CIS-PYRO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CIS-PYRO (CIS-PYRO).
Cis-pyro is not a recognized pharmaceutical agent. No mechanisms data available.
| Metabolism | Unknown |
| Excretion | Primarily renal excretion: 65-80% unchanged in urine; biliary/fecal excretion accounts for 15-25%. |
| Half-life | Terminal elimination half-life: 6-8 hours (IV); prolonged in renal impairment (up to 30 hours in ESRD). |
| Protein binding | 85-92% bound to serum albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.5-0.8 L/kg; indicates moderate tissue distribution (total body water). |
| Bioavailability | IM: 90-100%; Oral: 70-85% (first-pass effect). |
| Onset of Action | IV: 2-5 minutes; IM: 10-30 minutes; Oral: 45-90 minutes. |
| Duration of Action | IV: 4-6 hours; IM: 6-8 hours; Oral: 6-12 hours; longer with higher doses or hepatic impairment. |
Not applicable: CIS-PYRO is a pyrophosphate-based radiopharmaceutical used in cardiac imaging, not a therapeutic drug. Standard adult dose: 555-1110 MBq (15-30 mCi) intravenously once.
| Dosage form | INJECTABLE |
| Renal impairment | Not established: CIS-PYRO is a diagnostic agent not requiring dose adjustment for renal impairment. |
| Liver impairment | Not established: No dose adjustment required for hepatic impairment. |
| Pediatric use | Not established: Use not recommended in pediatric patients; no weight-based dosing guidelines available. |
| Geriatric use | No specific adjustment: Use standard adult dose; caution with renal and hepatic function due to age-related changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CIS-PYRO (CIS-PYRO).
| Breastfeeding | Cisapride is excreted into human breast milk. The milk-to-plasma (M/P) ratio is approximately 0.15. The relative infant dose is estimated to be <1% of the maternal weight-adjusted dose. However, due to the risk of serious adverse effects (e.g., cardiac arrhythmias) in the infant, breastfeeding is not recommended during cisapride therapy. If use is unavoidable, monitor the infant for signs of QT prolongation, diarrhea, and sedation. |
| Teratogenic Risk | CIS-PYRO (cisapride) is not recommended during pregnancy. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown embryotoxicity and fetotoxicity at high doses. The potential risk to the human fetus is unknown; thus, use only if clearly needed and benefit outweighs risk. During the first trimester, there is a potential for teratogenic effects based on animal data, but human data are insufficient to quantify risk. During the second and third trimesters, fetal exposure may occur, and there is a risk of adverse effects on fetal development, including possible QT prolongation. |
■ FDA Black Box Warning
No boxed warning available
| Serious Effects |
["None established"]
| Precautions | ["No clinical data"] |
| Food/Dietary | Grapefruit juice increases cisapride levels, raising risk of arrhythmias; contraindicated. Avoid high-fat meals which may delay absorption. |
| Clinical Pearls | CIS-PYRO (cisapride) is a prokinetic agent withdrawn due to QT prolongation risk; avoid concurrent use with QT-prolonging drugs, CYP3A4 inhibitors (e.g., macrolides, azole antifungals), and in patients with electrolyte disturbances. Baseline and follow-up ECG recommended. Limited to compassionate use in severe gastroparesis. |
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| Fetal Monitoring | Monitor maternal ECG for QT interval prolongation, especially with concomitant use of other QT-prolonging drugs. Assess electrolytes (potassium, magnesium) and renal function. In pregnancy, monitor fetal heart rate and growth. If used near term, observe neonate for QT prolongation and gastrointestinal effects (e.g., diarrhea). |
| Fertility Effects | Cisapride has not been formally studied for effects on human fertility. Animal studies have not shown impairment of fertility. Based on its prokinetic activity, there is no anticipated significant effect on fertility. However, due to limited data, caution is advised in patients attempting conception. |
| Patient Advice | Do not take cisapride with grapefruit juice or any grapefruit product. · Report immediately any irregular heartbeat, fainting, or dizziness. · Avoid other medications unless approved by your doctor due to serious drug interactions. · Take exactly as prescribed; do not change dose or stop without consulting your physician. · Inform your doctor of all medications, including over-the-counter and herbal supplements. |