Cyanocobalamin (Lexi-Drugs)

Pronunciation

(sye an oh koe BAL a min)

Brand Names: US

B-12 Compliance Injection; Nascobal; Physicians EZ Use B-12; Vitamin Deficiency System-B12

Brand Names: Canada

Cobex; Cyano Vit B12; JAMP-Cyanocobalamin

Pharmacologic Category

Vitamin, Water Soluble

Dosing: Adult

Aphthous ulcers, recurrent (off-label use):

Oral (sublingual): 1,000 mcg once every evening for 6 months (Volkov 2009)

IM: 1,000 mcg once daily for 7 days, followed by weekly for 1 month, followed by monthly for 6 months (Gulcan 2008)

Vitamin B12 deficiency: Note: Folic acid supplementation may also be required.

Intranasal (Nascobal): 500 mcg in 1 nostril once weekly; may increase dose if vitamin B12 levels decline after 1 month of treatment. Alternate route (eg, IM, SubQ) should be considered if B12 levels are persistently low.

Oral: 1,000 to 2,000 mcg daily for 1 to 2 weeks; maintenance: 1,000 mcg daily (Langan 2011; Oh 2003)

IM, deep SubQ: May use initial treatment similar to that for pernicious anemia depending on severity of deficiency: 100 mcg daily for 6 to 7 days; if improvement, administer same dose on alternate days for 7 doses, then every 3 to 4 days for 2 to 3 weeks; once hematologic values have returned to normal, maintenance dosage: 100 mcg monthly.

Note: Higher doses may be preferred, especially in cases of severe deficiency; consider alternate dosing regimens with initial doses ranging from 100 to 1,000 mcg every day or every other day for 1 to 2 weeks and maintenance doses of 100 to 1,000 mcg every 1 to 3 months (Oh 2003) or 1,000 mcg once a week for 8 weeks followed by 1,000 mcg once a month (Langan 2011).

Mild B12 deficiency (eg, malabsorption, atrophic gastritis, metformin use, chronic acid reducing medication use):

Oral: 500 to 1,000 mcg orally once daily (Stabler 2013)

IM: 1,000 mcg once daily or every other day for 1 week, then 1,000 mcg weekly for 4 to 8 weeks, and then 1,000 mcg monthly for life (Stabler 2013)

Pernicious anemia:

IM: 1,000 mcg once daily or every other day for 1 week, then 1,000 mcg weekly for 4 to 8 weeks, then 1,000 mcg once monthly for life (Stabler 2013) or 100 to 1,000 mcg every day or every other day for 1 to 2 weeks followed by 100 to 1,000 mcg every 1 to 3 months (Oh 2003) or 1,000 mcg once a week for 8 weeks followed by 1,000 mcg once a month for life (Langan 2011)

Oral: 1,000 to 2,000 mcg once daily for life (Stabler 2013)

IM, deep SubQ: Initial: 100 mcg once daily for 6 to 7 days; if improvement, administer same dose on alternate days for 7 doses, then every 3 to 4 days for 2 to 3 weeks; maintenance (once hematologic values have returned to normal): 100 mcg once monthly for life

Severe B12 deficiency (due to gastrectomy, ileal resection, inflammatory bowel disease, sprue):

IM: 1,000 mcg once daily or every other day for 1 week, then 1,000 mcg weekly for 4 to 8 weeks, then 1,000 mcg once monthly for life (Stabler 2013)

Oral: 1,000 to 2,000 mcg once daily for life (Stabler 2013).

Vitamin B12 repletion in gastric bypass surgery patients: IM or SubQ: 1,000 mcg once daily until normal B12 levels are achieved and then resume supplementations dosage (ASBMS [Parrott 2017]) or 1,000 mcg IM once daily or every other day for 1 week, then 1,000 mcg IM weekly for 4 to 8 weeks, followed by supplementation dosing (Stabler 2013).

Vitamin B12 supplementation in gastric bypass surgery patients:

IM or SubQ: 1,000 mcg once monthly (ASMBS [Parrott 2017]) or 1,000 mcg once monthly to 1,000 to 3,000 mcg once every 6 to 12 months (if oral or intranasal therapy are ineffective) (AACE/TOS/ACE [Mechanick 2013]) or 1,000 mcg IM once monthly for life (Stabler 2013).

