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PMS-PRUCALOPRIDE 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: AND CLINICAL USE ........................................................................................ 3 CONTRAINDICATIONS ............................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Due to the specific mode of action of pms-PRUCALOPRIDE (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy. If the intake of once daily pms-PRUCALOPRIDE 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. Recommended Dose and Dosage Adjustment Adults: 2 mg once daily.
, rescue treatment) during the ongoing pms-PRUCALOPRIDE treatment. Elderly (>65 years): 1 mg tablet once daily (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics); if needed the dose can be increased to 2 mg once daily. Children (<18 years): pms-PRUCALOPRIDE is not recommended in children younger than 18 years old (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).
73 m2 ) is 1 mg once daily (see CONTRAINDICATIONS and 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 WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
No dose adjustment is required for patients with mild to moderate hepatic impairment. 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. Administration pms-PRUCALOPRIDE film-coated tablets are for oral use and can be taken with or without food, at any time of the day.
pms-PRUCALOPRIDE – Product Monograph 13 of
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. Patients with renal impairment requiring dialysis.
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.
, 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 pms-PRUCALOPRIDE to patients with these conditions.
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 Product Monograph PART II, TOXICOLOGY). Cardiovascular pms-PRUCALOPRIDE should be used with caution in patients with a history of arrhythmias or ischemic cardiovascular disease.
Prucalopride has been associated with a slight increase of heart rate in healthy volunteers, as well as a decrease in the PR interval (see ACTIONS AND 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 ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
pms-PRUCALOPRIDE – Product Monograph 5 of 37 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 pms-PRUCALOPRIDE and consult their physician. Ischemic colitis is a potential and rare adverse event. No cases of ischemic colitis have been reported with prucalopride during the clinical studies.
Nonetheless, patients should be advised to discontinue pms-PRUCALOPRIDE 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 pms-PRUCALOPRIDE to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see DOSAGE AND ADMINISTRATION).
Psychomotor Impairment No studies on the effects of prucalopride on the ability to drive and use machines have been performed. Prucalopride 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 ADVERSE REACTIONS).
Psychiatric Suicides, suicide attempts, and suicidal ideation have been reported in clinical trials. A causal association between treatment with prucalopride 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 pms-PRUCALOPRIDE and contact the healthcare provider immediately.
Renal Renal excretion is the main route of elimination of prucalopride (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). A dose of 1 mg is recommended in patients with severe renal impairment (see DOSAGE AND ADMINISTRATION).
Patients with severe renal impairment should be closely followed due to limited safety data. pms-PRUCALOPRIDE – Product Monograph 6 of 37 Special Populations Pregnant Women: Experience with prucalopride during pregnancy is very limited.
Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
pms- PRUCALOPRIDE is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with pms-PRUCALOPRIDE.
Nursing Women:
Prucalopride is excreted in breast milk. In the absence of human data, it is not recommended to use pms-PRUCALOPRIDE during breast-feeding. Pediatrics (<18 years of age): pms-PRUCALOPRIDE is not recommended in children.
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 […]