Cyanocobalamin (B12) Injection, USP
  • AP Rated
  • Vial closure is not made with rubber latex
  • Preserved with 1.5% Benzyl Alcohol


NDC Number
Strength
Size
Shelf Pack
Availability
Product Information
Arrow Up 0517-0031-25 1000 mcg/mL 1 mL 25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10003480 2529212 1073931 1310242 780171
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0031-25 25 90 40


Arrow Up 0517-0130-05 1000 mcg/mL 30 mL
Multiple Dose Vial
5 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10048103 3453719 1459486 1984673 476101
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0130-05 5 42 50


Arrow Up 0517-0032-25 1000 mcg/mL 10 mL
Multiple Dose Vial
25 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036540 1193689 5171020 1621986 104752
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0032-25 25 16 64




NDC Number
Arrow Up 0517-0031-25
Strength
1000 mcg/mL
Size
1 mL
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10003480 2529212 1073931 1310242 780171
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0031-25 25 90 40


NDC Number
Arrow Up 0517-0130-05
Strength
1000 mcg/mL
Size
30 mL
Multiple Dose Vial
Shelf Pack
5
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10048103 3453719 1459486 1984673 476101
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0130-05 5 42 50


NDC Number
Arrow Up 0517-0032-25
Strength
1000 mcg/mL
Size
10 mL
Multiple Dose Vial
Shelf Pack
25
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10036540 1193689 5171020 1621986 104752
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0032-25 25 16 64




Rx Only Avoid using the intravenous route. INDICATIONS AND USAGE 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, 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). Use of this product intravenously will result in almost all of the vitamin being lost in the urine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B12 is a contraindication. WARNINGS 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 B12 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. 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 Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 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 B12, because the former may prevent anemia but allow progression of subacute combined degeneration. 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 B12, 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. Pregnancy Category C Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 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 B12 is known to be excreted in human milk. Amounts of vitamin B12 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. Adverse Reactions Generalized: Anaphylactic shock and death which have been reported with administration of parenteral vitamin B12
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










Rx Only Avoid using the intravenous route. INDICATIONS AND USAGE 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, 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). Use of this product intravenously will result in almost all of the vitamin being lost in the urine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B12 is a contraindication. WARNINGS 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 B12 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. 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 Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 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 B12, because the former may prevent anemia but allow progression of subacute combined degeneration. 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 B12, 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. Pregnancy Category C Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 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 B12 is known to be excreted in human milk. Amounts of vitamin B12 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. Adverse Reactions Generalized: Anaphylactic shock and death which have been reported with administration of parenteral vitamin B12
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


© 2017, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company
PP-AS-US-0014     4/2017