice daily.

Eye-drop regimen and spacing

Use one drop in the affected eye(s) twice daily, commonly morning/evening. Separate other topical ophthalmic medicines by at least five minutes. Both forms contain dorzolamide 2% plus timolol 0.5%; increasing drop frequency is not an established way to compensate for inadequate control. Reassess IOP with the ophthalmology team rather than add duplicate beta-blocker drops.

ParameterLabel instruction
Affected eye(s)One drop twice daily
Other eye medicinesAt least five minutes apart
Combination concentrationDorzolamide 2% / timolol 0.5%
Cosopt PF opened vialUse immediately for one/both prescribed eyes; discard remainder

Preserved bottle and contact lenses

Wash hands, avoid touching eye/eyelid/surfaces with the tip, and replace the cap promptly. Preserved Cosopt contains benzalkonium chloride; remove contact lenses before use and wait at least 15 minutes before reinsertion. Do not enlarge the dropper hole or extract extra residual contents. Report possible contamination, infection, injury or surgery before continuing a questionable bottle.

Preservative-free vial handling

Open a vial only when ready to dose, instill promptly and discard the opened vial and remainder immediately, even if it looks sufficient for another dose. One vial can provide the prescribed dose to one or both eyes. Return unopened vials to their original foil pouch; discard unused vials 15 days after first pouch opening. The pouch limit does not permit storing an opened vial.

Organ function and age

No universal renal reduced-drop schedule is supplied. The combination is not recommended with severe renal impairment CrCl < 30 mL/min because dorzolamide/metabolite are predominantly renally excreted and unstudied there. Use cautiously in hepatic impairment. Older age alone does not require a label dose change, but comorbidity and systemic tolerance remain relevant.

03

Safety

Systemic beta-blockade, sulfonamide reactions and eye-surface risks require assessment.

Warnings and precautions

Although applied to the eye, both ingredients reach systemic circulation. Timolol can cause severe bronchospasm, bradycardia, hypotension or heart failure. Mild/moderate COPD or other bronchospastic disease generally should not receive beta blockers. It can mask hypoglycemia or hyperthyroid signs, worsen myasthenic weakness and reduce response to ordinary epinephrine doses during anaphylaxis.

Dorzolamide is a sulfonamide and can cause severe skin, hepatic or blood-cell hypersensitivity reactions; stop and urgently evaluate serious symptoms. Low corneal endothelial-cell counts increase corneal-edema risk. Tell surgical/anesthesia teams about beta-blocker drops; withdrawal decisions are individualized. Preserved multidose contamination can cause bacterial keratitis and vision-threatening damage.

Contraindications

Contraindicated with bronchial asthma or its history, severe COPD, sinus bradycardia, second/third-degree AV block, overt cardiac failure, cardiogenic shock or component hypersensitivity. A sulfa-allergy history needs careful reaction review; formal component hypersensitivity and severe-reaction precautions are distinct. PF packaging does not make the product appropriate when these contraindications exist.

Boxed-warning status

The selected Cosopt and Cosopt PF labels have no formal boxed warning. Potentially fatal bronchospasm, serious cardiac effects and severe sulfonamide hypersensitivity remain major precautions.

Adverse reactions

Common effects include bitter/unusual taste, ocular burning/stinging, redness, blurred vision, itching and superficial punctate keratitis. Serious reports include bradycardia, heart block/failure, respiratory failure/bronchospasm and severe allergic/skin reactions. Reports of individual-component or oral beta-blocker effects are not all measured combination-event frequencies.

04

Drug interactions

Review systemic and ophthalmic beta blockers, cardiac drugs and carbonic-anhydrase inhibitors.

Carbonic-anhydrase and salicylate interactions

Concomitant oral carbonic-anhydrase inhibitors are not recommended because systemic effects can add. High-dose salicylate therapy raises concern for interactions associated with carbonic-anhydrase inhibition; no fixed aspirin dose correction is established. Do not independently stop prescribed antiplatelet therapy; have the clinician review the actual dose and indication.

Beta blockers and cardiac conduction

Systemic beta blockers can add to both IOP and systemic blockade; use of two topical beta blockers is not recommended. Calcium-channel blockers, digoxin and catecholamine-depleting drugs can increase bradycardia, conduction disturbance, hypotension or ventricular failure; impaired cardiac function makes some combinations unsuitable. Monitor clinically rather than infer that topical timolol has no interaction.

CYP2D6 inhibitors and clonidine

CYP2D6 inhibitors such as quinidine or certain SSRIs have potentiated systemic timolol effects. Oral beta blockers can worsen clonidine-withdrawal hypertension; ophthalmic-timolol reports are lacking in this label, not proof of absence of risk. Coordinate changes to either drug rather than abruptly stop a regimen.