Oral: 350 to 500 mcg (disintegrating tablet, sublingual, or liquid) once daily (ASMBS [Parrott 2017]) or ≥1,000 mcg once daily (AACE/TOS/ACE [Mechanick 2013]) or 1,000 to 2,000 mcg orally once daily for life (Stabler 2013)

Intranasal: 500 mcg in one nostril once weekly (ASMBS [Parrott 2017]; AACE/TOS/ACE [Mechanick 2013]).

Vitamin B12 supplementation to reduce toxicity associated with pemetrexed: IM: 1,000 mcg every 9 weeks, beginning 1 to 3 weeks prior to pemetrexed treatment initiation; continue for 3 weeks after last pemetrexed dose; administer with oral folic acid supplementation (Scagliotti 2008; Vogelzang 2003); may administer cyanocobalamin on the same day as pemetrexed.

Vitamin B12 supplementation to reduce toxicity associated with pralatrexate: IM: 1,000 mcg every 8 to 10 weeks; administer with oral folic acid supplementation (O’Connor 2011); begin cyanocobalamin within 10 weeks prior to pralatrexate treatment initiation. After the initial dose, may administer cyanocobalamin on the same day as pralatrexate.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Some formulations may also contain aluminum, which may accumulate in renal impairment.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Adequate intake (AI) (IOM 1998): Oral: Note: Neonates born to vegan mothers should be supplemented with the AI for vitamin B12 from birth; they may have low vitamin B12 stores at birth and, if breastfeeding, may only receive a small amount of the vitamin from the mother’s milk (Mangels 2001).

Infants 1 to 6 months: 0.4 mcg/day (0.05 mcg/kg/day)

Infants 7 to 12 months: 0.5 mcg/day (0.05 mcg/kg/day)

Recommended daily allowance (RDA) (IOM 1998): Oral:

Children and Adolescents:

1 to 3 years: 0.9 mcg/day

4 to 8 years: 1.2 mcg/day

9 to 13 years: 1.8 mcg/day

Adolescents ≥14 years: 2.4 mcg/day

Pernicious anemia: Note: Concurrent folic acid supplementation may also be needed.

Manufacturer’s labeling: Infants, Children, and Adolescents: IM, SubQ: 100 mcg once daily for 6 to 7 days; if improvement occurs, administer 100 mcg on alternate days for 7 doses, then every 3 to 4 days for 2 to 3 weeks; once hematologic values have returned to normal, maintenance dose: 100 mcg monthly

Alternate dosing: Limited data available: Infants, Children, and Adolescents: IM, SubQ: Initial: 1,000 mcg/day for 2 to 7 days based upon clinical response; followed by 100 mcg once weekly for 4 weeks and then maintenance dose: 100 mcg/month; for severe anemia, a lower initial dose of 0.2 mcg/kg/dose for 2 days followed by the above regimen has been recommended due to potential hypokalemia observed during initial treatment of adults with severe anemia (Orkin 2015; Rasmussen 2001; Stabler 2013); however, in more recent experience, while some adult patients may experience hypokalemia with initial treatment, this is unlikely to be clinically significant (Carmel 2008). For infants and young children, some experts have recommended doses as low as 50 to 100 mcg (Orkin 2015).

Vitamin B12 deficiency, severe: Limited data available; dosing regimens variable:

Dietary deficiency: Infants (breastfed with vitamin B12 deficient mothers): IM: 250 to 1,000 mcg once daily for 1 to 2 weeks, followed by weekly dosing until patient recovers (Stabler 2013); patients with neurologic symptoms have been treated with doses of 1,000 mcg (Guez 2012; Roumeliotis 2012)

Malabsorption: Infants, Children, and Adolescents: IM: 250 to 1,000 mcg daily or every other day for 1 week, then weekly for 4 to 8 weeks, and then monthly for life; younger children should receive monthly doses of 100 mcg (Bjørke-Monsen 2011; Kliegman 2016; Stabler 2013). For infants and young children, some experts have recommended doses as low as 50 to 100 mcg (Orkin 2015).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. Some formulations may also contain aluminum, which may accumulate in renal impairment.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Vitamin B12 deficiency: Treatment of pernicious anemia, vitamin B12 deficiency due to dietary deficiencies, gastrointestinal malabsorption, folic acid deficiency, parasitic infestation, inadequate secretion of intrinsic factor, and inadequate utilization of B12 (eg, during neoplastic treatment); treatment of increased B12 requirements due to pregnancy, thyrotoxicosis, hemorrhage, malignancy, liver or kidney disease

Use: Off-Label: Adult

  Aphthous ulcers (recurrent)Level of Evidence [B]

Data from 2 small studies support the use of cyanocobalamin in reducing the frequency of recurrent aphthous ulcers in patients with normal or low serum vitamin B12 levels at baseline Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Administration: IM

IM or deep SubQ are preferred routes of administration. IV administration is not recommended.

