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Cyanocobalamin
Overview
What is Cyanocobalamin?
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. Hydrochloric acid and/or sodium hydroxide 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 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 Cyanocobalamin look like?
What are the available doses of Cyanocobalamin?
Sorry No records found.
What should I talk to my health care provider before I take Cyanocobalamin?
Sorry No records found
How should I use Cyanocobalamin?
Cyanocobalamin is indicated for vitamin B deficiencies due to malabsorption which may be associated
with the following conditions:
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 ), 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 B 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 B absorption test ().
Avoid using the intravenous route. Use of this product
intravenously will result in almost all of the vitamin being lost in the
urine.
Pernicious Anemia:
Patients with Normal Intestinal
Absorption:
Schilling Test:
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit.
What interacts with Cyanocobalamin?
Sensitivity to cobalt and/or vitamin B is a contraindication.
What are the warnings of Cyanocobalamin?
Results from epidemiologic studies indicate an association between aspirin
and Reye’s Syndrome. Caution should be used in administering this product to
children, including teenagers, with chicken pox or flu.
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 Cyanocobalamin?
General Precautions:
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:
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:
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:
Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than
2 weeks may produce malabsorption of vitamin B.
Carcinogenesis, Mutagenesis, Impairment of
Fertility:
Pregnancy: Teratogenic Effects. Pregnancy
Category C:
Nursing Mothers:
Pediatric Use:
What are the side effects of Cyanocobalamin?
Generalized:
Cardiovascular:
Hematological:
Gastrointestinal:
Dermatological:
Miscellaneous:
What should I look out for while using Cyanocobalamin?
Sensitivity to cobalt and/or vitamin B is a
contraindication.
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 might happen if I take too much Cyanocobalamin?
No overdosage has been reported with this drug.
How should I store and handle Cyanocobalamin?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Cyanocobalamin Injection, USP 1000 mcg/mLNDC 54868-0762-1 1 mL Vial Tray of 25NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).PROTECT THE PRODUCT FROM LIGHT.IN0031Rev. 11/05MG #10565AMERICANREGENT, INC.SHIRLEY, NY 11967Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146
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.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.
Oils may enhance absorption of lindane, therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying Lindane Shampoo.
In addition, there are many drugs that may lower the seizure threshold, and Lindane Shampoo should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:
General Precautions:
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:
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:
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:
Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy: Teratogenic Effects. Pregnancy Category C:
Nursing Mothers:
Pediatric Use:
Generalized:
Cardiovascular:
Hematological:
Gastrointestinal:
Dermatological:
Miscellaneous:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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