FDA-filed SPL labeling · retrieved through openFDA

Dorzolamide and Timolol Ophthalmic

Dorzolamide and timolol ophthalmic is a combination eye drop used to lower elevated eye pressure in adults and children with open-angle glaucoma or ocular hypertension.

Brand names CosoptCosopt Pf
Drug classes Adrenergic Beta-antagonists
Rx Form 1 Route Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 24 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 10, 2025
Clinical labels in scope 24
AvailabilityRx
Earliest approval/marketing year 2009
FDA-listed product records 51
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 15, 2026
Dorzolamide and Timolol Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dorzolamide and timolol ophthalmic eye drops are an effective two-in-one treatment for lowering elevated eye pressure in open-angle glaucoma or ocular hypertension, especially when a beta-blocker alone isn't enough. Because timolol and dorzolamide are absorbed systemically even from the eye, people with asthma, certain heart conditions, or sulfonamide allergies should not use it. Used as directed — twice a day, with at least five minutes between other eye drops — it can play an important role in protecting your vision.

📖 Dorzolamide and Timolol Ophthalmic: Patient Information Guide

A plain-language walkthrough of Dorzolamide and Timolol Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Dorzolamide and timolol ophthalmic is used to lower elevated pressure inside the eye (intraocular pressure) in patients who haven't responded well enough to a beta-blocker eye drop on its own.

  • Open-angle glaucoma — the most common form of glaucoma, where eye pressure rises and can damage the optic nerve over time
  • Ocular hypertension — higher-than-normal eye pressure that raises the risk of glaucoma but hasn't yet caused visible damage
  • Cosopt PF (preservative-free formulation) is specifically indicated for the above uses in patients insufficiently responsive to beta-blockers
  • The individual components, dorzolamide and timolol, have established safety and effectiveness in children aged 2 and older when used separately; their combined use in adults and children follows these principles
⚙️How it works

These drops work through two separate but complementary pathways. Dorzolamide blocks an enzyme called carbonic anhydrase II in the eye's ciliary body (the tissue that makes eye fluid). With that enzyme blocked, less aqueous humor — the clear fluid that fills the eye — is produced, and eye pressure drops. Timolol is a non-selective beta-blocker that also reduces aqueous humor production by blocking beta-adrenergic receptors in the same tissue. Together, they lower eye pressure more than either drug alone, which helps protect the optic nerve from damage caused by elevated pressure.

💊How it's taken

These eye drops are used twice daily — one drop in the affected eye or eyes each time. If you are also using other eye medications, space them at least 5 minutes apart to avoid washing one out before it works.

  • Cosopt PF comes in single-use preservative-free vials — open one, use it right away, and discard any leftover solution; don't store opened units
  • There are no specific food restrictions with eye drops
  • If you miss a dose, use it as soon as you remember, then continue your regular schedule — don't double up
  • Always follow your prescriber's specific instructions
🤒Side effects — in detail

The most common side effects affect your eyes or your sense of taste right after using the drops.

  • Bitter, sour, or unusual taste in the mouth (up to 30% of users)
  • Burning or stinging in the eye (up to 30% of users)
  • Eye redness (conjunctival hyperemia)
  • Blurred or cloudy vision
  • Eye itching
  • Superficial punctate keratitis (tiny irritation spots on the corneal surface)
  • Eye discharge, tearing, or foreign body sensation
  • Headache or dizziness

Serious reactions — including breathing problems, signs of heart failure, or severe skin reactions such as blistering or peeling rash — require immediate medical attention. Stop using the drops and contact your doctor or emergency services right away if any of these occur.

