"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
Patients with pernicious anemia should be instructed that they will require weekly intranasal administration of Nascobal (cyanocobalamin) Nasal Spray for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration of the spinal cord.
(Hot foods may cause nasal secretions and a resulting loss of medication; therefore, patients should be told to administer Nascobal (cyanocobalamin) Nasal Spray at least one hour before or one hour after ingestion of hot foods or liquids).
A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Therefore, patients following such a diet should be advised to take Nascobal (cyanocobalamin) Nasal Spray weekly. The need for vitamin B12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.
Because the nasal dosage forms of Vitamin B12 have a lower absorption than intramuscular dosage, nasal dosage forms are administered weekly, rather than the monthly intramuscular dosage. As shown in the Figure above, at the end of a month, weekly nasal administration results in significantly higher serum Vitamin B12 levels than after intramuscular administration. The patient should also understand the importance of returning for follow-up blood tests every 3 to 6 months to confirm adequacy of the therapy.
Careful instructions on the actuator assembly, removal of safety clip, priming of the actuator and nasal administration of Nascobal (cyanocobalamin) Nasal Spray should be given to the patient. Although instructions for patients are supplied with individual bottles, procedures for use should be demonstrated to each patient.
Protect from light. Keep covered in carton until ready to use. Store upright at controlled room temperature 15°C to 30°C (59°F to 86°F). Protect from freezing.
Last reviewed on RxList: 12/12/2016
This monograph has been modified to include the generic and brand name in many instances.
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