TANDEM ferrous fumarate polysacchride iron complex capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7)

Available from:

US Pharmaceutical Corporation

INN (International Name):

FERROUS FUMARATE

Composition:

FERROUS FUMARATE 162 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

TANDEM - FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX CAPSULE
TANDEM - F - FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC
ACID CAPSULE
TANDEM PLUS - FERROUS FUMARATE AND POLYSACCHRIDE IRON VITAMIN MINERAL
COMPLEX
SUPPLEMENT 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._
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SEE ALL PRESCRIBING INFORMATION FOR TANDEM
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 akagane ite), 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