Administration: Injectable Detail

pH: 4.5 to 7

Administration: Oral

Oral administration is not generally recommended due to variable absorption; however, oral therapy in appropriate doses has been effective for anemia if IM/SubQ routes refused or not tolerated. Some tablets are available for sublingual administration.

Administration: Subcutaneous

IM or deep SubQ are preferred routes of administration. IV administration is not recommended.

Administration: Intranasal

Nasal spray (Nascobal): Administer 1 hour before or 1 hour after ingestion of hot foods/liquids.

Administration: Pediatric

Oral: Not generally recommended for treatment of severe vitamin B12 deficiency due to poor oral absorption (lack of intrinsic factor); oral administration may be used in less severe deficiencies and maintenance therapy; may be administered without regard to food

Parenteral: IM or deep SubQ are preferred routes of administration: Avoid IV administration due to a more rapid system elimination with resulting decreased utilization

Dietary Considerations

Strict vegetarian diets (eg, without eggs or dairy products) may result in vitamin B12 deficiency.

Adequate intake (IOM 1998):

1 to 6 months: 0.4 mcg daily

7 to 12 months: 0.5 mcg daily

Recommended intake (IOM 1998):

1 to 3 years: 0.9 mcg daily

4 to 8 years: 1.2 mcg daily

9 to 13 years: 1.8 mcg daily

≥14 years: 2.4 mcg daily

Pregnancy: 2.6 mcg daily

Lactation: 2.8 mcg daily

Storage/Stability

Injection: Clear pink to red solutions are stable at room temperature. Protect from light.

Intranasal spray: Store at 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, headache, anxiety, vomiting, or nausea. Have patient report immediately to prescriber signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), severe diarrhea, severe loss of strength and energy, angina, shortness of breath, burning or numbness feeling, excessive weight gain, change in balance, swelling of arms or legs, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Contraindications

Hypersensitivity to cyanocobalamin (vitamin B12), cobalt, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: Vitamin B12 deficiency for >3 months results in irreversible degenerative CNS lesions; neurologic manifestations will not be prevented with folic acid unless vitamin B12 is also given. Spinal cord degeneration might also occur when folic acid used as a substitute for vitamin B12 in anemia prevention.

• Hypokalemia: According to the manufacturer, treatment of severe vitamin B12 megaloblastic anemia may result in severe hypokalemia, sometimes fatal, due to intracellular potassium shift upon anemia resolution; however, in more recent experience, while some patients may experience hypokalemia with initial treatment, this is unlikely to be clinically significant (Carmel 2008).

• Thrombocytosis: Treatment of severe vitamin B12 megaloblastic anemia may result in thrombocytosis.

Disease-related concerns:

• Leber disease: Patients with Leber disease who received B12 treatment have suffered from severe rapid optic atrophy. Use of cyanocobalamin in these patients is not recommended.

• Megaloblastic anemia: Vitamin B12 doses >10 mcg daily may produce a hematologic response in patients with folate deficient megaloblastic anemia and mask previously unrecognized folate deficiency; vitamin B12 is not a substitute for folic acid.

• Pernicious anemia: Appropriate use: IM/SubQ routes are used to treat pernicious anemia; oral and intranasal administration are not indicated until hematologic remission and no signs of nervous system involvement.

• Polycythemia vera: Vitamin B12 deficiency masks signs of polycythemia vera; vitamin B12 administration may unmask this condition.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register, 2002). See manufacturer’s labeling.

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Intranasal administration: The effectiveness of intranasal cyanocobalamin in patients with allergic rhinitis, nasal congestion, and upper respiratory tract infections has not been determined. Defer treatment until symptoms have subsided.

