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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Dorzolamide Hydrochloride And Timolol Maleate
Brand Name
Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
Generic Name
Dorzolamide Hydrochloride And Timolol Maleate
Active Ingredient
DorzolamideCategory
Other
Salt Form
Hydrochloride
Variants
2
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 22.3 mg/mL | SOLUTION/ DROPS | OPHTHALMIC | 72162-2381 |
| 22.3 mg/mL | SOLUTION/ DROPS | OPHTHALMIC | 42571-147 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution, you must consult a qualified healthcare professional.
Detailed information about Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
Dorzolamide is a potent carbonic anhydrase inhibitor used primarily to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It works by decreasing the production of aqueous humor in the eye.
For the treatment of open-angle glaucoma or ocular hypertension, the standard adult dosage of dorzolamide 2% ophthalmic solution is:
When dorzolamide is used as an adjunctive therapy (added to another glaucoma medication like a beta-blocker), the dosage is typically one drop twice daily (BID). However, your ophthalmologist (eye specialist) will determine the exact frequency based on your intraocular pressure (IOP) response. Clinical trials have demonstrated that the three-times-daily regimen provides the most consistent pressure-lowering effect throughout a 24-hour period.
Dorzolamide has been studied in pediatric patients. For children with glaucoma or elevated IOP, the dosage is generally the same as the adult dosage:
Safety and efficacy have been established in children as young as infants, though it is used with caution. Pediatric patients should be monitored closely for systemic side effects, particularly if they are also taking oral carbonic anhydrase inhibitors.
Dorzolamide is primarily excreted by the kidneys. Because the drug and its metabolites can accumulate in the setting of kidney disease, dorzolamide is not recommended for patients with severe renal impairment (Creatinine Clearance < 30 mL/min). There are no specific dose adjustments for mild to moderate renal impairment, but caution is advised.
Dorzolamide has not been extensively studied in patients with hepatic (liver) impairment. Because the drug is metabolized in the liver, it should be used with caution in patients with known liver disease.
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage remains the standard 2% solution TID.
Proper administration is crucial to ensure the medication reaches the eye and to minimize systemic absorption:
If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Do not apply a double dose to make up for a missed one. Maintaining a consistent schedule is vital for controlling eye pressure.
While systemic overdose from topical ophthalmic use is unlikely, accidental ingestion or excessive use can occur. Symptoms of systemic CAI overdose may include electrolyte imbalance, development of an acidotic state (metabolic acidosis), and potential central nervous system effects (dizziness, fatigue). In the event of an overdose, seek emergency medical attention or contact a poison control center immediately. Treatment is typically supportive, focusing on maintaining electrolyte balance.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop using the medication without medical guidance, as this can lead to a dangerous spike in eye pressure.
The most frequently reported side effect of dorzolamide is a bitter, sour, or unusual taste (dysgeusia) in the mouth shortly after application. This occurs because the medication drains through the tear ducts into the throat.
Other very common effects include:
Dorzolamide is a sulfonamide (a 'sulfa' drug). Although it is applied topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with dorzolamide. This includes the risk of severe skin reactions and blood disorders. Patients should be aware that if they have a known allergy to sulfa medications, they are at a higher risk of reacting to dorzolamide.
No FDA black box warnings for Dorzolamide.
Conditions where Dorzolamide must NEVER be used include:
There are no adequate and well-controlled studies of dorzolamide in pregnant women. In animal studies (rabbits), dorzolamide administered at doses that caused maternal toxicity (metabolic acidosis) resulted in skeletal malformations of the vertebral bodies.
It is not known whether dorzolamide is excreted in human milk. However, because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dorzolamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used, the mother should perform punctal occlusion (pressing the corner of the eye) to minimize systemic absorption.
Dorzolamide is a potent inhibitor of human carbonic anhydrase II (CA-II). Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells (RBCs) but also in other tissues.
Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a reduction in intraocular pressure (IOP). Dorzolamide is highly specific for CA-II and does not significantly inhibit other enzymes at therapeutic concentrations.
The onset of action for dorzolamide is typically within 60 to 90 minutes after a single dose. The peak effect occurs at approximately 2 hours, and the pressure-lowering effect is maintained for at least 8 to 12 hours. Unlike some other glaucoma medications, there is no evidence of tachyphylaxis (rapidly diminishing response) or significant tolerance development with long-term use of dorzolamide.
Common questions about Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
Dorzolamide is a prescription eye drop used to treat high pressure inside the eye, a condition known as ocular hypertension, or to manage open-angle glaucoma. By lowering eye pressure, it helps prevent damage to the optic nerve and protects against vision loss or blindness. It belongs to a class of drugs called carbonic anhydrase inhibitors, which work by reducing the amount of fluid (aqueous humor) produced within the eye. Your doctor may prescribe it as a standalone treatment or in combination with other eye drops. It is important to use it regularly as prescribed to maintain stable eye pressure.
