AZOPT Eye Drops 1.0% contain brinzolamide. The chemical structure of brinzolamide is:
HN
(R)
N O
H2N
S
S S
O O
O O
383.51
Empirical formula: C12H21N3O5S3
(R)-4-(Ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno[3,2-e]- 1,2-thiazine-6-sulfonamide-1,1-dioxide
138890-62-7
Brinzolamide is presented as white to off-white crystals or powder. Brinzolamide is very slightly soluble in water at neutral pH. AZOPT Eye Drops 1.0% have been formulated as a sterile, preserved suspension for topical application to the eye. AZOPT Eye Drops 1.0% contain 10.0 mg/mL brinzolamide, together with sodium chloride, tyloxapol, mannitol, carbomer (974P), disodium edetate and purified water. The solution is preserved with benzalkonium chloride (0.1 mg/mL).
Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its high affinity for carbonic anhydrase II (CA-II), brinzolamide distributes extensively into the red blood cells (RBCs) and exhibits a long half-life in whole blood (approximately 111 days). In humans, the metabolite N-desethyl brinzolamide is formed, which also binds to CA and accumulates in RBCs. This metabolite binds mainly to CA-I in the presence of brinzolamide. In plasma, both parent brinzolamide and N-desethyl brinzolamide concentrations are low and generally below assay quantitation limits (<10 ng/mL). Binding to plasma proteins is not extensive (approximately 60%). Brinzolamide is eliminated predominantly in the urine as unchanged drug. N-Desethyl brinzolamide is also found in the urine along with lower concentrations of the N-desmethoxypropyl and O-desmethyl metabolites. An oral pharmacokinetic study was conducted in which healthy volunteers received 1 mg capsules of brinzolamide twice daily for up to 32 weeks. This regimen provided a higher systemic exposure rate than topical ocular administration of AZOPT Eye Drops 1.0% dosed in both eyes three times daily, and simulated systemic drug and metabolite concentrations similar to those achieved with long-term topical dosing. RBC CA activity was measured to assess the degree of systemic CA inhibition. Brinzolamide saturation of RBC CA-II was achieved within 4 weeks (RBC concentrations of approximately 20 mM). N-Desethyl brinzolamide accumulated in RBCs to steady state within 20-28 weeks reaching concentrations ranging from 6-30 mM. The inhibition of total RBC CA activity at steady state was approximately 70-75%, which is below that expected to adversely affect renal function or respiration in healthy subjects. An oral pharmacokinetic study was conducted in which subjects with mild to moderate renal impairment (creatinine clearance of 30-60 mL/minute) received 1 mg capsules of brinzolamide twice daily for up to 54 weeks. By week 4 of treatment, parent drug RBC concentrations ranged from approximately 20 to 40 mM and showed little subsequent change. At steady-state, parent drug and N-desethyl metabolite RBC concentrations ranged from 22.0 to 46.1 and 17.1 to 88.6 mM, respectively. Metabolite RBC concentrations, but not those of parent drug, showed a significant (p<0.05) increase with decreasing creatinine clearance. Total RBC CA activity, but not CA-II activity, showed a significant decrease as creatinine clearance decreased. In spite of the greater inhibition of total CA activity in subjects showing the highest degree of renal impairment, all subjects showed <90% total CA inhibition at steady-state. This is below the 99% or greater inhibition associated with systemic adverse effects. In a topical ocular study, patients with open-angle glaucoma or ocular hypertension received AZOPT Eye Drops 1.0% either two or three times daily for up to 18 months. Steady-state concentrations of brinzolamide were reached for most subjects within 6-9 months, while steady-state for the N-desmethyl metabolite was reached within 12 to 18 months. At steady-state, brinzolamide RBC concentrations were similar to those found in the oral study, but levels of the N-desethyl metabolite were lower. Carbonic anhydrase activity was approximately 40-70% of pre-dose levels, indicating a degree of inhibition that was substantially lower than that observed orally and unlikely to elicit systemic side effects.