Other warnings/precautions:

• IV administration: Avoid intravenous route; anaphylactic shock has occurred.

• Test dose: Intradermal test dose of vitamin B12 is recommended for any patient suspected of cyanocobalamin hypersensitivity prior to intranasal or injectable administration.

Geriatric Considerations

About one-quarter of individuals with vitamin B12 deficiency, particularly the elderly, will present with neurologic manifestations, yet hematologic indices won’t appear reflective of a megaloblastic anemia (Lindenbaum 1988). Evidence exists to support replacing vitamin B12 in those whose vitamin B12 levels are at the low end of normal (<300 pg/mL has been suggested), especially given the relative safety of replacement doses (Smith 2009).

Long-term treatment with metformin, proton pump inhibitors and H2 receptor blockers has shown to be associated with an increased risk of vitamin B12 deficiency. Therefore, monitoring vitamin B12 is a prudent recommendation for older adults who are receiving any of these therapies long term (Andres 2002; Lam 2013).

Pregnancy Considerations

Animal reproduction studies have not been conducted. Water soluble vitamins cross the placenta. Absorption of vitamin B12 may increase during pregnancy. Vitamin B12 requirements may be increased in pregnant women compared to nonpregnant women. Serum concentrations of vitamin B12 are higher in the neonate at birth than the mother (IOM 1998).

Breast-Feeding Considerations

Vitamin B12 is found in breast milk. Milk concentrations are similar to maternal serum concentrations and concentrations may be decreased in women who are vegetarians. Vitamin B12 requirements may be increased in nursing women compared to non-nursing women (IOM 1998).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Central nervous system: Headache (IM: 20%; intranasal: 4%)

Infection: Infection (12% to 13%)

Neuromuscular & skeletal: Asthenia (IM: 16%; intranasal: 4%)

1% to 10%:

Central nervous system: Paresthesia (4%)

Gastrointestinal: Glossitis (nasal: 4%), nausea (4%)

Respiratory: Rhinitis (4% to 8%)

Frequency not defined:

Cardiovascular: Cardiac failure, thrombosis (peripheral)

Dermatologic: Pruritus, skin rash (transient)

Endocrine & metabolic: Hypokalemia

Gastrointestinal: Diarrhea

Hematologic & oncologic: Polycythemia vera, thrombocythemia

Hypersensitivity: Anaphylactic shock (IM/SubQ)

Respiratory: Pulmonary edema

Miscellaneous: Swelling

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Chloramphenicol (Systemic): May diminish the therapeutic effect of Vitamin B12. Risk C: Monitor therapy

Colchicine: May decrease the serum concentration of Cyanocobalamin. Risk C: Monitor therapy

Food Interactions

Heavy ethanol consumption >2 weeks may impair vitamin B12 absorption.

Test Interactions

Methotrexate, pyrimethamine, and most antibiotics invalidate folic acid and vitamin B12 diagnostic blood assays

Monitoring Parameters

Vitamin B12, hemoglobin, hematocrit, erythrocyte and reticulocyte count; folate and iron levels should be obtained prior to treatment; vitamin B12 and peripheral blood counts should be monitored 1 month after beginning treatment (and vitamin B12 1 month after each dosage adjustment if using intranasal formulation), then every 3 to 6 months thereafter.

Evaluate serum methylmalonic acid and total homocysteine levels at baseline (prior to supplementation) in untreated patients to confirm vitamin B12 deficiency (and extent of deficiency); repeat to confirm adequate supplementation (Stabler 2013).

Megaloblastic/pernicious anemia: In addition to normal hematological parameters, serum potassium and platelet counts should be monitored during therapy. Note: Some patients may develop hypokalemia during initial treatment; however, this is unlikely to be clinically significant (Carmel 2008).

