DOCSLIB.ORG

Ophthalmology) Made in Its 42Nd Meeting Held on 29.09.2020 at CDSCO HQ New Delhi

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Ophthalmology) Made in Its 42Nd Meeting Held on 29.09.2020 at CDSCO HQ New Delhi Recommendations of the SEC (Ophthalmology) made in its 42nd meeting held on 29.09.2020 at CDSCO HQ New Delhi. Agenda File Name & Drug Recommendations Firm Name No Name, Strength New Drugs Division In light of earlier recommendation of SEC dated 19.08.2020, the firm presented toxicity data along with digital pictures from the animal data for Netrasudil 0.02% w/v + ND/MA/19/000024 Latanoprost 0.005% w/v Ophthalmic solution before the Netarsudil 0.02% M/s Ajanta Pharma committee. 1. w/v + Latanoprost limited The committee noted that the firm 0.005% w/v has completed Phase III CT with Ophthalmic solution Netarsudil 0.02% w/v Ophthalmic solution. After detailed deliberation, the committee recommended for grant of permission to conduct the Phase III CT as per protocol presented. Firm presented their proposal along with the Phase III CT report before ND/MA/18/000016 the committee. M/s Ajanta Pharma After detailed deliberation 2. Netarsudil 0.02% e/v limited committee recommended for grant Ophthalmic solution of permission to manufacture & market Netarsudil 0.02% w/v Ophthalmic solution. ND/CT18/FF/2020/2 Firm didn’t turn up for presentation 1772 M/s Santen India Pvt. 3. Diquafosol Sodium Ltd ophthalmic solution 3% w/v Biological Division Firm presented their proposal for 4-51/Reliance/PAC- approval of additional indications. R-Ranibizumab/ M/s Reliance Life The committee noted that the drug 4. 2020-BD Sciences Pvt. Ltd. has been recently approved for Ranibizumab marketing in the country. After detailed deliberation, the SEC (Ophthalmology) 29.09.2020 committee recommended that the firm should submit safety data from the Phase IV clinical trial before considering the approval of additional indications. Firm presented their proposal along with the protocol for conduct of Phase IV Clinical Trial before the committee. After detailed deliberation, the committee recommended for grant of permission to conduct the Phase IV Clinical Trial subject to the BIO/CT04/FF/2020/ following conditions – 20666 (CDSCO File M/s Bayer (1) Primary objective of the study 5. No: Pharmaceuticals Pvt. BIO/CT/20/000094) Ltd. should be safety and secondary Aflibercept objective should be efficacy. (2) The study shall be an interventional study. Accordingly, the firm should submit the revised protocol to CDSCO. Dr. Somesh Aggrawal did not participate in the deliberation. Firm presented their proposal along with the protocol for conduct of BIO/CT04/FF/2020/ Phase IV clinical trial before the 20653 (CDSCO File committee. M/s Reliance Life No.: 6. Sciences Pvt. Ltd. After detailed deliberation, the BIO/CT/20/000126) committee recommended for grant Ranibizumab of permission to conduct the Phase IV study as per the protocol presented. 04-31/Sandoz/PAC- Firm presented their proposal for inclusion of “Consulting Physician R-Erenumab/2020- M/s Sandoz Private and Ophthalmologist” as 7. BD Limited prescribers for Erenumab. Erenumab After detailed deliberation, the SEC (Ophthalmology) 29.09.2020 committee recommended that the proposal may be deliberated in the SEC (Neurology and Psychiatry) SND Division In light of earlier recommendation SND/CT/20/000024 of SEC meeting dated 15.07.2020, the firm presented the revised Brinzolamide M/s Shilpa medicare Phase III Clinical Trial protocol. Ophthalmic Solution 8. Ltd After detailed deliberation the 0.75% committee recommended for grant (Additional strength) of permission for conduct of Phase III Clinical Trial as per the protocol presented. In light of earlier recommendation of SEC meeting dated 22.06.2020 the firm presented the clarification on the composition of the ionic buffer preservative system used in the Travoprost Eye Drops 0.04% w/v and stated that it was a 12-136/2016-DC (Pt- typographical error in the PPT Akums-SND) presented during earlier SEC M/s Akums Drugs & meeting. Travoprost Eye 9. The committee was also informed Drops 0.04% w/v Pharmaceuticals Ltd that as per submitted dossier on Preserved with ionic CMC, the composition of buffer buffer system was in-line with innovator’s ionic buffer system composition. After detailed deliberation, the committee