FAQs
This page is intended for Irish Healthcare Professionals only.
FAQs for Irish Healthcare Professionals
What is Cariban?
Cariban is indicated for symptomatic treatment of nausea and vomiting during pregnancy in adults who do not respond to conservative management.1 It is a modified-release hard capsule containing a combination of doxylamine succinate 10mg and pyridoxine hydrochloride 10mg.1
How does Cariban work?
Cariban releases the active ingredients over a period of time, meaning that onset of pharmacological effects is delayed. After ingestion in fasted conditions, peak plasma concentration is reached after approx. 6-7 hours for doxylamine and approx. 4 hours for pyridoxine. The therapeutic activity of doxylamine is extended for a period of 4-6 hours.1
Doxylamine is an ethanolamine derivative, a first-generation antihistamine that competitively, reversibly and non-specifically blocks H1 receptors. It is also a non-specific antagonist that can block other receptors, such as central or peripheral muscarinic receptors. The antiemetic action of doxylamine is also associated with blocking of the central cholinergic and H1 receptors, although the mechanism of action is unknown.1
Pyridoxine is a water-soluble vitamin factor (vitamin B6) whose active form is pyridoxal 5’-phosphate. It acts as an enzyme co-factor in numerous biochemical reactions involved in the digestive breakdown of proteins and amino acids and, to a lesser extent, lipids and carbohydrates. Pyridoxine is also involved in the metabolism of unsaturated fatty acids (conversion of linoleic acid into arachidonic acid). It is a coenzyme for transaminases and decarboxylases and allows the conversion of tryptophan into nicotinic acid.1
What is the pack size of Cariban?
The size of the pack is 24 capsules.
What are the side effects with Cariban?
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.1
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.1
Refer to the Summary of Product Characteristics for a full list of adverse reactions.1
I have a patient who is concerned about taking Cariban in her first trimester due to safety concerns.
Epidemiological studies and meta-analyses indicates no malformative toxicity of doxylamine succinate and pyridoxine hydrochloride.1
Cariban is recommended on the Irish guidelines as the first line pharmacological treatment for NVP. 2 In addition, Cariban has been used by pregnant patients for over 50 years in Europe, with more than 500 million doses provided.3
Is Cariban sugar-free?
No, Cariban capsules contain sucrose. Patients with hereditary intolerance to fructose, glucose or galactose malabsorption, or sucrase – isomaltase insufficiency should not take this medicinal product.1
Is Cariban reimbursed?
Yes, Cariban can now be reimbursed for your patients. There is no longer a requirement to obtain a signed consultant form to secure reimbursement for Cariban.
I have prescribed Cariban for my patients before. What has changed?
Galen recognised the onerous process that Irish healthcare professionals and patients faced with regards to accessing Cariban.
As of August 2024, Galen is the new exclusive distributor of Cariban in Ireland, meaning that there is a fully licensed and reimbursed Cariban product available to the Irish market.
Previously, the only way reimbursement for Cariban was granted, was via completion of a long page form via a hospital Consultant. This process is no longer required and Cariban can be prescribed via a GP or specialist.
What is the dosing for Cariban?
The recommended dose is as follows1:
- If nausea occurs in the morning take 2 capsules at bedtime (Day 1). If this controls symptoms the next day, continue taking two capsules daily at bedtime.
- If symptoms persist into the afternoon of Day 2, the patient should continue the usual dose of two capsules at bedtime (Day 2) and on Day 3 take three capsules (one capsule in the morning and two capsules at bedtime).
- If these three capsules do not adequately control symptoms on Day 3, the patient can take four capsules starting on Day 4 (one capsule in the morning, one capsule mid-afternoon and two capsules at bedtime).
The maximum recommended dose is 4 capsules (one in the morning, one in the mid-afternoon & two at bedtime) daily.
Is Cariban effective?
Cariban is effective for treating Nausea and Vomiting in Pregnancy (NVP).1
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 in pregnant women suffering from NVP who had not responded to conservative treatment consisting of dietary/lifestyle advice.8
(doxylamine/pyridoxine n = 131 ; placebo n = 125)
This study showcased that treatment with doxylamine/pyridoxine combination versus placebo led to significantly greater improvements in NVP symptoms (P=0.006) and a significant improvement in quality of life (global assessment of well-being score) from baseline at day 15 (P = 0.005)8
Is Cariban on any National guidelines?
Cariban is the first-line pharmacological treatment recommended by the Irish clinical guidelines for the treatment of Nausea and Vomiting in Pregnancy (NVP).2
Can the patient drive after taking Cariban?
Cariban has major influence on the ability to drive and use machines.1
Cariban can cause somnolence and blurred vision, especially during the first few days of treatment. Therefore you should advise patients to avoid any situations which require complete mental alertness, such as driving, until you clear them to do so.1
What are the contraindications for Cariban?1
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics.
- 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.
Are there any birth defects associated with use of Cariban?
Epidemiological studies and meta-analyses indicates no malformative toxicity of doxylamine succinate and pyridoxine hydrochloride. 1
Ensure you are viewing relevant content
Please select from the following options:
Mailing list sign up
Keep up to date with the latest Cariban news and information by joining our mailing list.
Queries regarding Cariban?
If you have any questions regarding Cariban please contact us directly.