Bariatric surgery: Vitamin B12 levels at baseline and once a year postoperatively then every 3 to 6 months if supplemented; every trimester in pregnant females (Mechanick 2013). In patients on chronic administration of medications known to increase risk of B12 deficiency (eg, colchicine, metformin, neomycin, nitrous oxide, proton pump inhibitors, seizure medication), screen every 3 months for the initial postoperative year and then annually (Parrott 2017). Serum methylmalonic acid (MMA) is the recommended assay to evaluate vitamin B12 levels for patients who are asymptomatic, symptomatic, have a history of B12 deficiency, or preexisting neuropathy (Parrott 2017). Monitor for early signs/symptoms of B12deficiency, including pernicious anemia (pale skin/eyes, glossitis, fatigue, anorexia, diarrhea) or neuropathy (numbness, paresthesia in extremities, ataxia, decreased reflexes), lightheadedness or vertigo, dyspnea, tinnitus, palpitations, and /or increased HR; monitor for advanced signs/symptoms of B12 deficiency, including angina, HF symptoms and/or mental status changes (Parrott 2017).

Reference Range

Normal range of serum B12 is 150 to 900 pg/mL; this represents 0.1% of total body content. Metabolic requirements are 2 to 5 mcg/day; years of deficiency are required before hematologic and neurologic signs and symptoms are seen. Occasional patients with significant neuropsychiatric abnormalities may have no hematologic abnormalities and normal serum cobalamin levels, 200 pg/mL (SI: >150 pmol/L), or more commonly between 100 to 200 pg/mL (SI: 75 to 150 pmol/L).

Gastric bypass surgery patients: Normal B12 range: 200 to 1,000 pg/mL; Deficiency critical range: B12: <400 pg/mL (suboptimal) and <200 pg/mL (deficient) (Parrott 2017).

Advanced Practitioners Physical Assessment/Monitoring

Provide patient appropriate nutritional counseling.

Nursing Physical Assessment/Monitoring

Provide patient appropriate nutritional counseling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Injection:

B-12 Compliance Injection: 1000 mcg/mL [contains benzyl alcohol]

Physicians EZ Use B-12: 1000 mcg/mL [contains benzyl alcohol]

Vitamin Deficiency System-B12: 1000 mcg/mL [contains benzyl alcohol]

Generic: 1000 mcg/mL [DSC]

Liquid, Sublingual:

Generic: 3000 mcg/mL (52 mL)

Lozenge, Oral:

Generic: 50 mcg (100 ea); 100 mcg (100 ea); 250 mcg (100 ea, 250 ea); 500 mcg (100 ea, 250 ea)

Solution, Injection:

Generic: 1000 mcg/mL (1 mL, 10 mL, 30 mL)

Solution, Nasal:

Nascobal: 500 mcg/0.1 mL (1 ea) [contains benzalkonium chloride]

Tablet, Oral:

Generic: 100 mcg, 250 mcg, 500 mcg, 1000 mcg

Tablet, Oral [preservative free]:

Generic: 100 mcg [DSC], 500 mcg, 1000 mcg

Tablet Extended Release, Oral:

Generic: 1000 mcg

Tablet Sublingual, Sublingual:

Generic: 2500 mcg [DSC]

Tablet Sublingual, Sublingual [preservative free]:

Generic: 2500 mcg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Cobex: 1000 mcg/mL (10ml, 30ml)

Generic: 100 mcg/mL (1ml, 10ml); 1000 mcg/mL (1ml, 10ml, 30ml, 100ml)

Anatomic Therapeutic Chemical (ATC) Classification
  • B03BA01
Generic Available (US)

Yes

Pricing: US

Solution (Cyanocobalamin Injection)

1000 mcg/mL (per mL): $3.86 – $8.74

Solution (Nascobal Nasal)

500 mcg/0.1 mL (per each): $175.74

Tablet, controlled release (Vitamin B-12 ER Oral)

1000 mcg (per each): $0.05

Tablets (Vitamin B-12 Oral)

250 mcg (per each): $0.03

1000 mcg (per each): $0.05 – $0.21

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Coenzyme for various metabolic functions, including fat and carbohydrate metabolism and protein synthesis, used in cell replication and hematopoiesis

Pharmacodynamics/Kinetics

Onset of action:

Megaloblastic anemia: IM:

Conversion of megaloblastic to normoblastic erythroid hyperplasia within bone marrow: 8 hours

Increased reticulocytes: 2 to 5 days

Complicated vitamin B12 deficiency: IM, SubQ: Resolution of:

Psychiatric sequelae: 24 hours

Thrombocytopenia: 10 days

Granulocytopenia: 2 weeks

Absorption: Oral: Variable from the terminal ileum; requires the presence of calcium and gastric “intrinsic factor” to transfer the compound across the intestinal mucosa