recommended for grant of permission to manufacture and market Travoprost Eye Drops 0.04% w/v preserved with ionic buffer system. The firm presented their proposal along with the published literature SND/MA/20/000199 of various Clinical Trials for the proposed product. Atropine Sulfate M/s Sun Pharma It was noted that the proposed 10. Ophthalmic Solution Laboratories Ltd product is already approved in 0.01% w/v Japan, Singapore, Malaysia and Taiwan. After detailed deliberation the committee recommended for grant SEC (Ophthalmology) 29.09.2020 of permission to manufacture and market Atropine Sulfate Ophthalmic Solution 0.01% w/v subject to condition that firm should conduct Phase IV Clinical Trial to assess long term safety of the product. Accordingly, the firm should submit Phase IV Clinical Trial protocol within 3 months of approval of the product. GCT Division CT/24/20 M/s Novartis The firm presented their response to Clinical Trial NOC conditions. Online Submission After detailed deliberation the committee recommended for Brolucizumab conduct of the study subject to condition that during screening of 11. trial participants, every site should carry out PCR testing to rule out COVID-19 infection and also at every visits the investigator shall follow the prevailing COVID-19 guidelines. CT/87/20 M/s. Cliantha Firm presented their Phase III clinical trial proposal before the Online Submission committee. MYL-170IP Assessment of Risk versus benefit to the patients- The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial. Innovation vis-a-vis existing therapeutic- Evaluate the Safety 12. and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P- 3001 Study. Unmet medical need in the country- The test drug used for Diabetic Macular Edema. After detailed deliberation the committee recommended for grant of permission to conduct the study. SEC (Ophthalmology) 29.09.2020 Dr. Somesh Aggarwal didn’t participate in presentation. Medical Device Division IMP/MD/2020/2616 M/s Caregroup Sight Firm presented their proposal 5 Solution private before the committee. Trabecular Micro- limited The committee noted that device is Bypass System approved for marketing in USA, Canada, EU etc. After detailed deliberation, the committee recommended for grant 13. of permission to import & market the product subject to the condition that the firm should conduct Phase IV clinical investigation in India. Accordingly, the firm should submit Phase IV protocol within 3 months from the approval for further review by the committee. SEC (Ophthalmology) 29.09.2020 .
Load more

Recommended publications
  • Brimonidine Tartrate; Brinzolamide
    Contains Nonbinding Recommendations Draft Guidance on Brimonidine Tartrate ; Brinzolamide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Brimonidine tartrate; Brinzolamide Dosage Form; Route: Suspension/drops; ophthalmic Strength: 0.2%; 1% Recommended Studies: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.2%; 1% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes. Additional comments: Specific recommendations are provided below. ______________________________________________________________________________ Analytes to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference listed drug (RLD), each applied as one drop in both eyes three times daily at approximately 8:00 a.m., 4:00 p.m., and 10:00 p.m. for 42 days (6 weeks). 2. Inclusion criteria (the sponsor may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes b.
    [Show full text]
  • AZARGA, INN-Brinzolamide/Timolol
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). Excipient with known effect: One ml of suspension contains 0.10 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension (eye drops) White to off-white uniform suspension, pH 7.2 (approximately). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1). 4.2 Posology and method of administration Posology Use in adults, including the elderly The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4). 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) twice daily. When substituting another ophthalmic antiglaucoma medicinal product with AZARGA, the other medicinal product should be discontinued and AZARGA should be started the following day. Special populations Paediatric population The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established.
