Dorzolamide
Sold as Trusopt, Glaucopress, Ciplasopt, Gozopt, Glaumide, Dorzolamide eye pharma-q, Ocudor, Dorzopt, Dorzopres, Micogloma, Dorzolamide adco, Dorzolamide eye FDC, Dorzivra
(4S,6S)-4-(Ethylamino)-6-methyl-7,7-dioxo-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide
Drag to rotate. Structure from PubChem CID 5284549.
Background
Registration
- Applicants
- 8
- Registrations
- 13
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mundipharma (Pty) Ltd | Trusopt | 20mg | 290766 | S3 | PIPIL |
| Gen-eye (Pty) Ltd | Glaucopress, Glaumide | Not stated | 451035, 460683 | Not determined | None |
| Cipla Medpro (Pty) LtdCancelled | Ciplasopt, Gozopt | Not stated | 451077, 451080 | Not determined | None |
| Pharma-q Holdings (Pty) Ltd | Dorzolamide eye pharma-q | drops | 480709 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Ocudor | 2 % | 510100 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Dorzopt, Dorzopres | 20 mg | 550345, 550346.345 | S3 | PIPIL |
| Adcock ingram limited | Micogloma, Dorzolamide adco | 20 mg | 560841, 560842.841 | S3 | PIPIL |
| FDC SA (Pty) Ltd | Dorzolamide eye FDC, Dorzivra | drops | 561207, 561208.1207 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Trusopt 2 % EACH 1 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 20mgOphthalmic solution | 29076629/15.4/0766Approved 10 March 2015 | Registered | S3 | PIPIL |
| Glaucopress EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | Not listed | 45103545/15.4/1035 | Registered | Not determined | None |
| Ciplasopt EACH 5,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE 111,25 mg | Not listed | 45107745/15.4/1077 | Cancelled | Not determined | None |
| Gozopt EACH 5,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE 111,25 mg | Not listed | 45108045/15.4/1080 | Cancelled | Not determined | None |
| Glaumide EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | Not listed | 46068346/15.4/0683 | Registered | Not determined | None |
| Dorzolamide eye drops pharma-q EACH 1,0 ml contains 22,26 mg DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | Drops | 48070948/15.4/0709 | Registered | Not determined | None |
| Ocudor 2 % Each 1 ml of solution contains DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 2 % | 51010051/15.4/0100 | Registered | Not determined | None |
| Dorzopt EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 20 mgEye drops | 55034555/15.4/0345Approved 13 June 2023 | Registered | S3 | PIPIL |
| Dorzopres EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 20 mgEye drops | 550346.34555/15.4/0346.345Approved 13 June 2023 | Registered | S3 | PIPIL |
| Micogloma EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 20 mgEye drops solution | 56084156/15.4/0841Approved 15 October 2024 | Registered | S3 | PI |
| Dorzolamide adco EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg | 20 mgEye drops solution | 560842.84156/15.4/0842.841Approved 15 October 2024 | Registered | S3 | PIPIL |
| Dorzolamide eye drops FDC Each 1,0 ml Solution contains: Dorzolamide Hydrochloride equivalent to Dorzolamide | Drops | 56120756/15.4/1207 | Registered | Not determined | None |
| Dorzivra Each 1,0 ml Solution contains: Dorzolamide hydrochloride equivalent to Dorzolamide 20,0 mg | Not listed | 561208.120756/15.4/1208.1207 | Registered | Not determined | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S3, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Dorzolamide hydrochloride equivalent to dorzolamide
S3: Dorzolamide
Consolidated Schedules 06 July 2026, line 3486
Pharmacological class: Others. (class 15.4)
7 of 21 approved products with this ingredient carry S4 on their leaflet.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Trusopt 2 %, Mundipharma (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.