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AZARGA 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: AZARGA® (brinzolamide/timolol 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 AZARGA is considered appropriate. 1.1 Pediatrics (< 18 years…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations When substituting another ophthalmic antiglaucoma agent with AZARGA, the other agent should be discontinued and AZARGA should be started the following day. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
2 Recommended Dose and Dosage Adjustment The adult dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. 4 Administration Patients should be instructed to shake the bottle well before use. Nasolacrimal occlusion and gently closing the eyelid for 2 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. 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 if you use eye drop solutions that have become contaminated. Do not use suspension if the bottle is cracked or damaged in any way. Instruct patients to keep the bottle tightly closed when not in use.
After the cap is removed, if the tamper evident snap collar is loose, instruct patients to remove it before using the product. 5 Missed Dose If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine.
Do not use a double dose to make up for the one missed.
1 Adverse Reaction Overview In clinical studies involving over 500 patients treated with AZARGA, the most frequently reported adverse drug reaction was temporary blurred vision (6%) upon instillation, lasting from a few seconds to a few minutes.
Dysgeusia (bitter or unusual taste in the mouth following topical ocular instillation) was the most frequently reported systemic adverse drug reaction. It is likely caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is attributable to the brinzolamide component of this combination product.
Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce the incidence of this effect. AZARGA contains brinzolamide which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption. Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
The same type of adverse drug reactions that are attributable to oral carbonic anhydrase inhibitors may occur with topical administration. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, 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 5 clinical studies, AZARGA was administered to 501 patients at a dose of one drop two times daily for up to 1 year. The most frequent adverse drug reactions (≥1%) seen in clinical trials are presented in Table 2. 3 Less Common Clinical Trial Adverse Reactions Eye disorders: abnormal sensation in eye, anterior chamber flare, asthenopia, blepharitis, blepharitis allergic, conjunctivitis allergic, conjunctival hyperaemia, corneal disorder, corneal erosion, dry eye, erythema of eyelid, eye discharge, eyelid margin crusting, eyelids pruritis, eye pruritis, intraocular pressure decreased, lacrimation increased, ocular hyperaemia, photophobia, punctate keratitis, scleral hyperaemia.
; Hypersensitivity; Skin 12/2022 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 (< 18 years of age): ......................................................................................
2 Geriatrics (> 65 years of age): ...................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................
3 Reconstitution .............................................................................................................. 4 Administration .............................................................................................................
5 Missed Dose ................................................................................................................. 5 5 OVERDOSAGE............................................................................................................
brinzolamide/timolol ophthalmic suspension is contraindicated in patients with: • hypersensitivity to brinzolamide, timolol, or to any ingredient in the formulation or component of the container (for a complete listing, see section 6.
Dosage Forms, Composition and Packaging section of the Product Monograph) • bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease • sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock • severe allergic rhinitis and bronchial hyper-reactivity • hypersensitivity to other beta blockers • hyperchloraemic acidosis • severe renal impairment • hypersensitivity to sulfonamides No studies have been conducted with AZARGA or timolol maleate ophthalmic solution in patients with hepatic or renal impairment, or in patients with hyperchloraemic acidosis.
Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZARGA is, therefore, contraindicated in patients with severe renal impairment (CrCl<30 mL/min) or hyperchloraemic acidosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Psychiatric disorders: insomnia. Respiratory, thoracic and mediastinal disorders: chronic obstructive pulmonary disease, cough, pharyngolaryngeal pain, rhinorrhea. Skin and subcutaneous tissue disorders: hair disorder, lichen planus.
Vascular disorders: blood pressure decreased. Additional Adverse Reactions Observed in Clinical Trials with the Individual Components of AZARGA AZARGA contains brinzolamide and timolol (as timolol maleate). 0% Blood and the lymphatic system disorders: blood chloride increased, red blood cell count decreased.
Cardiac disorders: angina pectoris, arrhythmia, bradycardia, cardio-respiratory distress, heart rate increased, heart rate irregular, palpitation, tachycardia. Ear and labyrinth disorders: tinnitus, vertigo. Eye disorders: conjunctivitis, corneal epithelium defect, corneal epithelium disorder, corneal oedema, corneal staining, deposit eye, diplopia, eye allergy, eye swelling, eyelid disorder, eyelid oedema, glare, hypoaesthesia eye, intraocular pressure increased, keratitis, keratoconjunctivitis sicca, keratopathy, madarosis, meibomianitis, ocular discomfort, optic nerve cup/disc ratio increased, photopsia, pterygium, scleral pigmentation, subconjunctival cyst, visual acuity reduced, visual disturbance.
0) N = 501 (%) Eye Disorders blurred vision 6% 1% 3% 1% eye irritation 4% 12% 2% 3% eye pain 3% 9% 0% 1% foreign body sensation in eyes 1% 0% 0% 0% Nervous System Disorders dysgeusia 2% 2% 5% 0% AZARGA® brinzolamide and timolol (as timolol maleate) Page 12 of 39 Gastrointestinal disorders: abdominal discomfort, diarrhea, dry mouth, dyspepsia, flatulence, frequent bowel movements, gastrointestinal disorder, hypoaesthesia oral, nausea, oesophagitis, paraesthesia oral, stomach discomfort, upper abdominal pain, vomiting.
General disorders and administration site conditions: asthenia, chest discomfort, chest pain, fatigue, feeling abnormal, feeling jittery, irritability, malaise, medication residue, pain, peripheral oedema. Hepatobiliary disorders: liver function test abnormal.
Immune system disorders: hypersensitivity. Infections and infestations: nasopharyngitis, pharyngitis, rhinitis, sinusitis. Injury, poisoning and procedural complications: foreign body in eye. Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscle spasms, myalgia, pain in extremity.
Nervous system disorders: ageusia, amnesia, dizziness, headache, hypoaesthesia, motor dysfunction, memory impairment, paraesthesia, somnolence, tremor. Psychiatric disorders: apathy, depressed mood, depression, libido decreased, nervousness, nightmare.
Renal and urinary disorders: pollakiuria, renal pain. Reproductive system and breast disorders: erectile dysfunction. Respiratory, thoracic and mediastinal disorders: asthma, bronchial hyperactivity, dyspnoea, epistaxis, nasal congestion, nasal dryness, postnasal drip, sneezing, throat irritation, upper respiratory tract congestion.
Skin and subcutaneous tissue disorders: alopecia, dermatitis, erythema, pruritus generalized, rash, rash maculo-papular, skin tightness, urticaria. Vascular disorders: blood pressure increased, hypertension. 5% Cardiac disorders: arrhythmia, atrioventricular block, bradycardia, cardiac arrest, cardiac failure, palpitation.
Eye disorders: conjunctivitis, diplopia, eyelid ptosis, keratitis, visual disturbance. Gastrointestinal […]
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ..................................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-feeding .................................................................................................. 3 Pediatrics (< 18 years of age): ..........................................................................
4 Geriatrics (> 65 years of age): .......................................................................... 10 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview .......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................. 3 Less Common Clinical Trial Adverse Reactions .......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions................................................................................. 13 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............................................................................. 17 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
19 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 21 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 21 PART II: SCIENTIFIC INFORMATION .....................................................................................
22 13 PHARMACEUTICAL INFORMATION .......................................................................... 22 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication....................................................................................... 23 Intraocular Pressure (IOP) Reduction ..............................................................................
23 15 MICROBIOLOGY ...................................................................................................... 26 16 NON-CLINICAL TOXICOLOGY ....................................................................................
27 PATIENT MEDICATION INFORMATION […]