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Polysaccharide-Iron Complex

Pronunciation

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

Index Terms

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)]

IFerex 150: 150 mg [DSC] [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 [DSC]

Poly-Iron 150: 150 mg

Generic: 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.

Pharmacologic Category

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

Note: 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). Dose expressed in terms of elemental iron.

Iron-deficiency anemia: Oral: 50 to 200 mg elemental iron/day (Liu 2012; Schrier 2019). Note: Alternate-day dosing (eg, every other day or Monday, Wednesday, Friday) has been shown to result in greater absorption of iron; some experts recommend this dosing schedule in patients who can maintain adherence (Schrier 2019; Stoffel 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Dosages are expressed in terms of elemental iron.

Iron deficiency anemia; prevention: Oral:

Infants ≥4 months (receiving human milk as only nutritional source or >50% as source of nutrition without iron fortified food): 1 mg/kg/day (AAP [Baker 2010]); Note: In healthy, term infants, AAP does not recommend routine additional supplementation of iron be considered until at least 4 to 6 months of age if breastfed (full or partial) (AAP [Baker 2010]; Schanler 2011)

Infants ≥6 months and Children <2 years in areas where anemia prevalence is >40%: 10 to 12.5 mg daily for 3 consecutive months in a year (WHO 2016b)

Children 2 years to <5 years in areas where anemia prevalence is >40%: 30 mg daily for 3 consecutive months in a year (WHO 2016b)

Children ≥5 to 12 years in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016b)

Adolescent menstruating females (nonpregnant females of reproductive potential) in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Iron deficiency anemia, treatment: Infants, Children, and Adolescents: Oral: 3 to 6 mg/kg/day in 3 divided doses; suggested maximum daily dose: 200 mg/day (ASPEN Pediatric Nutrition Support Core Curriculum [Corkins 2015]; Kliegman 2016)

Iron supplementation: Note: Refer to product-specific labeling for approved pediatric ages.

Infants and Children <4 years: Oral liquid: Oral: 15 mg daily

Children ≥12 years and Adolescents: Oral: 50 mg daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Oral: Shake liquid well prior to administration.

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.

Dietary reference intake (elemental iron) (IOM 2001):

0 to 6 months: Adequate intake: 0.27 mg daily

7 to 12 months: RDA: 11 mg daily

1 to 3 years: RDA: 7 mg daily

4 to 8 years: RDA: 10 mg daily

9 to 13 years: RDA: 8 mg daily

14 to 18 years: RDA:

Males: 11 mg daily

Females: 15 mg daily

Pregnancy: 27 mg daily

Lactation: 10 mg daily

19-50 years: RDA:

Males: 8 mg daily

Females: 18 mg daily

Pregnancy: 27 mg daily

Lactation: 9 mg daily

≥50 years: RDA: 8 mg daily

Storage

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

Drug Interactions

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. Consider therapy modification

Antacids: May decrease the absorption of Iron Preparations. Management: Separate dosing of oral iron preparations and antacids as much as possible to avoid decreased efficacy of iron preparation. If coadministered with antacids, monitor for decreased therapeutic effects of iron preparations. Consider therapy modification

Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. 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. 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. 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. 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. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. 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. 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. 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. 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. 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. Consider therapy modification

Histamine H2 Receptor Antagonists: May decrease the absorption of Iron Preparations. Monitor therapy

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. 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. 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. 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. 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. Consider therapy modification

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

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. 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. 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. 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. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Constipation, darkening of stools, epigastric pain, gastrointestinal irritation, nausea, stomach cramps, vomiting

1% to 10%:

Gastrointestinal: Dental discoloration, diarrhea, heartburn

Genitourinary: Urine discoloration

<1%, postmarketing, and/or case reports: Local 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.

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.

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:

• 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

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]). Iron supplementation is recommended for 3 months once hemoglobin 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; 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]). Enteric-coated and slow/sustained-release preparations may be less effective and use should be avoided (ACOG 95 2008; BSH [Pavord 2019]).

Patient Education

What is this drug used for?

• It is used to help growth and good health.

• It is used to treat or prevent low iron in the body.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation

• Stool discoloration

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Black, tarry, or bloody stools

• Severe nausea

• Severe vomiting

• Severe abdominal pain

• Vomiting blood

• Abdominal cramps

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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