Prucalopride 2 mg/1
Prucalopride · TABLET · Ajanta Pharma USA Inc.
Prucalopride is a tablet containing prucalopride at 2 mg/1, taken oral. Manufactured by Ajanta Pharma USA Inc..
Key Facts
- Brand Name
- Prucalopride
- Generic Name
- Prucalopride
- NDC Code (Product)
27241-295- Manufacturer
- Ajanta Pharma USA Inc.
- Strength
- 2 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA219220
- Drug Class
- Serotonin-4 Receptor Agonist [EPC]
- Marketing Start
- 01/16/2026
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 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 (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 Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride tablets. 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 prucalopride tablets. ( 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 Apotex Corp. at 1-800-706-5575 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 prucalopride tablets 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 prucalopride tablets once daily or pl…
Frequently Asked Questions
What is Prucalopride used for?
Prucalopride contains Prucalopride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Prucalopride a controlled substance?
Prucalopride is not classified as a controlled substance by the DEA.
What is the generic name for Prucalopride?
The generic name for Prucalopride is Prucalopride. There are 8 other brand versions of Prucalopride.
What is the NDC code for Prucalopride 2 mg/1?
The NDC (National Drug Code) for Prucalopride 2 mg/1 is 27241-295, listed by Ajanta Pharma USA Inc..