NASCOBAL- cyanocobalamin spray

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Dostępny od:

Par Pharmaceutical , Inc

INN (International Nazwa):

CYANOCOBALAMIN

Skład:

CYANOCOBALAMIN 500 ug

Droga podania:

NASAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Nascobal 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 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 (ingesti

Podsumowanie produktu:

Nascobal Nasal Spray is available as a spray in 3 mL glass bottles containing 1.3 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 4 doses (NDC 49884-270-86). PHARMACIST ASSEMBLY INSTRUCTIONS FOR NASCOBAL NASAL SPRAY The pharmacist should assemble the Nascobal Nasal Spray unit prior to dispensing to the patient, according to the following instructions:

Status autoryzacji:

New Drug Application

Charakterystyka produktu

NASCOBAL- CYANOCOBALAMIN SPRAY
PAR PHARMACEUTICAL , INC
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DESCRIPTION
Cyanocobalamin is a synthetic form of vitamin B
with equivalent vitamin B
activity. The chemical
name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content
is 4.35%. The molecular
formula is C
H CoN O P, which corresponds to a molecular weight of 1355.38 and the
following
structural formula:
Cyanocobalamin occurs as dark red crystals or orthorhombic needles or
crystalline red powder. It is
very hygroscopic in the anhydrous form, and sparingly to moderately
soluble in water (1:80). Its
pharmacologic activity is destroyed by heavy metals (iron) and strong
oxidizing or reducing agents
(vitamin C), but not by autoclaving for short periods of time (15-20
minutes) at 121°C. The vitamin B
coenzymes are very unstable in light.
Nascobal® Nasal Spray is a solution of Cyanocobalamin, USP (vitamin
) for administration as a
spray to the nasal mucosa. Each bottle of Nascobal Nasal Spray
contains 1.3mL of a 500 mcg/0.1mL
solution of cyanocobalamin with sodium citrate, citric acid, and
glycerin and benzalkonium chloride in
purified water. The spray solution has a pH between 4.5 and 5.5. The
spray pump unit must be fully
primed (see Dosage and Administration) prior to initial use. After
initial priming, each spray delivers an
average of 500 mcg of cyanocobalamin and the 1.3mL of spray solution
contained in the bottle will
deliver 4 doses of Nascobal Nasal Spray. The unit must be re-primed
before each dose. (see Dosage
and Administration).
CLINICAL PHARMACOLOGY
GENERAL PHARMACOLOGY AND MECHANISM OF ACTION
Vitamin B
is 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 B
can be converted to coenzyme B
in tissues, and as such is essential for conversion of methylmalonate
to succinate and synthesis of
12
12
63
88
14
14
12
B12
12
12
12
12
methionine