Distribution: Principally stored in the liver and bone marrow, also stored in the kidneys and adrenals

Protein binding: Transcobalamins

Metabolism: Converted in tissues to active coenzymes, methylcobalamin and deoxyadenosylcobalamin; undergoes some enterohepatic recycling

Bioavailability: Intranasal (Nascobal): 6.1% (relative to IM); Oral: Pernicious anemia: 1.2%

Time to peak, serum: IM, SubQ: 30 minutes to 2 hours; Intranasal: 1.25 ± 1.9 hours

Excretion: Urine (50% to 98%, unchanged drug)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

CaloMist; Vitamin B12

References

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Orkin S, Nathan D, Ginsbirg, D, et al, eds. Nathan and Oski’s Hematology and Oncology of Infancy and Childhood. 8th ed. Saunders; 2015.

Parrott J, Frank L, Rabena R, et al. American Society for Metabolic and Bariatric Surgery Integrated Health Nutritional Guidelines for the Surgical Weight Loss Patient 2016 Update: Micronutrients. Surg Obes Relat Dis. 2017;13(5):727-741.[PubMed 28392254]

Rasmussen SA, Fernhoff PM, and Scanlon KS, “Vitamin B12 Deficiency in Children and Adolescents,” J Pediatr, 2001, 138(1):10-17.[PubMed 11148506]

Regland B, Gottfries CG, and Lindstedt G, “Dementia Patients With Low Serum Cobalamin Concentration: Relationship to Atrophic Gastritis,” Aging (Milano), 1992, 4(1):35-41.[PubMed 1627675]

Roumeliotis N, Dix D, Lipson A. Vitamin B(12) deficiency in infants secondary to maternal causes. CMAJ. 2012;184(14):1593-1598.[PubMed 22711730]

Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(21):3543-3551.[PubMed 18506025]

Schjonsby H, “Vitamin B12 Absorption and Malabsorption,” Gut, 1989, 30(12):1986-91.[PubMed 2693230]

Schnyder G, Roffi M, Flammer Y, et al, “Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Clinical Outcome After Percutaneous Coronary Intervention: The Swiss Heart Study: A Randomized Controlled Trial,” JAMA, 2002, 288(8):973-9.[PubMed 12190367]

Silbergleit R and Lee DC, “Bowel Obstruction and Radiopaque Vitamin B12 “Pseudobezoar”,” Am J Emerg Med, 1995, 13(1):112-3.[PubMed 7832937]

Smith AD, Refsum H. Vitamin B-12 and cognition in the elderly. Am J Clin Nutr. 2009;89(2):707S-711S.[PubMed 19116332]

Stabler SP. Clinical practice. Vitamin B12 deficiency. N Engl J Med. 2013;368(2):149-160.[PubMed 23301732]

Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003;21(14):2636-2644.[PubMed 12860938]

Volkov I, Rudoy I, Freud T, et al. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled trial. J Am Board Fam Med.2009;22(1):9-16.[PubMed 19124628]

Brand Names: International

Ambe 12 (LU); Ampavit (TH); Arcored (ID); B 12 SR (EG); B12 Ankermann (PL); Bedoc (GR); Bedodeka (IL); Bedoze (PT); Bedozil (BR); Behepan (SE); Betolvex (CH, DK, EG, FI, SE); Betolvex[inj.] (SE); Cianocobalamina B12 Davi (PT); Coba 1000 (LK); Cobalin (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Cobamin Ophth Soln (HK); Creliverol-12 (PE); Cromatonbic B12 (ES); Cynovit (BH); Cytacon (LK); Cytamen (AU, GB); Dobetin (IT, VE); Dodec (TR); Ecavit B12 (EG); Ecovitamine B12 (FR); Isopto B12 (ES); Kiddi Pharmaton (MX); Lagavit B12 (AE, BB, BM, BS, BZ, CY, GY, IQ, IR, JM, JO, KW, LB, LY, NL, OM, PR, QA, SA, SR, SY, TT, YE); Ledoxina (MX); Mono Vitamine B12 (FR); Neurobene (CZ, HN); Norivite-12 (ZA); Optovite B12 (ES); Oravit B12 SR (EG); Parecon Forte (ZW); Permadoze (PT); Permadoze oral (PT); Reedvit 10000 (AR); Reticulogen (ES); Rojamin (EC); Rubramin (PH); Sancoba (JP); Tribedoce DX (MX); Vegevit B12 (PL); Vicapan N (DE); Vitalen (MX); Vitam-Doce (AR); Vitamin B!1!2 (HR); Vitamin B12 (HU); Vitamin B12 Lannacher (AT); Vitamin B12 Recip (SE); Vitamina B12-Ecar (CO); Vitamine B12-Dulcis (LU); Vitaminum B12 (PL); Vitarubin (CH)

