Linked Life Data

Nascobal (Spray)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4022

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Nascobal (Spray)
dailymed-instance:dosage
The recommended initial dose of Nascobal Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Nascobal Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids. Periodic monitoring of serum Blevels should be obtained to establish adequacy of therapy. 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. Thenprime 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 Blevels and adjustment of dosage.
dailymed-instance:clinicalP...
GENERAL PHARMACOLOGY AND MECHANISM OF ACTION: Vitamin Bis essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Cells characterized by rapid division (e.g., epithelial cells, bone marrow, myeloid cells) appear to have the greatest requirement for vitamin B. Vitamin Bcan be converted to coenzyme Bin tissues, and as such is essential for conversion of methylmalonate to succinate and synthesis of methionine from homocysteine, a reaction which also requires folate. In the absence of coenzyme B, tetrahydrofolate cannot be regenerated from its inactive storage form, 5-methyltetrahydrofolate, and a functional folate deficiency occurs. Vitamin Balso may be involved in maintaining sulfhydryl (SH) groups in the reduced form required by many SH-activated enzyme systems. Through these reactions, vitamin Bis associated with fat and carbohydrate metabolism and protein synthesis. Vitamin Bdeficiency results in megaloblastic anemia, GI lesions, and neurologic damage that begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head. Cyanocobalamin is the most stable and widely used form of vitamin B, and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. The information below, describing the clinical pharmacology of cyanocobalamin, has been derived from studies with injectable vitamin B. Vitamin Bis quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection. It is bound to plasma proteins and stored in the liver. Vitamin Bis excreted in the bile and undergoes some enterohepatic recycling. Absorbed vitamin Bis transported via specific Bbinding proteins, transcobalamin I and II, to the various tissues. The liver is the main organ for vitamin Bstorage. Parenteral (intramuscular) administration of vitamin Bcompletely reverses the megaloblastic anemia and GI symptoms of vitamin Bdeficiency; the degree of improvement in neurologic symptoms depends on the duration and severity of the lesions, although progression of the lesions is immediately arrested. Gastrointestinal absorption of vitamin Bdepends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of vitamin Bprevents progression of neurologic damage. The average diet supplies about 4 to 15 mcg/day of vitamin Bin a protein-bound form that is available for absorption after normal digestion. Vitamin Bis not present in foods of plant origin, but is abundant in foods of animal origin. In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs). Vitamin Bis bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin Benters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B. Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B.<br/>PHARMACOKINETICS:<br/>Absorption: A three way crossover study in 25 fasting healthy subjects was conducted to compare the bioavailability of the Bnasal spray to the Bnasal gel and to evaluate the relative bioavailability of the nasal formulations as compared to the intramuscular injection. The peak concentrations after administration of intranasal spray were reached in 1.25 +/- 1.9 hours. The average peak concentration of Bobtained after baseline correction following administration of intranasal spray was 757.96 +/- 532.17 pg/mL. The bioavailability of the nasal spray relative to the intramuscular injection was found to be 6.1%. The bioavailability of the Bnasal spray was found to be 10% less than the Bnasal gel. The 90% confidence intervals for the log-transformed AUCand Cwas 71.71% - 114.19% and 71.6% - 118.66% respectively. In pernicious anemia patients, once weekly intranasal dosing with 500 mcg Bgel resulted in a consistent increase in pre-dose serum Blevels during one month of treatment (p<0.003) above that seen one month after 100 mcg intramuscular dose (Figure).<br/>Distribution: In the blood, Bis bound to transcobalamin II, a specific B-globulin carrier protein, and is distributed and stored primarily in the liver and bone marrow.<br/>Elimination: About 3-8 mcg of Bis secreted into the GI tract daily via the bile; in normal subjects with sufficient intrinsic factor, all but about 1 mcg is reabsorbed. When Bis administered in doses which saturate the binding capacity of plasma proteins and the liver, the unbound Bis rapidly eliminated in the urine. Retention of Bin the body is dose-dependent. About 80-90% of an intramuscular dose up to 50 mcg is retained in the body; this percentage drops to 55% for a 100 mcg dose, and decreases to 15% when a 1000 mcg dose is given. Figure. Vitamin BSerum Trough Levels After Intramuscular Solution (IM) of 100 mcg and Nasal Gel (IN) Administration of 500 mcg Cyanocobalamin After Weekly Doses.
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dailymed-instance:supply
Nascobal 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 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).
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cyanocobalamin
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Nascobal (Spray)
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The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin Bdeficient patients in hematologic remission receiving Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B(N=25). In the pharmacokinetic study comparing Nascobal Nasal Spray and Nascobal Nasal Gel, the incidence of adverse events was similar. The intensity of the reported adverse experiences following the administration of Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin Bwere 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 Bwere 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 Band 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: Generalized: Anaphylactic shock and death . 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.
dailymed-instance:indicatio...
Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin Btherapy and who have no nervous system involvement. Nascobal Nasal Spray is also indicated as a supplement for other vitamin Bdeficiencies, including: I. Dietary deficiency of vitamin Boccurring in strict vegetarians (Isolated vitamin Bdeficiency is very rare). II. Malabsorption of vitamin Bresulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin Babsorption. 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 Bdeficiency. 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 Bdeficiency. Structural lesions leading to vitamin Bdeficiency include regional ileitis, ileal resections, malignancies, etc. IV. Competition for vitamin Bby intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin Band infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin Bor folate. V. Inadequate utilization of vitamin B. 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 B. Requirements of vitamin Bin 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 Nasal Spray is not suitable for vitamin Babsorption test (Schilling Test).
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dailymed-instance:name
Nascobal