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Sulfamethoxazole, trimethoprim (Dynazole, Trixazole)

Sulfamethoxazole, trimethoprim

Ascendis Pharma (Pty) Ltd

S4

Registration

Applicant
Ascendis Pharma (Pty) Ltd
Registrations
2
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Dynazole suspension

EACH 5 ml CONTAINS SULFAMETHOXAZOLE 200 mg TRIMETHOPRIM 40 mg

Suspension27033527/20.2/0335RegisteredS4None
Trixazole

EACH TABLET CONTAINS SULFAMETHOXAZOLE 400 mg TRIMETHOPRIM 80 mg

Not listedZ0209Z/20.2/209RegisteredS4None

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 Sulfamethoxazole, trimethoprim

  • S4: Sulfamethoxazole

    • except when 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 8032 to 8033

  • S4: Trimethoprim

    • except when specifically intended and registered in combination with sulphonamides for the treatment of gastro-enteritis and pneumonia 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 8287 to 8289

Pharmacological class: Other than antibiotics. (class 20.2)

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.

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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