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Tandem Capsules
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  • FDA PI

Tandem Capsules

Generic name: ferrous fumarate and ferrous asparto glycinate
Dosage form: capsule
Drug class:Iron products

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

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.

DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .191.1 mg Polysaccharide Iron Complex..135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡).40 mg Vitamin B3 (from ProAscorb C‡) ..3 mg Inactive Ingredients: Hypromellose, Magnesium Stearate, Titanium Dioxide,

CLINICAL PHARMACOLOGY: IntegraTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows:
Ferrous Fumarate (anhydrous) 191.1 mg Polysaccharide iron complex (PIC) 135.9 mg
Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Iron absorption is maximal in the duodenum unlike Ferrous Sulfate, which must be protected against oxidation through coating. The IntegraTM Capsule is superior to enteric coated or sustained release preparations that are apt to pass beyond the duodenum and would therefore be poorly absorbed. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Calculation of Dose should be in terms of elemental iron and three doses ranging from 50-100 mg of elemental iron is usually adequate.
Polysaccharide Iron Complex: Provides about 62.5 mg elemental iron, as a cell-contracted akaganèite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch and is a dark brown powder, that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless.
All IntegraTM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content