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DUOKOPT is a brand name for Dorzolamide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DUOKOPT® (dorzolamide hydrochloride and timolol maleate ophthalmic solution) is indicated in the treatment of elevated intraocular pressure (IOP) in patients with: • ocular hypertension • open-angle glaucoma when concomitant therapy is appropriate. DUOKOPT® preservative-free formulation is indicated in patients who…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • When substituting DUOKOPT® for another ophthalmic antiglaucoma agent(s), discontinue the other agent(s) after proper dosing on one day, and start DUOKOPT® on the following day. • If another topical ophthalmic agent is being used, DUOKOPT® and the other agent should be administered at least ten minutes apart.
2 Recommended Dose and Dosage Adjustment • Adults (≥18 years of age): The dose is one drop of DUOKOPT® (dorzolamide hydrochloride and timolol maleate) in the affected eye(s) two times daily. • Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use (see Pediatrics).
4 Administration Do not allow the bottle dropper tip to touch the eye or areas around the eye. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.
This may result in a decrease in systemic side effects and an increase in local activity. If the patient has difficulty administering their DUOKOPT® eye drops, the assistance of a family member or caregiver may be needed. 5 Missed Dose If a dose is missed, it should be applied as soon as possible.
However, if it is almost time for the next dose, the missed dose should be skipped, and the next dose should be taken as usual.
1 Adverse Reaction Overview Adverse reactions have been seen with dorzolamide hydrochloride and timolol maleate, thus potential adverse reactions following use of DUOKOPT® may include: Dorzolamide Hydrochloride Headache; eyelid inflammation; eyelid crusting; eyelid irritation; asthenia/fatigue; iridocyclitis; rash; dizziness; paraesthesia; superficial punctate keratitis, transient myopia (which resolved upon discontinuation of therapy); signs and symptoms of local reactions including palpebral reactions and systemic allergic reactions including angioedema, bronchospasm, urticaria, epistaxis and pruritus; throat irritation, dry mouth.
Timolol Maleate (topical formulation) Signs and symptoms of ocular irritation, including conjunctivitis, blepharitis, keratitis, and decreased corneal sensitivity, dry eyes; visual disturbances, including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, and ptosis; choroidal detachment following filtration surgery, tinnitus; aggravation or precipitation of certain cardiovascular pulmonary and other disorders presumably related to effects of systemic beta-blockade has been reported (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
These include bradycardia; arrhythmia; hypotension; syncope; heart block; cerebrovascular accident; cerebral ischemia; palpitation; cardiac arrest, edema, claudication, Raynaud’s phenomenon, cold hands and feet; congestive heart failure, and in insulin- dependent diabetics masked symptoms of hypoglycemia have been reported rarely.
In clinical trials, slight reduction of the resting heart rate in some patients; bronchospasm (predominantly in patients DUOKOPT® (dorzolamide hydrochloride and timolol maleate) Page 11 of 31 with pre-existing bronchospastic disease); cough; headache; asthenia; fatigue; chest pain; alopecia; psoriasiform rash or exacerbation of psoriasis; signs and symptoms of allergic reactions including anaphylaxis angioedema, urticaria, localized and generalized rash; dizziness; increase in signs and symptoms of myasthenia gravis; insomnia; nightmares; memory loss; paresthesia; diarrhea, dyspepsia, dry mouth; abdominal pain; decreased libido, Peyronie’s disease; sexual dysfunction; systemic lupus erythematous; myalgia.
General As with other topically-applied ophthalmic agents, the active substances may be absorbed systemically. Dorzolamide is a sulfonamide and timolol is a beta-blocker. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides or beta-blockers may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Ophthalmic Solution, each mL contains dorzolamide 20 mg and timolol 5 mg hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection DUOKOPT® (dorzolamide hydrochloride and timolol maleate) Page 7 of 31 addition to ocular hypotensive agents.
Dorzolamide hydrochloride and timolol maleate ophthalmic solution has not been studied in patients with acute angle-closure glaucoma. Carcinogenesis and Mutagenesis Carcinogenicity Dorzolamide Hydrochloride The results of studies of dorzolamide hydrochloride administrated orally to male and female Sprague- Dawley rats have shown that urinary bladder papillomas were seen in male rats in the highest dosage group of 20 mg/kg/day and no treatment-related tumors were seen in female and male mice given oral doses up to 75 mg/kg/day.
Timolol Maleate The results of studies of timolol maleate in rats have shown an increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day and increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinoma in female mice at 500 mg/kg/day.