Brinzolamide is a carbonic anhydrase inhibitor. When instilled in the eye, AZOPT Eye Drops 1.0% have the action of reducing elevated intraocular pressure, whether or not accompanied by glaucoma. Glaucoma is defined as an optic neuropathy resulting in optic nerve head damage and visual field loss. The pathogenesis of glaucoma is multi-factorial, however, the primary risk factors are considered to be sustained elevated intraocular pressure and poor ocular perfusion. The ocular hypotensive action of brinzolamide is mediated through inhibition of carbonic anhydrase in the ciliary processes of the eye which decreases aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. Carbonic anhydrase is an enzyme found in many tissues of the body, including the eye. Carbonic anhydrase catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being CA-II, found primarily in red blood cells (RBCs), but also in other tissues. Brinzolamide is an inhibitor of carbonic anhydrase II (CA-II), the predominant iso-enzyme in the eye, with an in vitro IC50 of 3.2 nM and a Ki of 0.13 nM against CA-II. Brinzolamide has also been shown to have a low affinity for 34 receptors or second messenger systems, indicating selectivity for CA-II.
In two randomised, double-masked studies of 3 month duration, monotherapy with AZOPT Eye Drops 1.0% produced a significant reduction in intraocular pressure when dosed twice daily; this intraocular pressure reduction was equivalent to that of dorzolamide 2% dosed three t imes daily (see below). No additional clinically or statistically significant benefit was evident following administration of AZOPT Eye Drops 1.0% three times daily.
| Average Intraocular Pressure Reduction % Reduction, Absolute Reduction in mm Hg (n) | ||
| 10 AM | 6 PM | |
| Study 1 | ||
| AZOPT Eye Drops 1% twice daily * | -16.7%, -4.2 (109) | -15.3%, -3.7 (107) |
| Dorzolamide 2% three times daily * | -20.1%, -4.9 (112) | -18.2%, -4.3 (111) |
| Study 2 | ||
| AZOPT Eye Drops 1% twice daily * | -21.8%, -5.7 (144) | -18.9%, -4.8 (142) |
| Dorzolamide 2% three times daily * | -23.0%, -5.9 (146) | -21.2%, -5.4 (145) |
| Timolol maleate 0.5% twice daily * | -24.3%, -6.3 (61) | -21.4%, -5.5 (60) |
*
No clinically or statistically significant difference between treatments
In a long-term (18 month study) comparing AZOPT Eye Drops 1.0% (n=94) with timolol maleate 0.5% (n=49; both twice daily), the mean absolute changes in intraocular pressure (mm Hg) at 18 months were -4.0 (95% CI: -4.6, -3.4) and -5.5 (95% CI: -6.4, -4.7) respectively. Eighty-one patients completed the study; the results indicated that the intraocular pressure lowering effect of AZOPT Eye Drops 1.0% does not diminish over time. Thirty volunteers with a diagnosis of asthma or chronic obstructive pulmonary disease were enrolled in a masked, cross-over design study to compare the acute effects of AZOPT Eye Drops 1.0% versus timolol maleate 0.5% on pulmonary function as measured by forced expiratory volume in one second (FEV1). Within 15 minutes of the instillation of a single drop of timolol maleate 0.5%, statistically significant decreases in mean FEV1 were observed (compared to both baseline and AZOPT Eye Drops 1.0%); these continued for up to 3 hours following instillation. No effect was observed on FEV1 following the instillation of AZOPT Eye Drops 1.0%. Two masked, well-controlled studies, each of one-week duration, were designed to compare the comfort of AZOPT Eye Drops 1.0% twice daily to dorzolamide eye drops 2.0% three times daily. Each of these studies indicated that a significantly greater (p<0.001) percentage of patients experienced no discomfort following repeated instillation of AZOPT Eye Drops 1.0%, as tabulated below.
