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Drug overview for MOTEGRITY (prucalopride succinate):
Generic name: prucalopride succinate (proo-KAL-oh-pride)
Drug class: GI Stimulants
Therapeutic class: Gastrointestinal Therapy Agents
Prucalopride succinate, a selective type 4 serotonin (5-HT4) receptor agonist, is a GI prokinetic agent.
No enhanced Uses information available for this drug.
Generic name: prucalopride succinate (proo-KAL-oh-pride)
Drug class: GI Stimulants
Therapeutic class: Gastrointestinal Therapy Agents
Prucalopride succinate, a selective type 4 serotonin (5-HT4) receptor agonist, is a GI prokinetic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
MOTEGRITY 1 MG TABLET
MOTEGRITY 2 MG TABLET
The following indications for MOTEGRITY (prucalopride succinate) have been approved by the FDA:
Indications:
Chronic idiopathic constipation
Professional Synonyms:
None.
Indications:
Chronic idiopathic constipation
Professional Synonyms:
None.
The following dosing information is available for MOTEGRITY (prucalopride succinate):
Dosage of prucalopride succinate is expressed in terms of prucalopride.
For the symptomatic treatment of chronic idiopathic constipation, the recommended adult dosage of prucalopride is 2 mg once daily. In clinical trials, a dosage of 4 mg daily was not found to provide any additional benefit over the 2-mg dosage. In addition, most patients (81%) who received an initial dosage of 1 mg daily required an increase in dosage to 2 mg daily. (See Uses: Chronic Idiopathic Constipation.)
For the symptomatic treatment of chronic idiopathic constipation, the recommended adult dosage of prucalopride is 2 mg once daily. In clinical trials, a dosage of 4 mg daily was not found to provide any additional benefit over the 2-mg dosage. In addition, most patients (81%) who received an initial dosage of 1 mg daily required an increase in dosage to 2 mg daily. (See Uses: Chronic Idiopathic Constipation.)
Prucalopride succinate is administered orally once daily without regard to food.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MOTEGRITY 1 MG TABLET | Maintenance | Adults take 2 tablets (2 mg) by oral route once daily |
| MOTEGRITY 2 MG TABLET | Maintenance | Adults take 1 tablet (2 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PRUCALOPRIDE 1 MG TABLET | Maintenance | Adults take 2 tablets (2 mg) by oral route once daily |
| PRUCALOPRIDE 2 MG TABLET | Maintenance | Adults take 1 tablet (2 mg) by oral route once daily |
The following drug interaction information is available for MOTEGRITY (prucalopride succinate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for MOTEGRITY (prucalopride succinate):
Drug contraindication overview.
Prucalopride is contraindicated in patients with intestinal perforation or obstruction due to a structural or functional disorder of the gut wall, obstructive ileus, or severe inflammatory conditions of the intestinal tract including Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum. Prucalopride also is contraindicated in patients with known hypersensitivity to the drug.
Prucalopride is contraindicated in patients with intestinal perforation or obstruction due to a structural or functional disorder of the gut wall, obstructive ileus, or severe inflammatory conditions of the intestinal tract including Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum. Prucalopride also is contraindicated in patients with known hypersensitivity to the drug.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Crohn's disease |
| Gastrointestinal obstruction |
| Gastrointestinal perforation |
| Ileus |
| Toxic megacolon |
| Ulcerative colitis |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Depression |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Suicidal ideation |
The following adverse reaction information is available for MOTEGRITY (prucalopride succinate):
Adverse reaction overview.
Adverse effects reported in clinical trials in 2% or more of patients with chronic idiopathic constipation receiving prucalopride and at an incidence greater than that reported with placebo include headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
Adverse effects reported in clinical trials in 2% or more of patients with chronic idiopathic constipation receiving prucalopride and at an incidence greater than that reported with placebo include headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Self-injurious ideation Suicidal Suicidal ideation |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Acute abdominal pain Diarrhea Dizziness Fatigue Flatulence Headache disorder Nausea Vomiting |
None. |
| Rare/Very Rare |
|---|
|
Anorexia Bowel sounds hyperactive Depression Dyspnea Facial edema Hallucinations Increased urinary frequency Insomnia Migraine Nightmares Pruritus of skin Skin rash Symptoms of anxiety Urticaria |
The following precautions are available for MOTEGRITY (prucalopride succinate):
Safety and efficacy of prucalopride have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data from case reports of prucalopride use in pregnant women are insufficient to identify any drug-associated risks of spontaneous abortion, major birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies in rats and rabbits, no adverse embryofetal developmental effects were observed at dosages up to approximately 390 and 780 times, respectively, the recommended human dosage. The highest dosage in rats was maternally toxic; a slight decrease in pup survival was observed at this dosage.
Prucalopride is distributed into human milk. It is not known whether prucalopride affects the breast-fed child or affects milk production. The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
During weaning, prucalopride was distributed into human breast milk with a milk-to-plasma ratio of 2.65:1 (based on area under the concentration-time curve (AUC)); mean infant exposure was estimated to be 1.74 mcg/kg daily (about 6% of the maternal dose) adjusted for body weight. However, the manufacturer states that the prucalopride concentration in breast milk during weaning may not reflect the concentration attained during full milk production.
During weaning, prucalopride was distributed into human breast milk with a milk-to-plasma ratio of 2.65:1 (based on area under the concentration-time curve (AUC)); mean infant exposure was estimated to be 1.74 mcg/kg daily (about 6% of the maternal dose) adjusted for body weight. However, the manufacturer states that the prucalopride concentration in breast milk during weaning may not reflect the concentration attained during full milk production.
In controlled trials of at least 12-weeks' duration in patients with chronic idiopathic constipation, 15% of patients receiving prucalopride 1 or 2 mg daily were 65 years of age or older, while 5% were 75 years of age or older. No overall differences in safety and efficacy were observed in these studies between geriatric patients and younger adults, and no unanticipated safety concerns were identified in an additional 4-week double-blind, placebo-controlled, dose-escalation study in 89 geriatric nursing home patients with chronic idiopathic constipation. Geriatric patients had higher prucalopride exposure (26-28% higher AUC and peak plasma concentrations) compared with younger adults; however, the effect of age on the pharmacokinetics of prucalopride appears to be related to decreased renal function. Therefore, dosage of the drug in geriatric patients should be based on renal function.
The following prioritized warning is available for MOTEGRITY (prucalopride succinate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MOTEGRITY (prucalopride succinate)'s list of indications:
| Chronic idiopathic constipation | |
| K59.04 | Chronic idiopathic constipation |
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