Prucalopride 2 mg Tablet, Film Coated, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin-4 Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Prucalopride is used to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Prucalopride is in a class of medications called serotonin receptor agonists. It works by increasing the movement of waste through the bowel.
Read the full MedlinePlus article ↗- Chronic idiopathic constipation — or CIC — is ongoing constipation where doctors can't find a specific underlying cause. It's not constipation from a medication or another disease;...
- What exactly is chronic idiopathic constipation, and is that what this is for?
- Prucalopride reaches steady, stable levels in your bloodstream within about 3 to 4 days of once-daily dosing, so many people start to notice a difference within the first week. The...
- You can take prucalopride with or without food — it makes no difference to how well the medication is absorbed. Pick whatever time of day works best for your routine and stick with...
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.657 | $19.72 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $6.83 | $204.89 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $3.13 | $93.93 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Prucalopride 2 mg 00054-0750-13 | Hikma | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 00406-6302-03 | SpecGx | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 00781-8159-31 | Sandoz | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 31722-0392-30 | Camber | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mgthis 60505-4807-03 | Apotex | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 69097-0219-02 | Cipla | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 69238-2699-01 | Amneal | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride succinate 2 mg 70069-0822-01 | Somerset | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 70748-0390-01 | Lupin | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 70954-0597-10 | ANI | 30 tablets | $0.657 | AB | Availability likely | — |
| Prucalopride 2 mg 72205-0219-30 | Novadoz | 30 tablets | $0.657 | AB | Availability likely | — |
| Motegrity 2 mg 54092-0547-01 | Takeda | 30 tablets | $17.750 | AB | Availability likely | +2600% |
| Prucalopride 2 mg 27241-0295-30 | Ajanta | 30 tablets | — | AB | FDA listed | — |
| prucalopride 2 mg 70771-1900-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| prucalopride 2 mg 72578-0222-06 | Viona | 30 tablets | — | AB | FDA listed | — |
| Prucalopride 2 mg 73190-0039-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| Prucalopride 2 mg 83085-0006-30 | SKG | 30 tablets | — | AB | FDA listed | — |
| Prucalopride 2 mg 46708-0078-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Prucalopride 2 mg 62332-0078-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60505-4807-03 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3) | 2025-06-24 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and 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 and 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 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Prucalopride Tablets: 1 mg prucalopride: White to off-white, round shape, biconvex film-coated tablet, engraved “APO” on one side, “P1” on the other side. 2 mg prucalopride: Pink, round shape, biconvex film-coated tablet, engraved “APO” on one side, “P2” on the other side. Tablets: 1 mg, 2 mg of prucalopride. ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Suicidal Ideation and Behavior 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 prucalopride tablets [see Adverse Reactions ( 6.1 , 6.2 )]. A causal association between treatment with prucalopride tablets and an increased risk of suicidal ideation and behavior has not been established.
Monitor all patients treated with prucalopride tablets 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 prucalopride tablets immediately and contact their healthcare provider if they experience any of these symptoms.
🤒 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 .
6.1Clinical 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 placebo and at an incidence greater than in the placebo group from the six double-blind placebo-controlled trials described above.
Table 2: Common Adverse Reactions* in Double-Blind Placebo-Controlled Trials of CIC of at least 12 Weeks Duration Adverse Reaction Prucalopride 2 mg Once Daily N=1,251 † % Placebo N=1,279 % Headache 19 9 Abdominal pain ‡ 16 11 Nausea 14 7 Diarrhea 13 5 Abdominal distension 5 4 Dizziness 4 2 Vomiting 3 2 Flatulence 3 2 Fatigue 2 1 * Reported in ≥2% of patients receiving prucalopride tablets and a rate higher than patients receiving placebo. † Includes 93 patients who started on prucalopride tablets 1 mg and increased to prucalopride tablets 2 mg. ǂ Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal tenderness, abdominal discomfort, and epigastric discomfort.
Less Common Adverse Reactions Less common adverse reactions occurring in <2% of patients receiving prucalopride tablets 2 mg once daily include: Gastrointestinal disorders: Abnormal gastrointestinal sounds Metabolism and nutrition disorders: Decreased appetite Nervous system disorders: Migraine Renal and urinary disorders: Pollakiuria Diarrhea Of the patients who reported diarrhea, 70% (110 out of 157) reported it in the first week of treatment. Diarrhea typically resolved within a few days in 73% (80 out of 110) of those patients.