The most common side effect reported by patients is a bitter or unusual taste in the mouth shortly after applying the drops, which occurs as the medicine drains into the throat. Many people also experience a temporary burning or stinging sensation in the eye immediately after use. Other frequent side effects include blurred vision, eye redness, itching, and increased tearing. These effects are usually mild and short-lived. However, if you experience severe eye pain or persistent irritation, you should contact your ophthalmologist. Always report any signs of a skin rash, as this could indicate a more serious allergic reaction.
There is no known direct interaction between alcohol and dorzolamide eye drops. Because dorzolamide is applied topically, very little of the drug reaches your bloodstream compared to oral medications. However, excessive alcohol consumption can sometimes affect your overall eye health and may interfere with your ability to follow your dosing schedule. It is generally safe to consume alcohol in moderation while using these drops. If you have any concerns about how alcohol might affect your specific condition or other medications you are taking, it is best to consult your healthcare provider for personalized advice.
Dorzolamide is classified as FDA Pregnancy Category C, meaning there are no adequate studies in humans, but animal studies have shown potential risks to the fetus at high doses. It should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the unborn baby. High eye pressure must be controlled to protect the mother's vision, but your doctor may explore other treatment options or monitor you more closely. If you are pregnant or planning to become pregnant, discuss the risks and benefits with both your eye specialist and your obstetrician. Performing punctal occlusion (pressing the corner of the eye) can help reduce the amount of drug that reaches the baby.
Dorzolamide begins to lower intraocular pressure relatively quickly, usually within 60 to 90 minutes after the first drop is applied. The maximum effect on eye pressure is typically reached about 2 hours after application. While the immediate effect is fast, it may take several days or even weeks of consistent use for your doctor to determine the full long-term effectiveness of the medication for your condition. You will likely need follow-up appointments to measure your eye pressure and ensure the drug is working as intended. Do not stop using the drops even if you do not 'feel' a difference, as glaucoma often has no symptoms.
You should never stop taking dorzolamide suddenly without first consulting your healthcare provider. Glaucoma is a chronic condition that requires continuous management to prevent permanent vision loss. If you stop the medication, your intraocular pressure will likely return to its previous high levels, which can cause silent and irreversible damage to your optic nerve. If you are experiencing bothersome side effects, your doctor can help you transition to a different medication safely. Always ensure you have a sufficient supply of your eye drops so that you do not run out and miss doses.
If you miss a dose of dorzolamide, you should apply the missed drop as soon as you realize it. However, if it is almost time for your next scheduled dose, you should skip the missed dose entirely and continue with your regular routine. Do not apply two drops at once to make up for the missed one, as this will not improve the effectiveness and may increase the risk of side effects. To help remember your doses, try to use the drops at the same time every day, such as when you wake up, at lunchtime, and before bed. Consistency is key to controlling eye pressure effectively.
Weight gain is not a recognized or common side effect of dorzolamide ophthalmic solution. Clinical trials and post-marketing surveillance have not shown a significant link between this eye drop and changes in body weight. Because the medication is applied topically to the eye, systemic absorption is very low, making systemic side effects like weight changes highly unlikely. If you experience sudden or unexplained weight gain while using this medication, it is likely due to other factors or medications. You should discuss any significant changes in your health or weight with your primary care physician to identify the underlying cause.
Dorzolamide can be used with many other medications, but some interactions are possible. It should generally not be used with oral carbonic anhydrase inhibitors like acetazolamide, as this can increase the risk of systemic side effects. If you use other eye drops, you must wait at least 5 to 10 minutes between applying each medication to ensure they are properly absorbed. You should also inform your doctor if you are taking high doses of aspirin, as this can occasionally interact with medications in the same class as dorzolamide. Always provide your healthcare team with a complete list of all prescriptions, over-the-counter drugs, and supplements you use.
Yes, dorzolamide is available as a generic medication, which is typically more cost-effective than the brand-name version, Trusopt. Generic dorzolamide 2% ophthalmic solution is FDA-approved and required to meet the same strict standards for quality, strength, and purity as the brand-name drug. Both the brand and generic versions work in the same way to lower eye pressure. Availability may vary by pharmacy, but most major providers carry the generic version. If you have concerns about the cost of your medication, ask your pharmacist or doctor if a generic version is appropriate for you.
Other drugs with the same active ingredient (Dorzolamide)
While rare, some side effects require urgent medical intervention.
> Warning: Stop taking Dorzolamide and call your doctor immediately if you experience any of these:
Prolonged use of dorzolamide is generally well-tolerated. However, long-term exposure to the preservative benzalkonium chloride (found in many multi-dose bottles) can lead to Dry Eye Syndrome or ocular surface disease. Patients on long-term therapy should have their corneal health monitored regularly. There is also a theoretical risk of systemic accumulation in red blood cells, though clinical consequences of this in patients with healthy kidneys are negligible.
