Cyanocobalamin
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 0517-0130-01 30 mL Multiple Dose Vial Boxes of 1 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. 10/18 MG #10565 AMERICAN REGENT, INC. SHIRLEY, NY 11967; PRINCIPAL DISPLAY PANEL: B-12 Compliance Injection Kit 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 P harma 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. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 REV 09/2015 This product is not eligible for Medicare or Medicaid reimbursement B-12 Compliance Injection Kit B-12 Compliance Injection Kit
- HOW SUPPLIED 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 0517-0130-01 30 mL Multiple Dose Vial Boxes of 1 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. 10/18 MG #10565 AMERICAN REGENT, INC. SHIRLEY, NY 11967
- PRINCIPAL DISPLAY PANEL: B-12 Compliance Injection Kit 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 P harma 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. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 REV 09/2015 This product is not eligible for Medicare or Medicaid reimbursement B-12 Compliance Injection Kit B-12 Compliance Injection Kit
Overview
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 B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. Cyanocobalamin Structural Formula Cyanocobalamin Structural Formula
Indications & Usage
Cyanocobalamin is indicated for vitamin B 12 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 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 B 12 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 B 12 absorption test (SCHILLING TEST). USE For preparation of the skin prior to injection.
Dosage & 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 B 12 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 B 12 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. DIRECTIONS Wipe injection site vigorously and discard.
Warnings & Precautions
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 B 12 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. WARNINGS For external use only Flammable, keep away from flame or fire Not for use with electrocautinary devices or procedures Do not use in eyes Sterile unless package is damaged or open Stop use and ask a doctor if: Irritation or redness develops Condition persists for more than 72 hours Cleansing of an injection site Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Contraindications
Sensitivity to cobalt and/or vitamin B 12 is a contraindication.
Adverse Reactions
Generalized: Anaphylactic shock and death have been reported with administration of parenteral vitamin B 12 (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
Purpose
PURPOSE Antiseptic
Storage & Handling
OTHER INFORMATION Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F Avoid excessive heat Reorder No. 1113 Made in China Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.com Revised: 11/2019
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