See NON-CLINICAL TOXICOLOGY. Mutagenicity Dorzolamide Hydrochloride Dorzolamide hydrochloride was devoid of mutagenic potential in the conducted evaluations. Timolol Maleate Timolol Maleate was devoid of mutagenic potential in the conducted evaluations.
Dorzolamide hydrochloride and timolol maleate are contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with reactive airway disease, bronchospasm, including bronchial asthma or a history of bronchial asthma, or chronic obstructive pulmonary disease. • Patients with sinus bradycardia, sino-atrial block, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.
5 mL/s), as dorzolamide hydrochloride and its metabolite are excreted predominantly by the kidney. DUOKOPT® has not been studied in these patients and is not recommended. • Patients taking an oral carbonic anhydrase inhibitor, as there is potential for an additive effect with the known systemic effects of carbonic anhydrase inhibition.
The concomitant administration of DUOKOPT® and oral carbonic anhydrase inhibitors has not been studied and is not recommended. DUOKOPT® (dorzolamide hydrochloride and timolol maleate) Page 5 of 31
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Timolol Maleate (systemic formulation) Adverse reactions reported in clinical experience with oral timolol maleate may be considered potential side effects of ophthalmic timolol maleate. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In clinical studies, no adverse reactions specific to this combination drug have been observed. Adverse reactions have been limited to those that were reported previously with dorzolamide hydrochloride and/or timolol maleate. In general, common adverse reactions were mild and did not cause discontinuation.
During clinical studies of up to 15 months duration, 1035 patients were treated with dorzolamide hydrochloride and timolol maleate ophthalmic solution. 4% of all patients discontinued therapy with dorzolamide hydrochloride and timolol maleate ophthalmic solution because of local ocular adverse reactions.
2% of all patients discontinued use because of local adverse reactions suggestive of allergy or hypersensitivity. 0%), and ocular itching. 9%). In an active treatment-controlled clinical study of 3 months duration, 131 patients received dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative-free formulation.
1% of patients receiving dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative-free formulation discontinued therapy due to adverse reactions. 8% of all patients receiving dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative-free formulation discontinued therapy because of adverse reactions suggestive of allergy and/or hypersensitivity.
1%). 5 Post-Market Adverse Reactions The following adverse reactions have been reported in post-marketing experience: dyspnea, respiratory failure, contact dermatitis, bradycardia, heart block, hypertension, choroidal detachment following filtration surgery, nausea, corneal edema in glaucoma patients with endothelial abnormalities including cellular density and/or morphology, Stevens-Johnson syndrome, tachycardia, and toxic epidermal necrolysis.
DUOKOPT® (dorzolamide hydrochloride and timolol maleate) Page 12 of 31
See NON-CLINICAL TOXICOLOGY. Cardiovascular Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with DUOKOPT®. Patients with a history of cardiac disease, including cardiac failure should be watched for signs of deterioration of these diseases, and pulse rates should be checked.
Due to its negative effect on conduction time, beta blockers should be given with caution to patients with first degree heart block. Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and rarely death in association with cardiac failure, have been reported following administration of timolol maleate ophthalmic solution.
g. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution. Contamination To minimize the contamination potential, patients should not touch the eye, the area around the eye, or any other surface with the tip of the container.
It may become contaminated with bacteria. This can cause eye infections. This could lead to serious damage of the eye including loss of vision. Keep the tip of the container away from contact with any surface. DUOKOPT® (dorzolamide hydrochloride and timolol maleate) Page 8 of 31 Driving and Operating Machinery Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycemia. , tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.
Hepatic/Biliary/Pancreatic DUOKOPT® has not been studied in patients with hepatic impairment and therefore should be used with caution in such patients. Immune Immunology and Hypersensitivity In clinical studies, local ocular adverse effects, primarily conjunctivitis and eyelid reactions, were reported with chronic administration of dorzolamide hydrochloride ophthalmic solution.
Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. Similar reactions have been reported with dorzolamide hydrochloride and timolol maleate ophthalmic solution.
If such reactions are observed, discontinuation of treatment with DUOKOPT® should be considered. While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to accidental, diagnostic, or therapeutic repeated challenge with such allergens.
Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions. Monitoring and Laboratory Tests Dorzolamide hydrochloride and timolol maleate ophthalmic solution was not associated with clinically meaningful electrolyte disturbances.
, diplopia, ptosis and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenic symptoms. Cerebrovascular Insufficiency Because of potential effects of beta-adrenergic blocking agents relative to blood pressure and pulse, these agents should be used with caution in patients […]