| Percent Patients Experiencing No Discomfort (n) | ||
| AZOPT Eye Drops 1.0% BID | Dorzolamide Eye Drops 2.0% TID | |
| Study 4 | 71.2 (37) | 19.6 (10) |
| Study 5 | 81.3 (39) | 17.0 (8) |
Two Phase IV clinical studies assessed the efficacy and safety of AZOPT Eye Drops when added concomitantly to prostaglandins (i.e. travoprost and latanoprost). The available data support a lowering of IOP when AZOPT Eye Drops are added to these agents. One 12-week, double-masked, randomised study in which 215 patients with ocular hypertension or primary open-angle glaucoma were enrolled, was conducted. A total of 201 patients were randomised and 192 were included in the per protocol analysis. The primary objective of the study was to compare the efficacy and safety of brinzolamide 1% and timolol 0.5%, each administered twice daily when added to travoprost 0.004% administered once daily in the evening. Patients who were considered inadequately controlled on monotherapy (travoprost, latanoprost or bimatoprost) were eligible to be enrolled in this study. The primary endpoint was mean diurnal IOP. There was no statistically significant difference in mean diurnal IOP at 12 weeks between the treatment groups (18.1 mm Hg vs 18.1 mm Hg in the brinzolamide and timolol groups, respectively). The mean reductions in diurnal IOP were 3.4 mm Hg and 3.2 mm Hg for the brinzolamide and timolol groups, respectively. Overall, the efficacy of brinzolamide 1%, as concomitant therapy, was comparable to concomitant therapy with timolol 0.5%. There was a higher incidence of local adverse effects (conjunctival hyperaemia, burning or foreign body sensation) with brinzolamide than with timolol; however, the differences were not statistically significant. A second, open-label 12-week study was conducted in 82 patients with open-angle glaucoma or ocular hypertension. A total of 79 patients were evaluable for the intent-to-treat analysis. Patients, requiring additional IOP-lowering from a baseline of travoprost eye drops, received brinzolamide 1% concomitantly. The primary efficacy endpoint was the mean reduction in IOP at 12 weeks. There was a mean reduction of 3.9 mm Hg after 4 weeks and 4.2 mm Hg after 12 weeks. Overall, 43 patients (60.6%) had an IOP below 18 mm Hg at the conclusion of the study. Additional studies have been published concerning IOP control (Tsukamoto et al. J. Ocular Pharmacol. Ther. 21:170-173, 2005, Tsukamoto et al. J. Ocular Pharmacol. Ther. 21: 395-399, 2005). These studies suggest that brinzolamide might be added to dual therapy (latanoprost plus beta blocker) or substituted for dorzolamide in triple therapy. When used twice daily, adjunctively to timolol maleate 0.5% for 3 months, AZOPT Eye Drops 1.0% provided an additional intraocular pressure lowering effect. This was equivalent to dorzolamide 2% dosed twice daily adjunctively to timolol maleate 0.5% (see below). No additional clinically or statistically significant benefit was evident following administration of AZOPT Eye Drops 1.0% three times daily.
| Average Intraocular Pressure Reduction % Reduction, Absolute Reduction in mm Hg (n) | ||
| 9 AM | 11 AM | |
| Study 3 | ||
| AZOPT Eye Drops 1% twice daily * | -17.1%, -4.3 (101) | -19.9%, -4.9 (102) |
| Dorzolamide 2% twice daily * | -16.6%, -4.3 (105) | -20.8%, -5.0 (103) |
*
No clinically or statistically significant difference between treatments
During this study, up to 89.3% (at peak) receiving AZOPT Eye Drops 1.0% in combination with timolol maleate 0.5% achieved an intraocular pressure reduction 5 mm Hg or had their intraocular pressure reduced to 21 mm Hg. These results were equivalent to those seen with dorzolamide eye drops 2.0% in combination with timolol maleate 0.5% (85.4%).
AZOPT Eye Drops 1.0% are indicated to decrease intraocular pressure in: ocular hypertension open-angle glaucoma.
AZOPT Eye Drops 1.0% are contraindicated in patients with a known hypersensitivity to brinzolamide, sulfonamides or any of the excipients (see DESCRIPTION). AZOPT Eye Drops 1.0% are also contraindicated in patients with severe renal impairment and in patients with hyperchloraemic acidosis.
