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Ferrous Gluconate

Pronunciation

Pronunciation

(FER us GLOO koe nate)

Index Terms

  • Iron Gluconate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Fergon: 240 mg [elemental iron 27 mg] [DSC] [contains tartrazine (fd&c yellow #5)]

Generic: 240 mg [elemental iron 27 mg], 324 mg [elemental iron 38 mg], 325 mg [elemental iron 36 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]

Ferate: 256 mg [elemental iron 28 mg] [DSC] [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), sodium free, soy free, sugar free, wheat free, yeast free]

Brand Names: U.S.

  • Ferate [OTC]
  • Fergon [OTC] [DSC]

Pharmacologic Category

  • Iron Salt

Pharmacology

Replaces iron found in hemoglobin, myoglobin, and enzymes; allows the transportation of oxygen via hemoglobin

Onset of Action

Hematologic response: Oral: 3-10 days; peak reticulocytosis occurs in 5-10 days, and hemoglobin values increase in ∼2-4 weeks

Use: Labeled Indications

Prevention and treatment of iron-deficiency anemias

Contraindications

Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia

Dosing: Adult

Note: Dose expressed in terms of elemental iron; ferrous gluconate contains ~12% elemental iron:

Dietary Reference Intake: Oral:

19 to 50 years: Males: 8 mg/day; Females: 18 mg/day; Pregnant females: 27 mg/day; Lactating females: 9 mg/day

≥50 years: 8 mg/day

Iron deficiency anemia, prevention: Oral: 60 mg daily (Stoltzfus 1998; WHO 2001)

Iron deficiency anemia, treatment of iron deficiency: Oral: 100 to 200 mg daily in 2 to 3 divided doses (Liu 2012; Stoltzfus 1998; WHO 2001)

Dosing: Geriatric

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).

Dosing: Pediatric

Note: Dose expressed in terms of elemental iron; ferrous gluconate contains ~12% elemental iron:

Dietary Reference Intake: Oral:

0 to 6 months: 0.27 mg/day (adequate intake)

7 to 12 months: 11 mg/day

1 to 3 years: 7 mg/day

4 to 8 years: 10 mg/day

9 to 13 years: 8 mg/day

14 to 18 years: Males: 11 mg/day; Females: 15 mg/day; Pregnant females: 27 mg/day; Lactating females: 10 mg/day

Iron deficiency anemia, prevention: Oral:

Children ≥5 years in areas where anemia prevalence is >40%: 30 mg daily with folic acid (WHO 2001)

Adolescents in areas where anemia prevalence is >40%: 60 mg /daily with folic acid (WHO 2001)

Iron deficiency anemia, treatment of iron deficiency: Oral: 3 to 6 mg/kg/day in 3 divided doses (Carney 2010; Kliegman, 2011)

Administration

Administer 2 hours before or 4 hours after antacids. Administration of iron preparations to premature infants with vitamin E deficiency may cause increased red cell hemolysis and hemolytic anemia, therefore, vitamin E deficiency should be corrected if possible.

Dietary Considerations

Should be taken with water or juice on an empty stomach; 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.

Storage

Store at 20°C to 25°C (68°F to 77°F). Iron is a leading cause of fatal poisoning in children. Store out of children's reach and in child-resistant containers.

Drug Interactions

Alpha-Lipoic Acid: Iron Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Salts. Consider therapy modification

Antacids: May decrease the absorption of Iron Salts. Consider therapy modification

Bisphosphonate Derivatives: Iron Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral iron supplements within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Consider therapy modification

Cefdinir: Iron Salts 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. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Consider therapy modification

Deferiprone: Iron Salts 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. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination

Dolutegravir: Iron Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Consider therapy modification

Eltrombopag: Iron Salts may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any iron-containing product. Consider therapy modification

Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Salts. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron salts. Therapy with oral iron salts should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Consider therapy modification

H2-Antagonists: May decrease the absorption of Iron Salts. Monitor therapy

Levodopa: Iron Salts 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. Consider therapy modification

Levothyroxine: Iron Salts may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron salts and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron salts or levothyroxine. Consider therapy modification

Methyldopa: Iron Salts may decrease the serum concentration of Methyldopa. Consider therapy modification

Pancrelipase: May decrease the absorption of Iron Salts. Monitor therapy

PenicillAMINE: Iron Salts may decrease the absorption of PenicillAMINE. Only oral iron salts are a concern. Consider therapy modification

Phosphate Supplements: Iron Salts may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate and iron administration. Administer oral phosphate supplements at least 1 hour before, or 2 hours after, oral iron salt administration. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

Proton Pump Inhibitors: May decrease the absorption of Iron Salts. Monitor therapy

Quinolone Antibiotics: Iron Salts may decrease the serum concentration of Quinolone Antibiotics. Management: Administer 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-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral iron salts. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Tetracycline Derivatives: May decrease the absorption of Iron Salts. Iron Salts may decrease the serum concentration of Tetracycline Derivatives. Consider therapy modification

Trientine: May decrease the serum concentration of Iron Salts. Iron Salts may decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent use with oral iron salts due to the risk for impaired GI absorption of both trientine and the iron salt. Short courses of iron may be used; however, separate administration by at least 2 hours. Consider therapy modification

Test Interactions

False-positive for blood in stool by the guaiac test

Adverse Reactions

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% (Limited to important or life-threatening): Contact dermatitis

Warnings/Precautions

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.

Other warnings/precautions:

• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.

Monitoring Parameters

Serum iron, total iron binding capacity, reticulocyte count, hemoglobin

Pregnancy Considerations

It is recommended that pregnant women meet the dietary requirements of iron with diet and/or supplements in order to prevent adverse events associated with iron deficiency anemia in pregnancy. Treatment of iron deficiency anemia in pregnant women is the same as in nonpregnant women and in most cases, oral iron preparations may be used. Except in severe cases of maternal anemia, the fetus achieves normal iron stores regardless of maternal concentrations.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, constipation, stool discoloration, lack of appetite, or abdominal cramps. Have patient report immediately to prescriber black, tarry, or bloody stools; severe nausea; severe vomiting; severe abdominal pain; or vomiting blood (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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