Drug Reference
Cobamamide
Vitamin B12 (cyanocobalamin and analogues)
Rx only
Fact box
- Therapeutic class
- Vitamin B12 (cyanocobalamin and analogues)
- Habit forming
- No
- Availability
- Prescription (Rx)
Available as
0.1 MG
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
INDICATIONS: EnBrace HR ® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate. Requirements of vitamin B 9 and/or vitamin B 12 in excess of normal due to pregnancy can usually be met with oral supplementation.
How it works
MECHANISM OF ACTION: Vitamin B 12 [ TREATMENT ]; FOLATE [ PREVENTION ]; OTHER [ SUPPLEMENTATION ];
How to use / dosing
DOSAGE AND ADMINISTRATION : The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs. As a general rule reticulocyte plasma count, folate and vitamin B 12 status must be obtained prior to treatment. Do not exceed the recommended dose. Call your medical practitioner about side effects. You may report side effects by calling (866) 280-5961.
Side effects
ADVERSE REACTIONS: Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyNo information
No specific information in the FDA label.
BreastfeedingNo information
No specific information in the FDA label. Check LactMed →
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Current FDA labels (DailyMed)
- ENBRACE HR (LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, AND PHOSPHATIDYL SERINE) CAPSULE, DELAYED RELEASE PELLETS [JAYMAC PHARMACEUTICALS, LLC]
- ENLYTE (LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE) CAPSULE, DELAYED RELEASE PELLETS [JAYMAC PHARMA]
- BIOPAR DELTA-FORTE (1 NF UNITS, 50 MCG CBL, 2.5 MG F-THF, 1 MG PTEGLU-, 7 MG ME-THF) CAPSULE [JAYMAC PHARMA]
- PAXLYTE (LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULE) CAPSULE [JAYMAC PHARMACEUTICALS]
- ENL (LEUCOVORIN, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE) CAPSULE, LIQUID FILLED [JAYMAC PHARMA]
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.