NDC | 58607-112-00 |
Set ID | ed2308e3-5310-41bd-9333-615c26183493 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | MARTIN EKWEALOR PHARMACEUTICALS, INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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DESCRIPTION:
Myferon 150 Forte capsules are highly water soluble low molecular weight polysaccharide iron complex and vitaminns.
Each capsule contains:
Elemental Iron .......... 150 mg
(as Polysaccharide Iron Complex)Folic Acid .................. 1 mg
Vitamin B 12 ............... 25 mcg.
(Cyanocobalamin)Other ingredients: Microcrystalline Cellulose, Gelatin, Dicalcium, Phosphate, Stearic Acid, Pharmaceutical Glaze, Magnesium Stearate, Iron Oxides, Titanium Dioxide, FD and C Red #40 Lake and FD and C Blue #1 Lake.
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CLINICAL PHARMACOLOGY:
Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several enzymes, including cytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid by dihydrofolate reductase. Vitamin B 12 is required for the maintenance of normal erythhropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of Vitamin B 12 from the gastric tract.
- INDICATIONS AND USAGE:
- CONTRAINDICATIONS:
- WARNINGS:
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PRECAUTIONS:
General: Do not exceed recommended dose.
The type of anemia and the underlying cause or causes should be determined before starting therapy with Myferon 150 Forte. 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.
Folic Acid: Folic Acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
- WARNING:
- ADVERSE REACTIONS:
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OVERDOSE:
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematamesis, 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 had no adverse effects. The oral LD50 of polysaccharide iron complex was estimated to be greater than 5000 mg/kg in rats.
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HOW SUPPLIED:
Myferon 150 Forte is supplied in Unit Dose blister packs, 10 capsules per card. Capsules are opaque maroon. Store at 25° C (77° F); excursions permitted to 15° -30° C (59° -86° F). (See USP controlled Room Temperature). Avoid excessive heat 40° C (104° F). Avoid freezing.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
All prescription substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book Product.
- Myferon 150 Forte Product Label
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INGREDIENTS AND APPEARANCE
MYFERON 150 FORTE
iron sucrose, folic acid, cyanocobalamin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58607-112 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 FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 25 ug Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) GELATIN (UNII: 2G86QN327L) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) STEARIC ACID (UNII: 4ELV7Z65AP) SHELLAC (UNII: 46N107B71O) MAGNESIUM STEARATE (UNII: 70097M6I30) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color red (MAROON) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code B198 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58607-112-00 100 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(58607-112)