Severe diarrhea was reported in 1.8% of patients treated with prucalopride tablets 2 mg compared to 1% of patients in the placebo group, and had a similar onset and duration as diarrhea overall. Headache Of the patients who reported headache, 66% (157 out of 237) treated with prucalopride tablets 2 mg once daily reported onset in the first 2 days of treatment. Symptoms typically resolved within a few days in 65% (102 out of 157) of those patients.
Adverse Reactions Leading to Discontinuation In the 6 clinical trials described above, 5% of patients treated with 2 mg of prucalopride tablets once daily discontinued due to adverse reactions, compared to 3% of patients in the placebo group. The most common adverse reactions leading to discontinuation were nausea (2% prucalopride, 1% placebo), headache (1% prucalopride, 1% placebo), diarrhea (1% prucalopride, <1% placebo), or abdominal pain (1% prucalopride, 1% placebo). Adverse Reactions of Special Interest Adverse reactions of special interest were evaluated in a pool of 28 completed clinical trials (19 double-blind and 9 open-label) for prucalopride tablets at doses including 0.5 mg, 1 mg, 2 mg, or 4 mg per day in adult patients with CIC (the recommended dosage of prucalopride tablets for CIC is 2 mg once daily).
The total exposure in the double-blind trials was 565 patient-years in the prucalopride group, 384 patient-years in the placebo group, and 2,769 patient-years…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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. In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data In oral embryofetal development studies in rats and rabbits, prucalopride was administered to pregnant animals at doses of 5, 20, and 80 mg/kg/day throughout the period of organogenesis. No adverse embryofetal developmental effects were observed in either rats or rabbits up to the highest oral dose of 80 mg/kg/day (about 390 times and 780 times the recommended human dose of 2 mg/day, respectively, based on body surface area). In an oral pre- and post-natal development study in rats, prucalopride was administered at doses of 5, 20, and 80 mg/kg/day.
At the 80-mg/kg dose (about 390 times the recommended human dose of 2 mg/day, based on body surface area), a slight decrease in overall survival rate of pups after 7 days was observed, which could be due to maternal toxicity observed at this dose.
8.2Lactation Risk Summary Prucalopride is present in breast milk (see Data) . There are no data on the effects of prucalopride on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prucalopride and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition.
Data In an open-label study in 8 healthy lactating women in the weaning stage, plasma and milk samples were collected at predose (day 1 and 4), and then 2, 4, 8, 12, and 24 hours (day 4) after a 2-mg dose of prucalopride was administered once daily for 4 days. Prucalopride is excreted in breast milk with a milk to plasma AUC ratio of 2.65:1; the average amount passed to the infant was estimated to be 1.74 mcg/kg/day, which is about 6% of the maternal dose, adjusted for body weight. The prucalopride concentration detected in breast milk during weaning may not reflect the prucalopride concentration in breast milk during full milk production.
8.4Pediatric Use 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.
8.5Geriatric Use 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. 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 appe…
🤰 Pregnancy ▾
8.1Pregnancy 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. In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data In oral embryofetal development studies in rats and rabbits, prucalopride was administered to pregnant animals at doses of 5, 20, and 80 mg/kg/day throughout the period of organogenesis. No adverse embryofetal developmental effects were observed in either rats or rabbits up to the highest oral dose of 80 mg/kg/day (about 390 times and 780 times the recommended human dose of 2 mg/day, respectively, based on body surface area). In an oral pre- and post-natal development study in rats, prucalopride was administered at doses of 5, 20, and 80 mg/kg/day.
At the 80-mg/kg dose (about 390 times the recommended human dose of 2 mg/day, based on body surface area), a slight decrease in overall survival rate of pups after 7 days was observed, which could be due to maternal toxicity observed at this dose.
🧒 Pediatric Use ▾
8.4Pediatric Use 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.
🧓 Geriatric Use ▾
8.5Geriatric Use 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. 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 )].
🆘 Overdosage ▾
10 OVERDOSAGE 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 tablets 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A , 5-HT 2B , 5-HT 3 , motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater. In isolated GI tissues from various animal species, prucalopride facilitated acetylcholine release to enhance the amplitude of contractions and stimulate peristalsis.
In rats and dogs, prucalopride stimulated gastrointestinal motility with contractions starting from the proximal colon to the anal sphincter.
