Cyanocobalamin
96edc686-afea-47e1-adf2-e3d478125b96
HUMAN PRESCRIPTION DRUG LABEL
Jul 1, 2010
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cyanocobalamin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
SPL UNCLASSIFIED SECTION
Rx Only
DOSAGE & ADMINISTRATION SECTION
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 1000 mcg.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED SECTION
HOW SUPPLIED
Cyanocobalamin Injection, USP 1000 mcg/mL
NDC 54868-0762-1 1 mL Vial Tray of 25
NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1
NDC 54868-0762-2 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. 11/05
MG #10565
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146