Lactulose
Sold as Duphalac dry, Senokot lactulose, Laxette, Cipla-medpro lactulose, Puritone lactulose laxative, Eezilax, Megalax lactulose, Laxette dry lemon, Laxette dry, Bifiteral dry, Agarol lactulose, Anlac, Lactulose ipharma, Lennon lactulose peach, Brooklax lactulose lemon, Lactuloase, Duphalac, Lacson, Freshen liquilax
(2S,3R,4S,5R,6R)-2-[(2R,3S,4S,5R)-4,5-Dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol
Drag to rotate. Structure from PubChem CID 11333.
Background
Registration
- Applicants
- 8
- Registrations
- 19
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Abbott Laboratories S.A. (Pty) LtdCertificate held by Abbott Laboratories SA (Pty) Ltd | Duphalac dry, Bifiteral dry, Duphalac | 10g, 10g/5ml | 280427, 370642, K0180 | Not determined | PIPIL |
| Reckitt Benckinser Pharmaceuticals (Pty) LtdCancelled | Senokot lactulose | Not stated | 280644 | Not determined | None |
| Cipla Medpro (Pty) Ltd1 of 4 cancelled | Laxette, Cipla-medpro lactulose, Laxette dry lemon, Laxette dry | Not stated | 290609, 340060, 360239, 360240 | Not determined | None |
| Adcock ingram limited3 of 4 cancelled | Puritone lactulose laxative, Eezilax, Megalax lactulose, Freshen liquilax | syrup | 340486, 340487, 340488, Z0136 | Not determined | None |
| Pharmacare limited û woodmead2 of 4 cancelled | Agarol lactulose, Lennon lactulose peach, Brooklax lactulose lemon, Lacson | Not stated | 380166, A390260, A390263, Z0055 | Not determined | None |
| BGM Pharmaceuticals (Pty) Ltd | Anlac | syrup | 410764 | Not determined | None |
| Ipharma (Pty) Ltd | Lactulose ipharma | 670 MG/ML | 490905 | Not determined | None |
| Resmed healthcare | Lactuloase | 3,3 g /5 mL | H1227 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Duphalac dry EACH 10,0 g POWDER CONTAINS LACTULOSE 10,0 g | 10gCrystalline powder / syrup | 28042728/11.5/0427Approved 27 May 1994 | Registered | Not determined | PIPIL |
| Senokot - lactulose EACH 4 ml SYRUP CONTAINS LACTULOSE 3,4 g | - | 28064428/11.5/0644 | Cancelled | Not determined | None |
| Laxette EACH 5 ml SOLUTION CONTAINS LACTULOSE 3,3 g | Not listed | 29060929/11.5/0609 | Registered | Not determined | None |
| Cipla-medpro lactulose EACH 5,0 ml SOLUTION CONTAINS LACTULOSE 3,3 g | Not listed | 34006034/11.5/0060 | Cancelled | Not determined | None |
| Puritone - lactulose laxative EACH 5,0 ml SYRUP CONTAINS LACTULOSE 3,3 g | - | 34048634/11.5/0486 | Cancelled | Not determined | None |
| Eezilax syrup EACH 5,0 ml SYRUP CONTAINS LACTULOSE 3,3 g | Syrup | 34048734/11.5/0487 | Cancelled | Not determined | None |
| Megalax lactulose EACH 5,0 ml SYRUP CONTAINS LACTULOSE 3,3 g | Not listed | 34048834/11.5/0488 | Cancelled | Not determined | None |
| Laxette dry - lemon EACH SACHET CONTAINS LACTULOSE 10,0 g | - | 36023936/11.5/0239 | Registered | Not determined | None |
| Laxette dry EACH SACHET CONTAINS LACTULOSE 10,0 g | Not listed | 36024036/11.5/0240 | Registered | Not determined | None |
| Bifiteral dry EACH 10,0 g SACHET CONTAINS LACTULOSE 10,0 g | Not listed | 37064237/11.5/0642 | Registered | Not determined | None |
| Agarol lactulose EACH 5,0 ml CONTAINS LACTULOSE 3,3 g | Not listed | 38016638/11.5/0166 | Registered | Not determined | None |
| Anlac syrup EACH 5,0 ml SYRUP CONTAINS LACTULOSE 5,0 ml | Syrup | 41076441/11.5/0764 | Registered | Not determined | None |
| Lactulose 670 mg/ml solution ipharma Each 1,0 ml contains LACTULOSE 670,0 mg | 670 MG/MLSolution | 49090549/11.5/0905 | Registered | Not determined | None |
| Lennon lactulose peach EACH 5,0 ml SOLUTION CONTAINS LACTULOSE 3,250 g | Not listed | A390260A39/11.5/0260 | Cancelled | Not determined | None |
| Brooklax lactulose lemon EACH 5,0 ml SOLUTION CONTAINS LACTULOSE 3,297 g | Not listed | A390263A39/11.5/0263 | Cancelled | Not determined | None |
| Lactuloase 3,3 g /5 ML Each liquid contains: 5ml lactulose 3.3g | 3,3 g /5 mL | H1227 | Old Medicine | Not determined | None |
| Duphalac EACH 5 ml SYRUP CONTAINS LACTULOSE 3,3 g | 10g/5mlSyrup | K0180K/11.5/180Approved 27 May 1994 | Registered | Not determined | PI |
| Lacson EACH 5 ML CONTAINS LACTULOSE 3,3 G | Not listed | Z0055Z/11.5/0055 | Registered | Not determined | None |
| Freshen liquilax EACH 5 ml SYRUP CONTAINS LACTULOSE 3,3 g | Not listed | Z0136Z/11.5/136 | Registered | 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.
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.