ferrous fumarate (Rx, OTC)

Brand and Other Names:Feostat, Ferro-Sequels, more...Hemocyte, Nephro Fer, Palafer
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 63mg (20mg Fe)
  • 324mg (106mg Fe)
  • 325mg (106mg Fe)

tablet extended release

  • 150mg (50mg Fe)

Iron Deficiency, Chronic Hemodialysis with Erythropoietin Treatment

150-200 mg Fe (elemental iron)/day PO; may administer 60-100 mg elemental iron q12hr or up to 60 mg elemental iron q6hr

Prophylaxis of Iron Deficiency

60-100 mg Fe (elemental iron)/day PO

Dosage Forms & Strengths

tablet

  • 63mg (20mg Fe)
  • 200mg (66mg Fe)
  • 324mg (106mg Fe)
  • 325mg (107mg Fe)

tablet extended release

  • 150mg (50mg Fe)

Iron-deficiency Anemia, Treatment

3-6 mg Fe/kg/day qDay or divided q8hr PO  

Iron-deficiency Anemia, Prophylaxis

1-2 mg Fe/kg/day qDay or divided q8hr PO ≤15 mg/day  

Recommended Daily Allowance

Males aged >10 years: 12 mg/day Fe PO

Females aged >10 years: 15 mg/day Fe PO

Lower doses of 15-50 mg elemental iron/day recommended may cause fewer GI adverse ements

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Dizziness

            Headache

            Nausea

            Constipation

            Urine discoloration

            Stomach cramping

            Dark stools

            Heartburn

            Diarrhea

            Esophagitis

            Gastrointestinal discomfort

            Gastrointestinal hemorrhage, perforation (rare)

            Dental staining

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            Warnings

            Black Box Warnings

            Severe iron toxicity may occur in overdose, especially when ingested by children.

            Nonintentional iron overdose is the leading cause of fatal poisoning in children younger than 6 years. Keep out of reach of children

            Contraindications

            Hemochromatosis, hemosiderosis, hemolytic anemia (unless iron-deficient state is also present)

            Hypersensitivity

            Cautions

            Do not administer oral iron with parenteral iron

            Absorption may be hindered by antacids containing Al or Mg

            Accidental overdose is leading cause of children <6 years

            Not for use in patients with peptic ulcer, ulcerative colitis, or enteritis

            Caution in patients with porphyria

            Avoid use in patients receiving blood transfusions

            Inability of reticuloendothelial system to reclaim available iron stores, is usually responsible for anemia in the elderly rather than blood loss; anemia of chronic disease is not secondary to iron deficiency

            Avoid use in premature infants

            Prophylactic Palafer CF during pregnancy should be discontinued at term & switched to Palafer (or other iron supplements) post-parturition

            Drug interaction overview

            • Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other

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            Pregnancy & Lactation

            Pregnancy Category: not available

            Lactation: enters breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin

            Pharmacokinetics

            Onset: 3-10 days (reticulocytosis); 2-4 weeks (hemoglobin values increase)

            Protein bound: Serum transferrin

            Excretion: Sweat, urine, menses, sloughing of intestinal mucosa

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            Administration

            Oral Administration

            For maximum absorption take on empty stomach, but may take with or after meals to minimize GI irritation

            Vitamin C may enhance absorption

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Ferretts oral
            -
            325 mg (106 mg iron) tablet
            Ferrocite oral
            -
            324 mg (106 mg iron) tablet
            ferrous fumarate oral
            -
            324 mg (106 mg iron) tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ferrous fumarate oral

            IRON SUPPLEMENTS - ORAL

            WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years. Keep this product out of reach of children. If overdose does occur, seek immediate medical attention or call a poison control center.

            USES: This medication is an iron supplement used to treat or prevent low blood levels of iron (such as those caused by anemia or pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.

            HOW TO USE: Follow all directions on the product package, or take as directed by your doctor. Do not take more than the recommended dosage. If you have any questions, ask your doctor or pharmacist.Iron is best absorbed on an empty stomach (usually if taken 1 hour before or 2 hours after meals). If stomach upset occurs, you may take this medication with food. See the instructions below for the liquid drops for infants/children. Avoid taking antacids, dairy products, tea, or coffee within 2 hours before or after this medication because they will decrease its effectiveness.Take tablets or capsules with a full glass of water (8 ounces or 240 milliliters) unless otherwise directed by your doctor. Do not lie down for at least 10 minutes after taking your tablet or capsule dose.Swallow extended-release capsules whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.If you are taking chewable tablets, chew the medication thoroughly, then swallow.If you are taking a liquid suspension form of this medication, shake the bottle well before each dose.If you are taking the liquid form for adults, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Mix the dose in a glass of water or juice, and drink the mixture through a straw to prevent staining the teeth.If you are giving the liquid drops to an infant or child, use the dropper provided to carefully measure the dose. The dose may be placed directly into the mouth (towards the back of the tongue) or it may be mixed in formula (not milk), fruit juice, cereal, or other food as directed to increase your child's acceptance. It is best to give this medication right after a meal. Follow the directions on the product package for the brand that you use.Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

            SIDE EFFECTS: Constipation, diarrhea, stomach cramps, or upset stomach may occur. These effects are usually temporary and may disappear as your body adjusts to this medication. If any of these effects last or get worse, contact your doctor or pharmacist promptly.Iron may cause your stools to turn black, an effect that is not harmful.If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before taking this medication, tell your doctor or pharmacist your medical history, especially of: iron overload disorder (such as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver problems, stomach/intestinal problems (such as ulcer, colitis).If your brand of iron supplement also contains folic acid, be sure to tell your doctor or pharmacist if you have vitamin B12 deficiency (pernicious anemia) before taking it. Folic acid may falsely improve certain laboratory tests for vitamin B12 deficiency without actually treating this anemia. Untreated vitamin B12 deficiency may result in serious nerve problems (for example, peripheral neuropathy symptoms such as numbness/pain/tingling sensations). Consult your doctor or pharmacist for details.Chewable tablets of this medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.Liquid preparations of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This product can decrease the absorption of other drugs such as bisphosphonates (for example, alendronate), levodopa, penicillamine, quinolone antibiotics (for example, ciprofloxacin, levofloxacin), thyroid medications (for example, levothyroxine), and tetracycline antibiotics (for example, doxycycline, minocycline). Separate your doses of these medications as far as possible from your doses of this product. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.Avoid taking this medication at the same time as antacids. Wait at least 2 hours between taking this medication and an antacid.If your brand of iron also contains folic acid, be sure to tell your doctor or pharmacist if you take certain anti-seizure drugs (for example, hydantoins such as phenytoin).This medication may interfere with certain laboratory tests (such as fecal occult blood tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: stomach pain, nausea, vomiting, diarrhea.

            NOTES: If your doctor has prescribed this medication, do not share it with others.Lab and/or medical tests (such as complete blood count) may be done while you are taking this product. Keep all medical and lab appointments. Consult your doctor for more details.This medication is not a substitute for a proper diet. It is important to maintain a well-balanced diet. Foods rich in iron include red meats (especially liver), fish, beans, dried fruit, and iron-fortified/enriched cereals and bread.

            MISSED DOSE: If you are taking this product on a prescribed schedule and miss a dose, take it as soon as you remember. If it is near the time for the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not freeze liquid forms of this medication. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised November 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.