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SANDOZ DORZOLAMIDE/TIMOLOL 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/Timolol (dorzolamide hydrochloride (2% base) and timolol maleate (0.5% base) 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. 1.1 Pediatrics Pediatrics (<18…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 07/2024 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. Studies have shown that timolol does not dialyze readily. Specific therapeutic measures for the treatment of overdosage with timolol maleate are reproduced below for ease of reference.
Gastric lavage:
If ingested. 25 to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously. In refractory cases, the use of a transvenous cardiac pacemaker may be considered.
Hypotension:
Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases, the use of glucagon hydrochloride has been reported to be useful.
Bronchospasm:
Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.
Acute cardiac failure:
Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases, the use of intravenous aminophylline is suggested. If necessary, this may be followed by glucagon hydrochloride which has been reported to be useful.
Heart block (second or third degree):
Use isoproterenol hydrochloride or a transvenous cardiac pacemaker. For management of a suspected drug overdose, contact your regional poison control centre. Sandoz Dorzolamide/Timolol Page 7 of 35 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form /Strength / Composition Non-medicinal Ingredients Ophthalmic Solution / each mL contains dorzolamide 20 mg and timolol 5 mg Benzalkonium chloride (preservative), dihydrate sodium citrate, hydroxyethyl cellulose, mannitol, sodium hydroxide and water for injection.
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 addition to ocular hypotensive agents. Dorzolamide hydrochloride and timolol maleate 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 Sandoz Dorzolamide/Timolol Page 8 of 35 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 16 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.
See 16 NON-CLINICAL TOXICOLOGY. Cardiovascular Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with dorzolamide hydrochloride and timolol maleate. 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.
Sandoz Dorzolamide/Timolol 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.
• 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. Dorzolamide hydrochloride and timolol maleate 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 dorzolamide hydrochloride and timolol maleate and oral carbonic anhydrase inhibitors has not been studied and is not recommended. Sandoz Dorzolamide/Timolol Page 5 of 35
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Sandoz Dorzolamide/Timolol is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution in standard white LDPE plastic DROP-TAINER® bottle with natural LDPE dispensing plug and a blue polypropylene (PP) closure.
Security seal is provided by a polyvinyl chloride (PVC) shrink band around the neck and closure of the DROP-TAINER bottle. 0075 %), added as preservative, dihydrate sodium citrate, hydroxyethyl cellulose, mannitol, sodium hydroxide and water for injection.
Sandoz Dorzolamide/Timolol is available in 5 mL and 10 mL bottles. 7 WARNINGS AND PRECAUTIONS 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 addition to ocular hypotensive agents. Dorzolamide hydrochloride and timolol maleate 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 Sandoz Dorzolamide/Timolol Page 8 of 35 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 16 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.
See 16 NON-CLINICAL TOXICOLOGY. Cardiovascular Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with dorzolamide hydrochloride and timolol maleate. 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. Sandoz Dorzolamide/Timolol Page 9 of 35 Driving and Operating Machinery Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism Masking of […]
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. Sandoz Dorzolamide/Timolol Page 9 of 35 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 Dorzolamide hydrochloride and timolol maleate 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.
If such reactions are observed, discontinuation of treatment with Sandoz Dorzolamide/Timolol 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 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. Sandoz Dorzolamide/Timolol Page 10 of 35 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 with cerebrovascular insufficiency.
If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Sandoz Dorzolamide/Timolol, alternative therapy should be considered. Ophthalmologic […]