Get your patient on Cyanocobalamin - Cyanocobalamin injection (Cyanocobalamin)

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 (see Drug 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.

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).

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 ofthe patient's life. The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered byintramuscular 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 3weeks. 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 similarto 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.

Sensitivity to cobalt and/or vitamin B12 is a contraindication.

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

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 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 B12 coenzymes are very unstable in light.

The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39.

The structural formula is represented below.

Vitamin B12 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 B12 is transported via specific B12 binding proteins, transcobalamin I and II to the various tissues. The liver is the main organfor vitamin B12 storage. Within 48 hours after injection of 100 or 1,000 mcg of vitamin B12, 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 B12 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 B12 prevents progression of neurologic damage.

The average diet supplies about 5 to 15 mcg/day of vitamin B12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B12 is not present in foods of plant origin, but is abundant in foods of animal origin. Inpeople 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 B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 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 orother conditions resulting in malabsorption of vitamin B12.

Cyanocobalamin is the most widely used form of vitamin B12, and has hematopoietic activity apparently identical to that of theantianemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.

Cyanocobalamin Injection, USP 1,000 mcg/mL

70512-840-01 1 mL Multiple-Dose Vial

70512-840-25 Box of 25

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

PROTECT THE PRODUCT FROM LIGHT.

Rev 10/2022

Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA

Made in India

TN/DRUGS/616/1996

US/LF/047 V01

PLF 169