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SANDOZ DORZOLAMIDE 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: Sandoz Dorzolamide (Dorzolamide Hydrochloride Ophthalmic Solution) 2% is indicated in the treatment of elevated intraocular pressure in patients with: • ocular hypertension • open-angle glaucoma 1.1 Pediatrics Pediatrics (<18 years of age): Safety and effectiveness in children have not been established. No data are…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 2024/03 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
5 5 OVERDOSAGE ............................................................................................................... 5
). Treatment should be symptomatic and supportive. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Significant lethality was observed in female rats and mice after single oral doses of dorzolamide hydrochloride of 11 369 mg/m2 or 1 927 mg/kg (24 000 times the maximum recommended human ophthalmic dose) and 3 960 mg/m2 or 1 320 mg/kg (16 000 times the maximum recommended human ophthalmic dose), respectively.
For management of a suspected drug overdose, contact your regional poison control centre. 3 mg of dorzolamide hydrochloride) Hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection.
0075% is added as a preservative. Sandoz Dorzolamide is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride supplied in standard white LDPE plastic DROP-TAINER® bottle with natural LDPE dispensing plug and an orange polypropylene (PP) closure.
Security seal is provided by a polyvinyl chloride (PVC) shrink band around the neck and closure of the DROP-TAINER bottle. Sandoz Dorzolamide is supplied in 5 mL and 10 mL bottles. 7 WARNINGS AND PRECAUTIONS General Dorzolamide hydrochloride 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 reactions such as Stevens- Johnson syndrome and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in patients with acute angle-closure glaucoma.
General Dorzolamide hydrochloride 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 reactions such as Stevens- Johnson syndrome and toxic epidermal necrolysis.
If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents.
Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in patients with acute angle-closure glaucoma. Carcinogenesis and Mutagenesis Carcinogenicity 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 maximum recommended human ophthalmic dose).
Papillomas were not seen in rats given oral doses equivalent to approximately twelve times the maximum 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 maximum recommended human ophthalmic dose).
SANDOZ DORZOLAMIDE (Dorzolamide Hydrocholoride Ophthalmic Solution) Page 7 of 29 The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class- effect of carbonic anhydrase inhibitors in rats and is secondary to increased urinary sodium, potassium, pH and crystals, all changes induced by carbonic anhydrase inhibitors.
Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria and sodium salts of diverse compounds that are inert when given as calcium salts. No changes in bladder urothelium were seen in dogs given oral dorzolamide for one year at 2 mg/kg/day or monkeys given oral dorzolamide for one month at 50 mg/kg/day (the urothelial changes in the bladder occurred with oral dosing in rats within one month).
Sandoz Dorzolamide is 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
5 mL/s) as dorzolamide hydrochloride and its metabolite are excreted predominantly by the kidney. Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in these patients and is not recommended. • Patients taking oral carbonic anhydrase inhibitors, as there is potential for an additive effect with the known systemic effects of carbonic anhydrase inhibition.
The concomitant administration of Dorzolamide Hydrochloride Ophthalmic Solution and oral carbonic anhydrase inhibitors has not been studied and is not recommended.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Carcinogenesis and Mutagenesis Carcinogenicity 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 maximum recommended human ophthalmic dose).
Papillomas were not seen in rats given oral doses equivalent to approximately twelve times the maximum 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 maximum recommended human ophthalmic dose).
SANDOZ DORZOLAMIDE (Dorzolamide Hydrocholoride Ophthalmic Solution) Page 7 of 29 The increased incidence of urinary bladder papillomas seen in the high-dose male rats is a class- effect of carbonic anhydrase inhibitors in rats and is secondary to increased urinary sodium, potassium, pH and crystals, all changes induced by carbonic anhydrase inhibitors.
Rats are particularly prone to developing papillomas in response to foreign bodies, compounds causing crystalluria and sodium salts of diverse compounds that are inert when given as calcium salts. No changes in bladder urothelium were seen in dogs given oral dorzolamide for one year at 2 mg/kg/day or monkeys given oral dorzolamide for one month at 50 mg/kg/day (the urothelial changes in the bladder occurred with oral dosing in rats within one month).
