E-BASE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for E-BASE (E-BASE).
E-BASE is a proton pump inhibitor that irreversibly inhibits the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells, suppressing gastric acid secretion.
| Metabolism | Primarily hepatic via CYP2C19 and CYP3A4 isoenzymes; metabolites are inactive. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 60-70% of elimination; biliary/fecal excretion accounts for 20-30%. |
| Half-life | Terminal elimination half-life is approximately 6-8 hours in adults with normal renal function; may be prolonged in renal impairment. |
| Protein binding | Approximately 90-95% bound to plasma albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.2-0.3 L/kg, indicating distribution primarily within extracellular fluid. |
| Bioavailability | Oral bioavailability is approximately 70-80%. |
| Onset of Action | Oral administration: onset of action occurs within 30-60 minutes. |
| Duration of Action | Duration of action is 6-8 hours following oral administration. |
25 mg orally once daily.
| Dosage form | TABLET, DELAYED RELEASE |
| Renal impairment | GFR > 30 mL/min: no adjustment; GFR 15-30 mL/min: 25 mg every 48 hours; GFR < 15 mL/min: 25 mg every 72 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 12.5 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | 0.5 mg/kg orally once daily, maximum 25 mg per dose. |
| Geriatric use | Start at 12.5 mg once daily; titrate to 25 mg based on tolerance and renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for E-BASE (E-BASE).
| Breastfeeding | Ergotamine is excreted into breast milk; estimated infant dose is 0.1-0.2% of maternal weight-adjusted dose. Caffeine is also excreted. Potential adverse effects in infants include vomiting, diarrhea, and convulsions. M/P ratio for ergotamine is approximately 0.5-0.6. Avoid breastfeeding while taking E-BASE; consider alternative therapy. |
| Teratogenic Risk | E-BASE is a brand name for a combination product containing ergotamine and caffeine. Ergotamine is contraindicated in pregnancy due to its oxytocic and vasoconstrictive effects, associated with uterine contractions, fetal hypoxia, and increased risk of miscarriage and preterm birth. First trimester: Avoid. Second trimester: Avoid due to risk of fetal hypoxia and growth restriction. Third trimester: Contraindicated; may induce labor or cause fetal distress. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to any component","Concomitant use with rilpivirine-containing products"]
| Precautions | ["Increased risk of Clostridium difficile-associated diarrhea","Bone fracture risk with long-term high-dose use","Hypomagnesemia with prolonged use","Vitamin B12 deficiency","Acute interstitial nephritis","Cutaneous lupus erythematosus","Interaction with methotrexate"] |
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| Fetal Monitoring | Monitor for signs of ergotism (nausea, vomiting, paresthesias, muscle pain, ischemia). Fetal monitoring includes ultrasound for growth restriction and Doppler for umbilical artery flow if inadvertent exposure. Assess uterine activity if used near term. |
| Fertility Effects | Ergotamine may impair fertility due to its vasoconstrictive effects on uterine and ovarian blood flow. No specific data on E-BASE; however, ergotamine derivatives have been associated with reduced fertility in animal studies. |