Dexamethasone, tobramycin
Sold as Nebcin co eye, Mydex, Octudex, Tobroft, Xamflam, Tobradex eye
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 5
- Registrations
- 7
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead | Nebcin co eye | drops | 460047 | S4 | None |
| Gen-eye (Pty) Ltd | Mydex | Not stated | 460196 | S4 | None |
| Ranbaxy (SA) (Pty) Ltd | Octudex | Not stated | 511074 | S4 | None |
| Austell Pharmaceuticals (Pty) Ltd | Tobroft, Xamflam | 1 mg, 3 mg | 540408, 540409.408 | S4 | PIPIL |
| Novartis South Africa (Pty) Ltd | Tobradex eye | drops, ointment | X0091, X0092 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Nebcin co eye drops EACH 1,0 ml SOLUTION CONTAINS DEXAMETHASONE 1,0 mg TOBRAMYCIN 3,0 mg | Drops | 46004746/15.3/0047 | Registered | S4 | None |
| Mydex Each 1ml contains: Tobramycin 3,0 mg and Dexamethasone 1,0 mg | Not listed | 46019646/15.3/0196 | Registrered | S4 | None |
| Octudex Each 1,0 ml contains TOBRAMYCIN 3,0 mg and DEXAMETHASONE 1,0 mg | Not listed | 51107451/15.3/1074 | Registered | S4 | None |
| Tobroft EACH 1,0 ml SUSPENSION CONTAINS DEXAMETHASONE 1,0 mg TOBRAMYCIN 3,0 mg | 1 mg, 3 mgEye drops | 54040854/15.3/0408Approved 4 April 2023 | Registered | S4 | PIPIL |
| Xamflam EACH 1,0 ml SUSPENSION CONTAINS DEXAMETHASONE 1,0 mg TOBRAMYCIN 3,0 mg | 1 mg, 3 mgEye drops | 540409.40854/15.3/0409.408Approved 4 April 2023 | Registered | S4 | PIPIL |
| Tobradex eye drops EACH 1,0 ml SUSPENSION CONTAINS DEXAMETHASONE 1,0 mg TOBRAMYCIN 3,0 mg | Drops | X0091X/15.3/91 | Registered | S4 | None |
| Tobradex eye ointment EACH 1,0 g OPHTHALMIC OINTMENT CONTAINS DEXAMETHASONE 1,0 mg TOBRAMYCIN 3,0 mg | Ointment | X0092X/15.3/92 | Registered | S4 | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, matched to the Consolidated Schedules by ingredient, confidence medium.
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 Dexamethasone, tobramycin
S4: Dexamethasone
Consolidated Schedules 06 July 2026, line 6001
S4: Tobramycin
Consolidated Schedules 06 July 2026, line 8234
Pharmacological class: Combination antibiotics. (class 15.3)
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
Tobroft, Austell Pharmaceuticals (Pty) Ltd is scheduled S4 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.