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Polysaccharide-Iron Complex, Vitamin B12, and Folic Acid

Pronunciation

(pol i SAK a ride-EYE ern KOM pleks, VYE ta min bee twelve & FOE lik AS id)

Index Terms

  • Iron-Polysaccharide Complex, Vitamin B12, and Folic Acid

Dosage Forms

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

Capsule, Oral:

Ferrex 150 Forte: Elemental iron 150 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [DSC] [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake]

iFerex 150 Forte: Elemental iron 150 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Myferon 150 Forte: Elemental iron 150 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake]

Poly-Iron 150 Forte: Elemental iron 150 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake]

Tablet, Oral:

BiferaRx: Iron as polysaccharide iron complex 22 mg, iron as heme iron polypeptide 6 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [DSC] [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake]

BiferaRx: Iron as polysaccharide iron complex 22 mg, iron as heme iron polypeptide 6 mg, cyanocobalamin 25 mcg, and folic acid 1 mg [scored; contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake]

Irofol: Elemental iron 150 mg, cyanocobalamin 25 mcg, and folic acid 1 mg

Brand Names: U.S.

  • BiferaRx
  • Ferrex 150 Forte [OTC] [DSC]
  • iFerex 150 Forte
  • Irofol [OTC]
  • Myferon 150 Forte
  • Poly-Iron 150 Forte

Pharmacologic Category

  • Iron Salt

Use: Labeled Indications

Prevention and treatment of iron-deficiency anemias and/or nutritional megaloblastic anemias

Dosing: Adult

Iron deficiency (prevention/treatment): Oral: 1-2 capsules daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

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 at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Poly-Iron 150 Forte: Store at 15°C to 30°C (59°F to 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

Fosphenytoin: Folic Acid may decrease the serum concentration of Fosphenytoin. Monitor therapy

Green Tea: May decrease the serum concentration of Folic Acid. Monitor therapy

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

PHENobarbital: Folic Acid may decrease the serum concentration of PHENobarbital. Monitor therapy

Phenytoin: Folic Acid may decrease the serum concentration of Phenytoin. Monitor therapy

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

Primidone: Folic Acid may decrease the serum concentration of Primidone. Additionally, folic acid may decrease concentrations of active metabolites of primidone (e.g., phenobarbital). Monitor therapy

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

Raltitrexed: Folic Acid may diminish the therapeutic effect of Raltitrexed. Avoid combination

SulfaSALAzine: May decrease the serum concentration of Folic Acid. Monitor therapy

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

Frequency not defined.

Gastrointestinal: Abdominal pain, constipation, dark stools, diarrhea, epigastric pain, GI irritation, nausea, stomach cramping, vomiting

Genitourinary: Discolored urine

Miscellaneous: Hypersensitivity reaction

Warnings/Precautions

Disease-related concerns:

• Anemia: Not appropriate for with pernicious, aplastic, or normocytic anemias when anemia is present with vitamin B12 deficiency.

• Pernicious anemia: Folate doses >0.1 mg/day may obscure pernicious anemia in that hematologic remission can occur with continuing irreversible nerve damage progression.

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.

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, diarrhea, or stool discoloration. 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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