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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Last Editorial Review: 11/11/2009
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Source: Y! Health News Search RSS Feed [2009.11.10]
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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 – measurement of holotranscobalamin or cobalamins –
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 1–5 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
life.
The purpose of this study is to determine if cobalamin supplementation may influence the
metabolic profile related to cobalamin status in infants.
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.
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? [Completed]
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal
products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage.
Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the
diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test
called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However,
the Schilling’s test is no longer easy accessible because of increasing difficulties to
obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for
Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer
available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12
has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to
examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin
B12 in patients with evident vitamin B12 deficiency.
Cobalamin Status in Young Children With Developmental Delay [Recruiting]
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.
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