INJECTION, USP

RX ONLY

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 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.

Cyanocobalamin Structure

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 organ for Vitamin B12 storage.

Within 48 hours after injection of 100 or 1000 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. 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 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 or other 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 the antianemia factor in purified liver extract. Hydroxocobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.

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 bacterial 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 INTERACTION), 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).

Sensitivity to cobalt and/or Vitamin B12 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 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.

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

No overdosage has been reported with this drug.

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 1000 mcg.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Cyanocobalamin Injection, USP 1000 mcg/mL

NDC 0517-0031-25                    1 mL Fill in a 2 mL Vial                  Boxes of 25
NDC 0517-0032-25                    10 mL Multiple Dose Vial               Boxes of 25
NDC 0517-0130-05                    30 mL Multiple Dose Vial               Boxes of 5

Store 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.

IN0031
Rev. 4/14
MG #10565

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Isopropyl Alcohol, 70 % v/v

 Antiseptic

• Antiseptic cleanser
• Kills harmful bacteria and germs
• First aid to help prevent infection

• For External Use Only.
• Avoid contact with the eyes. If contact  occurs, flush eyes with water

 Flammable, keep away from fire or flame.

• Use as part of your daily cleansing routine
• May be covered with a sterile bandage

• Store at room temperature: 15º-30ºC (59º-86ºF)
• Avoid excessive heat

• Water

January 2014

Manufactured for:
Dynarex Corporation
Orangeburg, NY 10962
www.dynarex.com

Made in India

NDC 49836-527-01

RX-Only

B-12 Compliance
Injection Kit

Kit Contains:
1 Cyanocobalamin Injection, USP 1,000 mcg/mL (1 mL)
1 Sterile Isopropyl Alcohol 70% Prep Pad
1 Pair Nitrile Powder Free sterile Gloves (Size 7.5)
1 Sterile Towel Drape
1 Sterile Adhesive Bandage

1 Dose

Needles and Syringes Not Included

B-12 Compliance
Injection Kit

DISTRIBUTED BY:
SCHMIGS
HAUPPAUGE, NY 11788
NDC 49836-527-01

MANUFACTURED BY:
Rx Pharma Pack
HAUPPAUGE, NY 11788

Questions/Comments 1-844-632-7898

Kit Contents:

Cyanocobalamin Injection, USP 1,000 mcg/mL*
(Manufactured by American Regent)
Each mL contains: benzyl alcohol 1.5%; sodium chloride 9mg;
Water for Injection q.s. pH adjusted with hydrochloric acid or sodium hydroxide if necessary.

Sterile Alcohol Prep Pad  (Dynarex)*
Gamma-Sterilized* Isopropyl Alcohol, 70% by Volume

Nitrile Powder Free Sterile Gloves (Dynarex) - Size 7.5*

Sterile Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

*Internal package components remain sterile when stated as long as items are unopened and undamaged.

WARNING: KEEP THIS AND ALL MEDICATION 
OUT OF THE REACH OF CHILDREN. IN CASE OF
ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL
ASSISTANCE OR CONTACT A POISON CONTROL
CENTER IMMEDIATELY.

PROTECT FROM LIGHT 

STORE AT CONTROLLED ROOM TEMPERATURE
20º-25ºC (68º-77º F) [SEE USP CONTROLLED
ROOM TEMPERATURE]

For Single use Only.

REV 09/2015

This product is not eligible for Medicare or Medicaid reimbursement

B-12 Compliance Injection Kit

NDC 0517-0031-25

CYANOCOBALAMIN
INJECTION, USP

1000 mcg/mL

FOR IM OR SC USE ONLY

1 mL VIAL

Rx Only

Cyanocobalamin

                              NDC# 67777-121-13
Made in India 

                   Sterile Alcohol
                            Prep Pad

       For External Use Only
Apply topically as needed
   Discard after single use
                 Sterile Solution                        dynarex
      Sterile unless pouch is
          opened or damaged

                                                       Not made with natural
                                                                       rubber latex

1
Pad    Medium

                                                             Reorder No. 1113

Sterile Alcohol Prep Pad