Label: MYFERON 150- iron sucrose capsule
Contains inactivated NDC Code(s)
NDC Code(s): 58607-111-85
- Packager: MARTIN EKWEALOR PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated February 20, 2014
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- SUPPLEMENTAL FACTS
- WARNING: Keep this product out of reach of children.
- INDICATIONS AND USAGE:
- DOSAGE AND ADMINISTRATION:
- Inactive Ingredients OTHER INGREDIENTS:
Myferon 150, Polysaccharide Iron Complex capsules are a preparation of ferric Iron complexed to a low molecular weight polysaccharide. This polysaccharide is obtained by extensive hydrolysis of starch.
Myferon 150 is a dark brown powder that when dissolved in water, forms a very dark brown solution. As an organic complex, polysaccharide iron contains no free iron. It is tasteless, odorless and readily soluble in water.
Iron is an essential compound in the formation of hemoglobin. Adequate amounts of iron are necessary for the effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.
A radioiscope tracer study in man demonstrated that absorption of a polysacchride-iron is comparable to that of ferrous sulfate. Clinical studies demonstrate that polysaccharide-iron produces good hematological response shown by increases in hemoglobin and hematocrit in children and adult patients. Polysaccharide-iron is effective in maintaining the hematopoietic status in end-stage kidney disease patients receiving epoetin alfa therapy.
The type of anemia and the underlying cause or causes should be determined before initiating treatment with Myferon 150. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected if possible. As with all oral iron preparations, Myferon 150 should be stored out of the reach of children to protect against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron products can cause dark or black stools.
- ADVERSE REACTIONS:
The clinical cause of acute iron overdose can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months has no adverse effects. The Oral LD 50 of polysaccharide-iron complex was estimated to be greater than 5000 mg. iron/kg in rats.
- HOW SUPPLIED:
- Myferon 150 Product Label
INGREDIENTS AND APPEARANCE
iron sucrose capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58607-111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 150 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) Product Characteristics Color orange (ORANGE;BROWN) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code B203 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58607-111-85 100 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/1996 Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386) Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386) Establishment Name Address ID/FEI Business Operations MARTIN EKWEALOR PHARMACEUTICALS, INC. 624528386 manufacture(58607-111)