Flucloxacillin (Macropen, Macropen S, Apen, Apen S, Xixia-flucloxacillin S)
Flucloxacillin
Viatris South Africa (Pty) Ltd
Registration
- Applicant
- Viatris South Africa (Pty) Ltd
- Certificate holder
- Viatris South Africa (Pty) Ltd
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Macropen 500 EACH CAPSULE CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO 250 mg AMOXYCILLIN FLUCLOXACILLIN SODIUM EQUIVALENT TO 250 mg FLUCLOXACILLIN | 250 mgCapsules and macropen powder for suspension | 27010627/20.1.2/0106Approved 30 January 2026 | Registered | S4 | PIPIL |
| Macropen s EACH 5 ml SUSPENSION CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO 125 mg AMOXYCILLIN FLUCLOXACILLIN SODIUM EQUIVALENT TO 125 mg FLUCLOXACILLIN | Not listed | 27010727/20.1.2/0107 | Registered | S4 | None |
| Apen 500* EACH CAPSULE CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO 250 mg AMOXYCILLIN FLUCLOXACILLIN SODIUM EQUIVALENT TO 250 mg FLUCLOXACILLIN | 500 | 27010827/20.1.2/0108 | Registered | S4 | None |
| Apen s EACH 5,0 ml SUSPENSION CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO 125,0 mg AMOXYCILLIN FLUCLOXACILLIN SODIUM EQUIVALENT TO 125,0 mg FLUCLOXACILLIN | Not listed | 27010927/20.1.2/0109 | Registered | S4 | None |
| Xixia-flucloxacillin s EACH 5,0 ml SUSPENSION CONTAINS FLUCLOXACILLIN SODIUM EQUIVALENT TO FLUCLOXACILLIN 125,0 mg | Not listed | 29055129/20.1.2/0551 | 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, 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 Amoxycillin trihydrate equivalent to amoxycillin, flucloxacillin sodium equivalent to flucloxacillin
S4: Flucloxacillin
Consolidated Schedules 06 July 2026, line 6349
Pharmacological class: Penicillins. (class 20.1.2)
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.
(2S,5R,6R)-6-[[3-(2-Chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
Drag to rotate. Structure from PubChem CID 21319.
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.