4 mg/kg/day (~ 5 times the maximum recommended human ophthalmic dose) for one year had no urothelial changes in the bladder. Mutagenicity Dorzolamide hydrochloride was devoid of mutagenic potential when evaluated in the following 5 tests: (1) in vivo (mouse) in the cytogenetic assay at doses up to 500 mg/kg/day (6 250 times the maximum recommended human ophthalmic dose); (2) in vitro in the chromosomal aberration assay; (3) in the alkaline elution assay; (4) in the V-79 assay (doses up to 10 mcM); and (5) in the Ames test, in which the highest concentration of dorzolamide hydrochloride used, 10 000 mcg/plate, did not result in a two-fold or greater increase in revertants with tester strains of S.
typhimurium and E. coli. Please see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and Genotoxicity. 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 and could lead to serious damage of the eye including loss of vision. Keep the tip of the container away from contact with any surface. Driving and Operating Machinery Possible side effects such as visual disturbances may affect the ability to drive and use machines.
Hepatic/Biliary/Pancreatic Hepatic Impairment Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in patients with hepatic impairment and should therefore 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 SANDOZ DORZOLAMIDE (Dorzolamide Hydrocholoride Ophthalmic Solution) Page 8 of 29 resolved upon discontinuation of drug therapy. If such reactions are observed, discontinuation of treatment with Sandoz Dorzolamide should be considered.
Monitoring and Laboratory Tests Dorzolamide Hydrochloride Ophthalmic Solution was not associated with clinically meaningful electrolyte disturbances. Ophthalmologic Corneal Edema […]
4 mg/kg/day (~ 5 times the maximum recommended human ophthalmic dose) for one year had no urothelial changes in the bladder. Mutagenicity Dorzolamide hydrochloride was devoid of mutagenic potential when evaluated in the following 5 tests: (1) in vivo (mouse) in the cytogenetic assay at doses up to 500 mg/kg/day (6 250 times the maximum recommended human ophthalmic dose); (2) in vitro in the chromosomal aberration assay; (3) in the alkaline elution assay; (4) in the V-79 assay (doses up to 10 mcM); and (5) in the Ames test, in which the highest concentration of dorzolamide hydrochloride used, 10 000 mcg/plate, did not result in a two-fold or greater increase in revertants with tester strains of S.
typhimurium and E. coli. Please see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and Genotoxicity. 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 and could lead to serious damage of the eye including loss of vision. Keep the tip of the container away from contact with any surface. Driving and Operating Machinery Possible side effects such as visual disturbances may affect the ability to drive and use machines.
Hepatic/Biliary/Pancreatic Hepatic Impairment Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in patients with hepatic impairment and should therefore 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 SANDOZ DORZOLAMIDE (Dorzolamide Hydrocholoride Ophthalmic Solution) Page 8 of 29 resolved upon discontinuation of drug therapy. If such reactions are observed, discontinuation of treatment with Sandoz Dorzolamide should be considered.
Monitoring and Laboratory Tests Dorzolamide Hydrochloride Ophthalmic Solution was not associated with clinically meaningful electrolyte disturbances. Ophthalmologic Corneal Edema There is an increased risk of developing irreversible corneal edema in a subset of glaucoma patients with endothelial abnormalities including cellular density and/or morphology.
In this group of patients, evaluation of the cornea with particular attention to the corneal endothelium is recommended prior and during treatment with Sandoz Dorzolamide. Corneal Edema and Irreversible Corneal Decompensation Corneal edema and irreversible corneal decompensation have been reported in patients with pre-existing chronic corneal defects and/or a history of intraocular surgery while using dorzolamide.
Sandoz Dorzolamide should be used with caution in such patients. Contact Lenses Dorzolamide Hydrochloride Ophthalmic Solution has not been studied in patients wearing contact lenses. The preservative in Sandoz Dorzolamide, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients should be instructed to remove their lenses before application of the drops and not to re-insert the lenses earlier than 15 minutes after use. , dorzolamide) after filtration procedures. Management of eyes with chronic or recurrent choroidal detachment should include stopping all forms of aqueous suppressant therapy and treating endogenous inflammation vigorously.
1 Pregnant Women There are no adequate and well-controlled studies in pregnant women. Sandoz Dorzolamide should be used during pregnancy only if the potential […]