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RESOTRAN is a brand name for Prucalopride, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RESOTRAN® (prucalopride succinate tablets) is indicated for: • The treatment of chronic idiopathic constipation in adult female patients in whom laxatives failed to provide adequate relief. There were an insufficient number of male patients in the clinical trials to demonstrate efficacy. The efficacy of prucalopride…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Due to the specific mode of action of RESOTRAN® (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy. • If the intake of once daily RESOTRAN® is not effective during the first 4 weeks of treatment, therapy should be discontinued.
• The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months. In case of prolonged treatment the benefit should be re- assessed at regular intervals. 2 Recommended Dose And Dosage Adjustment Adults: 2 mg once daily.
, rescue treatment) during the ongoing RESOTRAN® treatment. 3 Pharmacokinetics); if needed the dose can be increased to 2 mg once daily. 3 Pharmacokinetics). 3 Pharmacokinetics). No dose adjustment is required for patients with mild to moderate renal impairment.
Patients with hepatic impairment:
Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
No dose adjustment is required for patients with mild to moderate hepatic impairment. 4 Administration RESOTRAN® film-coated tablets are for oral use and can be taken with or without food, at any time of the day. 5 Missed Dose Prucalopride has a terminal half-life of approximately 1 day.
The dose should not be doubled to make up for a missed dose.
). Caution should also be observed in patients with pre-excitation syndromes such as Wolff- Parkinson-White syndrome or Lown-Ganong-Levine syndrome, or atrio-ventricular nodal rhythm disorders, such as AV junctional rhythms with retrograde activation or ectopic atrial rhythms.
Palpitations have been reported during clinical studies. Clinical monitoring is recommended particularly in patients with cardiovascular conditions. If palpitations are severe and persistent patients should consult with their physician.
Gastrointestinal In case of severe diarrhea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
If severe or persistent diarrhea occurs during treatment, patients should be advised not to continue therapy with RESOTRAN® and consult their physician. Ischemic colitis is a potential and rare adverse event. No cases of ischemic colitis have been reported with RESOTRAN® during the clinical studies.
Nonetheless, patients should be advised to discontinue RESOTRAN® therapy and consult their physician if they develop severe, persistent, and/or worsening abdominal symptoms, bloody diarrhea or rectal bleeding. Hepatic/Biliary/Pancreas Caution should be exercised when prescribing RESOTRAN® to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment Resotran (prucalopride succinate tablets) Page 9 of 43 (see 4 DOSAGE AND ADMINISTRATION).
Monitoring and Laboratory Tests Laboratory parameters were reviewed to detect changes over time. The overall incidence of abnormal laboratory values was similar between placebo and prucalopride-treated subjects in Phase 2 and 3 double-blind, placebo-controlled studies.
, liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) as well as patients with insulin-dependent diabetes mellitus have not been studied. Caution should be exercised when prescribing RESOTRAN® to patients with these conditions.
Resotran (prucalopride succinate tablets) Page 8 of 43 Carcinogenesis and Mutagenesis Prucalopride tested weakly positive in the TA100 bacterial strain of the Ames assay and was negative or equivocal in several other in vitro and in vivo genotoxicity assays.
Prucalopride increased liver, thyroid, mammary, pituitary, adrenal medulla, and pancreatic islet cell tumor incidences in mice and/or rats. Mechanistic studies indicated that the increased tumor incidences may be due to rodent-specific epigenetic mechanisms and/or occurred at >60-times human exposure (see 16 NON CLINICAL TOXICOLOGY).
Cardiovascular RESOTRAN® should be used with caution in patients with a history of arrhythmias or ischemic cardiovascular disease. RESOTRAN® has been associated with a slight increase of heart rate in healthy volunteers, as well as a decrease in the PR interval (see 10 CLINICAL PHARMACOLOGY, Electrocardiography).
Caution should be observed in patients with conditions that might be worsened by an increase in heart rate, such as ischemic heart disease or tachyarrhythmias (see
Prucalopride succinate is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGINGS.
3 Pharmacokinetics. • Patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum.
Resotran (prucalopride succinate tablets) Page 5 of 43
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There were no consistent or clinically relevant treatment-related trends. Psychomotor Impairment No studies on the effects of RESOTRAN® on the ability to drive and use machines have been performed. RESOTRAN® has been associated with dizziness and fatigue particularly during the first day of treatment which may have an effect on driving and using machines (see 8 ADVERSE REACTIONS).
Psychiatric Suicides, suicide attempts, and suicidal ideation have been reported in clinical trials. A causal association between treatment with RESOTRAN® and an increased risk of suicidal ideation and behavior has not been established.
Patients should be monitored for persistent worsening of depression or the emergence of suicidal thoughts and behaviors. Counsel the patients and their caregivers and family members to be aware of any unusual changes in mood or behavior, and to discontinue RESOTRAN® and contact the healthcare provider immediately.
3 Pharmacokinetics). A dose of 1 mg is recommended in patients with severe renal impairment (see 4 DOSAGE AND ADMINISTRATION). Patients with severe renal impairment should be closely followed due to limited safety data. Sensitivity/Resistance Galactose Intolerance The tablets contain lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption must not take this medicinal product. 1 Pregnant Women • Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to RESOTRAN® is unknown.
• Animal studies do not indicate direct or indirect harmful effects with respect to Resotran (prucalopride succinate tablets) Page 10 of 43 pregnancy, embryonal/fetal development, parturition or postnatal development. Experience with RESOTRAN® during pregnancy is very limited.
RESOTRAN® is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with RESOTRAN®. 2 Breast-Feeding Prucalopride is excreted in breast milk. 3 Pharmacokinetics). 3 Pediatrics Pediatrics (<18 years of age): RESOTRAN® is not recommended in children.
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Geriatrics (> 65 years of age): Limited evidence does not indicate a change in the safety profile of prucalopride other than an increase in some events that are associated with age in the general population.
Geriatric patients are likely to have reduced renal function and therefore a lower starting dose should be considered in this group of patients (see 7 WARNINGS AND PRECAUTIONS/Renal and 4 DOSAGE AND ADMINISTRATION). 1 Adverse Reaction Overview Adverse events were compiled from Phase 2/3 controlled studies.
Doses up to 4 mg prucalopride were used in these studies. RESOTRAN® has been given orally to 2,717 patients with chronic constipation in controlled clinical studies. Of these patients, 938 patients received RESOTRAN® at the recommended dose of 2 mg per day, while 1,361 patients were treated with 4 mg RESOTRAN® daily.
Overall, adverse events occurred in 69% of subjects treated with prucalopride and 60% of subjects treated with placebo. The most common adverse events (≥10%) encountered with RESOTRAN® are gastrointestinal (nausea, diarrhea, abdominal pain) and nervous system disorders (headache).
Approximately half of the adverse events of nausea, diarrhea and headache occurred during the first 1 to 2 days of treatment. For abdominal pain about 36% occurred early on treatment. The majority of these adverse events were mild to moderate in Resotran (prucalopride succinate tablets) Page 11 of 43 severity.
The incidence of these adverse events tended to increase with dose (see Table 2 below). Serious treatment emergent adverse events (regardless of […]