Dexmedetomidine

Sold as Dexdomitor, Precedex, Sedalpha, Eccladex, Adcopres, Dexisun, Sedmedex, Sesodex, Tomexa, Eusedex, Dexithera, Intudex, Dexmedetomidine b. Braun, Dexsedate, Dexmirub, Dexumex rtu, Prexuject rtu, Sedmedex rtu

C₁₃H₁₆N₂200.28 g/mol

5-[(1S)-1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole

Drag to rotate. Structure from PubChem CID 5311068.

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Registration

Applicants: 14
Registrations: 28
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Zoetis South Africa (Pty) Ltd	Dexdomitor	Not stated	17-Aug	S5	None
Pfizer Laboratories (Pty) Ltd	Precedex, Eusedex	1 mL	340239, 560850	S5	PI PIL
Accord Healthcare (Pty) Ltd	Sedalpha	100 μg/ml	480969	S5	None
Equity Pharmaceutical (Pty) LtdCertificate held by Equity Pharmaceuticals (Pty) Ltd.	Eccladex	100 ug/ml	500374	S5	PI PIL
Adcock Ingram Critical Care (Pty) Ltd	Adcopres	Not stated	530717	S5	None
Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd	Dexisun	100,0 μg	540218	S5	PI PIL
Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) Ltd	Sedmedex, Sedmedex rtu	50 ml, 100 μg, 100 ml	540696, 590983, 590984	S5	PI PIL
Austell Pharmaceuticals (Pty) Ltd	Sesodex, Intudex	200 μg	550841, 560992	S5	PI PIL
Pharmacorp (Pty) Ltd	Tomexa	200 µg/2 ml, 400 µg/4 ml, 1000 µg/10 ml	560233, 560234, 560235	S5	None
Abbott Laboratories S.A. (Pty) LtdCertificate held by Abbott Laboratories South Africa (Pty) Ltd	Dexithera	4 μg, 100 µg/ml 2 ml, 100 µg/ml 4 ml, 100 µg/ml 10 ml	560938, 560939, 560940, 560941	S5	PI PIL
B Braun Medical (Pty) Ltd	Dexmedetomidine b. Braun	000 μg 1, 200 μg, 400 μg	570631, 570632, 570633	S5	None
Pharma-q (Pty) Ltd	Dexsedate	Not stated	570783	S5	None
Ruby Pharmaceuticals (Pty) Ltd	Dexmirub	Not stated	580261	S5	None
Abex Pharmaceutica (Pty) Ltd	Dexumex rtu, Prexuject rtu	200 μg/50 ml, 400 μg/100 ml	590096, 590097, 590098.096, 590099.097	S5	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Dexdomitor EACH 1,0 ml SOLUTION CONTAINS DEXMEDETOMIDINE 0,5 mg	Not listed	17-Aug08/1.4.2/17	Registered	S5	None
Precedex EACH 1,0 ml SOLUTION CONTAINS DEXMEDETOMIDINE 100,0 ug	1 mLConcentrated solution for intravenous infusion.	34023934/2.9/0239Approved 16 May 2023	Registered	S5	PI PIL
Sedalpha 100 μg/ml EACH 1,0 ML CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 100,0 μg	100 μg/ml	48096948/2.9/0969	Registered	S5	None
Eccladex EACH 1,0 ml VIAL CONTAINS: DEXMEDETOMIDINE 100,0 μg	100 ug/mlConcentrated solution for intravenous infusion.	50037450/2.9/0374Approved 11 April 2025	Registered	S5	PI PIL
Adcopres EACH VIAL CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 100,0 mcg	Not listed	53071753/2.9/0717	Registered	S5	None
Dexisun	100,0 μgConcentrated solution for intravenous infusion	54021854/2.9/0218Approved 21 June 2022	Registered	S5	PI PIL
Sedmedex 100 μg/ml DEXMEDETOMIDINE HYDROCHLORIDE	100 μgInjection	54069654/2.9/0696Approved 21 February 2023	Registered	S5	PI PIL
Sesodex DEXMEDETOMIDINE HYDROCHLORIDE	200 μgConcentrate for solution for infusion	55084155/2.9/0841Approved 7 February 2023	Registered	S5	PI PIL
Tomexa 200 µg/2 ML EACH 2,0 ml SOLUTION CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 200,0 µg	200 µg/2 ml	56023356/2.2/0233	Registered	S5	None
Tomexa 400 µg/4 ML EACH 4,0 ml SOLUTION CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 400,0 µg	400 µg/4 ml	560234560/2.2/0234	Registered	S5	None
