Cyanocobalamin (B₁₂)Injection, USP

“AP” Rated¹
Vial closure is not made with rubber latex
Preserved with 1.5% Benzyl Alcohol

	Pack NDC#	Strength	Supplied As	Shelf Pack	Vial Opening Size	Product Info	Availability
	Strength: 1000 mcg/mL Supplied As: 1 mL Multiple Dose Vial NDC#: 0517-0031-25	0517-0031-25	1000 mcg/mL	1 mL Multiple Dose Vial	25	13 mm	Product Label Full Prescribing Information Safety Data Sheet	In Stock
Shelf Pack 25 Availability In Stock Product Label Full Prescribing Information Safety Data Sheet Wholesaler Numbers ABC/SAP 10003480 Cardinal 2529212 McKesson 1310242 Morris & Dickson 780171 Case Information Unit of Sale NDC 0031-25 Order Size 25 Case Size 90 Case Per Tier 40 Locate Distributor Receive Availability Emails
	Strength: 1000 mcg/mL Supplied As: 30 mL Multiple Dose Vial NDC#: 0517-0130-01	0517-0130-01	1000 mcg/mL	30 mL Multiple Dose Vial	1	20 mm	Product Label Full Prescribing Information Safety Data Sheet	In Stock
Shelf Pack 1 Availability In Stock Product Label Full Prescribing Information Safety Data Sheet Wholesaler Numbers ABC/SAP 10048103 Cardinal 3453719 McKesson 1984673 Morris & Dickson 476101 Case Information Unit of Sale NDC 0130-01 Order Size 1 Case Size 192 Case Per Tier 32 Locate Distributor Receive Availability Emails
	Strength: 1000 mcg/mL Supplied As: 10 mL Multiple Dose Vial NDC#: 0517-0032-25	0517-0032-25	1000 mcg/mL	10 mL Multiple Dose Vial	25	20 mm	Product Label Full Prescribing Information Safety Data Sheet	In Stock
Shelf Pack 25 Availability In Stock Product Label Full Prescribing Information Safety Data Sheet Wholesaler Numbers ABC/SAP 10036540 Cardinal 1193689 McKesson 1621986 Morris & Dickson 104752 Case Information Unit of Sale NDC 0032-25 Order Size 25 Case Size 16 Case Per Tier 64 Locate Distributor Receive Availability Emails

¹Approved Drug Products with Therapeutic Equivalence Evaluations.
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=080737
Accessed August 21, 2018.

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Shirley, NY 11967

P: 631-924-4000
F: 631-924-1731

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Rx Only For intramuscular or deep subcutaneous injection. 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 diseases.

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.

Precautions
Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency.

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.

Patients with pernicious anemia have about three 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 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.

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.

Nursing Mothers: Vitamin B₁₂ is known to be excreted in human milk.

ADVERSE REACTIONS

Generalized: Anaphylactic shock and death 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.

For additional Safety Information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236
or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.

_{REF-0232 1/2021}

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Cyanocobalamin (B₁₂)Injection, USP