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AZOPT 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: AZOPT® (brinzolamide ophthalmic suspension) is indicated for: • the treatment of elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of AZOPT in pediatric patients have not been established;…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • AZOPT is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. With any evident signs of hypersensitivity or discomfort, AZOPT must be discontinued. • Caution is advised when using AZOPT in patients with mild to moderate renal impairment (see 7 WARNING AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Monotherapy: When used as a monotherapy, the recommended starting adult dose is one drop of AZOPT in the affected eye(s) two times daily. If the clinical response is not adequate after four weeks, the dosage may be increased to one drop three times daily.
Adjunctive Therapy with Beta-Blockers:
AZOPT may be used as adjunctive therapy with ophthalmic beta-blockers (see 14 CLINICAL TRIALS). When AZOPT is used concomitantly with beta-blockers, the recommended dose is the same as when it is used as a monotherapy. The drugs should be administered at least ten minutes apart.
Health Canada has not authorized an indication for pediatric use. 4 Administration Shake well before use. Nasolacrimal occlusion or gently closing the eyelid for two minutes after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least ten 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, a single drop should be applied as soon as possible before reverting to the regular routine.
However, if it is almost time for the subsequent dose, the missed dose should be skipped and the regular dosing schedule resumed. Do not use a double dose to make up for a missed dose.
1 Adverse Reaction Overview In clinical trials, the most frequently reported adverse drug reactions were blurred vision and dysgeusia (see description below). Dysgeusia (bitter or unusual taste in the mouth following instillation) was a frequently reported systemic adverse reaction associated with the use of AZOPT during clinical trials.
It is likely to be caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal. Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce the occurrence of this effect. 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.
Safety and efficacy of Azopt was evaluated in well-controlled, short- and long-term clinical studies. These studies included adult patients with elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
One drop twice- or thrice-daily dosing regimens of Azopt was evaluated as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.
Details of these studies are available in 14 CLINICAL TRIALS. Adverse reactions related to AZOPT were generally mild to moderate and usually did not lead to discontinuation of therapy. The most frequently reported ocular adverse reaction was blurred vision (5%).
6%). Adverse reactions with a frequency ≥ 1% are presented in Table . 5 Post-Market Adverse Reactions The following adverse reactions were identified from subsequent clinical trials: Cardiac disorders: angina pectoris, heart rate irregular Ear and labyrinth disorders: tinnitus Eye disorders: asthenopia, conjunctivitis allergic, corneal edema, corneal erosion, diplopia, hypoesthesia eye, periorbital edema, photophobia, photopsia, punctate keratitis, visual acuity reduced Gastrointestinal disorders: abdominal discomfort, diarrhea General disorders and administration site conditions: asthenia, chest pain, fatigue, feeling jittery, irritability Nervous system disorders: memory impairment, somnolence Psychiatric disorders: insomnia Respiratory, thoracic and mediastinal disorders: bronchial hypersensitivity, cough, epistaxis, nasal congestion, nasal dryness, oropharyngeal pain, rhinorrhea, sinus congestion, throat irritation, upper airway cough syndrome, upper airway tract congestion Skin and subcutaneous tissue disorders: pruritus generalised, urticaria AZOPT (Brinzolamide) Page 11 of 24 The following adverse reactions were identified via spontaneous post-market reporting: Hypersensitivity or Skin disorders: Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN) Metabolism and nutrition disorders: decreased appetite Musculoskeletal and connective tissue disorders: arthralgia Nervous system disorders: hypoesthesia Vascular disorders: blood pressure decreased
; Hypersensitivity; Skin 01/2023 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 ......................................................................................... 2 Breast-feeding..............................................................................................
Brinzolamide ophthalmic suspension is contraindicated in: • Patients with hypersensitivity to brinzolamide 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 with severe renal impairment (CrCl < 30 mL/min), as brinzolamide and its metabolite are excreted predominantly by the kidney. • Patients with hyperchloremic acidosis. • Patients taking oral carbonic anhydrase inhibitors due to the potential additive systemic effects of carbonic anhydrase inhibition.
No studies have been conducted with AZOPT in patients with hepatic or renal impairment, or in patients with hyperchloremic acidosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 9 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions (<1%).........................................
5 Post-Market Adverse Reactions........................................................................ 10 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 test interactions ..................................................................... 12 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action.................................................................................. 2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics .......................................................................................
12 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 13 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 13 PART II: SCIENTIFIC INFORMATION ......................................................................................
14 13 PHARMACEUTICAL INFORMATION............................................................................ 14 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 14 Intraocular Pressure (IOP) Reduction ......................................................................... 14 15 MICROBIOLOGY ........................................................................................................
16 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 16 PATIENT MEDICATION INFORMATION ................................................................................. 18 AZOPT (Brinzolamide) Page 4 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AZOPT® (brinzolamide ophthalmic suspension) is indicated for: • the treatment of elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma.
1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of AZOPT in pediatric patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics […]