TANDEM DHA — ferrous fumarate, iron, ascorbic acid, pyridoxine hydrochloride, omega-3-acid ethyl esters and folic acid capsule
US Pharmaceutical Corporation
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.
Ferrous Fumarate (Elemental Iron) . . . . . . . . . . . . . . . 15 mg
Vitamin C (Sodium Ascorbate) . . . . . . . . . . . . . . . . . 20 mg FolicAcid␣␣ …………………………… 1mg
Vitamin B6 (Pyridoxine HCI)␣␣ . . . . . . . . . . . . . . . . . . . 25 mg Omega-3FattyAcids␣␣ …………………. 310.1mg
PPolysaccharide Iron Complex (Elemental Iron) ␣␣ . . . . . . (Equivalent to about 30 mg of elemental iron)
((Derived from 450 mg Fish Oil)␣␣
Docosahexaenoic Acid (DHA)␣␣ . . . . . . . . . . . . ␣␣ Eicosapentaenoic Acid (EPA)␣␣ . . . . . . . . . . . . . .
2215.12 mg 53.46 mg
Clinical Studies: The licensee U.S. Pharmaceutical Corporation and JLM Pharmatech, Inc. had jointly sponsored new research pertaining to this formulation (Liesa M. Diehl August 2005: A 14-Day Comparative Pharmacokinetic Study of Ferrous Fumarate and Ferrous Fumarate-Polysaccharide Iron Complex Administered by the Oral (Gavage) Route to Rats, Charles River Laboratories, Preclinical Services: Spencerville, OH). (Personal Communication, Study number NEM00001, August 2005). 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® DHA (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress. The Liesa Diehl study maintains that, “the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated than the oral administration of Ferrous Fumarate alone.” Overall, greater statistically and toxicologically significant effects in hematology and clinical chemistry parameters were observed in Group 2 animals (Ferrous Fumarate only) than were observed in Group 3 animals (Ferrous Fumarate and PIC) as compared to controls.
␣␣ 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 both compositions provide equivalent efficacy at increasing serum iron levels, but that the Group 3 material (i.e., the composition named in the patent), is significantly better tolerated than is Ferrous Fumarate alone, although the concentration of Ferrous Fumarate is the same in both compositions.” In other words, the results support the conclusion 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.
INDICATIONS: Tandem® DHA is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Tandem® DHA may also be used to improve the nutritional status of women before conception. ␣␣
␣␣CONTRAINDICATIONS: Tandem® DHA is contraindicated in patients with known hypersensitivity to any of its ingredients, including fish or fish oil; 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.
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.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. ␣␣ WARNING: Folic acid alone is improper therapy in the treatment for 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.
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® DHA 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.
DOSAGE AND ADMINISTRATION: 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 DHA |
vitamin- mineral omega-3 supplement capsule
|Labeler — US Pharmaceutical Corporation (048318224)|
|Registrant — US Pharmaceutical Corporation (048318224)|
Revised: 12/2009 US Pharmaceutical Corporation
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