CIDA-STAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CIDA-STAT (CIDA-STAT).
CIDA-STAT is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis, leading to increased hepatic LDL receptor expression and reduced plasma LDL cholesterol levels.
| Metabolism | Primarily metabolized by CYP3A4 isoenzyme in the liver; also undergoes glucuronidation. Metabolites are excreted in feces and urine. |
| Excretion | Renal: 30% unchanged; Biliary/fecal: 60% as metabolites; 10% other |
| Half-life | Terminal half-life: 12-15 hours; requires dose adjustment in renal impairment (CrCl <30 mL/min) |
| Protein binding | 99% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | Vd: 0.8-1.2 L/kg, indicating extensive tissue distribution |
| Bioavailability | Oral: 85% (fasting); reduced to 60% with high-fat meal |
| Onset of Action | Oral: 30-60 minutes; IV: 5-10 minutes |
| Duration of Action | 12-24 hours; extended in hepatic impairment; monitoring recommended |
10 mg orally once daily
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-89 mL/min: No adjustment; GFR 15-29 mL/min: 5 mg once daily; GFR <15 mL/min or dialysis: Not recommended |
| Liver impairment | Child-Pugh A: No adjustment; Child-Pugh B: 5 mg once daily; Child-Pugh C: Not recommended |
| Pediatric use | 0.2 mg/kg orally once daily; maximum 10 mg |
| Geriatric use | No specific dose adjustment; monitor renal function and volume status |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CIDA-STAT (CIDA-STAT).
| Breastfeeding | Contraindicated; M/P ratio unknown. Drug is highly protein-bound and likely transferred into breast milk, posing risk of infant renal toxicity. |
| Teratogenic Risk | First trimester: Avoid; animal studies show fetal cardiovascular and neural tube defects at maternal doses. Second trimester: Increased risk for oligohydramnios and fetal renal impairment. Third trimester: Risk of premature ductus arteriosus closure (if used after 28 weeks) and neonatal pulmonary hypertension. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning reported for CIDA-STAT.
| Serious Effects |
["Active liver disease or unexplained persistent transaminase elevations","Pregnancy and lactation","Concomitant use with strong CYP3A4 inhibitors (e.g., cyclosporine, gemfibrozil)"]
| Precautions | ["Myopathy/rhabdomyolysis risk","Hepatic enzyme elevation","New-onset diabetes mellitus","Neurologic and psychiatric adverse reactions"] |
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| Maternal: blood pressure weekly, serum creatinine and electrolytes monthly, liver function tests baseline and quarterly. Fetal: ultrasound for amniotic fluid index and renal anatomy at 20 weeks; after 28 weeks, nonstress test weekly. |
| Fertility Effects | Reversible ovarian dysfunction in females (anovulatory cycles, decreased ovarian reserve) and reduced sperm count in males; use with caution in those planning pregnancy. |