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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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
Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption [Completed]
In the present study the design of the vitamin B12 absorption test, CobaSorb, is further
optimised. We investigate which test â€“ measurement of holotranscobalamin or cobalamins â€“
could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration
of vitamin B12 administration in order to determine the final duration of the vitamin B12
absorption test CobaSorb.
Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9
microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are
collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.
Cobalamins and holotranscobalamin are measured on day 1â€“5 and 8. The performance of the
vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of
holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than
2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused
by absorption of the administered vitamin B12.
Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development [Completed]
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in
infants. We have earlier investigated cobalamin status in healthy children and we observed
metabolic evidence of impaired cobalamin status during the first 6 months, but not later in
The purpose of this study is to determine if cobalamin supplementation may influence the
metabolic profile related to cobalamin status in infants.
Folic Acid and Vitamin B12 in Young Indian Children [Recruiting]
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or
without simultaneous administration of vitamin B12 reduces the rates of acute lower
respiratory tract infections (ALRI), clinical pneumonia and diarrhea.
Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of
folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a
low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months
will be identified through a survey. Eligible and willing Children aged 6-30 months will be
randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by
the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child
weight and length taken. The baseline blood samples will be collected. The supplements will
be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by
Supplementary Vitamin B12 Affects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial [Recruiting]
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.
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People [Completed]
The purpose of this trial is to study the effects of oral vitamin B12 supplementation and
vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in
elderly people with mild vitamin B12 deficiency.