Trade Name: DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 20; 5 mg/mL; mg/mL

Storage and handling

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution 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 and timolol maleate ophthalmic solution 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 .
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a carbonic anhydrase inhibitor, and timolol maleate a beta-adrenergic receptor blocking agent 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.
  • The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily.
  • The dose is one drop of dorzolamide hydrochloride and 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 .
  • The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily.
  • Ophthalmic Solution containing dorzolamide 20 mg/mL (2%) equivalent to 22.26 mg/mL of dorzolamide hydrochloride and timolol 5 mg/mL (0.5%) equivalent to 6.83 mg/mL of timolol maleate.
  • Ophthalmic Solution containing dorzolamide 20 mg/mL (2%) and timolol 5 mg/mL (0.5%).
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with:
  • Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. (4.1)
  • Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. (4.2)
  • Hypersensitivity to any component of this product. (4.3, 5.3)
  • No data
  • Potentiation of Respiratory Reactions Including Asthma (5.1)
  • Cardiac Failure (5.2)
  • Sulfonamide Hypersensitivity (5.3)
  • Obstructive Pulmonary Disease (5.4)
  • Increased Reactivity to Allergens (5.5)
  • Potentiation of Muscle Weakness (5.6)
  • Masking of Hypoglycemic Symptoms in Patients with Diabetes
  • Mellitus (5.7)
  • Masking of Thyrotoxicosis (5.8)
  • Renal and Hepatic Impairment (5.9)
  • Impairment of Beta-Adrenergically Mediated Reflexes During Surgery (5.10)
  • The most frequently reported adverse reactions were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging in up to 30% of patients. Conjunctival hyperemia, blurred vision, superficial punctate keratitis or eye itching were reported between 5 to 15% of patients.
  • To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride and timolol maleate ophthalmic solution (7.1)
  • Potential acid-base and electrolyte disturbances. (7.2)
  • Concomitant use with systemic beta-blockers may potentiate
  • systemic beta-blockade. (7.3)
  • Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension.
  • (7.4)
  • Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. (7.5)
  • Digitalis and calcium antagonists, may have additive effects in prolonging atrioventricular conduction time. (7.6)
  • CYP2D6 inhibitors may potentiate systemic beta-blockade. (7.7)
  • No data
  • 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 effu00a0ects. 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.
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent.
  • Dorzolamide hydrochloride USP is described chemically as: ()-4- (ethylamino)- 5,6-dihydro-6-methyl-4H-[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride USP is optically active. The specific rotation is:
  • [u03b1] 25u00b0C (C=1, water) = ~ u221217u00b0.
  • 405 nm
  • Its empirical formula is CHNOSu2022HCl and its structural formula is:
  • Dorzolamide hydrochloride USP has a molecular weight of 360.91. It is a white to ou00a0-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.
  • Timolol maleate USP 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 USP is:
  • [u03b1] 25u00b0C in 1N HCl (C = 5) = u221212.2u00b0(-11.7u00b0 to -12.5u00b0).
  • 405 nm
  • Its molecular formula is CHNOSu2022CHO and its structural formula is:
  • Timolol maleate USP has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate USP is stable at room temperature.
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buu00a0ffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution USP contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride USP) and 5 mg timolol (equivalent to 6.83 mg timolol maleate USP). Inactive ingredients are sodium citrate dihydrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.
  • No data
  • In a two-year study of dorzolamide hydrochloride administered orally to male and female Sprague-Dawley rats, urinary bladder papillomas were seen in male rats in the highest dosage group of 20 mg/kg/day (250 times the recommended human ophthalmic dose). Papillomas were not seen in rats given oral doses equivalent to approximately 12 times the recommended human ophthalmic dose. No treatment-related tumors were seen in a 21-month study in female and male mice given oral doses up to 75 mg/kg/day (~900 times the recommended human ophthalmic dose).
  • The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class-effu00a0ect of carbonic anhydrase inhibitors in rats. Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria, and diverse sodium salts.
  • No changes in bladder urothelium were seen in dogs given oral dorzolamide hydrochloride for one year at 2 mg/kg/day (25 times the recommended human ophthalmic dose) or monkeys dosed topically to the eye at 0.4 mg/kg/day (~5 times the recommended human ophthalmic dose) for one year.
  • In a two-year study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Similar diu00a0fferences were not observed in rats administered oral doses equivalent to approximately 14,000 times the maximum recommended human ophthalmic dose.
  • In a lifetime oral study of timolol maleate in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.
  • The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.
  • The following tests for mutagenic potential were negative for dorzolamide: (1) (mouse) cytogenetic assay; (2) chromosomal aberration assay; (3) alkaline elution assay; (4) V-79 assay; and (5) Ames test.
  • Timolol maleate was devoid of mutagenic potential when tested (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2. A ratio of 2 is usually considered the criterion for a positive Ames test.
  • Reproduction and fertility studies in rats with either timolol maleate or dorzolamide hydrochloride demonstrated no adverse effu00a0ect on male or female fertility at doses up to approximately 100 times the systemic exposure following the maximum recommended human ophthalmic dose.
