Tobramycin

Sold as Pharma-q tobramycin, Tobrabact, Tobrahale respules, Cipla-tobramycin respules, Tobi, Tobrex eye, Tobramycin fresenius

C₁₈H₃₇N₅O₉467.50 g/mol

(2S,3R,4S,5S,6R)-4-Amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol

Drag to rotate. Structure from PubChem CID 36294.

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Registration

Applicants: 6
Registrations: 10
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Pharma-q Holdings (Pty) Ltd	Pharma-q tobramycin	20 mg/2 ml, 80 mg/2 ml	310155, 310156	S4	None
Adcock ingram limitedCancelled	Tobrabact	Not stated	370082	S4	None
Cipla Medpro (Pty) LtdCancelled	Tobrahale respules, Cipla-tobramycin respules	Not stated	440048, 440049	S4	None
Viatris South Africa (Pty) LtdCertificate held by Viatris south africa (pty)ltd	Tobi	300 mg/5 ml	A400522	S4	PI PIL
Novartis South Africa (Pty) Ltd	Tobrex eye	drops, ointment	P0058, P0205	S4	None
Fresenius Kabi Manufacturing SA (Pty) Ltd	Tobramycin fresenius	20 mg/2 ml, 80 mg/2 ml	Z0286, Z0287	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Pharma-q tobramycin injection 20 mg/2 ML EACH 2 ml SOLUTION CONTAINS TOBRAMYCIN SULPHATE EQUIVALENT TO 20 mg TOBRAMYCIN	20 mg/2 mlInjection	31015531/20.1.1/0155	Registered	S4	None
Pharma-q tobramycin injection 80 mg/2 ML EACH 2 ml SOLUTION CONTAINS TOBRAMYCIN SULPHATE EQUIVALENT TO 80 mg TOBRAMYCIN	80 mg/2 mlInjection	31015631/20.1.1/0156	Registered	S4	None
Tobrabact EACH 1,0 ml DROPS CONTAINS TOBRAMYCIN 3,0 mg	Not listed	37008237/15.1/0082	Cancelled	S4	None
Tobrahale respules EACH 5,0 ml RESPULE CONTAINS TOBRAMYCIN 300,0 mg	Not listed	44004844/20.1.1/0048	Cancelled	S4	None
Cipla-tobramycin respules EACH 5,0 ml RESPULE CONTAINS TOBRAMYCIN 300,0 mg	Not listed	44004944/20.1.1/0049	Cancelled	S4	None
Tobi 300 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS TOBRAMYCIN 300,0 ml	300 mg/5 mlClear slightly yellow solution	A400522A40/20.1.1/0522Approved 14 November 2023	Registered	S4	PI PIL
Tobrex eye drops EACH 1,0 ml OPHTHALMIC SOLUTION CONTAINS TOBRAMYCIN 3,0 mg	Drops	P0058P/15.1/58	Registered	S4	None
Tobrex eye ointment EACH 1,0 g OPHTHALMIC OINTMENT CONTAINS TOBRAMYCIN 3,0 mg	Ointment	P0205P/15.1/205	Registered	S4	None
Tobramycin fresenius 20 mg/2 ML EACH 2 ml VIAL CONTAINS TOBRAMYCIN SULPHATE EQUIVALENT TO 20 mg TOBRAMYCIN	20 mg/2 ml	Z0286Z/20.1.1/286	Registered	S4	None
Tobramycin 80 mg/2 ML fresenius EACH 2 ml VIAL CONTAINS TOBRAMYCIN SULPHATE EQUIVALENT TO 80 mg TOBRAMYCIN	80 mg/2 mlSolution for injection or infusion	Z0287Z/20.1.1/287Approved 9 September 2022	Registered	S4	PI PIL

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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 high.

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 Tobramycin sulphate equivalent to tobramycin

S4: Tobramycin
Consolidated Schedules 06 July 2026, line 8234

Pharmacological class: Broad and medium spectrum antibiotics. (class 20.1.1)

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

Professional information (PI)For healthcare professionalsTobi 300 mg/5 ML, Viatris South Africa (Pty) Ltd Patient information leaflet (PIL)For patients and carersTobi 300 mg/5 ML, Viatris South Africa (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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