The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. AZOPT Eye Drops 1.0% have not been studied in patients with acute angle-closure glaucoma. Brinzolamide is a sulfonamide and, although administered topically, is absorbed systemically. The same types of adverse reactions or hypersensitivity that are attributable to sulfonamides may, therefore, occur with topical administration. AZOPT Eye Drops 1.0% should be discontinued if signs of serious reactions or hypersensitivity occur. There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and AZOPT Eye Drops 1.0%. The concomitant administration of AZOPT Eye Drops 1.0% and oral carbonic anhydrase inhibitors has not been studied and is not recommended. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. Use with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis. 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). Careful monitoring of patients with compromised corneas, such as patients with diabetes mellitus or corneal dystrophies, is recommended.
Specific drug interaction studies have not been performed with AZOPT Eye Drops 1.0%. In clinical studies, however, AZOPT Eye Drops 1.0% were used concomitantly with the following medications without evidence of adverse interactions: timolol maleate eye drops, systemic medications including ACE inhibitors, calcium-channel blockers, diuretics, non-steroidal anti-inflammatory drugs including aspirin, and hormones (e.g. oestrogen, insulin, thyroxine). Association between AZOPT Eye Drops 1.0% and miotics or adrenergic agonists has not been fully evaluated during adjunctive glaucoma therapy. Brinzolamide is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically. In clinical studies, brinzolamide was not associated with acid-base disturbances. These disturbances have, however, been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g. toxicity associated with high-dose salicylate therapy). The potential for such drug interactions should, therefore, be considered in patients receiving AZOPT Eye Drops 1.0%.
Studies in animals with brinzolamide have shown reproductive toxicity following systemic administration. Radioactivity was found to cross the placenta and was present in the foetal tissues and blood following oral administration of 14C-brinzolamide to pregnant rats. Developmental toxicity studies in rabbits at oral doses up to 6 mg/kg/day brinzolamide produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of foetal variations, such as accessory skull bones; at 1 and 6 mg/kg/day the incidence was only slightly higher than seen historically. In rats, statistically significant decreased body weights of foetuses from dams receiving oral doses of 18 mg/kg/day during gestation were proportional to the reduced maternal weight gain, with no statistically significant effects on organ or tissue development. No treatment-related malformations were seen. No studies of the use of ophthalmic brinzolamide have been conducted in pregnant women. AZOPT Eye Drops 1.0% should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Studies in animals have shown that following oral administration brinzolamide is excreted in breast milk. Following oral administration of 14C-brinzolamide to lactating rats, radioactivity was found in milk at concentrations below those in the blood and plasma. Decreases in pup bodyweights were observed at 15 mg/kg/day in a pre-and postnatal study in which rats were given brinzolamide by oral gavage at doses up to 15 mg/kg/day. It is not known whether brinzolamide is excreted in human milk following topical ocular administration. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from brinzolamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
In clinical studies conducted with AZOPT Eye Drops 1.0%, the probability of having an adverse reaction was independent of age. No differences in patients experiencing adverse reactions were noted when patients less than 65 years of age were compared to patients greater than 65 years of age. There are no modifications to the recommended dosing regimen for elderly patients.
The safety and effectiveness of AZOPT Eye Drops 1.0% in paediatric patients have not been established.
AZOPT Eye Drops 1.0% have not been studied in patients with hepatic impairment. Caution should, therefore, be exercised if a decision is made to commence therapy with AZOPT Eye Drops 1.0% in such patients. AZOPT Eye Drops 1.0% have not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or in patients with hyperchloraemic acidosis. Brinzolamide and its main metabolite are predominantly excreted by the kidney; AZOPT Eye Drops 1.0% are, therefo re, contraindicated in such patients (see CONTRAINDICATIONS).
