SUMMARY
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Sodium hydroxide and/or hydrochloric acid may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light.
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
- Addisonian (pernicious) anemia
- Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy
- Fish tapeworm infestation
- Malignancy of pancreas or bowel
- Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).
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NEWS HIGHLIGHTSMedia Articles Related to Cyanocobalamin Injection
Luspatercept Eyes Treatment of Anemia in Low-Risk MDS Source: Medscape Pathology & Lab Medicine Headlines [2017.09.27] Luspatercept, an investigational agent, shows promise in treating anemia in low-risk myelodysplastic syndromes based on a phase 2 study. Larger studies are underway. Medscape Medical News
Anemia Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2017.09.21] Title: Anemia Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 9/21/2017 12:00:00 AM
Sickle Cell Disease (Sickle Cell Anemia) Source: MedicineNet Alpha Thalassemia Specialty [2016.09.07] Title: Sickle Cell Disease (Sickle Cell Anemia) Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 9/7/2016 12:00:00 AM
Published Studies Related to Cyanocobalamin Injection
Oral cyanocobalamin supplementation in older people with vitamin B12 deficiency: a dose-finding trial. [2005.05.23] BACKGROUND: Supplementation with high doses of oral cobalamin is as effective as cobalamin administered by intramuscular injection to correct plasma markers of vitamin B(12) deficiency, but the effects of lower oral doses of cobalamin on such markers are uncertain... CONCLUSION: The lowest dose of oral cyanocobalamin required to normalize mild vitamin B(12) deficiency is more than 200 times greater than the recommended dietary allowance, which is approximately 3 mug daily.
Clinical Trials Related to Cyanocobalamin Injection
Cobalamin Status in Young Children With Developmental Delay [Completed]
During fetal life and infancy, an adequate cobalamin status is important for normal growth
and central nervous system development. During the last years we have detected cobalamin
deficiency in a number of infants admitted to the Pediatric Department with various
symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given
to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in
improved physical condition.
In this study we want to establish the prevalence of cobalamin deficiency in infants with
developmental delay and regression and other vague neurological symptoms. Cobalamin status
will be investigated in all children aged 8 months and younger, admitted to the Pediatric
Department with these symptoms. In a randomised intervention trial we will evaluate the
effect of cobalamin supplementation in children with these symptoms and metabolic evidence
of impaired cobalamin status.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin
deficiency, will lead to loss of symptoms and in improved physical condition.
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems [Completed]
During fetal life and infancy, an adequate cobalamin status is important for normal growth
and central nervous system development. During the last years we have detected cobalamin
deficiency in a number of infants admitted to the Pediatric Department with various
symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given
to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in
improved physical condition.
In this study we want to establish the prevalence of cobalamin deficiency in infants with
gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in
all children aged 8 months and younger, admitted to the Pediatric Department with these
symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin
supplementation in children with these symptoms and metabolic evidence of impaired cobalamin
status.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin
deficiency, will lead to loss of symptoms and in improved physical condition.
Vitamin B12 Acceptance and Biomarker Response Study [Recruiting]
In this study, biomarker response after supplementation with oral and intramuscular vitamin
B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will
be used to control for non compliance as a possible confounder in oral treatment.
Additionally subjective acceptance in terms of presumed preferences will be compared with
oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial [Completed]
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary
animal produce, which can elevate homocysteine. There is strong evidence indicating that
elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as
primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant
decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin
B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly [Completed]
This study was designed to determine whether elderly residents of long term care facilitated
who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to
have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal
spray improved these subjects' vitamin B12 status.
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Page last updated: 2017-09-27
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