cyanocobalamin (Rx, OTC)

Brand and Other Names:vitamin B12, Nascobal, more...Athlete, Calomist, cobalamin, Cobex, Crystamine, Prime, Rubramin PC, Vibisone, Eligen B12
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mcg
  • 250mcg
  • 500mcg
  • 1000mcg

tablet, extended release

  • 1000mcg

tablet, sublingual

  • 2500mcg

injectable solution

  • 1000mcg/mL

nasal spray

  • 500mcg/spray

Nutritional Supplementation

Recommended daily allowance (RDA)

>19 years: 2.4 mcg

Pregnant women: 2.6 mcg

Breastfeeding women: 2.8 mcg

Dietary supplement: 50-6,000 mcg/day

Pernicious Anemia

Manufacturer recommendation: 100 mcg IM/SC once daily for 6-7 days, then every other day for 7 doses, then every 3-4 days for 2-3 weeks, then monthly

Alternative parenteral dosing: 1000 mcg IM/SC once daily for 7 days, then weekly for 1 month, then monthly

Nasal spray: 500 mcg (1 spray in 1 nostril) weekly; if patient is taking hot meals, spray should be administered 1 hour before or after meal

B12 Deficiency

Initial: 30 mcg IM once daily for 5-10 days

Maintenance: 100-200 mcg IM monthly

Nasal dose: 500 mcg once weekly

Limitations of use

  • Nasal spray should not be used for the vitamin B12 absorption test (Schilling test).
  • In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long­term use of nasal spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established
  • The effectiveness of nasal spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined; treatment with nasal spray should be deferred until symptoms subsided

Dosing modifications

  • If serum levels of B12 decline after one month of treatment, consider increasing dose; assess serum B12 level one month after each dose adjustment; if serum B12 levels are persistently low, consider alternative therapy (eg, intramuscular or subcutaneous vitamin B12 therapy)
  • In patients whose underlying cause of vitamin B12 deficiency has been corrected and are deemed no longer at risk for vitamin B12 deficiency, discontinue nasal spray administration; safety and effectiveness of continued long-term use in these individuals not established; in patients with pernicious anemia, continue appropriate vitamin B12 treatment indefinitely

Dosing considerations

  • PO absorption requires intrinsic factor
  • Cyanide poisoning: See Hydroxycobalamin AD
  • In patients with concurrent folate and vitamin B12 deficiency, administer folic acid in addition to the nasal spray
  • Administer iron in addition to the nasal spray in patients with concurrent iron and vitamin B12 deficiency
  • Consider measures to treat underlying condition associated with vitamin B12 deficiency in addition to treatment with nasal spray
  • In patients with suspected cobalamin hypersensitivity, consider administering an intradermal test dose of parenteral vitamin B12 prior to use of nasal spray

Dosage Forms & Strengths

tablet

  • 100mcg
  • 250mcg
  • 500mcg
  • 1000mcg

tablet, extended release

  • 1000mcg

tablet, sublingual

  • 2500mcg

injectable solution

  • 1000mcg/mL

nasal spray

  • 500mcg/spray

Nutritional Supplementation

RDA

0-6 months: 0.4 mcg

7-12 months: 0.5 mcg

1-3 years: 0.9 mcg

4-8 years: 1.2 mcg

9-13 years: 1.8 mcg

>14 years: 2.4 mcg

Pernicious Anemia

30-50 mcg IM/SC once daily for &ge2 weeks for total dose of 1,000 mcg to 5,000 mcg administer concomitantly with 1 mg/day of folic acid for 1 month

Maintenance: 100 mcg IM/SC monthly

B12 Deficiency

0.2 mcg/kg for 2 days; follow by 1,000 mcg/day for 2-7 days; follow by 100 mcg/day for 2-7 days; then 100 mcg/week for 1 month

Maintenance: 100 mcg IM/SC monthly

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Interactions

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            Adverse Effects

            >10%

            Arthralgia (12%)

            Dizziness (12%)

            Headache (12%)

            Nasopharyngitis (12%)

            Frequency Not Defined

            Anaphylaxis

            Angioedema

            Congestive heart failure

            Peripheral vascular disease

            Pulmonary edema

            Diarrhea

            Dyspepsia

            Polycythemia vera

            Sore throat

            Nervousness

            Rhinitis

            Glossitis

            Hypoesthesia

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            Warnings

            Contraindications

            Hypersensitivity to product; sensitivity to cobalt

            Cautions

            Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death; monitor serum potassium and platelet counts more frequently in these patients

            Nasal disease; defer use until symptoms resolve

            Injection is incompatible with some common drugs (eg, warfarin and several phenothiazines) but is compatible with vitamins B and C