05

Use in specific populations

Renal function, respiratory/cardiac history and age matter even for eye drops.

Children and older adults

The labels cite separate dorzolamide/timolol pediatric evidence from age two and no established use below two. Choice of fixed combination and follow-up must remain clinician-directed. Overall older/younger trial differences were not observed, but assess bradycardia, respiration, falls and concomitant medicines in vulnerable adults.

Renal and hepatic impairment

Not recommended at CrCl < 30 mL/min; do not invent an alternate-day or half-drop workaround. Hepatic impairment is unstudied and requires caution. Beta-blocker contraindications and corneal/respiratory/cardiac risk remain relevant even with otherwise adequate kidney function.

Pregnancy

Adequate controlled studies of the combination in pregnant patients are lacking. Current PF labeling describes animal data without establishing human absence of risk. Discuss maternal IOP-treatment needs and alternatives with the clinician; older preserved-product pregnancy wording is not a current guarantee of safety.

Breastfeeding

Current PF label states milk excretion information is uncertain and calls for caution and individualized maternal-treatment/infant benefit-risk assessment. The older preserved label has more restrictive nursing language. These product labels do not establish zero infant exposure or a universal feeding interruption; review the actual product and infant circumstances.

06

Clinical pharmacology

Both components reduce aqueous-humor production through different pathways.

Mechanism

Dorzolamide inhibits carbonic anhydrase II in ciliary processes, reducing bicarbonate-related sodium/fluid transport and aqueous secretion. Timolol is a nonselective beta 1/beta 2 blocker that also reduces aqueous production. Lowering IOP addresses a major optic-nerve damage risk factor; no guarantee of reversing established visual-field loss is inferred.

Disposition

Dorzolamide reaches circulation and accumulates in red cells via carbonic-anhydrase binding; its N-desethyl metabolite also accumulates. Drug/metabolite are renally excreted; late red-cell washout has a roughly four-month half-life, not an eye-drop effect duration or dosing interval. Ophthalmic timolol produces measurable systemic exposure, consistent with respiratory/cardiac precautions.

07

Monitoring and counseling

Follow IOP, ocular health, systemic tolerance and correct handling.

Monitoring

Assess baseline IOP/response over repeated measurements, contraindications, renal function, corneal status and interacting medicines. Follow IOP and clinically appropriate optic-nerve/visual-field care, plus pulse/BP, breathing and symptoms when risk warrants. Check diabetes/hypoglycemia and myasthenic issues. No universal lab or visit interval is invented.

Counseling and urgent assessment

Use only in prescribed eyes and do not share. Avoid tip contamination; follow spacing and the correct bottle/vial discard rule. Seek urgent care for breathing difficulty, collapse, severe allergic/skin symptoms or sudden visual deterioration. Contact the eye clinician for infection, injury, surgery or persistent irritation and before continuing possibly contaminated medication. Tell surgical teams and every treating clinician about the drops.

08

Product identification

Preserved bottle and preservative-free single-dose vials share active strengths but differ in packaging.

Representative product identity

Selected preserved Cosopt is a clear nearly colorless sterile solution in a 10 mL white plastic bottle with blue cap, NDC 82584-605-10. PF uses 0.2 mL single-dose plastic containers, 15 per foil pouch and 60 per pack. Current FDA PF label and DailyMed §16 print different package NDC prefixes; verify the actual package rather than use a disputed identifier here.

Dosage forms and strengths

Both contain dorzolamide 2% (20 mg/mL active, 22.26 mg/mL hydrochloride) plus timolol 0.5% (5 mg/mL active, 6.83 mg/mL maleate). Preserved Cosopt has benzalkonium chloride 0.0075%; PF has no preservative. These are topical ophthalmic solutions, not gel-forming timolol monotherapy, oral medicines or injectable preparations.

Storage and handling

Selected preserved Cosopt: 20–25°C, protect from light; current label permits use after opening until the bottle expiration date. Do not replace another generic’s own expiry instructions with this rule. PF: 20–25°C, do not freeze; keep unopened vials in original foil pouch and discard 15 days after pouch opening. Opened PF vial is used once and discarded immediately.

09

References

Original sources for the clinical and product information.

  1. Thea / DailyMedCosopt · Current preserved-bottle full label

    PI05/2022; patient leaflet 05/2023; SPL 4 effective April 17, 2024; published April 30, 2024.

  2. Thea / DailyMedCosopt PF · Current preservative-free full label

    PI05/2026; patient leaflet 04/2026; SPL 5 effective May 13, 2026; published May 15, 2026.

  3. FDACosopt PF · Current FDA approved label

    2026 NDA202667 supplement 005; full 23-page label retained; relevant current clinical/product sections compared.

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