Description
STEADIFER is a combination of Ferrous Fumarate and Folic Acid, which is specially designed to treat iron deficiency anemia in certain specific conditions.
Pharmacology
Ferrous fumarate provides elemental iron in a well-tolerated form, specifically to meet iron requirements of the red blood cell formation and building of tissue iron stores. The dosage of iron recommended for prevention and control of iron deficiency anemia is 100 mg elemental iron.
Ferrous fumarate is used to treat iron deficiency anemia (lack of red blood cells caused by having too little iron in the body). Ferrous fumarate is a type of iron. In the body, iron becomes a part of hemoglobin and myoglobin. Hemoglobin carries oxygen through blood to the tissues and organs. Myoglobin helps the muscle cells store oxygen.
Folic acid is a member of the Vitamin B group. Folic acid is reduced in the body to tetrahydrofolate, which is a coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides and hence, in the synthesis of DNA. Deficiency of folic acid can result in megaloblastic anemia.
Folic acid supplementation prevents adverse events in individuals with chronic kidney disease and end-stage renal disease. Folic acid remains the cornerstone therapy for elevated homocysteine. Patients with renal failure often require high doses. No risks have been reported with the use of folic acid. Administration of high dosage folic acid (5mg/day) lowers homocysteine by 25% sufficient to normalize levels.
Indications
STEADIFER is indicated in the treatment and maintenance of:
- Iron deficiency anemia
- Megaloblastic anemia of nutritional origin
- Anemia of pregnancy
- Other anemias deemed responsive to the ingredients
Contraindications
STEADIFER is contraindicated in patients with proven allergy to any ingredient, symptoms of iron intolerance, paroxysmal nocturnal hemoglobinuria, hemosiderosis and hemochromatosis.
Warning
STEADIFER alone should not be relied upon for correction of isolated folic acid deficiency and specific therapy should be instituted in these cases. Cases not responding satisfactorily to STEADIFER should be investigated for sites of continued blood loss or other causes of apparent haematinic failure.
Precautions
Avoid use in patients with active peptic ulcers, repeated blood transfusion, regional enteritis and ulcerative colitis. Caution when used in patients with folate-dependent tumors.
Side Effects and Adverse Reactions
As with all orally administered iron salts, STEADIFER may cause gastric irritation, dyspepsia, anorexia nausea, vomiting, constipation etc in sensitive individuals. Stool darkening may occur. Allergies to folic acid have been reported.
Dosage and Administration
As directed by the physician. Do not take more than the recommended dosage.
Take STEADIFER on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid taking antacids or antibiotics within 2 hours before or after. If upset stomach occurs, you may take this medication with food. Avoid taking antacids, dairy products, tea or coffee within 2 hours before or after this medication because they will decrease its effectiveness. Do not lie down for 30 minutes after taking this medication. Do not crush, chew or break the capsule. Doing so can destroy the long action of the drug and may increase side effects.
Concomitant Therapy
Concurrent administration may reduce the efficacy of fluoroquinolones, levodopa, carbidopa, thyroxine and biophosphates. Iron may reduce the absorption of penicillamine by forming complexes. Concurrent administration may lead to reduced absorption of tetracycline and iron. Antacids may reduce the absorption of iron. Serum levels of anticonvulsants may be reduced by folic acid.
Overdosage
Symptoms of overdosage can be any of those described under “Precautions” and “Side Effects and Adverse Reactions” above. If any symptoms of intolerance occur, the drug should be temporarily or permanently discontinued.
Storage
Store at room temperature, away from light and moisture.
Presentation
15 capsules packed in a blister, 5 such blisters packed in a carton