Efficacy & Safety
Information

This page is intended for Irish Healthcare Professionals only.

Delivering Effective Treatment

Extensive clinical experience with the drug combination in the symptomatic treatment of NVP1

Cariban has been used by pregnant patients for over 50 years in Europe, with more than 500 million doses provided3

Irish clinical guidelines state that Cariban is the first line pharmacological treatment for NVP2

Koren et al 20108

The main clinical evidence for the combination of doxylamine and pyridoxine (Cariban’s active ingredients) for NVP comes from a Phase III, randomised, double-blind, multicenter placebo controlled trial.8 

This 15-day study included pregnant women suffering from NVP,  (PUQE ≥6) between 7 – 14 weeks gestation, who had not responded to conservative treatment consisting of dietary/lifestyle advice. 

(doxylamine/pyridoxine n =131 ; placebo n = 125)

Participants completed the Pregnancy Unique Quantification of Emesis (PUQE) score and the study diary once daily every morning before study dose at approximately the same time each day. Participants completed the global assessment of well being scale of the PUQE on days 1, 8, and 14 at the same time that the PUQE score was completed.

This study showed that treatment with Cariban’s
active ingredients versus placebo led to:

Significantly greater improvements in NVP symptoms and significant improvement in PUQE score, P = 0.006 from baseline at day 15, as compared with placebo.

Significantly less women in the doxylamine/pyridoxine group used alternative therapies for NVP symptoms concomitantly compared to the placebo group.
(P = 0.04)

Significantly more asking to continue on the blinded active (after study completion) on compassionate grounds compared to placebo.
(P = 0.009)

A significant improvement in quality of life (global assessment of well-being score) from baseline at day 15.
(P = 0.005) as compared with placebo.

Important Safety Information1

Adverse reactions

Adverse reactions associated with the use of the combination of doxylamine / pyridoxine are comparable to those occurring with the sedating antihistamines as the sole active ingredient. The most frequent adverse reactions include somnolence and anticholinergic effects (1%-9%) such as dry mouth, constipation, urinary retention, increased bronchial secretion and blurred vision.

Refer to the Summary of Product Characteristics for a full list of adverse reactions. Click here to view the SPC.

Birth defects

Epidemiological studies and meta-analyses indicates no malformative toxicity of doxylamine succinate and pyridoxine hydrochloride.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients.
  • Hypersensitivity reactions to any other ethanolamine derivative antihistamines.
  • Concomitant use with monoamine oxidase (MAO) inhibitors, since the adverse central nervous system effects of Cariban are intensified and prolonged.
  • Concomitant use with potent inhibitors of CYP450 isoenzymes.
  • Porphyria.

Effects on ability to drive and use machines

Cariban has major influence on the ability to drive and use machines. This medicinal product may cause somnolence and blurred vision, especially during the first few days of treatment. Therefore patients should avoid engaging in activities requiring complete mental alertness, such as driving or using heavy machinery.

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