            Vitamin B12 deficiency for >3 months results in irreversible degenerative CNS lesions

            Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia

            Oral and intranasal route are not indicated for the treatment of pernicious anemia until symptoms resolve

            Vitamin B12 deficiency masks signs of polycythemia vera; vitamin B12 administration may unmask condition; patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation

            IM and SC route used to treat pernicious anemia; oral and intranasal not indicated until hematologic remission and no signs of nervous system involvement

            Parenteral product may contain aluminum; toxic aluminum concentrations may occur with renal dysfunction, high doses, or prolonged use

            Efficacy of intranasal administration in patients with nasal pathology or concomitant therapy has not been determined; use with caution

            Cyanocobalamin products, not recommended for use in patients with Leber’s optic atrophy; for patients with Leber’s disease requiring vitamin B12, consider alternative therapy (eg, hydroxocobalamin) for B12 supplementation; severe and swift optic atrophy reported in patients with early Leber’s disease (hereditary optic nerve atrophy) treated with vitamin B12

            Anaphylactic shock and death reported after parenteral vitamin B12 administration; if patients are to start nasal spray before having tolerated cyanocobalamin parenterally, consider administering an intradermal test doseof parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity

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            Pregnancy & Lactation

            Pregnancy

            Administration of approved recommended dose is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes

            There are risks associated with vitamin B12 deficiency during pregnancy; severe maternal vitamin B12 deficiency during pregnancy may result in adverse pregnancy outcomes such as low birth weight, preterm birth and megaloblastic anemia

            Lactation

            Vitamin B12 is present in human milk; administration of approved recommended dose is not expected to cause harm to a breastfed child; there is no information on effects the breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism

            Plays role in cell replication and hematopoiesis

            Absorption

            Bioavailability: 6.1% (intranasal solution relative to IM)

            Distribution

            Distributed to liver, bone marrow, and other tissues

            Protein bound: Binding to transcobalamins

            Elimination

            Excretion: Urine (excess amount), bile (mostly reabsorbed)

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            Administration

            Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B12, folate, and iron levels; consider potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Nascobal nasal
            -
            500 mcg/spray liquid
            cyanocobalamin (vitamin B-12) oral
            -
            500 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            500 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
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            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            5,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            2,500 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            2,500 mcg chewable tablet
            cyanocobalamin (vitamin B-12) oral
            -
            500 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            250 mcg tablet
            cyanocobalamin (vitamin B-12) oral
            -
            1,000 mcg capsule
            cyanocobalamin (vitamin B-12) oral
            -
            100 mcg tablet
            Vitamin B-12 sublingual
            -
            2,500 mcg tablet
            Vitamin B-12 sublingual
            -
            2,500 mcg tablet
            Vitamin B-12 sublingual
            -
            5,000 mcg tablet
            Vitamin B-12 sublingual
            -
            2,500 mcg tablet
            cyanocobalamin (vitamin B-12) sublingual
            -
            1,000 mcg tablet
            cyanocobalamin (vitamin B-12) sublingual
            -
            500 mcg tablet
            cyanocobalamin (vitamin B-12) sublingual
            -
            2,500 mcg tablet
            cyanocobalamin (vitamin B-12) sublingual
            -
            5,000 mcg tablet
            Vitamin B-12 oral
            -
            250 mcg tablet
            Vitamin B-12 oral
            -
            100 mcg tablet
            Vitamin B-12 oral
            -
            500 mcg tablet
            Vitamin B-12 oral
            -
            500 mcg tablet
            Vitamin B-12 oral
            -
            500 mcg tablet
            Vitamin B-12 oral
            -
            1,000 mcg tablet
            Vitamin B-12 oral
            -
            1,000 mcg tablet
            Vitamin B-12 oral
            -
            2,000 mcg tablet
            Vitamin B-12 oral
            -
            100 mcg tablet
            Vitamin B-12 oral
            -
            250 mcg tablet
            Vitamin B-12 oral
            -
            1,000 mcg tablet
            Vitamin B-12 oral
            -
            500 mcg tablet
            B-12 DOTS oral
            -
            500 mcg tablet
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial
            cyanocobalamin (vit B-12) injection
            -
            1,000 mcg/mL vial

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

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            Patient Education
            cyanocobalamin (vitamin B-12) sublingual

            NO MONOGRAPH AVAILABLE AT THIS TIME

            USES: Consult your pharmacist.

            HOW TO USE: Consult your pharmacist.

            SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Consult your pharmacist.

            DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: No monograph available at this time.

            MISSED DOSE: Consult your pharmacist.

            STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.