Ampicillin, nystatin
Sold as Pentrex-f
Every registration of this product has been cancelled.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 1
- Registrations
- 2
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bristol-myers Squibb (Pty) LtdCancelled | Pentrex-f | 125MG/5ML, 250 MG | A0799, A0800 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pentrex-f suspension 125mg/5ml 5ML AMPICILLIN TRIHYDRATE A 144,34 MG NYSTATIN A 125 000 IU | 125MG/5MLSuspension | A0799 | Cancelled | Not determined | None |
| Pentrex-f capsules 250 MG CAPSULE AMPICILLIN TRIHYDRATE A 289 MG NYSTATIN A 40 MG | 250 MGCapsules | A0800 | Cancelled | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Ampicillin
- except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. (Act 36 of 1947)
Consolidated Schedules 06 July 2026, lines 5240 to 5242
S4: Nystatin
- when intended for systemic use or the initial treatment of vaginal candidiasis;
- except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
- except when intended for application to the skin, (S1) and
- except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, (S1)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 7340 to 7356
S2: Nystatin
- when presented as oral drops containing not more than100 000 I.U. per millilitre, and
- except when intended for application to the skin, (S1) and
- except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, (S1) and
- except when intended for systemic use or the initial treatment of vaginal candidiasis, (S4)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 2438 to 2449
S1: Nystatin
- when intended for application to the skin, and
- when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, and
- except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
- except when intended for systemic use or the initial treatment of vaginal candidiasis, (S4)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 926 to 937
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
SAHPRA has not published a professional information or patient information leaflet for this product.