Tomexa 1000 µg/10 ML EACH 10,0 ml SOLUTION CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 1000,0 µg	1000 µg/10 ml	56023556/2.2/0235	Registered	S5	None
Eusedex DEXMEDETOMIDINE HYDROCHLORIDE	1 mLConcentrated solution for intravenous infusion.	56085056/2.9/0850Approved 16 May 2023	Registered	S5	PI PIL
Dexithera 4 μg/ml EACH 1,0 ml SOLUTION CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 4,0 μg	4 μgSolution for infusion	56093856/2.9/0938Approved 2 September 2025	Registered	S5	PI PIL
Dexithera 100 µg/ml 2 ML EACH AMPOULE CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 200,0 µg	100 µg/ml 2 ml	56093956/2.9/0939	Registered	S5	None
Dexithera 100 µg/ml 4 ML EACH AMPOULE CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 200,0 µg	100 µg/ml 4 ml	56094056/2.9/0940	Registered	S5	None
Dexithera 100 µg/ml 10 ML EACH VIAL CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE 1 000 µg	100 µg/ml 10 ml	56094156/2.9/0941	Registered	S5	None
Intudex EACH VIAL CONTAINS DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 200,0 μg	Not listed	56099256/2.9/0992	Registered	S5	None
Dexmedetomidine 200 μg b. Braun EACH AMPOULE CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO: DEXMEDETOMIDINE 200,0 μg	200 μg	57063157/2.9/0631	Registered	S5	None
Dexmedetomidine 400 μg b. Braun EACH AMPOULE CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO: DEXMEDETOMIDINE 400,0 μg	400 μg	57063257/2.9/0632	Registered	S5	None
Dexmedetomidine 1 000 μg b. Braun EACH AMPOULE CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO: DEXMEDETOMIDINE 1 000,0 μg	000 μg 1	57063357/2.9/0633	Registered	S5	None
Dexsedate EACH 1,0 ml SOLUTION CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 100,0 μg	Not listed	57078357/2.9/0783	Registered	S5	None
Dexmirub EACH 1,0 ml SOLUTION CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 100,0 μg	Not listed	58026158/2.9/0261	Registered	S5	None
Dexumex 200 μg/50 ML rtu EACH VIAL CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 200,0 μg	200 μg/50 ml	59009659/2.9/0096	Registered	S5	None
Dexumex 400 μg/100 ML rtu EACH VIAL CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 400,0 μg	400 μg/100 ml	59009759/2.9/0097	Registered	S5	None
Prexuject 200 μg/50 ML rtu EACH VIAL CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 200,0 μg	200 μg/50 ml	590098.09659/2.9/0098.096	Registered	S5	None
Prexuject 400 μg/100 ML rtu EACH VIAL CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 400,0 μg	400 μg/100 ml	590099.09759/2.9/0099.097	Registered	S5	None
Sedmedex rtu 50 ML EACH 1,0 ml SOLUTION CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 4,0 μg	50 ml	59098359/2.9/0983	Registered	S5	None
Sedmedex rtu 100 ML EACH 1,0 ml SOLUTION CONTAINS: DEXMEDETOMIDINE HYDROCHLORIDE EQUIVALENT TO DEXMEDETOMIDINE 4,0 μg	100 ml	590984	Registered	S5	None

Regulatory status

Where S5 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.

Consolidated Schedules listings for Dexmedetomidine

S5: Dexmedetomidine
Consolidated Schedules 06 July 2026, line 9377

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

Schedule verified from official documents

Schedule Verification

Precedex, Pfizer Laboratories (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsPrecedex, Pfizer Laboratories (Pty) Ltd Patient information leaflet (PIL)For patients and carersPrecedex, Pfizer Laboratories (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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