Loteprednol etabonate (Lotemax Ophthalmic, Alrex)
Loteprednol etabonate
Soflens (Pty) Ltd
Registration
- Applicant
- Soflens (Pty) Ltd
- Certificate holder
- Soflens (Pty) Ltd
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lotemax ophthalmic suspension EACH 1,0 ml SUSPENSION CONTAINS LOTEPREDNOL ETABONATE 5,0 mg | 5mgEye drops. Suspension | 37058837/15.2/0588Approved 13 August 2020 | Registered | S4 | PIPIL |
| Alrex EACH 1,0 ml SUSPENSION CONTAINS LOTEPREDNOL ETABONATE 2,0 mg | 2,00 mgEye drops, suspension | 38020338/15.2/0203Approved 19 February 2016 | Registered | S4 | PIPIL |
| Lotemax ophthalmic gel Each 1,0 gram contains LOTEPREDNOL ETABONATE 5,0 mg | 0,5 %Eye gel | 51903651/15.2/9036Approved 17 October 2022 | Registered | S4 | PIPIL |
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, 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.
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.
Chloromethyl (8S,9S,10R,11S,13S,14S,17R)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylate
Drag to rotate. Structure from PubChem CID 444025.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.