Ferotrinsic (ferrous fumarate/ascorbic acid/B12-if/folic acid)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Vitamin B12, a cobalt-containing B complex vitamin, is commercially available as cyanocobalamin and hydroxocobalamin, which are synthetic forms of vitamin B12.
Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.
Folic acid is a water-soluble, B complex vitamin.
Ferrous fumarate, ferrous gluconate, ferrous sulfate, carbonyl iron, and polysaccharide-iron complex are iron preparations that are commercially available in the US for oral administration in the prevention and treatment of iron deficiency.
Folic acid is used for the treatment of megaloblastic and macrocytic anemias resulting from folate deficiency. The drug is usually indicated in the treatment of nutritional macrocytic anemia; megaloblastic anemias of pregnancy, infancy, and childhood; and megaloblastic anemia associated with primary liver disease, alcoholism and alcoholic cirrhosis, intestinal strictures, anastomoses, or sprue. Folate deficiency may also result from increased loss of folate secondary to renal dialysis or the administration of some drugs such as phenytoin, primidone, barbiturates, methotrexate, nitrofurantoin, or sulfasalazine.
Generic name: ferrous fumarate/ascorbic acid/B12-if/folic acid
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
No indications are available for this drug.
Dosing
Dosage of folic acid injection (sodium folate) is expressed in terms of folic acid. In general, although patient response to folic acid therapy depends on the degree and nature of the deficiency, once proper corrective measures are undertaken, folate-deficient patients generally respond rapidly. During the first 24 hours of treatment, the patient experiences an improved sense of well-being, and within 48 hours, the bone marrow begins to become normoblastic. Reticulocytosis generally begins within 2-5 days following initiation of folic acid therapy.
Dosage of oral iron preparations should be expressed in terms of elemental iron. The elemental iron content of the various preparations is approximately:
Table 1.
Drug Elemental Iron ferric pyrophosphate 120 mg/g ferrous gluconate 120 mg/g ferrous sulfate 200 mg/g ferrous sulfate, dried 300 mg/g ferrous fumarate 330 mg/g ferrous carbonate, anhydrous 480 mg/g carbonyl iron 1000 mg/g
carbonyl iron is elemental iron, not an iron salt.
Cyanocobalamin is administered by IM or deep subcutaneous injection. Cyanocobalamin also is administered orally and intranasally. Hydroxocobalamin is administered by IM injection or IV infusion. Oral therapy with vitamin B12 preparations is markedly inferior to parenteral therapy and should be used only for the treatment of dietary vitamin B12 deficiency in patients with normal GI absorption.
Folic acid is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered by deep IM, subcutaneous, or IV injection. However, most patients with malabsorption are able to absorb oral folic acid.
Oral iron preparations generally should be taken between meals (e.g., 1 hour before or 2 hours after a meal) for maximum absorption but may be taken with or after meals, if necessary, to minimize adverse GI effects. Patients who have difficulty tolerating oral iron supplements also may benefit from smaller, more frequent doses, starting with a lower dose and increasing slowly to the target dose, trying a different form or preparation, or taking the supplement at bedtime.
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Drug interactions
Safety of concomitant administration of other cyanide antidotes with hydroxocobalamin (Cyanokit(R)) has not been established. Caution is advised if another cyanide antidote is administered to patients receiving hydroxocobalamin.
Absorption of vitamin B12 from the GI tract may be decreased by aminoglycoside antibiotics, colchicine, extended-release potassium preparations, aminosalicylic acid and its salts, anticonvulsants (e.g., phenytoin, phenobarbital, primidone), cobalt irradiation of the small bowel, and by excessive alcohol intake lasting longer than 2 weeks. Neomycin-induced malabsorption of vitamin B12 may be increased by concurrent administration of colchicine.
Ascorbic acid may destroy substantial amounts of dietary vitamin B12 in vitro; this possibility should be considered when large doses of ascorbic acid are ingested within 1 hour of oral vitamin B12 administration.
Prednisone has been reported to increase the absorption of vitamin B12 and secretion of IF in a few patients with pernicious anemia, but not in patients with partial or total gastrectomy. The clinical importance of these findings is unknown.
Concurrent administration of chloramphenicol and vitamin B12 reportedly may antagonize the hematopoietic response to vitamin B12 in vitamin B12-deficient patients. The hematologic response to vitamin B12 in patients receiving both drugs should be carefully monitored and alternate anti-infectives should be considered.
In folate-deficient patients, folic acid therapy may increase phenytoin metabolism, resulting in decreased phenytoin serum concentrations. Although this interaction is not usually clinically important, an increase in seizure frequency may occur in some patients.
It has been reported that concurrent administration of chloramphenicol and folic acid in folate-deficient patients may result in antagonism of the hematopoietic response to folic acid. Although the importance and mechanism of the interaction is unclear, the hematologic response to folic acid in patients receiving both drugs should be carefully monitored.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Adequate and well-controlled studies have not been conducted in pregnant women. However, vitamin B12 requirements are increased in pregnant women. Parenteral preparations should be used during pregnancy only when the potential benefits justify the potential risks to the fetus.
During the first and second trimester of pregnancy, iron-deficiency anemia is associated with a twofold increased risk of premature delivery and a threefold increased risk of a low-birthweight delivery. Although iron supplementation during pregnancy has been shown to decrease the incidence of anemia, evidence on the effect of routine iron supplementation during pregnancy on adverse maternal and infant outcomes is inconclusive. Blood volume expands by about 35% during pregnancy, and growth of the fetus, placenta, and other maternal tissues increases the iron requirement threefold during the second and third trimesters of pregnancy to about 5 mg of iron daily. Although menstruation ceases and iron absorption increases during pregnancy, most pregnant women who do not use iron supplements to meet increased iron requirements cannot maintain adequate iron stores, particularly during the last 2 trimesters. Following delivery, iron in the fetus and placenta are lost to the woman, although some of the iron in the expanded blood volume may return to blood stores. Among low-income pregnant women enrolled in health programs in the US, the prevalence of iron-deficiency anemia is 9, 14, and 37% during the first, second, and third trimesters, respectively. While similar data currently are not available for all pregnant women in the US, the low dietary iron intake among US women of childbearing age, the high prevalence of iron deficiency and associated anemia among such women, and the increased iron requirements during pregnancy suggest that anemia during pregnancy may extend beyond low-income women. In addition, use of prenatal multivitamin and mineral supplements among African-Americans, native American and Alaskan Indians, women younger than 20 years of age, and those having less than a high school education is substantially lower than in the general US pregnant population.
The principal reasons for the current lack of widespread adoption of a recommended iron supplementation regimen during pregnancy in US women may include lack of health-care provider and patient perceptions that iron supplements improve maternal and infant outcomes, complicated dose schedules, and adverse effects (e.g., constipation, nausea, vomiting). However, adequate dietary iron intake and iron supplementation generally are recommended for primary prevention of iron deficiency during pregnancy. By employing low-dose (i.e., 30 mg of iron daily) regimens with simplified dose schedules (i.e., once-daily dosing), patient compliance may be improved; low-dose regimens have been shown to increase patient tolerance and are as effective as higher dosages (e.g., 60-120 mg iron daily) in preventing iron-deficiency anemia.
Vitamin B12 is distributed into human milk. Vitamin B12 requirements are increased in lactating women.
Hydroxocobalamin may be administered to lactating women with suspected or known cyanocobalamin poisoning. There is no data available to determine when breastfeeding may be restarted following administration of IV hydroxocobalamin.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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