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JAMP 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.
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 JAMP 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 JAMP Prucalopride should be used with caution in patients with a history of arrhythmias or ischemic cardiovascular disease.
Prucalopride succinate 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).
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
JAMP PRUCALOPRIDE Page 5 of 37 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 JAMP Prucalopride and consult their physician. Ischemic colitis is a potential and rare adverse event. No cases of ischemic colitis have been reported with prucalopride succinate during the clinical studies.
Nonetheless, patients should be advised to discontinue JAMP 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 JAMP 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 succinate on the ability to drive and use machines have been performed. Prucalopride succinate 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 succinate 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 JAMP 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. 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.
Special Populations Pregnant Women:
Experience with prucalopride succinate during pregnancy is very limited. Cases of spontaneous abortion have been observed during clinical studies, although, in the presence JAMP PRUCALOPRIDE Page 6 of 37 of other risk factors, the relationship to prucalopride succinate is unknown.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. JAMP Prucalopride is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with JAMP Prucalopride.
Nursing Women:
Prucalopride is excreted in breast milk. In the absence of human data, it is not recommended to use JAMP Prucalopride during breast-feeding.
Pediatrics (<18 years of age):
JAMP Prucalopride is not recommended in children. […]