    [Show full text]
  • WO 2014/066775 Al 1 May 2014 (01.05.2014) W P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/066775 Al 1 May 2014 (01.05.2014) W P O PCT (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61F 9/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US20 13/066834 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, 25 October 2013 (25.10.201 3) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (25) Filing Language: English OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (26) Publication Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (30) Priority Data: ZW. 61/719,144 26 October 2012 (26. 10.2012) US (84) Designated States (unless otherwise indicated, for every (71) Applicant: FORSIGHT VISION5, INC. [US/US]; 191 kind of regional protection available): ARIPO (BW, GH, Jefferson Drive, Menlo Park, CA 94025 (US). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (72) Inventors: RUBIN, Anne, Brody; 191 Jefferson Drive, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, Menlo Park, CA 94025 (US).
    [Show full text]
  • Estonian Statistics on Medicines 2016 1/41
    Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole
    [Show full text]
  • Latanoprost Ophthalmic Emulsion
    Contains Nonbinding Recommendations Draft Guidance on Latanoprost This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Latanoprost Dosage Form; Route: Emulsion; ophthalmic Strength: 0.005% Recommended Study: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.005% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes Additional comments: Specific recommendations are provided below Analyte s to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference standard (RS) product, each applied as one drop in both eyes once daily in the evening for 42 days (6 weeks). 2. Inclusion criteria (the applicant may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes. b. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
    [Show full text]
  • AZARGA® Eye Drops Brinzolamide 10 Mg/Ml and Timolol 5 Mg/Ml CONSUMER MEDICINE INFORMATION
    AZARGA® Eye Drops Brinzolamide 10 mg/mL and timolol 5 mg/mL CONSUMER MEDICINE INFORMATION What Is In This Leaflet Although AZARGA helps control your glaucoma, it does not cure it. Please read this leaflet carefully For more information about before you use any AZARGA Eye What AZARGA is used glaucoma, contact Glaucoma drops. for Australia on 1800 500 880 or Glaucoma New Zealand on 09 373 This leaflet answers some common AZARGA is used to lower pressure 8779. questions about AZARGA. It does in the eye and to treat glaucoma. not contain all of the available Glaucoma is a condition in which the Your doctor may have prescribed information. It does not take the pressure of fluid in the eye may be AZARGA for another reason. Ask place of talking to your doctor or high. However, some people with your doctor if you have any questions pharmacist. glaucoma may have normal eye about why AZARGA has been The information in this leaflet was pressure. prescribed for you. last updated on the date listed on the Glaucoma is usually caused by a There is no evidence that AZARGA final page. More recent information build-up of the fluid which flows is addictive. on the medicine may be available. through the eye. This build up occurs You should ensure that you speak because the fluid drains out of your Use in Children to your pharmacist or doctor to eye more slowly than it is being There is not enough information to obtain the most up to date pumped in. Since new fluid continues recommend the use of this medicine information on the medicine.
    [Show full text]
  • Safety and Efficacy of SIMBRINZA BID As an Adjunctive to DUOTRAV
    Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 1 of 71 a Novartis company Short Title Safety and Efficacy of SIMBRINZA BID as an Adjunctive to DUOTRAV Long Title Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV) Protocol Number: GLJ576-P001/ NCT02730871 Study Phase: 4 Sponsor Name and Alcon Research, Ltd. Address: 6201 South Freeway Fort Worth, Texas 76134-2099 Investigational Product: SIMBRINZA Brinzolamide 1% (10 mg/mL)/Brimonidine 0.2% (2 mg/mL) eye drops suspension US IND# / EudraCT 2016-000176-20 Indication Studied: Ocular Hypertension Open Angle Glaucoma Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 2 of 71 Investigator Agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Additionally, I will comply with all procedures for data recording and reporting, will permit monitoring, auditing, and inspection of my research center, and will retain all records until notified by the Sponsor. Principal Investigator: Signature Date Name: Address: Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 3 of 71 1 SYNOPSIS Sponsor: Alcon Research, Ltd.
