REDISOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for REDISOL (REDISOL).
Hydroxocobalamin is a synthetic form of vitamin B12 that acts as a cofactor for methionine synthase and methylmalonyl-CoA mutase, essential for DNA synthesis, myelin formation, and hematopoiesis. It also binds to cyanide ions to form cyanocobalamin, which is excreted renally, thereby detoxifying cyanide.
| Metabolism | Metabolized in the liver to active coenzymes (methylcobalamin and adenosylcobalamin). In cyanide poisoning, hydroxocobalamin binds cyanide to form cyanocobalamin, which is excreted in urine. |
| Excretion | Primarily renal (50-80% as unchanged drug); minimal biliary/fecal |
| Half-life | ~50-100 minutes; prolonged in renal impairment |
| Protein binding | 65-75% primarily to albumin |
| Volume of Distribution | 1-2 L/kg; extensive tissue distribution |
| Bioavailability | Oral: 20-30%; IM: 80-100%; IV: 100% |
| Onset of Action | IV: <1 min; IM: 5-10 min; Oral: 30-60 min |
| Duration of Action | IV/IM: 30-60 min for antiarrhythmic effect; Oral: 3-6 hours |
Cyanocobalamin 1000 mcg intramuscularly or subcutaneously once daily for 5-10 days, then 100-1000 mcg monthly for maintenance; intranasal: 500 mcg intranasally once weekly.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for renal impairment; safety and efficacy in ESRD not established. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Cyanocobalamin 1000 mcg IM or SC once monthly; for infants and children, 1-5 mg given over 2 or more weeks in divided doses, then 100-1000 mcg monthly. |
| Geriatric use | Same as adult dosing; monitor for polycythemia vera and potassium depletion during initial therapy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for REDISOL (REDISOL).
| Breastfeeding | Cyanocobalamin is naturally present in breast milk. Exogenous supplementation at recommended doses is considered compatible with breastfeeding. The M/P ratio is not defined as it is an endogenous substance. No adverse effects on the nursing infant have been reported. |
| Teratogenic Risk | Cyanocobalamin (REDISOL) is a naturally occurring vitamin B12 essential for DNA synthesis and neurological function. No teratogenic effects have been reported in animal studies or human pregnancies at recommended doses. It is classified as FDA Pregnancy Category C (prior to 2015) or generally considered safe; however, high doses should be avoided unless indicated for deficiency. No known fetal risks in any trimester when used therapeutically. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to hydroxocobalamin, cyanocobalamin, or any component of the formulation","Leber's disease (hereditary optic nerve atrophy)"]
| Precautions | ["Hypersensitivity reactions (urticaria, angioedema) may occur","Severe allergic reactions including anaphylaxis reported","May interfere with clinical laboratory tests (e.g., bilirubin, creatinine) due to red color","Use caution in patients with Leber's disease (optic atrophy) as vitamin B12 may worsen condition","Monitor potassium levels during treatment of megaloblastic anemia (risk of hypokalemia upon B12 repletion)"] |
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| Fetal Monitoring | Monitor maternal serum vitamin B12 levels, complete blood count, and neurologic status as clinically indicated. In pregnancy, assess for signs of megaloblastic anemia and neurological symptoms. Fetal monitoring is not specifically required for this vitamin supplement unless treating severe deficiency. |
| Fertility Effects | No adverse effects on fertility are known. Adequate vitamin B12 is necessary for normal reproductive function; deficiency may impair fertility, but supplementation restores normal levels without negative impact. |