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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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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 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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 SA1B764746
A synthetic polymer commonly used as a solvent and binder in medicines. It helps dissolve active ingredients, improve texture, and ensure consistent tablet or capsule formation.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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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 XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
11 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 | $3.31 | $99.41 / 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 mgthis 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 mg 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
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00781-8159-31 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (0781-8159-31) | 2025-06-13 | 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 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 and 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, biconvex film-coated tablet debossed with "A" on one side and "457" on the other side. 2 mg prucalopride: Pink colored, round, biconvex film-coated tablet debossed with "A" on one side and "458" 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. 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 (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 Appco Pharma LLC at 1-855-672-7726 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 2530 patients (1251 received prucalopride tablets, 2 mg once daily and 1279 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 tablet 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 tablet 2 mg Once Daily N=1251 † % Placebo N=1279 % 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 tablet, 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 tablet, 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 tablets, 1% placebo), headache (1% prucalopride tablets, 1% placebo), diarrhea (1% prucalopride tablets, <1% placebo), or abdominal pain (1% prucalopride tablets, 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 tablets group, 384 patient…
👥 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 tablets and any potential adverse effects on the breastfed child from prucalopride tablets 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 tablet have not been established in pediatric patients. Prucalopride tablet was evaluated in a 12-week randomized, double-blind, placebo controlled study, followed by a 36-week double-blind extension study in patients 6 months to 17 years with functional constipation. The interim analysis of the primary endpoint showed that the number of spontaneous bowel movements per week over 12 weeks was similar between the prucalopride tablet and placebo groups, indicating that the study was unlikely to demonstrate effectiveness.
Therefore, the study was terminated early for futility. Adverse reactions reported in pediatric patients in this study were similar to those reported in adults.
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-w…
🤰 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 tablet have not been established in pediatric patients. Prucalopride tablet was evaluated in a 12-week randomized, double-blind, placebo controlled study, followed by a 36-week double-blind extension study in patients 6 months to 17 years with functional constipation. The interim analysis of the primary endpoint showed that the number of spontaneous bowel movements per week over 12 weeks was similar between the prucalopride tablet and placebo groups, indicating that the study was unlikely to demonstrate effectiveness.
Therefore, the study was terminated early for futility. Adverse reactions reported in pediatric patients in this study were similar to those reported in adults.
🧓 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 (1000 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 fece…
🧬 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, biconvex film-coated tablet debossed with "A" on one side and "457" on the other side. They are supplied as: NDC 0781-8158-31: HDPE bottle of 30 tablets, with child-resistant closure. Prucalopride tablets containing 2 mg prucalopride are pink colored, round, biconvex film-coated tablet debossed with "A" on one side and "458" on the other side.
They are supplied as: NDC 0781-8159-31: 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 between 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 butanedioate. 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 dimethyl suphoxide and water. Each 1-mg film-coated prucalopride tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, and triacetin. Each 2-mg film-coated prucalopride tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains FD&C Blue #2, hypromellose, lactose monohydrate, polyethylene glycol 3000, red iron oxide, titanium dioxide, triacetin and yellow iron oxide. pruca-spl-structure
💬 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. Manufactured for: Sandoz Inc, Princeton, NJ 08540 200719 For more information call 1-855-672-7726 The brands listed are trademarks of their respective owners.
PATIENT INFORMATION Prucalopride (proo-kal-oh-pride) tablets, for oral use What are prucalopride tablets? Prucalopride tablets are a prescription medicine used in adults to treat a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown.
It is not known if prucalopride tablets are safe and effective in children. Do not take prucalopride tablets if you: • are allergic to prucalopride tablets. Allergic reaction symptoms may include trouble breathing, rash, itching and swelling of your face, lips, tongue or throat. • have a tear in your stomach or intestinal wall (bowel perforation), a bowel blockage (intestinal obstruction) or serious conditions of the intestinal wall such as Crohn’s disease or ulcerative colitis.
Before taking prucalopride tablets, tell your healthcare provider about all of your medical conditions, including if you: • have or have had depression, suicidal thoughts or actions, or mood problems. • have kidney problems. Your healthcare provider may give you a lower dose of prucalopride tablets. • are pregnant or plan to become pregnant. It is not known if prucalopride tablets will harm your unborn baby. • are breastfeeding or plan to breastfeed.
Prucalopride can pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take prucalopride tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take prucalopride tablets? • Take 1 prucalopride tablet each day or as directed by your healthcare provider. • Take prucalopride tablets exactly as your healthcare provider tells you to take it. • Take prucalopride tablets with or without food. What are the possible side effects of prucalopride tablets? Prucalopride tablets may cause serious side effects, including: unusual changes in mood or behavior, thoughts of hurting yourself, trying to hurt yourself, or suicide.
Stop taking prucalopride tablets right away and tell your healthcare provider immediately if your depression gets worse, you feel sad, hopeless, begin to have thoughts of suicide, thoughts of hurting yourself or you have tried to hurt yourself or if you develop new depression. The most common side effects of prucalopride tablets include: headache Stomach area (abdominal pain or bloating) nausea diarrhea dizziness vomiting gas fatigue These are not all the possible side effects of prucalopride tablets. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. How should I store prucalopride tablets? • Store prucalopride tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Store prucalopride tablets in the original container to protect from moisture. Keep prucalopride tablets and all medicines out of the reach of children.
General information about the safe and effective use of pruca…