⚠️Warnings & precautions
  • Breathing problems: Timolol is absorbed into the bloodstream even from the eye. It can trigger severe bronchospasm or respiratory failure in people with asthma or COPD — this medication is contraindicated in those patients. Even patients with milder lung disease should generally avoid it.
  • Heart risks: Timolol can worsen heart failure or cause dangerously slow heart rate or heart block. Stop the drops and get immediate help if you develop signs of heart failure. People with sinus bradycardia, heart block, overt cardiac failure, or cardiogenic shock must not use this medication.
  • Sulfonamide reactions: Dorzolamide is a sulfonamide. Even as an eye drop, it can trigger rare but life-threatening reactions including Stevens-Johnson syndrome (a severe skin-blistering condition), toxic epidermal necrolysis, liver failure, and serious blood disorders. Any sign of a severe systemic reaction means stop the drops immediately.
  • Masking of low blood sugar: Timolol can hide the racing heartbeat that normally warns you of hypoglycemia. Diabetic patients — especially those on insulin — need to be extra vigilant.
  • Masking of thyroid problems: Timolol can hide the fast heart rate that signals an overactive thyroid (thyrotoxicosis). Don't stop the drops abruptly if thyroid disease is suspected, as this could trigger a thyroid storm.
  • Allergen sensitivity: If you have a history of severe allergic reactions, beta-blockers may make you less responsive to standard epinephrine (adrenaline) used to treat anaphylaxis.
🔀What it interacts with

Because timolol and dorzolamide enter the bloodstream from the eye, they can interact with several other medications.

  • Oral carbonic anhydrase inhibitors (e.g., acetazolamide): not recommended together — doubles up on the same mechanism and increases the risk of systemic side effects
  • Oral or topical beta-blockers: additive beta-blocking effects on heart rate and eye pressure; two topical beta-blockers should not be used together
  • Calcium channel blockers (e.g., verapamil, diltiazem): can cause heart rhythm disturbances, low blood pressure, or worsening heart function, especially in patients with cardiac problems
  • Digoxin combined with calcium channel blockers: may further slow electrical conduction through the heart
  • Catecholamine-depleting drugs (e.g., reserpine): can cause severe low blood pressure or very slow heart rate, leading to dizziness or fainting
  • CYP2D6 inhibitors (e.g., quinidine, certain SSRIs like fluoxetine): raise timolol blood levels, intensifying beta-blocking effects including slowed heart rate and mood effects
  • High-dose salicylates (e.g., high-dose aspirin): possible acid-base or electrolyte disturbances when combined with dorzolamide
  • Clonidine: stopping clonidine while using a beta-blocker may cause rebound high blood pressure

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have asthma, a history of asthma, or severe COPD — this is an absolute contraindication
  • Do not use if you have sinus bradycardia, second- or third-degree heart block, overt heart failure, or cardiogenic shock
  • Do not use if you are allergic to any component, including sulfonamide-type drugs
  • Tell your doctor if you have mild or moderate COPD, emphysema, or any bronchospastic condition — beta-blockers should generally be avoided in these situations
  • Tell your doctor if you have diabetes — timolol can mask hypoglycemia symptoms
  • Tell your doctor if you have a thyroid condition — timolol can hide signs of an overactive thyroid
  • Tell your doctor if you have kidney disease — dorzolamide has not been studied in severe kidney impairment and is not recommended in that setting; mild-to-moderate kidney disease warrants caution
  • Tell your doctor if you have liver disease — dorzolamide has not been studied in patients with severe hepatic impairment
  • Pregnancy: No adequate studies in pregnant women; animal studies showed some fetal effects at high doses. Discuss the risks and benefits with your doctor.
  • Breastfeeding: It is not known if these drugs pass into breast milk. Discuss with your doctor before using while nursing.
  • Children under 2 years: Safety and effectiveness have not been established in this age group
  • Older adults: No overall differences in safety or effectiveness have been observed compared to younger patients
  • Tell your surgeon or anesthesiologist you use these drops before any procedure — timolol can interfere with reflexes during surgery
🚑If you take too much

If too much of this medication enters the body — whether from the eye drops or accidentally — symptoms may include slow heart rate (bradycardia), bronchospasm (airway tightening), shortness of breath, dizziness, headache, electrolyte imbalances, abnormal blood pH, and in severe cases, cardiac arrest or effects on the central nervous system. If an overdose is suspected, seek emergency medical care right away. The label notes that timolol does not clear the body easily through dialysis.

📡Pharmacodynamics — effects in the body

Both dorzolamide and timolol work by reducing the production of aqueous humor — the fluid inside the eye — which directly lowers intraocular pressure (IOP). High IOP is the main risk factor for optic nerve damage and progressive vision loss in glaucoma. Using both agents together lowers IOP more than either drug alone. The combined twice-daily regimen produces a meaningful reduction in eye pressure, though it is slightly less than what is achieved when each drug is used at its maximum separate frequency.

