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warnings
WARNINGS Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B 12 suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B 12 . Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 -deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B 12 -deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration. No such reactions have been reported in clinical trials with Nascobal Nasal Spray or Nascobal Nasal Gel. Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.
ADVERSE REACTIONS The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin B 12 deficient patients in hematologic remission receiving Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B 12 (N=25). In the pharmacokinetic study comparing Nascobal Nasal Spray and Nascobal Nasal Gel, the incidence of adverse events was similar. Table. Adverse Experiences by Body System, Number of Patients and Number of Occurrences by Treatment Following Intramuscular and Intranasal Administration of Cyanocobalamin. Body System Adverse Experience Number of Patients (Occurrences) Vitamin B 12 Nasal Gel, 500 mcg N=24 Intramuscular Vitamin B 12 , 100 mcg N=25 Body as a Whole Asthenia 1 (1) 4 (4) Back Pain 0 (0) 1 (1) Generalized Pain 0 (0) 2 (3) Headache 1 (2) There may be a possible relationship between these adverse experiences and the study drugs. These adverse experiences could have also been produced by the patient's clinical state or other concomitant therapy. 5 (11) Infection Sore throat, common cold 3 (4) 3 (3) Cardiovascular System Peripheral Vascular Disorder 0 (0) 1 (1) Digestive System Dyspepsia 0 (0) 1 (2) Glossitis 1 (1) 0 (0) Nausea 1 (1) 1 (1) Nausea & Vomiting 0 (0) 1 (1) Vomiting 0 (0) 1 (1) Musculoskeletal System Arthritis 0 (0) 2 (2) Myalgia 0 (0) 1 (1) Nervous System Abnormal Gait 0 (0) 1 (1) Anxiety 0 (0) 1 (1) Dizziness 0 (0) 3 (3) Hypoesthesia 0 (0) 1 (1) Incoordination 0 (0) 1 (2) Nervousness 0 (0) 1 (3) Paresthesia 1 (1) 1 (1) Respiratory System Dyspnea 0 (0) 1 (1) Rhinitis 1 (1) 2 (2) The intensity of the reported adverse experiences following the administration of Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B 12 were generally mild. One patient reported severe headache following intramuscular dosing. Similarly, a few adverse experiences of moderate intensity were reported following intramuscular dosing (two headaches and rhinitis; one dyspepsia, arthritis, and dizziness), and dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (one headache, infection, and paresthesia). The majority of the reported adverse experiences following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B 12 were judged to be intercurrent events. For the other reported adverse experiences, the relationship to study drug was judged as "possible" or "remote". Of the adverse experiences judged to be of "possible" relationship to the study drug, anxiety, incoordination, and nervousness were reported following intramuscular vitamin B 12 and headache, nausea, and rhinitis were reported following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration. The following adverse reactions have been reported with parenteral vitamin B 12 : Generalized: Anaphylactic shock and death (see WARNINGS and PRECAUTIONS ). Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological: Polycythemia vera. Gastrointestinal: Mild transient diarrhea. Dermatological: Itching; transitory exanthema. Miscellaneous: Feeling of swelling of the entire body.