Loading…
SIMBRINZA is a brand name for Brinzolamide, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SIMBRINZA (brinzolamide / brimonidine tartrate ophthalmic suspension) is indicated for: • the reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction AND when the use of SIMBRINZA is considered appropriate. 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • SIMBRINZA is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. With any evident signs of hypersensitivity or discomfort, SIMBRINZA must be discontinued. • Caution is advised when using SIMBRINZA in patients with mild to moderate renal impairment.
2 Recommended Dose and Dosage Adjustment The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily. Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be instructed to shake the bottle well before use.
Nasolacrimal occlusion or gently closing the eyelid after instillation for up to one minute is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events.
SIMBRINZA may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures, because this could cause eye injury or contaminate the tip with common bacteria known to cause eye infections.
Serious damage to the eye with subsequent loss of vision may result from using contaminated eye drop solutions. Do not use suspension if the bottle is cracked or damaged in any way. 5 Missed Dose If a dose is missed, treatment should be continued with the next dose as planned.
The dose should not exceed one drop in the affected eye(s) two times daily.
section). Rechallenge irrespective of the route of administration should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN (see 7 Warning and Precautions, Skin). Neurologic SIMBRINZA may cause fatigue and somnolence.
Carbonic anhydrase inhibitors can impair ability to perform tasks requiring mental alertness and/or physical coordination. As SIMBRINZA is absorbed systemically, caution in advised when using SIMBRINZA in patients requiring mental alertness and/or physical coordination.
Ophthalmologic SIMBRINZA is not recommended in patients with acute or narrow-angle glaucoma. SIMBRINZA has not been studied in patients with acute or narrow-angle glaucoma. Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal epithelium.
There is an increased potential for developing corneal edema in patients with low endothelial cell counts. The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
Specifically, patients SIMBRINZA Brinzolamide/Brimonidine Tartrate Page 8 of 39 wearing contact lenses have not been studied and careful monitoring of these patients when using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and wearing contact lenses might increase the risk for the cornea.
Careful monitoring of patients with compromised corneas, such as patients with diabetes mellitus or corneal dystrophies, is recommended. SIMBRINZA contains benzalkonium chloride as preservative, which may cause eye irritation and is known to discolour soft contact lenses.
Contact with soft contact lenses is to be avoided. Patients must be instructed to remove contact lenses prior to the instillation of SIMBRINZA and wait at least 15 minutes after dosing before contact lenses are reinserted. Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
; Hypersensitivity; Renal; Skin 12/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .................................................................................................. 1 Pregnant Women ...............................................................................................
3, Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): No overall differences in safety and effectiveness have been observed between elderly and other adult patients. 2 CONTRAINDICATIONS Brinzolamide / Brimonidine Tartrate ophthalmic suspension is contraindicated in: • Patients with hypersensitivity to brinzolamide, brimonidine, or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with hypersensitivity to sulfonamides. • Patients receiving monoamine oxidase (MAO) inhibitor therapy. g. tricyclic antidepressants and mianserin).
• Patients with severe renal impairment. • Patients with hyperchloroaemic acidosis. • Neonates and infants under the age of 2 years. SIMBRINZA is not recommended in patients with hepatic impairment. SIMBRINZA has not been studied in patients with hepatic impairment.
SIMBRINZA is contraindicated in patients with severe renal impairment (CrCl<30 ml/min). SIMBRINZA has not been studied in patients with severe renal impairment (CrCl< 30 mL/min) or in patients with hyperchloroaemic acidosis. Since the brinzolamide component of SIMBRINZA and its metabolite are excreted predominantly by the kidney, SIMBRINZA is contraindicated in such patients.
SIMBRINZA Brinzolamide/Brimonidine Tartrate Page 5 of 39
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Brinzolamide in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Close monitoring is required with frequent or prolonged use. SIMBRINZA may cause temporary blurred vision or other visual disturbances that can affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Animal studies show that brinzolamide and brimonidine significantly accumulates in iris-ciliary body, choroid and/or retina during BID topical ocular administration of SIMBRINZA (see 16 NON-CLINICAL TOXICOLOGY, Animal Pharmacokinetics).
Brimonidine tartrate may cause ocular allergic reactions. If allergic reactions are observed, treatment should be discontinued. Psychiatric Caution is advised with using SIMBRINZA in patients with depression.
Renal:
SIMBRINZA is contraindicated in patients with severe renal impairment. Caution is advised when using SIMBRINZA in patients with mild to moderate renal impairment because of the possible risk of metabolic acidosis.
Reproductive Health:
Female and Male Potential • Fertility The effect of SIMBRINZA on human fertility is unknown. Nonclinical data do not suggest an effect of brinzolamide or brimonidine on fertility. In animals, developmental toxicity was observed with brinzolamide at doses that induced maternal toxicity.
(see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology). Skin SIMBRINZA should be discontinued immediately at the appearance of a skin rash, as the rash may be, in some instances, followed by dermatological reactions/hypersensitivity syndrome including SJS and TEN.
At the time of prescription, patients should be informed of the signs and symptoms, and advised to monitor closely for skin reactions. 1 Pregnant Women SIMBRINZA is not recommended during pregnancy or in women of child-bearing potential not using contraception.
Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (43, 129, and 258 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg.
In rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg/kg/day (783 times the recommended human ophthalmic dose) during gestation were proportional to the reduced maternal weight gain, with no statistically significant effects on organ or tissue development.
Increases in unossified sternebrae, reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically significant. No treatment-related malformations were seen. Following oral administration of 14C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood.
In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Drug derived material was eliminated from fetal tissues by 24 hours post dose. (See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
2 Breast-feeding SIMBRINZA should not be used by women nursing neonates/infants. It is not known whether topical SIMBRINZA is excreted in human milk; however, a risk to the nursing child cannot be excluded. Available pharmacodynamic/toxicological data in animals have shown that following oral administration, brinzolamide and brimonidine are excreted in breast milk.
3 Pediatrics Pediatrics (< 18 years of age): SIMBRINZA is contraindicated in neonates and infants under the age of 2 years. Several serious adverse reactions have been reported in association with the administration of brimonidine tartrate to infants.
(see 2. CONTRAINDICATIONS) SIMBRINZA is not recommended in children between 2 and 18 years. […]
2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
4 Geriatrics ............................................................................................................ 9 8 ADVERSE REACTIONS...............................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ...................................................... 5 Post-Market Adverse Reactions.............................................................................
12 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ...............................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Interactions ................................................................................ 14 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 15 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
17 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 17 PART II: SCIENTIFIC INFORMATION ..................................................................................... 18 13 PHARMACEUTICAL INFORMATION ..........................................................................
18 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..............................................................................
19 Intraocular Pressure (IOP) Reduction .............................................................................. 19 15 MICROBIOLOGY ......................................................................................................
24 16 NON-CLINICAL TOXICOLOGY .................................................................................... 25 PATIENT MEDICATION INFORMATION ................................................................................ 32 SIMBRINZA Brinzolamide/Brimonidine Tartrate Page 4 of 39 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SIMBRINZA (brinzolamide / brimonidine tartrate ophthalmic suspension) is indicated for: • the reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction AND when the use of SIMBRINZA is considered appropriate.
1 Pediatrics Paediatrics (< […]