🔬Pharmacokinetics — how your body processes it

Even though these are eye drops, both ingredients are absorbed into the bloodstream. Dorzolamide accumulates in red blood cells over time; its breakdown product is excreted in the urine. After stopping dorzolamide, it clears from red blood cells slowly — with a late-phase half-life of about four months. Timolol is also absorbed systemically from the eye; peak blood levels after a morning dose are very low but measurable. These systemic levels are enough to cause drug interactions and side effects typical of oral beta-blockers and sulfonamides, which is why careful patient selection matters.

📦How to store it

Store Dorzolamide hydrochloride and Timolol maleate Ophthalmic Solution, USP (preservative free) at 20° to 25°C (68° to 77°F) . Do not freeze. Store in the original pouch.

📄 Written from Dorzolamide and Timolol Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

71

Supplements & herbs that interact with Dorzolamide and Timolol Ophthalmic

71 supplements and herbal products have documented interactions with Dorzolamide and Timolol Ophthalmic in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 59
  • Minor · 11
Every supplement checked against Dorzolamide and Timolol Ophthalmic — ranked by severity The full interaction hub: 1 major · 59 moderate · 11 minor · every one linked to its full report. Check Dorzolamide and Timolol Ophthalmic against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Dorzolamide and Timolol Ophthalmic has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Dorzolamide and Timolol Ophthalmic nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dorzolamide and Timolol Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does this eye drop do — why do I need to lower my eye pressure?
Your eye constantly produces a small amount of clear fluid called aqueous humor. When that fluid doesn't drain well, pressure builds up inside the eye. Over time, high pressure can damage the optic nerve — the cable that sends what you see to your brain — and lead to vision loss or blindness. These drops contain two ingredients that each reduce how much fluid is made, bringing pressure down and helping protect your vision.
It's just an eye drop — can it really affect the rest of my body?
Yes, and this is really important to know. Both timolol and dorzolamide are absorbed into your bloodstream through the eye, even in small amounts. Timolol is a beta-blocker, so it can affect your heart and lungs just like a heart or blood pressure pill can. Dorzolamide is a sulfonamide, a drug class that rarely causes serious reactions in other parts of the body. That's why your doctor needs to know all your health conditions and other medications before you start these drops.
I have asthma — is this drop safe for me?
No — you should not use this drop if you have asthma or a history of asthma. Timolol, the beta-blocker in the drop, can trigger severe bronchospasm (airway tightening) and breathing problems, even at the small amounts absorbed through the eye. There have been reports of death from bronchospasm in asthma patients using timolol eye drops. Tell your doctor about your asthma so they can prescribe an alternative.
What side effects should I expect, and which ones mean I need to call someone?
The most common side effects are a bitter or unusual taste in your mouth right after using the drop, and some burning or stinging in the eye. You might also notice eye redness, itching, or temporarily blurred vision — these are bothersome but usually not dangerous. Call your doctor right away if you develop wheezing or trouble breathing, signs of a slow or irregular heartbeat, swelling, or unusual fatigue. A severe skin rash with blistering or peeling also needs emergency attention immediately.
How do I use the preservative-free version (Cosopt PF) correctly?
Cosopt PF comes in small single-use vials. Open one vial right before you use it, apply one drop to the affected eye or eyes, and then throw the vial away — even if there's liquid left over. Because it has no preservative, it can't stay sterile once opened, so saving it for later isn't safe. If you use other eye drops, wait at least 5 minutes between each one so they don't wash each other out.
I'm pregnant — is it okay to keep using this drop?
There are no well-controlled studies in pregnant women, so the safety isn't fully known. Animal studies at high doses showed some concerns. Don't stop the drops on your own without talking to your doctor first, because uncontrolled eye pressure has its own risks. Your doctor can help you weigh the benefits and risks and decide on the best plan for you and your baby. If you're breastfeeding, let your doctor know as well — it's unknown whether these drugs pass into breast milk.
Is Dorzolamide and Timolol Ophthalmic available over the counter?
Dorzolamide and Timolol Ophthalmic is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dorzolamide and Timolol Ophthalmic first available?
Dorzolamide and Timolol Ophthalmic has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dorzolamide and Timolol Ophthalmic?
Dorzolamide and Timolol Ophthalmic is supplied by 16 manufacturers listed in the FDA NDC Directory, including Aurobindo Pharma Limited, Akorn, Micro Labs Limited.

