MedPath

Vitamin B12

Generic Name
Vitamin B12
Brand Names
Infuvite Pediatric, Mvc-fluoride, Animi-3 With Vitamin D, Dodex, Fortaplex, Irospan 24/6 Kit, Cobex, Natafort, Infuvite, Vitafol-one, Nascobal, Mvi Pediatric, Hematogen, Folbic, Ferralet 90, Foltabs, Concept Ob, Pregvit, Tandem Plus, B-12
Drug Type
Small Molecule
Chemical Formula
C62H88CoN13O14P
CAS Number
13408-78-1
Unique Ingredient Identifier
8406EY2OQA

Overview

Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .

Background

Cyanocobalamin (commonly known as Vitamin B12) is a highly complex, essential vitamin, owing its name to the fact that it contains the mineral, cobalt. This vitamin is produced naturally by bacteria , and is necessary for DNA synthesis and cellular energy production. Vitamin B12 has many forms, including the cyano-, methyl-, deoxyadenosyl- and hydroxy-cobalamin forms. The cyano form, is the most widely used form in supplements and prescription drugs , . Several pharmaceutical forms of cyanocobalamin have been developed, including the tablet, injection, and nasal spray forms , , . This drug was initially approved by the FDA in 1942 .

Indication

Nasal spray The cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement . Note: CaloMist , the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency. Injection forms (subcutaneous, intramuscular) These forms are indicated for vitamin B12 deficiencies due to various causes, with or without neurologic manifestations . Vitamin B12 deficiency is frequently caused by malabsorption, which is often associated with the following conditions : Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of the pancreas or bowel Folic acid deficiency Oral forms Vitamin B12 supplements are widely available and indicated in patients who require supplementation for various reasons. Dose requirements for vitamin B12 which are higher than normal (caused by pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be achieved with oral supplementation . Oral products of vitamin B12 are not recommended in patients with malabsorption, as these forms are primarily absorbed in the gastrointestinal tract .

Associated Conditions

  • Neuritis
  • Vitamin Deficiency
  • Vitamin B6 Deficiency
  • Diabetic Neuropathies
  • Vitamin B1 deficiency
  • Anemia, Pernicious
  • Vitamin B12 Deficiency
  • Convalescence
  • Iron Deficiency Anemia (IDA)
  • Folate deficiency
  • Combined Vitamin B1 and B12 deficiency
  • Vitamin B12 concentration
  • Anemia

FDA Approved Products

Multivitamin with Fluoride
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:4.5 ug in 1 1
Approved: 2021/12/30
NDC:63629-1139
Vitrexyl
Manufacturer:PureTek Corporation
Route:ORAL
Strength:8 ug in 1 1
Approved: 2023/01/11
NDC:59088-164
Multi-Vit-Flor
Manufacturer:Cameron Pharmaceuticals
Route:ORAL
Strength:4.5 ug in 1 1
Approved: 2023/09/18
NDC:42494-434
Prometa
Manufacturer:PureTek Corporation
Route:ORAL
Strength:10 ug in 1 1
Approved: 2023/02/08
NDC:59088-172
Cyanocobalamin
Manufacturer:BluePoint Laboratories
Route:SUBCUTANEOUS
Strength:1000 ug in 1 mL
Approved: 2023/05/05
NDC:68001-542

Singapore Approved Products

VITAMIN B12 INJECTION 1000 mcg/ml
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:INJECTION
Strength:1000 mcg/ml
Online:Yes
Approved: 1994/10/20
Approval:SIN07876P
DANEURON TABLET
Manufacturer:PT. HEXPHARM JAYA LABORATORIES
Form:TABLET, FILM COATED
Strength:200 mcg
Online:Yes
Approved: 2002/09/17
Approval:SIN12077P
NUTRIHEALTH NEUROVIT FORTE TABLET
Manufacturer:HOVID BHD, HOVID Bhd.
Form:TABLET, FILM COATED
Strength:1.0 mg
Online:Yes
Approved: 1998/10/14
Approval:SIN10260P
NUTRIHEALTH NEUROVIT TABLET
Manufacturer:HOVID BHD
Form:TABLET, FILM COATED
Strength:100 mcg
Online:Yes
Approved: 1998/10/14
Approval:SIN10261P
ENZYPLEX TABLET
Manufacturer:PT MEDIFARMA LABORATORIES INC
Form:ENTERIC COATED TABLET
Strength:5 mcg
Online:Yes
Approved: 1991/05/03
Approval:SIN06211P

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