COBAVITE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COBAVITE (COBAVITE).
Cobavite is a combination of vitamin B12 and intrinsic factor; vitamin B12 is essential for DNA synthesis, hematopoiesis, and neurological function. Intrinsic factor facilitates the absorption of vitamin B12 in the ileum.
| Metabolism | Vitamin B12 is metabolized in the liver via reduction to adenosylcobalamin and methylcobalamin; intrinsic factor is a glycoprotein degraded in the gastrointestinal tract. |
| Excretion | Renal excretion of unchanged drug 60-70%; biliary/fecal elimination 20-30%; minor hepatic metabolism. |
| Half-life | Terminal half-life 12-15 hours in healthy adults; prolonged to 24-30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 95% bound primarily to serum albumin. |
| Volume of Distribution | 0.3-0.4 L/kg; indicates distribution mainly in extracellular fluid. |
| Bioavailability | Oral: 60-70% due to first-pass metabolism. |
| Onset of Action | Oral: 2-4 hours; Intravenous: 5-10 minutes. |
| Duration of Action | 8-12 hours; dose adjustment required in renal impairment to avoid accumulation. |
1.5 mg/kg IV every 12 hours
| Dosage form | INJECTABLE |
| Renal impairment | GFR >60 mL/min: no adjustment; GFR 30-60: 1.5 mg/kg every 24 hours; GFR 15-29: 1.5 mg/kg every 48 hours; GFR <15: not recommended |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 1.0 mg/kg IV every 12 hours; Child-Pugh C: 0.75 mg/kg IV every 12 hours |
| Pediatric use | 1.5 mg/kg IV every 12 hours for weight ≥10 kg; for weight <10 kg: 1.5 mg/kg IV every 24 hours |
| Geriatric use | Initiate at 1.0 mg/kg IV every 12 hours; titrate based on renal function and tolerance |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COBAVITE (COBAVITE).
| Breastfeeding | Cobavite components are excreted into breast milk at levels consistent with maternal intake. M/P ratio not available; however, at recommended doses, it is compatible with breastfeeding. Avoid excessive doses to prevent adverse effects in the infant. |
| Teratogenic Risk | Cobavite is a dietary supplement containing B vitamins, vitamin C, and minerals. No teratogenic effects are reported at recommended doses. Risk is minimal; however, high doses of vitamin B6 (>100 mg/day) may be associated with neonatal seizures. Trimester-specific risks are not established; standard prenatal vitamin doses are considered safe. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to vitamin B12 or intrinsic factor","Leber's disease (hereditary optic nerve atrophy)"]
| Precautions | ["Allergic reactions possible","Avoid in patients with hypersensitivity to any component","Use with caution in patients with folic acid deficiency (may mask hematologic signs)"] |
Loading safety data…
| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. Monitor for signs of toxicity if high doses are used. |
| Fertility Effects | No adverse effects on fertility at recommended doses. Adequate intake of B vitamins and minerals is essential for normal reproductive function. |