CYANOCOBALAMIN injection, solution

Cyanocobalamin by

Drug Labeling and Warnings

Cyanocobalamin by is a Prescription medication manufactured, distributed, or labeled by Sagent Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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/Laboratory Test 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 Injection.

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 is also suitable for the vitamin B12 absorption test (Schilling test).

  • 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 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

    General Precautions

    Vitamin B12 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 B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, 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 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.

    A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Patients following such a diet, should be advised to take oral vitamin B12 regularly.

    The need for vitamin B12 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 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.

    Drug/Laboratory Test Interactions

    Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays.

    Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

    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

    Teratogenic Effects

    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 have been reported with administration of parenteral vitamin B12 (see WARNINGS).

    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

    To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • OVERDOSAGE

    No overdosage has been reported with this drug.

  • DOSAGE AND ADMINISTRATION

    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

    Parenteral vitamin B12 is the recommended treatment and will be required for the remainder of the patient's life. The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed.

    Patients with Normal Intestinal Absorption

    Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B12 preparation. If other vitamin deficiencies are present, they should be treated.

    Schilling Test

    The flushing dose is 1,000 mcg.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    Cyanocobalamin Injection, USP is supplied as follows:

    NDCCyanocobalamin Injection, USP (1,000 mcg per mL)Package Factor
    25021-502-01 1,000 mcg per mL Multi-Dose Vial 25 vials per carton
    25021-502-10 10,000 mcg per 10 mL Multi-Dose Vial 10 vials per carton
    25021-502-11 10,000 mcg per 10 mL Multi-Dose Vial 25 vials per carton
    25021-502-30 30,000 mcg per 30 mL Multi-Dose Vial 10 vials per carton
    25021-502-31 30,000 mcg per 30 mL Multi-Dose Vial 5 vials per carton

    Storage Conditions

    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]

    Protect from light.

    Sterile, Nonpyrogenic.

    The container closure is not made with natural rubber latex.

    SAGENT®
    Mfd. for SAGENT Pharmaceuticals
    Schaumburg, IL 60195 (USA)
    Made in India
    ©2021 Sagent Pharmaceuticals, Inc.

    August 2021

    SAGENT Pharmaceuticals®

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

    NDC: 25021-502-01

    Rx only

    Cyanocobalamin Injection, USP

    1,000 mcg per mL

    For IM or SC Use Only

    1 mL Multi-Dose Vial

    Contains a preservative

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
  • INGREDIENTS AND APPEARANCE
    CYANOCOBALAMIN 
    cyanocobalamin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 25021-502
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin1000 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 25021-502-0125 in 1 CARTON03/15/2023
    11 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21510703/15/2023
    Labeler - Sagent Pharmaceuticals (796852890)

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