DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE_- dorzolamide hydrochloride and timolol maleate_solution/ drops

Dorzolamide hydrochloride and 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. 1 2 [See Clinical Studies (14) Dorzolamide Hydrochloride.

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 [see Clinical Studies (14) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, 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. [see Drug Interactions (7. 3) The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily.

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. (6) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www. gov/medwatch. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cardiovascular: Digestive: Immunologic: Nervous System/Psychiatric: Skin: Hypersensitivity: Respiratory: Endocrine: Special Senses: Urogenital: Musculoskeletal The following adverse reactions have been identified during post-approval use of dorzolamide hydrochloride and timolol maleate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: bradycardia, cardiac failure, cerebral vascular accident, chest pain, choroidal detachment following filtration surgery, depression, diarrhea, dry mouth, dyspnea, heart block, hypotension, iridocyclitis, myocardial infarction, nasal congestion, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, photophobia, respiratory failure, skin rashes, urolithiasis, and vomiting. Allergic: Body as a Whole: Cardiovascular: Digestive: Hematologic: Endocrine: Skin: Musculoskeletal: Nervous System/Psychiatric: Respiratory: Urogenital:.

Dorzolamide hydrochloride and timolol maleate is contraindicated in patients with: Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. 1) Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. 2) Hypersensitivity to any component of this product. 3) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5. 1) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see Warnings and Precautions (5. 2) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.

Teratogenic Effects It is not known whether dorzolamide is excreted in human milk. Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from dorzolamide hydrochloride and timolol maleate in nursing infants, 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. The safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. Use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride and timolol maleate. 1) Potential acid-base and electrolyte disturbances. 2) Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. 3) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. 4) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. 5) Digitalis and calcium antagonists, may have additive effects in prolonging atrioventricular conduction time. 6) CYP2D6 inhibitors may potentiate systemic beta-blockade. 7) There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide hydrochloride and timolol maleate. The concomitant administration of dorzolamide hydrochloride and timolol maleate and oral carbonic anhydrase inhibitors is not recommended. Although acid-base and electrolyte disturbances were not reported in the clinical trials with dorzolamide hydrochloride ophthalmic solution, these disturbances have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e. , toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving dorzolamide hydrochloride and timolol maleate. Patients who are receiving a beta-adrenergic blocking agent orally and dorzolamide hydrochloride and timolol maleate should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Caution should be used in the coadministration of beta-adrenergic blocking agents, such as dorzolamide hydrochloride and timolol maleate, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided. Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs, such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension. The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. Potentiated systemic beta-blockade (e. , decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e. , quinidine, SSRIs) and timolol. Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.