    [Show full text]
  • Drugs That May Be Used Based on Licensure Designation Page 1 of 7 Updated February 2021 by the Pennsylvania State Board of Optometry
    Drugs Which May Be Used Based on Licensure Designation Approved Drugs a.) Administration and prescription of pharmaceutical agents for therapeutic purposes. Optometrists who are certified to prescribe and administer pharmaceutical agents for therapeutic purposes under section 4.1 of the Optometric Practice and Licensure Act (63 P. S. § 244.4a), may prescribe and administer the drugs listed in subsections (c)(1) – (11) below in their practice of optometry. See also 49 Pa. Code § 23.202 for the application procedure for optometrists to administer and prescribe pharmaceutical agents for therapeutic purposes. b.) Administration and prescription of pharmaceutical agents to treat glaucoma. Optometrists who are certified to prescribe and administer pharmaceutical agents to treat glaucoma under section 4.2 of the Optometric Practice and Licensure Act (63 P.S. § 244.4b), may prescribe and administer the drugs listed in subsection (c)(12) below in their practice of optometry. See also 49 Pa. Code § 23.205 for the application procedure for optometrists to administer and prescribe pharmaceutical agents to treat glaucoma. c.) DEA registration reminder. Licensees who hold, or plan to obtain, a DEA registration are reminded to review and comply with PDMP standards. d.) Allowable pharmaceutical products. Optometrists may prescribe and administer the following pharmaceutical products or the A-rated generic therapeutically equivalent drug: (1) Topical Anesthetics (i) benoxinate (ii) lidocaine (iii) proparacaine (iv) tetracaine (2) Topical Ocular Lubricants
    [Show full text]
  • Estonian Statistics on Medicines 2013 1/44
    Estonian Statistics on Medicines 2013 DDD/1000/ ATC code ATC group / INN (rout of admin.) Quantity sold Unit DDD Unit day A ALIMENTARY TRACT AND METABOLISM 146,8152 A01 STOMATOLOGICAL PREPARATIONS 0,0760 A01A STOMATOLOGICAL PREPARATIONS 0,0760 A01AB Antiinfectives and antiseptics for local oral treatment 0,0760 A01AB09 Miconazole(O) 7139,2 g 0,2 g 0,0760 A01AB12 Hexetidine(O) 1541120 ml A01AB81 Neomycin+Benzocaine(C) 23900 pieces A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+Thymol(dental) 2639 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+Cetylpyridinium chloride(gingival) 179340 g A01AD81 Lidocaine+Cetrimide(O) 23565 g A01AD82 Choline salicylate(O) 824240 pieces A01AD83 Lidocaine+Chamomille extract(O) 317140 g A01AD86 Lidocaine+Eugenol(gingival) 1128 g A02 DRUGS FOR ACID RELATED DISORDERS 35,6598 A02A ANTACIDS 0,9596 Combinations and complexes of aluminium, calcium and A02AD 0,9596 magnesium compounds A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 591680 pieces 10 pieces 0,1261 A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 1998558 ml 50 ml 0,0852 A02AD82 Aluminium aminoacetate+Magnesium oxide(O) 463540 pieces 10 pieces 0,0988 A02AD83 Calcium carbonate+Magnesium carbonate(O) 3049560 pieces 10 pieces 0,6497 A02AF Antacids with antiflatulents Aluminium hydroxide+Magnesium A02AF80 1000790 ml hydroxide+Simeticone(O) DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 34,7001 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 3,5364 A02BA02 Ranitidine(O) 494352,3 g 0,3 g 3,5106 A02BA02 Ranitidine(P)
    [Show full text]
  • Glaucoma Drugs
    Top 5 Ophthalmology Peer Reviewed TOP 5 Glaucoma Drugs Erin M. Scott, VMD, & Gillian J. McLellan, BVMS, PhD, DVOphthal, DECVO, DACVO, MRCVS University of Wisconsin –Madison laucoma is typically associated with elevated intraocular pres - sure (IOP) resulting from impaired aqueous humor outflow and leads to irreversible damage to the optic nerve and G TOP 5 GLAUCOMA DRUGS retina. 1,2 Primary glaucomas are relatively common and have strong breed predilections in dogs but are rarely diagnosed in cats. 1,3,4 Sec - ondary glaucomas are as frequent as primary glaucomas in dogs and 1. Carbonic anhydrase inhibitors constitute 95% to 98% of glaucoma cases in cats. 1,4-7 They are usually 2. Prostaglandin analogs secondary to an ocular or systemic disorder that impairs aqueous humor outflow (eg, uveitis, neoplasia, lens luxation, trauma). 