Generic Name: ferrous fumarate, iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, niacinamide, calcium pantothenate, magnesium sulfate and cupric sulfate
Dosage Form: capsule
see all prescribing information for Tandem OB
DESCRIPTION: Each capsule contains:
Ferrous Fumarate (anhydrous) .....................................162 mg (Equivalent to about 106 mg of Elemental Iron) PolysaccharideIronComplex .....................................115.2mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 200 mg
Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 10 mg Riboflavin (B2).......................................................................... 6 mg Niacinamide ............................................................................30 mg
d-Calcium Pantothenate (B5)............................................. 10 mg
Pyridoxine HCl (B6) ..............................................................5 mg
Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg
Magnesium (as Magnesium Sulfate)............................6.9 mg
Manganese (as Manganese Sulfate).............................1.3 mg
Zinc (as Zinc Sulfate) ....................................................... 18.2 mg
Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July - September 1982).
As mentioned above, the patented source of iron used in Tandem OBTM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress.
CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone.
Tandem® OB is a prenatal vitamin-mineral preparation designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Tandem® OB may also be used to improve the nutritional status of women before conception.
Tandem® OB is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
Adults (persons over 12 years of age), One (1) capsule daily, orally, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.
Tandem® OB are blue and pink capsules imprinted radially "Tandem-OB" and "US, US, US, US/US, US, US, US": Child resistant bottles of 90 capsules NDC# 52747-903-60. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15° to 30°C (59° to 86° F). Keep in a cool, dry place. Capsules are not USP.
WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
PRECAUTIONS: General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.
Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients.
Geriatric Use: No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases.
Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Tandem OBTM after meals may control occasional G.I. disturbances. Tandem OBTM is best absorbed when taken at bedtime.
OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Tandem OBTM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children.
Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 06/17/2006 | ||
| Labeler - US Pharmaceutical Corporation (048318224) |
| Registrant - US Pharmaceutical Corporation (048318224) |
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