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Dorzolamide Hydrochloride and Timolol Maleate

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Overview

What is Dorzolamide HCl and Timolol Maleate?

Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent.

Dorzolamide hydrochloride is described chemically as: (4)-4-(ethylamino)-5,6-dihydro-6-methyl-4-thieno[2,3-]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:

Its empirical formula is CHNOS•HCl and its structural formula is:

Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.

Timolol maleate is described chemically as: (-)-1-(-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:

Its molecular formula is CHNOS•CHOand its structural formula is: 

Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature.

Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.



What does Dorzolamide HCl and Timolol Maleate look like?



What are the available doses of Dorzolamide HCl and Timolol Maleate?

Solution containing 20 mg/mL dorzolamide and 5 mg/mL timolol. ()

What should I talk to my health care provider before I take Dorzolamide HCl and Timolol Maleate?

How should I use Dorzolamide HCl and Timolol Maleate?

Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day

The dose is one drop of dorzolamide hydrochloride-timolol maleate ophthalmic solution in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart


What interacts with Dorzolamide HCl and Timolol Maleate?

Sorry No Records found


What are the warnings of Dorzolamide HCl and Timolol Maleate?

Sorry No Records found


What are the precautions of Dorzolamide HCl and Timolol Maleate?

Sorry No Records found


What are the side effects of Dorzolamide HCl and Timolol Maleate?

Sorry No records found


What should I look out for while using Dorzolamide HCl and Timolol Maleate?

Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. ()

Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. ()

Hypersensitivity to any component of this product. (, )


What might happen if I take too much Dorzolamide HCl and Timolol Maleate?

Symptoms consistent with systemic administration of beta-blockers or carbonic anhydrase inhibitors may occur, including electrolyte imbalance, development of an acidotic state, dizziness, headache, shortness of breath, bradycardia, bronchospasm, cardiac arrest and possible central nervous system effects. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

A study of patients with renal failure showed that timolol did not dialyze readily.


How should I store and handle Dorzolamide HCl and Timolol Maleate?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution.No. 900 - Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied in a natural, LDPE plastic ophthalmic dispenser with a natural nozzle and a dark blue, tamper-evident cap.NDC StorageStore dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution.No. 900 - Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied in a natural, LDPE plastic ophthalmic dispenser with a natural nozzle and a dark blue, tamper-evident cap.NDC StorageStore dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution.No. 900 - Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied in a natural, LDPE plastic ophthalmic dispenser with a natural nozzle and a dark blue, tamper-evident cap.NDC StorageStore dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution.No. 900 - Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied in a natural, LDPE plastic ophthalmic dispenser with a natural nozzle and a dark blue, tamper-evident cap.NDC StorageStore dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is a clear, colorless to nearly colorless, slightly viscous solution.No. 900 - Dorzolamide hydrochloride-timolol maleate ophthalmic solution, USP is supplied in a natural, LDPE plastic ophthalmic dispenser with a natural nozzle and a dark blue, tamper-evident cap.NDC StorageStore dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dorzolamide hydrochloride-timolol maleate ophthalmic solution is comprised of two components: dorzolamide hydrochloride and timolol maleate. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma, by reducing aqueous humor secretion. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage.

Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase II. 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. Timolol maleate is a betaand beta(non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. The combined effect of these two agents administered as dorzolamide hydrochloride-timolol maleate ophthalmic solution twice daily results in additional intraocular pressure reduction compared to either component administered alone, but the reduction is not as much as when dorzolamide administered three times daily and timolol twice daily are administered concomitantly.

Non-Clinical Toxicology
Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. ()

Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. ()

Hypersensitivity to any component of this product. (, )

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

Absorption of tetracyclines is impaired by bismuth subsalicylate.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline may render oral contraceptives less effective.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Array

Dorzolamide hydrochloride-timolol maleate ophthalmic solution contains timolol maleate, a beta-adrenergic blocking agent; and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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