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Polysaccharide-iron complex, vitamin B12, and folic acid: Drug information

Polysaccharide-iron complex, vitamin B12, and folic acid: Drug information
(For additional information see "Polysaccharide-iron complex, vitamin B12, and folic acid: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ferrex 150 Forte [OTC];
  • Folvite-Fe [DSC];
  • Hematogen Forte [DSC];
  • Hematogen Forte [OTC];
  • IFerex 150 Forte;
  • Irofol [OTC] [DSC];
  • Poly-Iron 150 Forte;
  • Trigels-F Forte
Pharmacologic Category
  • Iron Preparations
Dosing: Adult

Formulation: Enteric-coated and slow-/sustained-release preparations are generally not preferred due to poor absorption (Ref). Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, lack of response to or poor tolerability of oral iron, chronic kidney disease, extensive blood loss) (Ref).

Iron-deficiency anemia, prevention/treatment

Iron-deficiency anemia, prevention/treatment: Oral:

Once-daily regimen: One capsule or tablet once daily. Note: Available products have varying products of iron and other components in the preparation; consult specific product labeling. Some experts do not typically exceed one dose per day as higher iron doses do not necessarily improve absorption and may increase the risk of adverse effects (Ref).

Alternate-day dosing regimens (off-label): One capsule or tablet every other day or one capsule or tablet on Monday, Wednesday, Friday (Ref). Note: Data have shown that alternate-day dosing regimens result in greater absorption of iron compared to more frequent administration; some experts prefer alternate-day dosing regimens in patients who can maintain adherence (Ref).

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

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified. Also see individual agents.

Frequency not defined:

Cardiovascular: Flushing (extremities and facial flushing)

Dermatologic: Skin rash

Gastrointestinal: Diarrhea, nausea, vomiting

Nervous system: Precordial pain

Contraindications

Hypersensitivity to any components of the formulation; hemochromatosis; hemosiderosis.

Warnings/Precautions

Disease-related concerns:

• Anemia: Not appropriate for treatment of pernicious or aplastic anemia.

• Gastrointestinal disease: Avoid in patients with peptic ulcer disease, enteritis, or ulcerative colitis.

• 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.

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).

Dosage Forms: US

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 [contains fd&c blue #1 (brill blue) aluminum lake, fd&c red #40(allura red ac)aluminum lake]

Hematogen Forte: Iron 460 mg, cyanocobalamin 10 mcg, and folic acid 1 mg with ascorbic acid 60 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #5 (tartrazine), soybean lecithin, soybean oil]

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

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

Trigels-F Forte: Iron 460 mg, cyanocobalamin 10 mcg, and folic acid 1 mg with ascorbic acid 60 mg [contains soybean oil]

Tablet, Oral:

Folvite-Fe: Iron 90 mg, cyanocobalamin 12 mcg, and folic acid 1 mg with ascorbic acid 120 mg [DSC] [contains fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

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

Generic Equivalent Available: US

May be product dependent

Pricing: US

Capsules (Ferrex 150 Forte Oral)

150-0.025-1 mg (per each): $0.15

Capsules (Hematogen Forte Oral)

460-60-0.01-1 mg (per each): $0.66

Capsules (IFerex 150 Forte Oral)

150-25-1 mg-mcg-mg (per each): $0.34

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: May be administered with or without food.

Use: Labeled Indications

Iron deficiency anemia, prevention/treatment: Prevention and treatment of iron-deficiency anemias.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Fluorouracil Products: Folic Acid may enhance the adverse/toxic effect of Fluorouracil Products. Risk C: Monitor therapy

Fosphenytoin-Phenytoin: Folic Acid may decrease the serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor therapy

Green Tea: May decrease the serum concentration of Folic Acid. Risk C: 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. Risk D: Consider therapy modification

Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination

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

Pafolacianine: Folic Acid may diminish the diagnostic effect of Pafolacianine. Risk X: Avoid combination

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

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

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

Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Iron Preparations. Management: Give oral iron products at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: 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). Risk C: Monitor therapy

Pyrimethamine: Folic Acid may diminish the therapeutic effect of Pyrimethamine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. 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

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

Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: Consider therapy modification

Sulfadoxine: Folic Acid may diminish the therapeutic effect of Sulfadoxine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider therapy modification

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

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 use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification

Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination

Pregnancy Considerations

Refer to individual monographs

Breastfeeding Considerations

Refer to individual monographs

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 (IOM 2001):

0 to 6 months of age: Adequate intake: 0.27 mg elemental iron/day.

7 to 12 months of age: RDA: 11 mg elemental iron/day.

1 to 3 years of age: RDA: 7 mg elemental iron/day.

4 to 8 years of age: RDA: 10 mg elemental iron/day.

9 to 13 years of age: RDA: 8 mg elemental iron/day.

14 to 18 years of age: 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 of age: 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 of age: RDA: 8 mg elemental iron/day.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (KR) Korea, Republic of: Femolbin q plus | Ferose | Ferri q | Ferriforce | Ferrinough f | Ferripol | Ferripol m | Ferritap F | Ferritop f | Feva gold | Gogai q | Hegatin Gold | Hemo Q Plus | Hemodeun | Hemodipine Plus | Hemodoctor f | Hemoformin | Hemoformin q | Hemogenic forte | Hemolbin Q | Hemolock a | Hemomom plus | Hemopol Plus | Hemoqueen Gold | Hemoqueentap | Hemostin | Hepomin | Hepomin f | Sk hemoone;
  • (PR) Puerto Rico: Ferrex 150 forte | Niferex forte;
  • (TN) Tunisia: Fer max;
  • (TW) Taiwan: Ferich Forte | Your iron
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  2. Auerbach M, Schrier S. Treatment of iron deficiency is getting trendy. Lancet Haematol. 2017;4(11):e500-e501. doi:10.1016/S2352-3026(17)30194-1 [PubMed 29032958]
  3. BiferaRx (Polysaccharide-Iron Complex, Vitamin B12, and Folic Acid) [prescribing information]. Marietta, GA: Alaven Pharmaceutical LLC; received May 2022.
  4. Hematogen Forte (polysaccharide-iron complex, vitamin B12, and folic acid) [prescribing information]. Cincinnati, OH: Nnodum Pharmaceuticals; December 2021.
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  6. Iferex 150 Forte (polysaccharide-iron complex, vitamin B12, and folic acid) [prescribing information]. Cincinnati, OH: Nnodum Pharmaceuticals; December 2021.
  7. IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Washington, DC: National Academy Press, 2001.
  8. Liu K and Kaffes AJ. Iron deficiency anaemia: a review of diagnosis, investigation and management. Eur J Gastroenterol Hepatol. 2012;24(2):109-116. doi: 10.1097/MEG.0b013e32834f3140. [PubMed 22157204]
  9. Moretti D, Goede JS, Zeder C, et al. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015;126(17):1981-1989. doi:10.1182/blood-2015-05-642223 [PubMed 26289639]
  10. Myferon 150 Forte (polysaccharide-iron complex, vitamin B12, and folic acid) [prescribing information]. Richmond, IN: M.E. Pharmaceuticals Inc; February 2014.
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  13. Schrier SL, Auerbach M. Treatment of iron deficiency anemia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 25, 2019.
  14. Stoffel NU, Cercamondi CI, Brittenham G. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. [PubMed 29032957]
  15. Trigels-F Forte (polysaccharide-iron complex, vitamin B12, and folic acid) [prescribing information]. Alpharetta, GA: Trigen Laboratories LLC; November 2021.
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