HEMATOGEN FORTE- ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Nnodum Pharmaceuticals

INN (International Name):

FERROUS FUMARATE

Composition:

FERROUS CATION 151 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence. Hemochromatosis and hemosiderosis are contraindications to iron therapy. Folic acid is contraindicated in patients with pernicious anemia (see PRECAUTIONS). Soybean oil, Lecithin, Di Calcium phosphate anhydrous, Beeswax yellow, hydrogenated soybean oil.

Product summary:

Each brown soft gelatin capsule is imprinted with “ziks633” on one side. NDC 63044-0633-21, 10 x 10, Unit Dose Packs, In Packs of 100’s. Store at controlled room temperature 15°- 30°C (59°- 86°F). Avoid excessive heat 40°C (104°F). Avoid freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

HEMATOGEN FORTE - FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID,
CYANOCOBALAMIN CAPSULE, GELATIN COATED
NNODUM PHARMACEUTICALS
_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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HEMATOGEN FORTE
DESCRIPTION
Each brown soft gelatin capsule contains:
Ferrous
fumarate............................................................................
460 mg
(151 mg elemental iron)
Ascorbic
acid....................................................................................
60 mg
Folic
acid............................................................................................
1 mg
Cyanocobalamin.............................................................................10
mcg
The amount of elemental iron and the absorption of the iron components
of commercial
iron preparations vary widely. It is further established that certain
"accessory
components" may be included to enhance absorption and utilization of
iron. Hematogen
Forte Capsules are formulated to provide the essential factors for a
complete, versatile
hematinic.
INACTIVE INGREDIENTS: Soybean oil, Lecithin, Glycerin, hydrogenated
soybean oil, Yellow
Beewax, Titanium Oxide.
ACTIONS/CLINICAL PHARMACOLOGY
HIGH ELEMENTAL IRON CONTENT: Ferrous fumarate, used in Hematogen Forte
Capsules,
is an organic iron complex which has the highest elemental iron
content of any hematinic
salt - 33%. This compares with 20% for 1,2 ferrous sulfate
(heptahydrate) and 13% for
ferrous gluconate. Hematogen Forte contains 151 mg of elemental iron.
MORE COMPLETE ABSORPTION: It has been repeatedly shown that ascorbic
acid, when
given in sufficient amounts, can increase the absorption of ferrous
iron from the
gastrointestinal tract. The absorption promoting effect is mainly due
to the reducing
action of ascorbic acid within the gastrointestinal lumen, 3 which
help to prevent or delay
the formation of insoluble or less dissociated ferric compoun