INDICATION

NASCOBAL® (Cyanocobalamin, USP) Nasal Spray is indicated as a supplement for vitamin B12 deficiency.

IMPORTANT SAFETY INFORMATION for NASCOBAL® Nasal Spray

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12, but not in clinical trials with NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

Treatment with vitamin B12 may unmask signs of polycythemia vera.

Treatment with NASCOBAL® should be deferred in patients with nasal congestion, allergic rhinitis and upper respiratory infections until symptoms have subsided.

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. All hematologic parameters should be normal when beginning treatment with NASCOBAL®. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, intramuscular vitamin B12 is necessary.

Most antibiotics, methotrexate or pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays. Conditions such as infection, uremia, concurrent iron or folic acid deficiency or drugs having bone marrow suppressant properties such as chloramphenicol, may blunt or impede therapeutic response to vitamin B12.

It is not known whether Vitamin B12 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Adverse experiences reported in a clinical trial were asthenia, headache, sore throat, common cold, glossitis, nausea, paresthesia and rhinitis.

Please see full Prescribing Information.

INDICATION

NASCOBAL® (Cyanocobalamin, USP) Nasal Spray is indicated as a supplement for vitamin B12 deficiency.

IMPORTANT SAFETY INFORMATION for NASCOBAL® Nasal Spray

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12, but not in clinical trials with NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

Treatment with vitamin B12 may unmask signs of polycythemia vera.

Treatment with NASCOBAL® should be deferred in patients with nasal congestion, allergic rhinitis and upper respiratory infections until symptoms have subsided.

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. All hematologic parameters should be normal when beginning treatment with NASCOBAL®. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, intramuscular vitamin B12 is necessary.

Most antibiotics, methotrexate or pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays. Conditions such as infection, uremia, concurrent iron or folic acid deficiency or drugs having bone marrow suppressant properties such as chloramphenicol, may blunt or impede therapeutic response to vitamin B12.

It is not known whether Vitamin B12 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Adverse experiences reported in a clinical trial were asthenia, headache, sore throat, common cold, glossitis, nausea, paresthesia and rhinitis.

Please see full Prescribing Information.