A two year bioassay, in which rats were dosed by oral gavage at doses up to 8 mg/kg/day brinzolamide revealed no evidence of a carcinogenic effect. A similar study conducted in mice (0, 1, 3 and 10 mg/kg/day brinzolamide dosed by oral gavage) also showed that brinzolamide was non-carcinogenic. The mouse study did, however, reveal a statistically significant increase in urinary bladder tumours in female mice given 10 mg/kg/day orally for 24 months. Dose-related proliferative changes in the urinary bladder were observed in female mice at all dose levels and among males at 10 mg/kg/day. The elevated bladder tumour incidence was due to the increased incidence of a tumour considered to be unique to mice. Genotoxicity studies with brinzolamide did not demonstrate any mutagenic potential in one in vitro (Ames assay) or chromosomal damage in an in vivo assay (micronucleus formation). Brinzolamide did induce forward mutations in the mouse lymphoma assay in vitro, with, but not without metabolic activation. Brinzolamide was negative in a sister chromatid exchange assay in mice. A fertility and early embryonic study, in which male and female rats were dosed by oral gavage with brinzolamide at doses up to 18 mg/kg/day, showed no effects on fertility or reproductive capacity.
If patients continue to wear soft (hydrophilic) contact lenses while under treatment with AZOPT Eye Drops 1.0%, they should remove their lens(es) prior to instilling AZOPT Eye Drops 1.0% in the affected eye(s) and should not insert their lens(es) until 15 minutes after instillation of the eye drops.
As with other ophthalmic medications, patients should be advised to exercise caution if they experience transient blurred vision following instillation of eye drops; patients should wait until their vision clears before driving or using machinery. Additionally, nervous system disorders have been reported with the use of the product which may affect the ability to drive or use machines (see ADVERSE EFFECTS).
In well-controlled clinical studies, undesirable effects related to AZOPT Eye Drops 1.0% were non-serious, generally mild to moderate, and usually did not lead to discontinuation of therapy. Tabulated adverse reaction data (considered to be possibly, probably or definitely related to treatment), providing comparisons to placebo and other active comparators (to an incidence of 1% or greater), which have been generated from all clinical studies with AZOPT Eye Drops 1.0%, are provided below. Uncommon ophthalmic events (incidence <1% and 0.1%) not detailed in the table below included blepharitis, conjunctivitis, lid margin crusting, sticky sensation, eye fatigue, abnormal vision, keratopathy, keratoconjunctivitis, corneal staining, eye disorder, photophobia, diplopia, meibomitis, vision changes, irritation, glare and lid disorder. Uncommon non-ocular events (incidence <1% and 0.1%) not detailed in the table below included: Body as a whole: chest pain, asthenia and pain. Digestive: dry mouth, nausea, dyspepsia, diarrhoea, gastrointestinal disturbance. Nervous: paraesthesia, depression, dizziness, dream abnormality, hypertonia, agitation, amnesia, depersonalisation, nervousness. Respiratory: dyspnoea, pharyngitis, bronchitis, dry nose, epistaxis. Skin and appendages: dermatitis, alopecia, urticaria, pruritus. Special senses: tinnitus. Urogenital: kidney pain, impotence.
| Tabulated Adverse Reaction Data Comparing Incidence (%) Figures | |||||
| Adverse Events | Brinz 1.0% | Brinz 1.0% + Tim 0.5% | Dorz 2% | Tim 0.5% | Placebo |
| N = 1227 | N = 204 | N = 524 | N = 252 | N = 116 | |
| Ocular | |||||
| Blurred Vision | 5.0 | 4.9 | 1.3 | 2.8 | 1.7 |
| Discomfort | 2.5 | 1.5 | 11.1 | 4.4 | 2.6 |
| Foreign body sensation | 1.8 | 1.0 | 0.6 | 0.8 | - |
| Hyperaemia | 1.2 | 0.5 | 1.9 | 0.8 | 0.9 |
| Dry eye | 1.1 | - | 0.4 | - | 0.9 |
| Pain | 1.0 | 0.5 | 0.4 | 1.2 | 0.9 |
| Discharge | 1.0 | 0.5 | - | - | 0.9 |
| Pruritus | 0.9 | - | 1.1 | 1.2 | 1.7 |
| Keratitis | 0.7 | - | - | 1.2 | - |
| Tearing | 0.2 | - | 1.3 | - | - |
| Non-ocular | |||||
| Body as a whole | |||||
| Headache | 1.3 | 0.5 | 1.3 | 0.8 | 0.9 |
| Respiratory | |||||
| Rhinitis | 0.2 | - | 1.0 | - | - |
| Dyspnoea | 0.2 | - | - | 2.0 | - |
| Asthma | - | 1.0 | - | 0.8 | - |
| Special Senses | |||||
| Taste Perversion | 5.5 | 4.4 | 5.2 | - | 0.9 |
| Brinz = Brinzolamide Tim = Timolol maleate Dorz = Dorzolamide - = not reported | |||||
Post Marketing Experience
The following adverse reactions have been reported during clinical studies with AZOPT Eye Drops 1.0% and are classified according to the subsequent convention: very common (>= 1/10), common (>= 1/100 to <1/10), uncommon (>=1/1,000 to <1/100), rare (>=1/10,000 to <1/1,000) and very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.
