MOTEGRITY 2 mg/1
PRUCALOPRIDE · TABLET, FILM COATED · Takeda Pharmaceuticals America, Inc.
MOTEGRITY is a tablet, film coated containing prucalopride at 2 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- MOTEGRITY
- Generic Name
- PRUCALOPRIDE
- NDC Code (Product)
54092-547- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Strength
- 2 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA210166
- Marketing Start
- 12/14/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION MOTEGRITY 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 (8.5 , 8.6) ] . 1 mg once daily Take with or without food. ( 2 ) Recommended dosage by patient population: Population with CIC Recommended Oral Dose Regimen Adults 2 mg once daily. ( 2 ) Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) 1 mg once daily. ( 2 , 8.5 , 8.6 )
Contraindications
4 CONTRAINDICATIONS 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 Adverse Reactions (6.2) ] . 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. Hypersensitivity to MOTEGRITY. ( 4 ) 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. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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 Takeda Pharmaceuticals at 1-800-828-2088 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. The data described below represent 2,530 patients (1,251 received MOTEGRITY 2 mg once daily and 1,279 received placebo) with CIC from 6 double-blind, placebo-controlled clinical trials of 12 weeks to 24 weeks in duration. In these trials overall, patients were primarily female (76%) and white (76%). The mean age was 47 years (range 17 to 95 years) [see Clinical Studies (14) ] . Common Adverse Reactions Table 2 below summarizes the incidence (%) of common adverse reactions occurring in at least 2% of patients with CIC receiving either 2 mg of MOTEGRITY once daily or placebo and at…
Frequently Asked Questions
What is MOTEGRITY used for?
MOTEGRITY contains PRUCALOPRIDE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is MOTEGRITY a controlled substance?
MOTEGRITY is not classified as a controlled substance by the DEA.
What is the generic name for MOTEGRITY?
The generic name for MOTEGRITY is PRUCALOPRIDE. There are 10 other brand versions of PRUCALOPRIDE.
What is the NDC code for MOTEGRITY 2 mg/1?
The NDC (National Drug Code) for MOTEGRITY 2 mg/1 is 54092-547, listed by Takeda Pharmaceuticals America, Inc..