PUREFE OB PLUS - ferrous fumarate and polysaccharide iron complex capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

PureTek Corporation

INN (इंटरनेशनल नाम):

FERROUS FUMARATE

रचना:

IRON 53 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

PureFe OB Plus 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. PureFe OB Plus may also be used to improve the nutritional status of women before conception. PureFe OB Plus 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.

उत्पाद समीक्षा:

PureFe OB Plus are red and white capsules imprinted horizontally "P-113", bottles of 90 capsules NDC 59088-113-66. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep in a cool, dry place.

प्राधिकरण का दर्जा:

unapproved drug other

उत्पाद विशेषताएं

PUREFE OB PLUS - FERROUS FUMARATE AND POLYSACCHARIDE IRON COMPLEX
CAPSULE
PURETEK 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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PRESCRIBING INFORMATION
CLINICAL PHARMACOLOGY:
PUREFE OB PLUS supplies important prenatal vitamins and minerals in a
formulation that was especially
designed to supplement the nutritional needs of pregnant women,
before, during and after pregnancy. In
PUREFE OB PLUS, patients receive the balanced support of 13 essential
vitamins and minerals, including
1 mg of folic acid. The essential role of iron supplementation for
pregnant women has long been
recognized. PUREFE OB PLUS is unique in that it utilizes two (2)
different forms of iron, i.e., Ferrous
Fumarate and Polysaccharide Iron Complex (as cell-contracted
akaganeite), making available a total of
106 mg of elemental iron per capsule as follows:
Ferrous Fumarate (anhydrous) 162 mg
Polysaccharide Iron Complex (PIC) 115.2 mg
FERROUS FUMARATE: Provides about 53 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. 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.
POLYSACCHARIDE IRON COMPLEX: Provides about 53 mg of elemental iron,
as a cell-contracted
akaganeite. It is a product of ferric iron complexed to a low
molecular weight polysaccharide. This
polysaccharide is produced by 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.
The most frequent cause of anemia in pregnant women is iron
defici