Meroglobin

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/Laboratory Test Interactions ), use of a gluten-free diet in nontr …

• 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 1,000 mcg
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

Intake in children should be in the amount (0.5 to 3 mcg daily) recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.

• Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B 12 for the remainder of their lives
• Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord
• Also, patients should be warned about the danger of taking folic acid in place of vitamin B 12 , because the former may prevent anemia but allow progression of subacute combined degeneration
• A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B 12
• Patients following such a diet, should be advised to take oral vitamin B 12 regularly. …

Sensitivity to cobalt and/or vitamin B 12 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 B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection 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. …

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 To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Pregnancy Teratogenic Effects Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B 12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

No overdosage has been reported with this drug.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.