8 Since 3. β-blockers glaucomas are heterogeneous in terms of pathogenesis, therapy must 4. Miotics be tailored to each patient (see Commonly Used Glaucoma Drugs at a Glance , next page ). Glaucoma medications target IOP by either 5. Hyperosmotic agents decreasing production or increasing outflow of aqueous humor. Carbonic Anhydrase Inhibitors Carbonic anhydrase, an enzyme present in the ciliary body epithelium, contributes to Glaucoma medications aqueous humor production. Carbonic anhydrase inhibitors (CAIs) can decrease aque - 1 ous humor production in dogs and cats by over 40%. 9,10 Dorzolamide 2% effectively target IOP by either lowers IOP when administered q8h. 10-13 It may be used in the management of acute decreasing production glaucomatous crises and for long-term control of IOP. Dorzolamide may be considered a safe first-line drug of choice for dogs and cats with glaucoma, regardless of cause.
    [Show full text]
  • Azarga (Brinzolamide and Timolol Maleate) Eye Drops
    AUSTRALIAN PRODUCT INFORMATION – AZARGA (BRINZOLAMIDE AND TIMOLOL MALEATE) EYE DROPS 1 NAME OF THE MEDICINE Brinzolamide and timolol maleate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of AZARGA Eye Drops suspension contains brinzolamide 10 mg (1%) and timolol 5 mg (0.5%) (as timolol maleate). The pH of AZARGA is approximately 7.2. May contain traces of potential allergens such as benzoates, sulfites and hydroxybenzoates from the manufacturing process. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops. AZARGA is a white to off-white uniform suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension for whom monotherapy with either component provides insufficient IOP reduction. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dosage is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. Shake the bottle well before use. Nasolacrimal occlusion and gently closing the eyelid after instillation are recommended. This may reduce the systemic absorption of eye drops and result in a decrease in systemic adverse reactions. If more than one topical ophthalmic medicine is being used, the medicines must be administered at least 5 minutes apart. 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) twice daily. When substituting another ophthalmic antiglaucoma agent with AZARGA, the other agent should be discontinued and AZARGA should be started the following day. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
    [Show full text]
  • Brinzolamide/ Timolol Mylan 10 Mg/Ml + 5 Mg/Ml Eye Drops
    Package leaflet: Information for for the treatment of glaucoma. Tell your the user doctor if you are taking or intend to take medicines to lower blood pressure like Brinzolamide/ parasympathomimetics and guanetidine, or other heart medicines including Timolol Mylan quinidine (used to treat heart conditions and some types of malaria), amiodarone 10 mg/ml + 5 mg/ml or other medicines to treat heart rhythm disorders and glycosides to treat heart eye drops, insufficiency. Also tell your doctor if you are taking or intend to take medicines suspension to treat diabetes, or to treat gastric brinzolamide/timolol ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as Read all of this leaflet carefully fluoxetine and paroxetine. before you start using this medicine because it contains important If you are taking another carbonic information for you. anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor. • Keep this leaflet. You may need to Increase in pupil size when taking read it again. Brinzolamide/Timolol Mylan and • If you have any further questions, ask your doctor or pharmacist. adrenaline (epinephrine) together has • This medicine has been prescribed been reported occasionally. for you only. Do not pass it on to Pregnancy and breast-feeding others. It may harm them even if You should not use Brinzolamide/Timolol their signs of illnesses are the same Mylan if you are pregnant or might get as yours. pregnant, unless your doctor considers it • If you get any side effects, talk to necessary. Talk to your doctor before you your doctor or pharmacist. This includes any possible side effects not use Brinzolamide/Timolol Mylan.
    [Show full text]