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Cyanocobalamin
Overview
What is Vitamin Deficiency Injectable System - B12?
Cyanocobalamin Injection (vitamin B) is a sterile solution of Cyanocobalamin. Each mL contains Cyanocobalamin 1000 mcg, sodium chloride 9 mg and benzyl alcohol 0.015 mL in water for injection. Hydrochloric acid and/or sodium hydroxide may have been added 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 B coenzymes are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is CHCoNOP. The cobalt content is 4.34%. The molecular weight is 1355.39.
The structural formula is represented below.
What does Vitamin Deficiency Injectable System - B12 look like?
What are the available doses of Vitamin Deficiency Injectable System - B12?
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What should I talk to my health care provider before I take Vitamin Deficiency Injectable System - B12?
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How should I use Vitamin Deficiency Injectable System - B12?
For preparation of the skin prior to an injection
Open packet
Remove pad
Apply topically as needed to cleanse intended area. Discard after single use.
What interacts with Vitamin Deficiency Injectable System - B12?
Sensitivity to cobalt and/or vitamin B is a contraindication.
What are the warnings of Vitamin Deficiency Injectable System - B12?
Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy.
Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely.
Anaphylactic shock and death have been reported after parenteral vitamin B administration. An intradermal test dose is recommended before Cyanocobalamin Injection, USP is administered to patients suspected of being sensitive to this drug.
This product contains Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
What are the precautions of Vitamin Deficiency Injectable System - B12?
General
Vitamin B deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B, irreversible damage will result.
Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
Information for Patients
Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B, because the former may prevent anemia but allow progression of subacute combined degeneration.
A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B. Patients following such a diet, should be advised to take oral vitamin B regularly. The need for vitamin B is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.
Laboratory Tests
During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary.
Hematocrit, reticulocyte count, vitamin B, folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.
Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.
Drug/Laboratory Test Interactions
Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B diagnostic blood assays.
Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.
Pregnancy
Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.
Nursing Mothers
Vitamin B is known to be excreted in human milk. Amounts of vitamin B that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation.
Pediatric Use
Intake in children should be in the amount (0.5 to 3 mcg daily) recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.
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What are the side effects of Vitamin Deficiency Injectable System - B12?
Generalized
Anaphylactic shock and death have been reported with administration of parenteral vitamin B (see ).
Cardiovascular
Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.
Hematological
Polycythemia vera
Gastrointestinal
Mild transient diarrhea
Dermatological
Itching; transitory exanthema
Miscellaneous
Feeling of swelling of entire body
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What should I look out for while using Vitamin Deficiency Injectable System - B12?
Sensitivity to cobalt and/or vitamin B is a contraindication.
What might happen if I take too much Vitamin Deficiency Injectable System - B12?
No overdosage has been reported with this drug.
How should I store and handle Vitamin Deficiency Injectable System - B12?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Cyanocobalamin Injection, USP 1000 mcg/mL is available in the following packages:NDC 0143-9621-25 1 mL Vial Boxes of 25 VialsNDC 0143-9620-10 10 mL Multiple Dose Vial Boxes of 10 VialsNDC 0143-9619-10 30 mL Multiple Dose Vial Boxes of 10 VialsCyanocobalamin Injection, USP 1000 mcg/mL is available in the following packages:NDC 0143-9621-25 1 mL Vial Boxes of 25 VialsNDC 0143-9620-10 10 mL Multiple Dose Vial Boxes of 10 VialsNDC 0143-9619-10 30 mL Multiple Dose Vial Boxes of 10 Vials
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Vitamin B is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis.
Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B is transported via specific B binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B storage.
Within 48 hours after injection of 100 or 1000 mcg of vitamin B, 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.
Gastrointestinal absorption of vitamin B depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of vitamin B prevents progression of neurologic damage.
The average diet supplies about 5 to 15 mcg/day of vitamin B in a protein-bound form that is available for absorption after normal digestion. Vitamin B is not present in foods of plant origin, but is abundant in foods of animal origin. In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs).
Vitamin B is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B.
Cyanocobalamin is the most widely used form of vitamin B, and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.
Non-Clinical Toxicology
Sensitivity to cobalt and/or vitamin B is a contraindication.Drugs With Ototoxic Potential (see )
Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.
Drugs With Nephrotoxic Potential
There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.
Lithium
Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.
Probenecid
Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide.
Indomethacin
Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.
Antihypertensives
Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.
Digoxin
Interaction studies in humans have shown no effect on digoxin blood levels.
Anticoagulants
Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
Vitamin B deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B, irreversible damage will result.
Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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