Integra F

Generic: FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACID

Prescription DrugORAL

Drug Information

Brand Name
Integra F
Generic Name
FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACID
Manufacturer
U.S. Pharmaceutical Corporation
Product Type
Prescription Drug
Route
ORAL
Application Number
025fee85-53a8-4161-a806-44fd95d0ca74

Pharmacological Class

Vitamin C [EPC]

Indications & Usage

INDICATIONS: Integra FTM is indicated for the treatment of iron deficiency anemia, and folate deficiency anemia. Integra FTM is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

Warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: General: Anemia is a manifestation that requires appropriate investigation to determine its ca...

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WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: General: Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. No single regimen fits all cases and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential. Blood examinations including hemoglobin and hematacrit should be done at the usual intervals to make certain that therapy is adequate. Use with care in the presence of peptic ulcer, regional enteritis, and ulcerative colitis. Folic acid, especially in doses above 0.1 mg -0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

Adverse Reactions

Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation, heartburn and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. ...

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Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation, heartburn and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Although the absorption of iron is best when taken between meals, giving Integra FTM after meals may control occasional G.I. disturbances. Integra FTM is best absorbed when taken at bedtime.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Integra F - Side Effects, Warnings, Uses | FDA Drug Database