  • Clinical studies of 3 to 15 months duration were conducted to compare the IOP-lowering effu00a0ect over the course of the day of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily (dosed morning and bedtime) to individually and concomitantly administered 0.5% timolol twice daily and 2% dorzolamide twice and three times daily. The IOP-lowering eu00a0ffect of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was greater (1 to 3 mmHg) than that of monotherapy with either 2% dorzolamide three times daily or 0.5% timolol twice daily. The IOP-lowering eu00a0ffect of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was approximately 1 mmHg less than that of concomitant therapy with 2% dorzolamide three times daily and 0.5% timolol twice daily.
  • Open-label extensions of two studies were conducted for up to 12 months. During this period, The IOP lowering eu00a0ffect of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was consistent during the 12 month follow-up period.
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP 2% / 0.5% is supplied in a10 mL white LDPE bottle with natural LDPE nozzle and blue colored HDPE cap as follows:
  • NDC 70069--01, 10 mL fill in 10 mL bottle.
  • NDC 70069--12, 12 bottles in an inner carton.
  • One bottle along with package insert in a monocarton and 12 monocartons in an inner carton.
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature]. Protect from light.
  • Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for use).
  • Potential for Exacerbation of Asthma and COPD
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution may cause severe worsening of asthma and COPD symptoms including death due to bronchospasm. Advise patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease not to take this product. .
  • Potential of Cardiovascular Effects
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution may cause worsening of cardiac symptoms. Advise patients with sinus bradycardia, second or third degree atrioventricular block, or cardiac failure not to take this product. .
  • Sulfonamide Reactions
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution contains dorzolamide (which is a sulfonamide) and, although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration, including severe skin reactions. Advise patients that if serious or unusual reactions or signs of hypersensitivity occur, they should discontinue the use of the product and seek their physician's advice. .
  • Handling Ophthalmic Solutions
  • Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. .
  • Intercurrent Ocular Conditions
  • Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
  • Concomitant Topical Ocular Therapy
  • If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
  • Contact Lens Use
  • Advise patients that dorzolamide hydrochloride and timolol maleate ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of dorzolamide hydrochloride and timolol maleate ophthalmic solution.
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Hollywood, FL 33024
  • Made in India
  • Code No.: KR/DRUGS/KTK/28/289/97
  • ST-DRT11/P/02
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
  • for topical ophthalmic use
  • What is Dorzolamide hydrochloride and timolol maleate ophthalmic solution?
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a prescription eye drop solution that contains two medicines, dorzolamide hydrochloride called an ophthalmic carbonic anhydrase inhibitor and timolol maleate called a beta-blocker.
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution is used to lower high pressure in the eye in people with open-angle glaucoma or ocular hypertension when a beta-blocking medicine alone does not work to control the eye pressure. It is not known if dorzolamide hydrochloride and timolol maleate ophthalmic solution is safe and effective in children 2 years of age and younger.
  • Do not use dorzolamide hydrochloride and timolol maleate ophthalmic solution if you
  • Before using dorzolamide hydrochloride and timolol maleate ophthalmic solution, tell your healthcare provider about all your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution may affect the way medicines work, and other medicines may affect how dorzolamide hydrochloride and timolol maleate ophthalmic solution works. Do not start a new medicine without first talking to your healthcare provider. Ask your healthcare provider or pharmacist for a list of medicines you are using, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I use Dorzolamide hydrochloride and timolol maleate ophthalmic solution?
  • What are the possible side effects of dorzolamide hydrochloride and timolol maleate ophthalmic solution?
  • Dorzolamide hydrochloride and timolol maleate ophthalmic solution may cause serious side effects, including:
  • Stop using dorzolamide hydrochloride and timolol maleate ophthalmic solution and call your healthcare provider or get emergency help right away if you get any of these symptoms of an allergic reaction:
  • The most common side effects of dorzolamide hydrochloride and timolol maleate ophthalmic solution include:
  • These are not all the possible side effects of dorzolamide hydrochloride and timolol maleate ophthalmic solution.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088
  • How should I store n- dorzolamide hydrochloride and timolol maleate ophthalmic solution?
  • Keep n- dorzolamide hydrochloride and timolol maleate ophthalmic solution and all medicine out of the reach of children.
  • General information about the safe and effective use of n- dorzolamide hydrochloride and timolol maleate ophthalmic solution.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use dorzolamide hydrochloride and timolol maleate ophthalmic solution for a condition for which it was not prescribed. Do not give dorzolamide hydrochloride and timolol maleate ophthalmic solution to other people, even if they have the same symptoms that you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about dorzolamide hydrochloride and timolol maleate ophthalmic solution that is written for health professionals.
  • What are the ingredients in n- dorzolamide hydrochloride and timolol maleate ophthalmic solution?
  • Active ingredients:
  • Inactive ingredients:
  • This Patient Package Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 11/2020
  • Container Label
  • Carton Label

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE) which is also known as DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 20; 5 mg/mL; mg/mL.

DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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