OVERDOSAGE
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. [See Adverse Reactions (6)
NONCLINICAL TOXICOLOGY
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). in vivo in vitro in vivo in vitro
CLINICAL STUDIES
Clinical studies of 3 to 15 months duration were conducted to compare the IOP-lowering effect over the course of the day of dorzolamide hydrochloride and timolol maleate 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 effect of dorzolamide hydrochloride and timolol maleate 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 effect of dorzolamide hydrochloride and timolol maleate twice daily was approximately 1 mmHg less than that of concomitant therapy with 2% dorzolamide three times daily and 0.5% timolol twice daily.
PATIENT INFORMATION
Dorzolamide Hydrochloride and Timolol Maleate (dor zoe'' la mide hye'''' droe klor'' ide and tim'' oh lol mal'' ee ate) Ophthalmic Solution, USP 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: have or have had asthma. have chronic obstructive pulmonary disease (COPD) which includes emphysema, chronic bronchitis or both. have heart problems including a slow heartbeat, heart block, heart failure, or your heart muscle suddenly becomes weak due to a severe heart attack or other heart problem that caused heart damage (cardiogenic shock). are allergic to any of the ingredients in dorzolamide hydrochloride and timolol maleate ophthalmic solution. See the end of this Patient Information leaflet for a complete list of ingredients in dorzolamide hydrochloride and timolol maleate ophthalmic solution. Before using dorzolamide hydrochloride and timolol maleate ophthalmic solution, tell your healthcare provider about all your medical conditions, including if you: have or have had allergies to sulfa drugs have a history of anaphylactic reactions to allergens have atopy (genetic disposition to develop allergic reactions) have or have had muscle weakness or myasthenia gravis have diabetes have thyroid disease have or have had kidney or liver problems plan to have any type of surgery wear contact lenses are using any other eye drops have an eye infection or eye trauma are pregnant or plan to become pregnant. It is not known if dorzolamide hydrochloride and timolol maleate ophthalmic solution will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using dorzolamide hydrochloride and timolol maleate ophthalmic solution. You and your healthcare provider will decide if you should use dorzolamide hydrochloride and timolol maleate ophthalmic solution while you are pregnant. are breastfeeding or plan to breastfeed. It is not known if dorzolamide hydrochloride and timolol maleate ophthalmic solution passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while using dorzolamide hydrochloride and timolol maleate ophthalmic solution. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use dorzolamide hydrochloride and timolol maleate ophthalmic solution? See the complete Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use dorzolamide hydrochloride and timolol maleate ophthalmic solution. Use dorzolamide hydrochloride and timolol maleate ophthalmic solution exactly as your healthcare provider tells you. Use 1 drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye or both eyes if needed, 2 times each day. 1 drop in the morning and 1 drop in the evening. If you are using dorzolamide hydrochloride and timolol maleate ophthalmic solution with another eyedrop, wait at least 5 minutes If you have eye surgery or have any problems with your eye such as trauma or an infection, talk to your healthcare provider about continuing to use the bottle (multi-dose) that contains dorzolamide hydrochloride and timolol maleate ophthalmic solution. Dorzolamide hydrochloride and timolol maleate ophthalmic solution contains a preservative called benzalkonium chloride. The preservative may be absorbed by soft contact lenses. If you wear contact lenses, remove them before using dorzolamide hydrochloride and timolol maleate ophthalmic solution. The lenses can be placed back into your eyes 15 minutes after using dorzolamide hydrochloride and timolol maleate ophthalmic solution. Do not If you think your dorzolamide hydrochloride and timolol maleate ophthalmic solution medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of dorzolamide hydrochloride and timolol maleate ophthalmic solution. If you use too much dorzolamide hydrochloride and timolol maleate ophthalmic solution you may have dizziness, headaches, shortness of breath, slow heartbeats, or problems breathing. If you have any of these symptoms call your healthcare provider or go to the nearest hospital emergency room right away. 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: severe breathing problems. heart failure. o shortness of breath serious sulfa (sulfonamide) reactions. o severe skin reactions 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: increased allergic reactions. 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: o swelling of your face, lips, mouth, or tongue o trouble breathing worsening muscle weakness. swelling of eye. 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-FDA-1088 How should I store dorzolamide hydrochloride and timolol maleate ophthalmic solution? Store at 20° to 25°C (68° to 77°F). Protect from light. Do not Keep 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 dorzolamide hydrochloride and timolol maleate ophthalmic solution. What are the ingredients in dorzolamide hydrochloride and timolol maleate ophthalmic solution? Active ingredients: Inactive ingredients: Manufactured for: Manufactured by: Issued: 03/2025 INSTRUCTIONS FOR USE Dorzolamide Hydrochloride and Timolol Maleate (dor zoe'' la mide hye'''' droe klor'' ide and tim'' oh lol mal'' ee ate) Ophthalmic Solution, USP Read this Instructions for Use before you start using dorzolamide hydrochloride and timolol maleate ophthalmic solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Important Information: Dorzolamide hydrochloride and timolol maleate ophthalmic solution is for use in the eye. If you are using dorzolamide hydrochloride and timolol maleate ophthalmic solution with another eyedrop, wait at least 5 minutes If you wear contact lenses, remove them before using dorzolamide hydrochloride and timolol maleate ophthalmic solution. The lenses can be placed back into your eyes 15 minutes after Do not If you think your dorzolamide hydrochloride and timolol maleate ophthalmic solution medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of dorzolamide hydrochloride and timolol maleate ophthalmic solution. Wash your hands before each use to make sure you do not infect your eyes while using dorzolamide hydrochloride and timolol maleate ophthalmic solution. Before using the eyedrops for the first time, be sure the tamper evident ring on the bottle is not broken. If the tamper evident ring is broken, call your pharmacist to get a new bottle of dorzolamide hydrochloride and timolol maleate ophthalmic solution. Figure A Step 3. not Figure B Step 5. Steps 3 and 4 Step 6. Do not Step 7. wait at least 15 minutes The dropper tip is made to give a single drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution. Do not After you have used all of your doses of dorzolamide hydrochloride and timolol maleate ophthalmic solution, there will be some dorzolamide hydrochloride and timolol maleate ophthalmic solution left in the bottle. There is an extra amount of dorzolamide hydrochloride and timolol maleate ophthalmic solution that has been added to the bottle. You will get the full amount of dorzolamide hydrochloride and timolol maleate ophthalmic solution that your doctor prescribed. Do not This Instructions for Use has been approved by the U. Food and Drug Administration Manufactured for: Manufactured by: Issued: 03/2025 dorzolamide-timolol-fig1 dorzolamide-timolol-fig2.

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DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE_- dorzolamide hydrochloride and timolol maleate_solution/ drops Product manual source documgent