Cyanocobalamin (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sye an oh koe BAL a min)

Brand Names: US

B-12 Compliance Injection; Nascobal; Physicians EZ Use B-12; Vitamin Deficiency System-B12

What is this drug used for?
  • It is used to treat anemia.
  • It is used to treat or prevent low vitamin B12.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to cyanocobalamin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Nose spray:
  • If you have any of these health problems: Nasal allergies, stuffy nose, or signs of a common cold.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Injection:
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Severe diarrhea.
  • Feeling very tired or weak.
  • Chest pain.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in balance.
  • A burning, numbness, or tingling feeling that is not normal.
  • Any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Headache.
  • Nervous and excitable.
  • Upset stomach or throwing up.
  • Diarrhea.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • All oral products:
  • Take with meals.
  • Chewable tablet:
  • Chew well before swallowing.
  • Long-acting tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Under the tongue (sublingual) tablet:
  • Place under tongue and let dissolve all the way. Do not chew, suck or swallow tablet.
  • Under the tongue (sublingual) spray:
  • Shake well before use.
  • Spray into the mouth under the tongue.
  • Oral liquid:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Lozenge and oral-disintegrating tablet:
  • Let dissolve in your mouth. Water is not needed.
  • Nose spray:
  • Do not take this drug by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
  • Blow your nose before use.
  • Check your spray use with your doctor at each visit. Read and follow the facts on how to use the spray. Make sure you use the spray the right way.
  • Use 1 hour before or after eating or drinking hot foods or liquids.
  • Read the package insert for more details.
  • Injection:
  • It is given as a shot into a muscle or under the skin.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to take this drug as you have been told by your doctor. Do not use more than you were told to use.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All other products:
  • Store at room temperature. Do not freeze.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Nose spray:
  • Store upright with the cap on.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Cyanocobalamin (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sye an oh koe BAL a min)

Brand Names: US

B-12 Compliance Injection; Nascobal; Physicians EZ Use B-12; Vitamin Deficiency System-B12

What is this drug used for?
  • It is used to treat anemia.
  • It is used to treat or prevent low vitamin B12.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Nose spray:
  • If your child has any of these health problems: Nasal allergies, stuffy nose, or signs of a common cold.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Injection:
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your child’s doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Feeling very tired or weak.
  • Severe diarrhea.
  • Chest pain.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in balance.
  • A burning, numbness, or tingling feeling that is not normal.
  • Any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Headache.
  • Nervous and excitable.
  • Upset stomach or throwing up.
  • Diarrhea.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • All oral products:
  • Give this drug with meals.
  • Chewable tablet:
  • Have your child chew all the way up before swallowing.
  • Long-acting tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Under the tongue (sublingual) tablet:
  • Place under your child’s tongue and let dissolve all the way before swallowing. Do not let your child chew, suck, or swallow the tablet.
  • Under the tongue (sublingual) spray:
  • Shake well before use.
  • Spray into the mouth under the tongue.
  • Oral liquid:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Lozenge and oral-disintegrating tablet:
  • Have your child let dissolve in the mouth. Water is not needed.
  • Nose spray:
  • Do not give this drug by mouth. Use in your child’s nose only. Keep out of your child’s mouth and eyes (may burn).
  • Have your child blow nose before use.
  • Check your child’s spray use with the doctor at each visit. Read and follow facts on how to use the spray. Make sure your child uses the spray the right way.
  • Have your child use 1 hour before or after eating or drinking hot foods or liquids.
  • Read the package insert for more details.
  • Injection:
  • It is given as a shot into a muscle or under the skin.
  • If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
  • Follow how to give this drug as you have been told by your child’s doctor. Do not give more than you were told to give.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All other products:
  • Store at room temperature. Do not freeze.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Nose spray:
  • Store upright with the cap on.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.