Note: Dosage expression: Dose is expressed in terms of elemental iron; ferrous gluconate contains ~12% elemental iron per mg of mineral salt (eg, each 324 mg tablet contains ~38 mg elemental iron). Formulation: Enteric-coated and slow/sustained-release preparations are generally not preferred due to poor absorption (Hershko 2014; Liu 2012). Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Auerbach 2021).
Iron deficiency or iron-deficiency anemia: Oral: 27 to 38 mg of elemental iron (1 tablet) once every other day or on Monday, Wednesday, and Friday. Note: Daily dosing has been shown to result in decreased absorption but may be reasonable in some individuals to improve adherence (Auerbach 2021; Stoffel 2017; Stoffel 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
(For additional information see "Ferrous gluconate: Pediatric drug information")
Note: Doses expressed as elemental iron. Ferrous gluconate contains ~12% elemental iron.
Iron deficiency, prevention:
WHO recommendations:
Areas where anemia prevalence is ≥40%:
Infants ≥6 months and Children <2 years: Oral: 10 to 12.5 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Children 2 to <5 years: Oral: 30 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Children ≥5 to 12 years: Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (WHO 2016b).
Adolescent menstruating patients (nonpregnant patients of reproductive potential): Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (WHO 2016a).
Areas where anemia prevalence 20% to <40%: Weekly intermittent dosing:
Children 2 to <5 years: Oral: 25 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (WHO 2011).
Children 5 to 12 years: Oral: 45 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (WHO 2011).
Iron deficiency, treatment: Oral: Children and Adolescents: Oral: Initial: 3 mg elemental iron/kg/day as a single daily dose (Kazal 2002; Oski 1993; Powers 2017; Reeves 1985) up to 60 to 120 mg elemental iron once daily (AAP [Kleinman 2019]); higher doses may be needed in select patients; dosage range: 3 to 6 mg/kg/day in 1 to 3 divided doses; usual maximum daily dose: 150 to 200 mg elemental iron/day (ASPEN [Corkins 2015]; Kliegman 2020; Zlotkin 2001); once-daily administration may be preferred for ease of administration and adherence (Zlotkin 2001). Studies in iron-depleted adults suggest that iron absorption may be improved by less frequent dosing (alternate-day dosing, or once daily versus multiple daily doses) (Moretti 2015; Stoffel 2017).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Lower doses (15 to 50 mg elemental iron/day) may have similar efficacy and less GI adverse events (eg, nausea, constipation) as compared to higher doses (eg, 150 mg elemental iron/day) (Rimon 2005).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 240 mg [elemental iron 27 mg], 324 mg [elemental iron 38 mg]
Tablet, Oral [preservative free]:
Ferate: 240 mg [elemental iron 27 mg] [corn free, dairy free, egg free, fragrance free, gluten free, no artificial flavor(s), sodium free, soy free, starch free, sugar free, wheat free, yeast free; contains fd&c blue #1 aluminum lake, fd&c yellow #6 aluminum lake]
Generic: 324 mg [elemental iron 37.5 mg]
Yes
Ferrous gluconate is ~12% elemental iron. Specific amount of elemental iron listed for each dosage form is per the manufacturer’s labeling.
Oral: Should be administered with water or juice on an empty stomach (Liu 2012).
Oral: Administer with water or juice prior to breakfast and/or between meals for maximum absorption (Kliegman 2020; Oski 1993); may administer with food if GI upset occurs; do not administer with milk or milk products.
Iron deficiency or iron-deficiency anemia: Prevention and treatment of iron-deficiency anemias.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
>10%: Gastrointestinal: Constipation, darkening of stools, nausea, stomach cramps, vomiting
1% to 10%:
Gastrointestinal: Dental discoloration, diarrhea, heartburn
Genitourinary: Urine discoloration
<1%, postmarketing, and/or case reports: Contact dermatitis
Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia
Disease-related concerns:
• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.
Special populations:
• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.
• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the “anemia of chronic disease” is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.
• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.
• Premature infants: Avoid use in premature infants until the vitamin E stores, deficient at birth, are replenished.
Dosage form specific issues:
• Oral iron formulations: Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012).
Other warnings/precautions:
• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.
Consider all iron sources when evaluating the dose of iron, including combination products, infant formulas, and liquid nutritional supplements.
None known.
