ATC codes: C08CA05
Preterm labour without delivery ICD11 code: JB00.0
Medicine type
Chemical agent
List type
Oral > Solid: 10 mg (immediate-release)
EML status history
First added in 2005 (TRS 933)
Adolescents and adults
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
An application was received from the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, the WHO Department of Reproductive Health and Research and BMJ Knowledge for the inclusion of nifedipine tablet and capsule 10mg and 20mg, as a tocolytic on the Model List. Comments were received from Médecins Sans Frontières. The Committee noted that there is strong evidence to support the use of nifedipine to inhibit preterm labour. Nifedipine was studied in 10 randomized controlled trials in a Cochrane review (1). The results indicated that, compared with any other tocolytic agent (mainly betamimetics), nifedipine or nicardipine reduced the frequency of neonatal respiratory distress syndrome, necrotizing enterocolitis, intraventricular haemorrhage and neonatal jaundice. The Committee concluded that nifedipine is effective and safe for this indication, and noted that the sublingual route is pharmacologically equivalent to the conventional oral route (1) because the medicine is absorbed low in the gastrointestinal tract. The Committee recommended that nifedipine (10-mg immediate release capsules) be included on the Model List in the subsection of tocolytics. 1. King JF et al. Calcium channel blockers for inhibiting preterm labour. Cochrane Database of Systematic Reviews 2003, (1):CD002255 (http:// www.cochrane.org/cochrane/revabstr/AB002255.htm, accessed 10 January 2005).