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ferrous sulfate (Slow FE, Fer-In-Sol, Feratab, Iron, Mol-Iron, Feosol, MyKidz Iron 10)

 

Classes: Iron Products

Dosing and uses of Slow FE, Fer-In-Sol (ferrous sulfate)

 

Adult dosage forms and strengths

oral solution

  • 220mg (44mg Fe)/5mL
  • 300mg (60mg Fe)/5mL
  • 15 mg elemental Fe/mL

oral liquid drops

  • 75mg (15mg Fe)/mL

tablet

  • 45mg elemental Fe
  • 200mg (65mg Fe)
  • 300mg (60mg Fe)
  • 325mg (65mg Fe)

tablet, delayed release

  • 325mg (65mg Fe)

tablet, extended release

  • 160mg (50mg Fe)
  • 142mg (45 mg Fe)
  • 140mg (45 mg Fe)

 

Recommended Daily Allowance (Elemental Iron)

19-50 years

  • Males: 8 mg/day
  • Females: 18 mg/day
  • Pregnant females: 27 mg/day
  • Lactating females: 9 mg/day

>50 years

  • 8 mg/day

 

Iron Deficiency Anemia

Treatment expressed as elemental iron

  • 100-200 mg PO divided q12hr; may administer extended release form once daily

Prophylaxis expressed as elemental iron

  • 60 mg PO once daily

 

Administration

For maximum absorption, agent should be taken on empty stomach but may be taken with or after meals to minimize GI irritation

Vitamin C may enhance absorption

 

Pediatric dosage forms and strengths

oral solution

  • 15mg elemental Fe/mL
  • 220mg (44mg Fe)/5mL

oral liquid drops

  • 75mg (15mg Fe)/mL

tablet

  • 45mg elemental Fe
  • 200mg (65mg Fe)
  • 300 mg (60mg Fe)
  • 325mg (65mg Fe)

tablet, delayed release

  • 325mg (65mg Fe)

tablet, extended release

  • 160mg (50mg Fe)
  • 142mg (45 mg Fe)
  • 140mg (45 mg Fe)

 

Recommended Daily Allowance (Elemental Iron)

0-6 months: 0.27 mg/day

6-12 months: 11 mg/day

1-3 years: 7 mg/day

3-8 years: 10 mg/day

8-13 years: 8 mg/day

>13 years

  • Males: 11 mg/day
  • Females: 15 mg/day
  • Pregnant females: 27 mg/day
  • Lactating females: 10 mg/day

 

Iron Deficiency Anemia

Treatment expressed as elemental iron

  • 3-6 mg Fe/kg/day PO divided q8hr

Prophylaxis expressed as elemental iron

  • 4 months and older receiving human milk as only nutritional source or >50% as source of nutrition: 1 mg/kg/day PO
  • 6 months to 2 years in areas where anemia prevalence is >40% and iron fortified food not available: 2 mg/kg/day
  • 2-5 years in areas where anemia prevalence >40%: 2 mg/kg/day PO; not to exceed 30 mg/day
  • >5 years in areas where anemia prevalence >40%: 30 mg/day with folic acid
  • Adolescents in areas where anemia prevalence is >40%: 60 mg/day with folic acid

 

Slow FE, Fer-In-Sol (ferrous sulfate) adverse (side) effects

Frequency not defined

Constipation

Contact irritation

Diarrhea

Dark stools

GI hemorrhage (rare)

GI irritation

GI obstruction (wax matrix products; rare)

GI perforation (rare)

Nausea

Stomach pain

Superficial tooth discoloration (oral solutions)

Urine discoloration

Vomiting

 

Warnings

Contraindications

Hypersensitivity

Hemochromatosis, hemolytic anemia

 

Cautions

Avoid use in peptic ulcer disease, ulcerative colitis, regional enteritis, and patients receiving frequent blood transfusions

Absorption is variable and incomplete

Liquid dosage forms contain 20% elemental iron; dried forms (usually monohydrate) have 30-33%

Avoid use in premature infants until vitamin E stores, which are deficient at birth are replenished

Avoid administering iron for >6 months except in patients with continuous bleeding or menorrhagia

Unintentional iron overdose is leading cause of fatal poisoning in children <6 years; keep out of reach of children

Hypersensitivity reactions, usually a delayed reaction, reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals; thrombocytopenia, ascites, pulmonary deterioration , and renal hepatic failure reported in premature neonates after receiving parenteral products containing polysorbate 80; some storage forms contain polysorbate 80

Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression

 

Pregnancy and lactation

Pregnancy category: Not studied

Lactation: Drug is excreted in 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.

 

Pharmacology of Slow FE, Fer-In-Sol (ferrous sulfate)

Mechanism of action

Replaces iron stores found in hemoglobin, myoglobin, and enzymes; allows transportation of oxygen via hemoglobin

 

Absorption

Bioavailability: 5-10% (20-30% during deficiency)

Onset: Reticulocytosis, 3-10 days; increased hemoglobin values, 2-4 wk

Protein binding: Binds to transferrin

 

Elimination

Excretion: Sweat, urine, menses, sloughed intestinal mucosa