💬 Answers drafted from Dorzolamide and Timolol Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Dorzolamide and Timolol Ophthalmic comes

Dorzolamide and Timolol Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Cosopt Cosopt Pf
How this form is used
What it may be used for
  • Cosopt PF (preservative-free) is indicated to reduce elevated intraocular pressure in adults with open-angle glaucoma or ocular hypertension who have not responded adequately to beta-blocker eye drops alone
  • Dorzolamide Hydrochloride and Timolol Maleate eye drops are indicated for the same use in patients with open-angle glaucoma or ocular hypertension insufficiently responsive to beta-blockers
  • Safety and effectiveness of the individual components have been established in pediatric patients aged 2 years and older
Important instructions
  • Cosopt PF is a preservative-free formulation supplied in single-use units — open one unit, use immediately in one or both eyes, and discard any remaining solution right away
  • Apply one drop into the affected eye or eyes twice daily, as directed by your prescriber
  • If you use other eye drops, wait at least 5 minutes between each medication
  • Do not save opened single-use Cosopt PF units — sterility cannot be maintained once opened
Available strengths 2 strengths
51 FDA-listed product records

📊 Dorzolamide and Timolol Ophthalmic across the U.S. market

How Dorzolamide and Timolol Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
16
Manufacturers
7
Brand names
51
FDA-listed product records
2009
First marketed
Aurobindo Pharma Limited14%
Akorn10%
Micro Labs Limited10%
A-S Medication Solutions10%
Thea Pharma Inc.10%
Bryant Ranch Prepack10%
Other makers37%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Dorzolamide and Timolol Ophthalmic is used

A general measure of how commonly Dorzolamide and Timolol Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dorzolamide and Timolol Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

259,157
Medicaid prescriptions filled (Q1–Q4 2025)
$6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dorzolamide and Timolol Ophthalmic prescribed? Of the 1,594 medications we measure, Dorzolamide and Timolol Ophthalmic ranks #349 by Medicaid prescriptions — more than 78% of them.

Where Dorzolamide and Timolol Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Dorzolamide and Timolol Ophthalmic product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Dorzolamide and Timolol Ophthalmic products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

259,157 Medicaid prescriptions (Q1–Q4 2025) 100% of Dorzolamide and Timolol Ophthalmic prescriptions shown $6M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 12 of 33 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dorzolamide and Timolol Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 33 listed Dorzolamide and Timolol Ophthalmic NDCs with Medicaid activity.

🔍 Compare Dorzolamide and Timolol Ophthalmic products

A representative set of FDA-listed product records for Dorzolamide and Timolol Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 51 of 51 products — FDA National Drug Code Directory. See every product, package size and price: browse all 51 Dorzolamide and Timolol Ophthalmic NDCs →

🏷️ Sold under these brand names

Cosopt Cosopt Pf

🏭 Manufacturers & labelers

Aurobindo Pharma Limited 7 Akorn 5 Micro Labs Limited 5 A-S Medication Solutions 5 Thea Pharma Inc. 5 Bryant Ranch Prepack 5 Gland Pharma Limited 3 Leading Pharma, LLC 3 Somerset Therapeutics, LLC 3 Bausch & Lomb Incorporated 2 Sandoz Inc 2 Alembic Pharmaceuticals Inc. 2 Golden State Medical Supply, Inc. 1 Ingenus Pharmaceuticals, LLC 1 Alembic Pharmaceuticals Limited 1 Genus Lifesciences 1

RxNorm drug class

Dorzolamide and Timolol Ophthalmic belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, non-selective, Beta blocking agents
How it works Adrenergic beta-Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 10, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dorzolamide and Timolol Ophthalmic.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dorzolamide and Timolol Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
24
NDC products indexed
51
Distinct labelers/manufacturers represented
16
Linked representative label
Akorn
Linked label effective
Sep 10, 2025
Composite sections available
23
Linked SPL Set ID
4e90c721-21e8-46ea-ab49-19f535bf7202
Linked SPL Document ID
5c6a634a-b5ed-417d-b4b9-bc389538f59d
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 24 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Akorn is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.