12.2Pharmacodynamics High Amplitude Propagating Contractions Following a single 2-mg dose of prucalopride in patients with CIC, prucalopride increased the number of high amplitude propagating contractions (HAPCs) during the first 12 hours as compared with an osmotic laxative treatment. In addition, prucalopride 4 mg once daily (2 times the maximum human recommended dose of 2 mg) for 7 days increased the amplitude of HAPCs in healthy subjects without affecting colonic phasic activity as compared with placebo. Colonic Transit Time An integrated analysis of 3 randomized, placebo-controlled, dose-finding studies in 280 patients with CIC showed that after once daily treatment with 2 mg of prucalopride, the mean colonic transit time was reduced by 12 hours from a baseline of 65 hours for prucalopride 2 mg, compared to an increase of 0.5 hours from a baseline of 66 hours in the placebo group.
Cardiac Electrophysiology At a dose 5 times the maximum approved recommended dose, prucalopride tablets does not prolong the QT interval to any clinically relevant extent.
12.3Pharmacokinetics The pharmacokinetics of prucalopride has been evaluated in healthy subjects and is dose-proportional within and beyond the therapeutic range (tested up to 20 mg, 10 times the maximum approved recommended dose). Prucalopride administered once daily displays time-independent kinetics during prolonged treatment. With once daily administration of 2 mg prucalopride, pharmacokinetic steady-state is attained within 3 to 4 days, and steady-state plasma concentrations fluctuate between trough and peak values of 2.5 and 7 ng/mL, respectively, with mean plasma AUC 0-24h of 109 ng∙h/mL.
The accumulation ratio after once daily dosing ranged from 1.9 to 2.3. The terminal half-life is approximately 1 day. Pharmacokinetic parameters in patients with CIC are similar to those seen in healthy subjects.
Absorption Following a single oral dose of 2 mg prucalopride in healthy subjects, peak plasma concentrations are observed within 2 to 3 hours after administration. The absolute oral bioavailability is >90%. Effect of Food Concomitant intake with a high-fat meal (1,000 kcal total, 500 kcal from fat) does not influence the oral bioavailability of prucalopride [see Dosage and Administration ( 2 )].
Distribution Prucalopride has a steady-state volume of distribution (V ss ) of 567 liters after intravenous administration. The plasma protein binding of prucalopride is approximately 30%. Elimination Renal excretion is the main route of elimination of prucalopride.
Non-renal elimination contributes up to about 35% of the total. The plasma clearance of prucalopride averages 317 mL/min. Metabolism Prucalopride is a substrate of CYP3A4, in vitro.
In an oral dose study with radiolabeled prucalopride in healthy subjects, prucalopride made up 92 to 94% of the total radioactivity in plasma. There are 7 different known minor metabolites, the most abundant metabolite (O-desmethyl prucalopride acid) represents 0 to 1.7% of the total plasma exposure. Excretion Following oral administration of radiolabeled prucalopride in healthy subjects, 60 to 65% of the administered dose is excreted unchanged in urine and about 5% in feces.…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A , 5-HT 2B , 5-HT 3 , motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater. In isolated GI tissues from various animal species, prucalopride facilitated acetylcholine release to enhance the amplitude of contractions and stimulate peristalsis.
In rats and dogs, prucalopride stimulated gastrointestinal motility with contractions starting from the proximal colon to the anal sphincter.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Prucalopride tablets containing 1 mg prucalopride are white to off-white, round shape, biconvex film-coated tablet, engraved “APO” on one side, “P1” on the other side. They are supplied as: NDC 60505-4806-3: HDPE bottle of 30 tablets, with child-resistant closure. Prucalopride tablets containing 2 mg prucalopride are pink, round shape, biconvex film-coated tablet, engraved “APO” on one side, “P2” on the other side.
They are supplied as: NDC 60505-4807-3: HDPE bottle of 30 tablets, with child-resistant closure. Store prucalopride tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (between 59°F to 86°F) [see USP Controlled Room Temperature]. Store prucalopride tablets in the original container to protect from moisture.
📋 Description ▾
11 DESCRIPTION Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N -[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96.
The structural formula is: Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N -dimethylformamide, N,N -dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media.
However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose.
The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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.
Instruct patients, caregivers, and family members to discontinue prucalopride tablets immediately and contact their healthcare provider if any of these symptoms occur [see Warnings and Precautions ( 5.1 )]. Storage Advise patients to keep prucalopride tablets in the original container to protect from moisture. For more information go to www.apotex.com or call 1-800-706-5575.
Rx Only APOTEX INC. PRUCALOPRIDE TABLETS 1 mg and 2 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Rev. 3