There are currently no FDA black box warnings for dorzolamide ophthalmic solution. However, the labeling contains significant warnings regarding its sulfonamide nature and the potential for severe hypersensitivity reactions.
Report any unusual symptoms or persistent irritation to your healthcare provider. If you develop an eye infection or sustain an eye injury, consult your doctor immediately regarding the continued use of your multi-dose bottle.
Patients using dorzolamide should undergo regular ophthalmic monitoring, including:
Dorzolamide may cause temporary blurred vision immediately after application. Do not drive, operate heavy machinery, or perform hazardous activities until your vision is clear. If you experience persistent dizziness or fatigue, consult your doctor.
There are no known direct interactions between alcohol and dorzolamide. However, alcohol can sometimes affect eye pressure and general hydration. It is best to consume alcohol in moderation while being treated for glaucoma.
Do not stop using dorzolamide abruptly unless directed by your doctor. Glaucoma is often a 'silent' disease with no symptoms until vision is lost. Stopping the medication can result in a rapid increase in intraocular pressure, which can cause irreversible damage to the optic nerve. There is no 'withdrawal syndrome,' but the return of high IOP is a significant risk.
> Important: Discuss all your medical conditions, especially kidney disease, liver disease, or sulfonamide allergies, with your healthcare provider before starting Dorzolamide.
There are no known specific food interactions with dorzolamide. Unlike some oral medications, its absorption is not affected by diet because it is applied topically. However, maintaining a consistent intake of potassium-rich foods is generally good practice for patients at risk of electrolyte shifts, though this risk is negligible with topical dorzolamide.
Dorzolamide is not known to interfere with common laboratory tests. However, because it is a sulfonamide, it could theoretically interfere with certain tests for urinary protein or glucose that use older chemical methods, though modern enzymatic tests are unaffected.
For each major interaction, the primary concern is the potential for systemic accumulation or additive pharmacological effects. In the case of oral CAIs, the mechanism is pharmacodynamic (both drugs hitting the same target), leading to increased risk of systemic acidosis. Management involves avoiding the combination or choosing an alternative class of glaucoma medication (like a prostaglandin analog).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter eye washes or allergy drops.
Conditions requiring careful risk-benefit analysis by a physician:
As mentioned, the primary cross-sensitivity concern is with other sulfonamides. This includes certain antibiotics (like sulfamethoxazole), sulfonylureas (used for diabetes), and certain diuretics (like furosemide or thiazides). While many patients with a 'sulfa' allergy can tolerate these other classes, the risk with dorzolamide is considered high enough to warrant a contraindication in the setting of severe prior reactions.
> Important: Your healthcare provider will evaluate your complete medical history, including any past allergic reactions to antibiotics or other eye drops, before prescribing Dorzolamide.
The safety and effectiveness of dorzolamide have been established in pediatric patients. In a 3-month clinical study, the side effect profile in children was generally similar to that in adults. However, some children experienced higher rates of conjunctivitis and eyelid irritation. It is approved for use in children, but dosing should be strictly supervised by a parent or caregiver to ensure proper technique and prevent contamination.
A large percentage of patients treated for glaucoma are over the age of 65. Clinical data indicates that the efficacy and safety of dorzolamide are comparable between elderly patients and younger adults. However, elderly patients may be more likely to have age-related renal decline. Since the drug is contraindicated in severe renal impairment, kidney function should be considered when prescribing for very elderly or frail patients.
As noted, dorzolamide is not recommended for patients with a GFR or CrCl < 30 mL/min. In patients with mild to moderate impairment, no specific dose adjustment is required, but they should be monitored for signs of systemic CAI toxicity, such as unusual fatigue or metallic taste.
Because dorzolamide is metabolized by the liver, patients with Child-Pugh Class B or C impairment should be treated with caution. While no specific dosing guidelines exist, these patients should be monitored for any signs of increased systemic drug effects.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are planning a pregnancy or are currently breastfeeding.
| Parameter | Value |
|---|---|
| Bioavailability | Low systemic levels; sequestered in RBCs |
| Protein Binding | Approximately 33% |
| Half-life (RBCs) | ~120 days |
| Tmax (Plasma) | N/A (Topical application) |
| Metabolism | Hepatic (N-desethyl metabolite) |
| Excretion | Renal (Parent and metabolite) |
Dorzolamide is classified as a Carbonic Anhydrase Inhibitor. It is distinct from other glaucoma classes such as Prostaglandin Analogs (e.g., latanoprost), Beta-Blockers (e.g., timolol), and Alpha-Agonists (e.g., brimonidine). It is frequently used when these other classes are insufficient or inappropriate for the patient.