Motegrity
(Prucalopride)Dosage & Administration
MOTEGRITY can be taken with or without food. The recommended dosage by patient population is shown in Table 1.
| 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 .Of the 2,484 patients treated with MOTEGRITY 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.In an additional 4-week double-blind, placebo-controlled dose escalation study in 89 elderly nursing home residents with CIC (PRU-USA-26, NCT00627692), no unanticipated safety issues were identified. Elderly subjects had higher prucalopride exposure compared to younger subjects. However, the effect of age on the pharmacokinetics of prucalopride appeared to be related to decreased renal function [see Clinical Pharmacology (12.3)] . Adjust the dosage in elderly patients based on renal function[see Dosage and Administration (2), Use in Specific Populations (8.6)] .No dosage adjustment is required for patients with mild and moderate renal impairment (creatinine clearance at least 30 mL/min, as determined from a 24-hour urine collection in the clinical trial). MOTEGRITY is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. A decreased dosage is recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min, as determined from a 24-hour urine collection in the clinical trial) [see Dosage and Administration (2)] .Avoid MOTEGRITY in patients with end-stage renal disease requiring dialysis [see Clinical Pharmacology (12.3)] . | 1 mg once daily |
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Motegrity Prescribing Information
MOTEGRITY® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
MOTEGRITY can be taken with or without food. The recommended dosage by patient population is shown in Table 1.
| 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 .Of the 2,484 patients treated with MOTEGRITY 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.In an additional 4-week double-blind, placebo-controlled dose escalation study in 89 elderly nursing home residents with CIC (PRU-USA-26, NCT00627692), no unanticipated safety issues were identified. Elderly subjects had higher prucalopride exposure compared to younger subjects. However, the effect of age on the pharmacokinetics of prucalopride appeared to be related to decreased renal function [see Clinical Pharmacology (12.3)] . Adjust the dosage in elderly patients based on renal function[see Dosage and Administration (2), Use in Specific Populations (8.6)] .No dosage adjustment is required for patients with mild and moderate renal impairment (creatinine clearance at least 30 mL/min, as determined from a 24-hour urine collection in the clinical trial). MOTEGRITY is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. A decreased dosage is recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min, as determined from a 24-hour urine collection in the clinical trial) [see Dosage and Administration (2)] .Avoid MOTEGRITY in patients with end-stage renal disease requiring dialysis [see Clinical Pharmacology (12.3)] . | 1 mg once daily |
MOTEGRITY Tablets:
- 1 mg prucalopride: White to off-white, round, biconvex film-coated tablet debossed with "PRU 1" on one side and no debossing on the other side.
- 2 mg prucalopride: Pink, round, biconvex film-coated tablet debossed with "PRU 2" on one side and no debossing on the other side.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MOTEGRITY during pregnancy. Healthcare providers are encouraged to register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/.
MOTEGRITY is contraindicated in patients with:
- A history of hypersensitivity to MOTEGRITY. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see.]
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of MOTEGRITY (prucalopride). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions: Dyspnea, rash, pruritus, urticaria, and facial edema[see Contraindications (4)].Psychiatric disorders:Suicide, suicide attempts, suicidal ideation, self-injurious ideation, depression, anxiety, insomnia, nightmares, and visual hallucinations[see Warnings and Precautions (5.1)]. - 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.
In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. Postmarketing cases of suicidal ideation and behavior as well as self-injurious ideation and new onset or worsening of depression have been reported within the first few weeks of starting MOTEGRITY
A causal association between treatment with MOTEGRITY and an increased risk of suicidal ideation and behavior has not been established.
Monitor all patients treated with MOTEGRITY for new onset or worsening of depression or the emergence of suicidal thoughts and behaviors. Counsel patients, their caregivers, and family members of patients to be aware of any unusual changes in mood or behavior and alert the healthcare provider. Instruct patients to discontinue MOTEGRITY immediately and contact their healthcare provider if they experience any of these symptoms.