Alpha-Lipoic Acid: Iron Preparations may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Preparations. Management: Separate administration of alpha-lipoic acid from that of any iron-containing compounds by several hours. If alpha-lipoic acid is given 30 minutes before breakfast, then administer oral iron-containing products at lunch or dinner. Risk D: Consider therapy modification
Antacids: May decrease the absorption of Iron Preparations. Management: No action is likely necessary for the majority of patients who only use antacids intermittently or occasionally. Consider separating doses of oral iron and antacids in patients who require chronic use of both agents and monitor for reduced iron efficacy. Risk D: Consider therapy modification
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Iron Preparations may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron preparations under fed conditions, but coadministration with or 2 hours after an iron preparation is not recommended under fasting conditions. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Cefdinir: Iron Preparations may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop when combined. Risk D: Consider therapy modification
Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Dolutegravir: Iron Preparations may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Risk D: Consider therapy modification
Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification
Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification
Entacapone: Iron Preparations may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Preparations. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron preparations. Therapy with oral iron preparations should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Risk D: Consider therapy modification
Levodopa: Iron Preparations may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification
Levothyroxine: Iron Preparations may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron preparations and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron preparations or levothyroxine. Risk D: Consider therapy modification
Methyldopa: Iron Preparations may decrease the serum concentration of Methyldopa. Management: Consider separating doses of methyldopa and orally administered iron preparation by 2 or more hours. Monitor for decreased efficacy of methyldopa if an oral iron preparation is initiated/dose increase, or increased efficacy if discontinued/dose decreased. Risk D: Consider therapy modification
PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification
Phosphate Supplements: Iron Preparations may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron preparation as possible to minimize the significance of this interaction. Risk D: Consider therapy modification
Quinolones: Iron Preparations may decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification
Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Risk D: Consider therapy modification
Tetracyclines: May decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour. Risk D: Consider therapy modification
Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.
Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; BSH [Pavord 2020]; IOM 2001).
In general, treatment of iron deficiency or IDA in pregnancy is the same as in nonpregnant females (USPSTF [Siu 2015]). Ferrous salts are preferred for oral management of IDA in pregnancy (BSH [Pavord 2020]). Continued supplementation is recommended for 3 months once Hb is within the normal range, and for at least 6 months postpartum to replenish maternal iron stores (BSH [Pavord 2020]; FIGO 2019). The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (FIGO 2019; Peña-Rosas 2015; Reveiz 2011; USPSTF [Siu 2015]). Oral preparations are generally sufficient; however, parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; BSH [Pavord 2020]). Ferrous gluconate has been evaluated in multiple studies as an iron supplement or for the treatment of IDA in pregnancy (Peña-Rosas 2015; Reveiz 2011). Enteric-coated and slow/sustained-release preparations may be less effective and use should be avoided (ACOG 95 2008; BSH [Pavord 2020]).
Iron is present in breast milk (IOM 2001).
Maternal iron requirements are increased in breastfeeding women (IOM 2001). Breast milk levels of iron are maintained in females with mild to moderate iron deficiency anemia (IDA), but concentrations decrease if IDA is severe (El-Farrash 2012; Kumar 2008).
It is not known if maternal use of ferrous gluconate significantly changes breast milk concentrations. The World Health Organization considers ferrous salts used for anemia to be compatible with breastfeeding (WHO 2002). All postpartum women at risk of gestational anemia (regardless of breastfeeding status) may be given oral iron with or without folic acid for 6 to 12 weeks postpartum to reduce the risk of anemia (WHO 2016c).
May be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.
Elemental iron content of ferrous gluconate: 12%.
Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.
Dietary reference intake (IOM 2001):
0 to 6 months: Adequate intake: 0.27 mg elemental iron/day.
7 to 12 months: RDA: 11 mg elemental iron/day.
1 to 3 years: RDA: 7 mg elemental iron/day.
4 to 8 years: RDA: 10 mg elemental iron/day.
9 to 13 years: RDA: 8 mg elemental iron/day.
14 to 18 years: RDA:
Males: 11 mg elemental iron/day.
Females: 15 mg elemental iron/day.
Pregnant patients: 27 mg elemental iron/day.
Lactating patients: 10 mg elemental iron/day.
19 to 50 years: RDA:
Males: 8 mg elemental iron/day.
Females: 18 mg elemental iron/day.
Pregnant patients: 27 mg elemental iron/day.
Lactating patients: 9 mg elemental iron/day.
≥50 years: RDA: 8 mg elemental iron/day.
Serum iron, total iron binding capacity, reticulocyte count, hemoglobin
Therapeutic: Males: 75 to 175 mcg/dL (SI: 13.4 to 31.3 micromole/L); Females: 65 to 165 mcg/dL (SI: 11.6 to 29.5 micromole/L); serum iron level >300 mcg/dL usually requires treatment of overdose due to severe toxicity
Replaces iron found in hemoglobin, myoglobin, and enzymes; allows the transportation of oxygen via hemoglobin
Onset of action: Hematologic response: Oral: 3 to 10 days; peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase in ∼2 to 4 weeks
Tablets (Ferate Oral)
240 (27 Fe) mg (per each): $0.05
Tablets (Ferrous Gluconate Oral)
240 (27 Fe) mg (per each): $0.02
324 (37.5 Fe) mg (per each): $0.04
324 (38 Fe) mg (per each): $0.06 - $0.11
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