Vitamin B12

Cyanocobalamin

Approved 9 Sept 2020NasalSpray, metered

The FDA lists this product in 38 strengths and forms.

Official labelAsk Osler about it

Indications

Cyanocobalamin Nasal Spray is indicated for:

Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia
Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use
Cyanocobalamin Nasal Spray should not be used for the vitamin B 12 absorption test (Schilling test).
In patients with correctible or temporary causes of vitamin B 12 deficiency, the benefit of continued long-term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B 12 deficiency and underlying disease has not been established.
The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided. Cyanocobalamin Nasal Spray is a vitamin B 12 indicated for:
Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement ( 1 )
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia ( 1 )
Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal ( 1 ) Limitations of Use:
Should not be used for the vitamin B 12 absorption test (Schilling test). ( 1 )
In patients with correctible or temporary causes of vitamin B 12 deficiency the benefit of continued long-term use following correction of vitamin B 12 deficiency and underlying disease has not been established. ( 1 )
In patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection effectiveness has not been established. ( 1 )

Contraindications

Indications

Cyanocobalamin Nasal Spray is indicated for:

Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia
Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use
Cyanocobalamin Nasal Spray should not be used for the vitamin B 12 absorption test (Schilling test).
In patients with correctible or temporary causes of vitamin B 12 deficiency, the benefit of continued long-term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B 12 deficiency and underlying disease has not been established.
The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided. Cyanocobalamin Nasal Spray is a vitamin B 12 indicated for:
Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement ( 1 )
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia ( 1 )
Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal ( 1 ) Limitations of Use:
Should not be used for the vitamin B 12 absorption test (Schilling test). ( 1 )
In patients with correctible or temporary causes of vitamin B 12 deficiency the benefit of continued long-term use following correction of vitamin B 12 deficiency and underlying disease has not been established. ( 1 )
In patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection effectiveness has not been established. ( 1 )

Warnings and precautions

Severe Optic Atrophy in Patients with Leber’s Disease: Patients with early Leber’s disease who were treated with vitamin B 12 suffered severe and swift optic atrophy. Cyanocobalamin Nasal Spray is not recommended for use in these patients. ( 5.1 )
Anaphylactic Reactions: Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration. If patients are to start Cyanocobalamin Nasal Spray before having tolerated cyanocobalamin parenterally, consider administering an intradermal test dose of parenteral vitamin B 12 to patients suspected of cyanocobalamin hypersensitivity. ( 2.1 , 5.2 )
Masking of Folate Deficiency with Vitamin B 12 Use: Doses of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficient megaloblastic anemia and may therefore mask a previously unrecognized folate deficiency. Assess both vitamin B 12 and folate levels prior to initiating therapy with Cyanocobalamin Nasal Spray or with folic acid. ( 5.3 )
Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia: Hypokalemia and sudden death may occur in severe megaloblastic anemia that is treated intensely with vitamin B 12 . Monitor serum potassium levels and platelet count during therapy. ( 5.4 )
Unmasking of Polycythemia Vera: Vitamin B 12 deficiency may suppress the signs of polycythemia vera. Treatment with Cyanocobalamin Nasal Spray may unmask this condition. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation. ( 5.5 )

5.1Severe Optic Atrophy in Patients with Leber’s Disease Patients

with early Leber’s disease (hereditary optic nerve atrophy) who were treated with vitamin B 12 suffered severe and swift optic atrophy. Cyanocobalamin products, including Cyanocobalamin Nasal Spray, is not recommended for use in patients with Leber’s optic atrophy. For patients with Leber’s disease requiring vitamin B 12 , consider alternative therapy (e.g., hydroxocobalamin) for B 12 supplementation.

5.2Anaphylactic Reactions

Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration. If patients are to start Cyanocobalamin Nasal Spray before having tolerated cyanocobalamin parenterally, consider administering an intradermal test dose of parenteral vitamin B 12 to patients suspected of cyanocobalamin hypersensitivity [see Dosage and Administration (2.1) ] .

5.3Masking of Folate Deficiency with Vitamin B 12 Use Doses

of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficient megaloblastic anemia and may therefore mask a previously unrecognized folate deficiency. Vitamin B 12 is not a substitute for folic acid [see Dosage and Administration (2.4) ] . Assess both vitamin B 12 and folate levels prior to initiating therapy with vitamin B 12 , including Cyanocobalamin Nasal Spray, or with folic acid [see Dosage and Administration (2.1) ] .

5.4Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia Hypokalemia

and sudden death may occur in severe megaloblastic anemia that is treated intensely with vitamin B 12 . Hypokalemia and thrombocytosis can occur upon conversion of severe megaloblastic anemia to normal erythropoiesis with vitamin B 12 therapy. Therefore, serum potassium levels and platelet count should be monitored carefully during therapy [see Dosage and Administration (2.3) ] .

5.5Unmasking of Polycythemia Vera Vitamin B

12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B 12 may unmask this condition. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation.

Cyanocobalamin

Indications

Contraindications

Two medicines in one question?

Cyanocobalamin

Indications

Contraindications

Two medicines in one question?

Warnings and precautions

5.1Severe Optic Atrophy in Patients with Leber’s Disease Patients

5.2Anaphylactic Reactions

5.3Masking of Folate Deficiency with Vitamin B 12 Use Doses

5.4Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia Hypokalemia

5.5Unmasking of Polycythemia Vera Vitamin B

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information

At a glance