Dexmedetomidine (Dexithera)
Dexmedetomidine
Abbott Laboratories S.A. (Pty) Ltd
Registration
- Applicant
- Abbott Laboratories S.A. (Pty) Ltd
- Certificate holder
- Abbott Laboratories South Africa (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 | PIPIL |
| 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 |
Regulatory status
Where S5 sits on the scale
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, 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.
Consolidated Schedules listings for Dexmedetomidine
S5: Dexmedetomidine
Consolidated Schedules 06 July 2026, line 9377
Pharmacological class: Other analgesics. (class 2.9)
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.
5-[(1S)-1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole
Drag to rotate. Structure from PubChem CID 5311068.
SAHPRA documents
Schedule Verification
This medication's schedule (S5) 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.