Prucalopride

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

• Prucalopride tablets can be taken with or without food
• The recommended dosage by patient population is shown in Table 1
• Table 1: Recommended Dosage Regimen and Dosage Adjustments by Population Population with CIC Recommended Oral Dose Regimen
• Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) [see Use in Specific Populations ]. 1 mg once daily
• Take with or without food
• Recommended dosage by patient population: Population with CIC Recommended Oral Dose Regimen
• Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) 1 mg once daily ]

Prucalopride Tablets: 1 mg prucalopride: Yellow colored, round shaped, film coated tablets, debossed with "J" on one side and "7" on other side. 2 mg prucalopride: White colored, round shaped, film coated tablets, debossed with "J" on one side and "6" on other side. Tablets:1 mg, 2 mg of prucalopride

• The safety and effectiveness of prucalopride tablets have not been established
• In pediatric patients
• Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Takeda Pharmaceuticals U.S.A., Inc's MOTEGRITY (prucalopride) tablets
• However, due to Takeda Pharmaceuticals U.S.A., Inc's marketing exclusivity rights, this drug product is not labeled with that information

Of the 2,484 patients treated with Prucalopride tablets 1 mg or 2 mg once daily in 6 controlled trials of at least 12-week duration in patients with CIC, 15% were 65 years of age and over, and 5% were 75 years of age and over [see Clinical Studies (14) ]. No overall differences in safety and effectiveness were observed between elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information) Suicidal Ideation and Behavior: Inform patients, their caregivers, and family members that suicidal ideation and behavior, self-injurious ideation as well as new onset or worsening depression have been reported in patients treated with prucalopride tablets
• Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior. …

• Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride
• Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see Adverse Reactions ]
• 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. …

Suicidal Ideation and Behavior: Monitor patients for suicidal ideation and behavior as well as self-injurious ideation and new-onset or worsening of depression. Instruct patients to discontinue prucalopride tablets immediately and contact their healthcare provider if they experience any unusual changes in mood or behavior, or they experience emerging suicidal thoughts or behaviors. 5.1 Suicidal Ideation and Behavior In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. …

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 PREGNANCY Risk Summary Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes. …

An overdose may result in appearance of symptoms from an exaggeration of the known pharmacodynamic effects of prucalopride and includes headache, nausea, and diarrhea. Specific treatment is not available for prucalopride overdose. Should an overdose occur, treat symptomatically and institute supportive measures, as required. Extensive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.