NEONATAL FE- iron, folic acid, cyanocobalamin, ascorbic acid tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)

Available from:

SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NEONATAL FE Rx Prenatal Vitamin With ferronyl iron Vitamin is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs. Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Product summary:

NEONATAL FE (NDC 73317-8222-3) is a green, round shaped, film-coated tablet and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature). To report a serious adverse event or obtain product information, call 866-760-6565 Dispensed by Prescription This product is a prescription-folate with or without other dietary ingredients that – due to increased  folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims. 1. Federal Register Notice of August 2, 1973 (38 FR 20750) 2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3. Federal Register Notice of March 5, 1996 (61 FR 8760) AUM Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC) .Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply chain control including pharmacies. THERAPEUTIC GUIDELINES FOR THE PATIENT Some facts you should know about Iron Deficiency Anemia Iron Deficiency Anemia, or IDA, is a common type of anemia. It's a condition in which blood lacks an adequate supply of healthy red blood cells. These cells carry oxygen to tissues. It is oxygenated blood that gives your body energy and your skin a healthy color. As the name suggests, Iron Deficiency Anemia results from insufficient iron. Your body needs iron to make a substance called hemoglobin. It's the hemoglobin in red blood cells that enables them to carry oxygen. What causes IDA? There are many causes of IDA. These include: Women in general are at higher risk of IDA, not only because they lose blood during menstruation but also because their bodies store less iron. How common is it? IDA is a common nutritional deficiency, with women most widely affected. Up to 20% of women have IDA. What are the symptoms? Some of the symptoms most commonly associated with IDA are fatigue, weakness, and headache. Symptoms may also include light-headedness, pale skin, shortness of breath, and cold hands and feet, among others. As the body becomes more deficient in iron and anemia worsens, the symptoms worsen as well. How is IDA diagnosed? A diagnosis is made primarily through blood tests. The doctor checks your hematocrit, the percentage of your blood volume made up of red blood cells and hemoglobin. A lower than normal hemoglobin level indicates anemia. Also, blood tests for IDA typically include a measurement of ferritin, a protein that helps store iron in your body. When the level of ferritin is low, usually the level of iron is, too. If a patient tests positive for IDA, additional tests may be ordered to identify an underlying cause. Does IDA lead to health complications? Mild cases of IDA usually don't cause complications. However, left untreated, IDA can increase in severity and contribute to serious health problems. For example, it may lead to a rapid or irregular heartbeat, a complicated pregnancy that can put the mother at risk for a premature delivery or low-birth-weight baby, and delayed growth in infants and children. The good news is that, because IDA is easily treatable, its potential health consequences are generally avoidable. How is IDA treated? It's essential to increase the amount of iron in your diet. Foods rich in iron include meat, fish, poultry, and whole grain breads. However, in most cases of IDA, diet alone isn't enough to correct the problem. Iron supplementation is usually needed for several months. Your doctor has prescribed NEONATAL FE, a safe and effective iron supplement to help restore your body's iron to normal levels. Plus, it offers the convenience of once-daily dosing. Together with an iron-rich diet, taking NEONATAL FE every day can make a big difference in helping restore your body's iron, and with it your energy and overall feeling of well-being. If you have questions about NEONATAL FE please call: 866-760-6565 AUM Pharmaceuticals 320 Oser Ave, Hauppauge, NY 11788-3608

Authorization status:

unapproved drug other

Summary of Product characteristics

NEONATAL FE- IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID TABLET,
FILM COATED
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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NEONATAL FE
WARNING: IF YOU ARE PREGNANT, NURSING OR TAKING MEDICATION, CONSULT
YOUR DOCTOR
BEFORE USE. ACCIDENTAL OVERDOSE OF IRON CONTAINING PRODUCTS IS A
LEADING CAUSE OF FATAL
POISONING IN CHILDREN UNDER 6. IN CASE OF ACCIDENTAL OVERDOSE, CALL A
DOCTOR OR POISON
CONTROL CENTER IMMEDIATELY.
DESCRIPTION
Each green film-coated tablet for oral administration contains:
Iron (Ferronyl)
90 mg
Folic Acid
1000 mcg
Vitamin B
(Cyanocobalamin) 12 mcg
Vitamin C (Ascorbic acid)
120 mg
INACTIVE INGREDIENTS: Microcrystalline cellulose, DI-Calcium
phosphate, stearic acid, magnesium
stearate, croscarmellose sodium, silicon dioxide, Titanium dioxide,
HPMC E15, HPMC E5/E6, FD&C
YELLOW # 5(LAKE), FD&C BLUE # 1 (LAKE ), FD&C YELLOW # 6 (LAKE).
CLINICAL PHARMACOLOGY
Oral iron is absorbed most efficiently when administered between
meals. Iron is critical for normal
hemoglobin synthesis to maintain oxygen transport energy production
and proper function of cells.
Adequate amounts of iron are necessary for effective erythropoiesis.
Iron also serves as a cofactor of
several essential enzymes, including cytochromes, which are involved
in electron transport. Folic acid
is required for nucleoprotein synthesis and the maintenance of normal
erythropoiesis. Folic acid is the
precursor of tetrahydrofolic acid, which is involved as a cofactor for
transformylation reactions in the
biosynthesis of purines and thymidylates of nucleic acids. Deficiency
of folic acid may account for the
defective deoxyribonucleic acid (DNA) synthesis that leads to
megaloblast formation and megaloblastic
macrocytic anemias. Vitamin B
is essential to growth, cell reproduction, hematopoiesis, nucleic
acid,
and myelin synthesis. Deficiency may result