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Polysaccharide-Iron Complex

Pronunciation

(pol i SAK a ride-EYE ern KOM pleks)

Index Terms

  • Iron-Polysaccharide Complex
  • Niferex

Dosage Forms

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

Capsule, Oral:

EZFE 200: 200 mg [non-toxic; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Ferrex 150: 150 mg [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake, fd&c yellow #5 aluminum lake]

Ferric x-150: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, tartrazine (fd&c yellow #5)]

FerUS: 150 mg [DSC]

iFerex 150: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Myferon 150: 150 mg

NovaFerrum 50: 50 mg

Nu-Iron: 150 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

PIC 200: 200 mg

Poly-Iron 150: 150 mg

Liquid, Oral:

NovaFerrum 125: Polysaccharide-iron complex 125 mg and cholecalciferol 100 units per 5 mL (180 mL) [alcohol free, dye free, gluten free, lactose free, sodium free, sugar free; contains sodium benzoate; raspberry-grape flavor]

NovaFerrum Pediatric Drops: 15 mg/mL (120 mL) [alcohol free, dye free, gluten free, lactose free, sodium free, sugar free; contains sodium benzoate; raspberry-grape flavor]

Brand Names: U.S.

  • EZFE 200 [OTC]
  • Ferrex 150 [OTC]
  • Ferric x-150 [OTC]
  • FerUS [OTC] [DSC]
  • iFerex 150 [OTC]
  • Myferon 150 [OTC]
  • NovaFerrum 125 [OTC]
  • NovaFerrum 50 [OTC]
  • NovaFerrum Pediatric Drops [OTC]
  • Nu-Iron [OTC]
  • PIC 200 [OTC]
  • Poly-Iron 150 [OTC]

Pharmacologic Category

  • Iron Salt

Absorption

Oral: Iron is absorbed in the duodenum and upper jejunum; in persons with normal iron stores 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores; food and achlorhydria will decrease absorption

Excretion

Urine, sweat, sloughing of intestinal mucosa, and by menses

Onset of Action

Hematologic response: Red blood cells form within 3 to 10 days; similar onset as parenteral iron salts; Maximum effect: Peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase within 2 to 4 weeks

Protein Binding

To transferrin

Use: Labeled Indications

Iron deficiency anemia: Management (prevention and treatment) of iron deficiency anemia

Contraindications

Known hypersensitivity to polysaccharide-iron complex or any component of the formulations; hemochromatosis; hemosiderosis

Documentation of allergenic cross-reactivity for other iron-containing products is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Dietary Reference Intake: Dose is RDA presented as elemental iron unless otherwise noted (IOM, 2001):

19-50 years: Males: 8 mg daily; Females: 18 mg daily; Pregnant females: 27 mg daily; Lactating females: 9 mg daily

≥50 years: 8 mg daily

Iron deficiency anemia: Oral: 150-300 mg daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Dietary Reference Intake: Dose is RDA presented as elemental iron unless otherwise noted (IOM, 2001):

0-6 months: 0.27 mg daily (adequate intake)

7-12 months: 11 mg daily

1-3 years: 7 mg daily

4-8 years: 10 mg daily

9-13 years: 8 mg daily

14-18 years: Males: 11 mg daily; Females: 15 mg daily; Pregnant females: 27 mg daily; Lactating females: 10 mg daily

Iron deficiency anemia: Oral:

Infants and Children <4 years: 15 mg daily

Children ≥12 years: 50 mg daily

Dietary Considerations

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 between 15°C and 30°C (59°F and 86°F).

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

Adverse Reactions

>10%: Gastrointestinal: Stomach cramping, constipation, nausea, vomiting, dark stools, GI irritation, epigastric pain

1% to 10%:

Gastrointestinal: Heartburn, diarrhea

Genitourinary: Discolored urine

Miscellaneous: Staining of teeth

<1% (Limited to important or life-threatening): Contact irritation

Warnings/Precautions

Concerns related to adverse effects:

• Stool discoloration: Oral iron preparations commonly cause dark or black stools; patients should be informed of the effect.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. May interfere with absorption of antibiotics.

Special populations:

• 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.

Other warnings/precautions:

• Appropriate use: Investigate type of anemia and potential underlying causes (eg, recurrent blood loss) prior to initiating iron supplementation.

• Excipient: Some formulations may contain tartrazine, which is associated with allergic-type reactions. Although rare, hypersensitivity is more frequently seen in individuals with aspirin allergy.

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 constipation, stool discoloration, or diarrhea. Have patient report immediately to prescriber black, tarry, or bloody stools; severe nausea; severe vomiting; severe abdominal pain; vomiting blood; or abdominal cramps (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 health care 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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