INDICATIONS
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 is also suitable for the vitamin
B12 absorption test (Schilling test).
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
|
NDC NO:
|
Sizes
|
Concentration
|
Pack
|
| 0517-0031-25 |
1 mL Vial |
1,000 mcg/mL |
25
|
| 0517-0032-25 |
10 mL Multiple Dose Vial |
1,000 mcg/mL |
25
|
| 0517-0130-01 |
30 mL Multiple Dose Vial |
1,000 mcg/mL |
Individually packaged |
Store at controlled room temperature 15°- 30° C(
59°- 86° F).
PROTECT THE PRODUCT FROM LIGHT.
CAUTION: Federal (USA) law prohibits
dispensing without prescription.
|
|
