FERRAPLUS 90- docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)

Available from:

Trigen Laboratories, LLC

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 50 mg

Administration route:

ORAL

Therapeutic indications:

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Product summary:

FerraPlus 90 is packaged in bottles of 90 tablets. Product Code: 13811-012-90

Authorization status:

Dietary Supplement

Summary of Product characteristics

FERRAPLUS 90- DOCUSATE SODIUM, FOLIC ACID, CARBONYL IRON,
CYANOCOBALAMIN,
AND ASCORBIC ACID TABLET, FILM COATED
TRIGEN LABORATORIES, LLC
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FERRAPLUS 90
TABLETS WITH 90 MG CARBONYL IRON
SUPPLEMENT FACTS
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients. Hemolytic anemia,
hemochromatosis, and
hemosiderosis are contraindications to iron therapy.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious
anemia and other
megaloblastic anemias where vitamin B
is deficient.
PRECAUTIONS
GENERAL: Take 2 hours after meals. Do not exceed recommended dose.
Discontinue
use if symptoms of intolerance appear. The type of anemia and
underlying cause or
causes should be determined before starting therapy with FerraPlus 90
tablets. Ensure
Hgb, Hct, reticulocyte count are determined before starting therapy
and periodically
thereafter during prolonged treatment. Periodically review therapy to
determine if it
needs to be continued without change or if a dose change or if a dose
change is
indicated.
FOLIC ACID: Folic acid in doses above 0.1 mg daily may obscure
pernicious anemia
assessment, such that hematologic remission can occur while
neurological
manifestations remain progressive. Pernicious anemia should be
excluded before using
these products since folic acid may mask the symptoms of pernicious
anemia.
PEDIATRIC USE: Safety and effectiveness of this product have not been
established in
pediatric patients.
GERIATRIC USE: Safety and effectiveness of this product have not been
established in
elderly patients.
DRUG INTERACTIONS
Prescriber should be aware of a number of iron/drug interactions,
including antacids,
tetracyclines, or fluoroquinolones.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include GI irritation,
constipation, diarrhea,
nausea, vomiting, and dark stools. Adverse reactions with iron therapy
are usually
12
nausea, vomiting, and dark stools. Adverse reactions with iron therapy
are usually
transient. Allergic sensitization has been reported following both
oral and par