"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"...
Nascobal (cyanocobalamin) Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.
Nascobal (cyanocobalamin) Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including:
I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).
II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.
III. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.
IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The ">blind loop syndrome may produce deficiency of vitamin B12 or folate.
V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of vitamin B12.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation.
Nascobal (cyanocobalamin) Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).
DOSAGE AND ADMINISTRATION
The recommended initial dose of Nascobal (cyanocobalamin) Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Nascobal (cyanocobalamin) Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids. Periodic monitoring of serum B12 levels should be obtained to establish adequacy of therapy.
Priming (Activation) of Pump
Before the first dose and administration, the pump must be primed. Remove the clear plastic cover and the plastic safety clip from the pump. To prime the pump, place nozzle between the first and second finger with the thumb on the bottom of the bottle. Pump the unit firmly and quickly until the first appearance of spray. Then prime the pump an additional 2 times. Now the nasal spray is ready for use. The unit must be re-primed before each dose. Prime the pump once immediately before each administration of doses 2 through 8.
See LABORATORY TESTS for monitoring B12 levels and adjustment of dosage.
Nascobal (cyanocobalamin) Nasal Spray is available as a spray in 3 mL glass bottles containing 2.3 mL of solution. It is available in a dosage strength of 500 mcg per actuation (0.1 mL/actuation). A screw-on actuator is provided. This actuator, following priming, will deliver 0.1 mL of the spray. Nascobal (cyanocobalamin) Nasal Spray is provided in a carton containing a nasal spray actuator with dust cover, a bottle of nasal spray solution, and a package insert. One bottle will deliver 8 doses (NDC 67871-773-35).
Pharmacist Assembly Instructions For Nascobal (cyanocobalamin) Nasal Spray
The pharmacist should assemble the Nascobal (cyanocobalamin) Nasal Spray unit prior to dispensing to the patient, according to the following instructions:
- Open the carton and remove the spray actuator and spray solution bottle.
- Assemble Nascobal (cyanocobalamin) Nasal Spray by first unscrewing the white cap from the spray solution bottle and screwing the actuator unit tightly onto the bottle. Make sure the clear dust cover is on the pump unit.
- Return the Nascobal (cyanocobalamin) Nasal Spray bottle to the carton for dispensing to the patient.
Mfd. for QOL Medical, LLC
Kirland, WA 98033, USA
www.nascobal (cyanocobalamin) .com
3078 Rev. 02/06
FDA rev date: 9/15/2006
Last reviewed on RxList: 12/12/2016
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