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Eligen B12 Generic Name & Formulations
Legal Class
Rx
General Description
Cyanocobalamin 1000mcg, salcaprozate sodium 100mg; tabs.
Pharmacological Class
Medical food.
How Supplied
Tabs—30
Manufacturer
Eligen B12 Indications
Indications
Dietary management of patients with Vit. B12 deficiency that cannot be managed by a modification of the normal diet alone (eg, pernicious anemia, malabsorption of Vit. B12, others).
Eligen B12 Dosage and Administration
Adult
Take on empty stomach (at least 1hr before a meal) with water. ≥18yrs: initially 1 tab daily; may adjust up to max 2 tabs daily.
Children
<18yrs: not established.
Eligen B12 Contraindications
Contraindications
Sensitivity to cobalt. Hereditary optic nerve atrophy (Leber's disease).
Eligen B12 Boxed Warnings
Not Applicable
Eligen B12 Warnings/Precautions
Warnings/Precautions
Confirm diagnosis. Risk of hypokalemia and sudden death in severe megaloblastic anemia. Infection, uremia, and iron or folic acid deficiency may reduce response. May unmask polycythemia vera. Obtain hematocrit, reticulocyte count, Vit. B12, folate, iron levels prior to treatment. May need supplemental folate. Reevaluate if low levels of Vit. B12 persist despite treatment. Monitor B12 blood levels 1 month after starting therapy, 1 month after any dose increase, and regularly at 3–6 month intervals. Monitor serum potassium, platelet counts. Pregnancy.
Eligen B12 Pharmacokinetics
See Literature
Eligen B12 Interactions
Interactions
Antibiotics, methotrexate, pyrimethamine may interfere with lab tests. Colchicine, para-aminosalicylic acid, chronic heavy alcohol use may impair Vit. B12 absorption; may need to adjust dose. Reduced response with bone marrow suppressants (eg, chloramphenicol).
Eligen B12 Adverse Reactions
Adverse Reactions
Pulmonary edema, CHF, peripheral vascular thrombosis, polycythemia vera, mild transient diarrhea, itching, transitory exanthema, body swelling, possible anaphylactic shock and death.
Eligen B12 Clinical Trials
See Literature
Eligen B12 Note
Not Applicable
Eligen B12 Patient Counseling
See Literature
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