Eye disorders
Common:vision blurred, eye pain, dry eye, eye discharge, ocular discomfort, ocular hyperaemia Uncommon:corneal erosion, punctate keratitis, keratitis, conjunctivitis, blepharitis, visual acuity reduced, photophobia, asthenopia, periorbital oedema, eye pruritus, lacrimation increased, eyelid margin crusting Rare:corneal oedema, diplopia, photopsia, hypoaesthesia eye
Psychiatric disorders
Uncommon:depression
Nervous system disorders
Common:headache, dysgeusia Uncommon:dizziness, paresthesia Rare:memory impairment, somnolence
Cardiac disorders
Rare:angina pectoris
Respiratory, thoracic and mediastinal disorders
Uncommon:dyspnoea, epistaxis, rhinorrhoea, oropharyngeal pain, upper airway cough syndrome, throat irritation Rare:bronchial hyperreactivity, upper respiratory tract congestion, sinus congestion, nasal congestion, cough
Gastrointestinal disorders:
Uncommon:nausea, diarrhoea, dyspepsia, abdominal discomfort, dry mouth
Skin and subcutaneous tissue disorders:
Uncommon:rash Rare:
urticaria, alopecia, pruritus generalised
General disorders and administration site conditions:
Uncommon:fatigue, irritability Rare:feeling jittery, asthenia Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data.
Eye disorders
Medication residue
Ear and labyrinth disorders
Tinnitis
Nervous system disorders
Hypoaesthesia
Vascular disorders
Blood pressure decreased
Musculoskeletal and connective tissue disorders
Arthralgia
General disorders and administration site conditions:
Chest pain
AZOPT Eye Drops 1.0% should be shaken well prior to use. Instil one drop of AZOPT Eye Drops 1.0% in the conjunctival sac of the affected eye(s) twice daily. When substituting AZOPT Eye Drops 1.0% for another ophthalmic anti-glaucoma agent, discontinue the other agent after a full day of correct dosing; AZOPT Eye Drops 1.0% should be used on the next day.
Azopt 1% Eye Drops have been used concomitantly with other agents e.g. travoprost, latanoprost, timolol (see Clinical Trials). In case of concomitant therapy with other agents, the eye drops should be administered with an interval of at least five minutes. Patients should be advised: that instillation of eye drops may cause initial discomfort (see ADVERSE REACTIONS); and to apply pressure to the tear duct for two minutes immediately after administration in order to minimise systemic absorption.
No information on systemic overdosage is available in humans. Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. A topical overdose of AZOPT 1.0% may be flushed from the eyes with warm tap water. In Australia, contact Poisons Information Centre on 13 11 26; in New Zealand call 0800 POISON or 0800 764 766 for advice on management.
Store below 25 C. Discard container 4 weeks after opening. AZOPT Eye Drops 1.0% 5 mL DROP-TAINER(r) dispenser (AUST R 72750).
Consumer Medicine Information is supplied with this product.
Alcon Laboratories (Australia) Pty Ltd 25 Frenchs Forest Road East Frenchs Forest, NSW 2086 Australia 4 Fisher Crescent Mt Wellington, Auckland 1060 New Zealand
Prescription Only Medicine (Schedule 4) Approved by TGA: May 23rd 2007 Date of most recent amendment: 02 September 2013
(r) Registered trademark