Ferrous sulphate (ferrous sulfate) contains iron that is essential for hemoglobin synthesis. It is also required for the muscles and other enzymes for optimal functioning.

Indications of Ferrous sulphate:

• Iron-deficiency anemia:

  • It is recommended in the prevention and treatment of iron-deficiency anemias.

• Off Label Use of Ferrous Sulfate in Adults:

  • Its use is also helpful in restless legs syndrome.

Ferrous sulphate treatment dosage in adults:

Note:

• This is applicable to both children and adults.
• Ferrous sulfate is present in various oral liquid concentrations.
• Ordering and administering ferrous sulfate requires notice of concentration.
• Inappropriate selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment can lead to fatal over/ underdosing.
• Iron deficiency anemia is preferably treated with immediate-release oral iron products.
• Poor absorption is seen in case of enteric-coated and slow/ sustained-release preparation.
• Doses are expressed in terms of elemental iron

ferrous sulfate contains about 20% elemental iron.

• Dried ferrous sulfate contains about 30% elemental iron.

Ferrous sulphate treatment dosage in the prevention of Iron-deficiency anemia, (in areas where anemia prevalence is ≥40%) (off-label):

• Women of childbearing age (non-pregnant):

  • 30 to 60 mg per oral once a day for 3 consecutive months in a year.

Ferrous sulphate treatment dosage  of Iron-deficiency anemia:

• 65 to 200 mg per oral per day.
• It can be given in three divided doses (depending on formulation).
• Note: Greater absorption of iron is seen with alternate-day dosing.
• This dosing is recommended for patients who can maintain adherence.

Ferrous sulphate treatment dosage of Restless legs syndrome (off-label):

• 65 mg per oral (325 mg ferrous sulfate) every 12 hourly concurrently with vitamin C in patients with a ferritin level ≤75 mcg/L.

Ferrous sulphate treatment dosage in children

Ferrous sulphate treatment dosage in children for the prevention of Iron deficiency anemia:

• Infants ≥4 months (receiving human milk as only nutritional source or >50% as source of nutrition without iron fortified food):

  • 1 mg iron/kg per day.
  • Note: In full-term infants, added supplementation of iron is not recommended by APP until at least 4-6 months of age if breastfed (full or partial).

• Infants ≥6 months and Children <2 years in areas where anemia prevalence is >40%:

  • 10 to 12.5 mg per oral once a day for 3 consecutive months in a year.

• Children 2 years to <5 years in areas where anemia prevalence is >40%:

  • 30 mg per oral per day for 3 consecutive months in a year.

• Children ≥5 to 12 years in areas where anemia prevalence is >40%:

  • 30 to 60 mg per oral per day for 3 consecutive months in a year.

• Adolescent menstruating females (nonpregnant females of reproductive potential) in areas where anemia prevalence is >40%:

  • 30 to 60 mg per oral per day for 3 consecutive months in a year.

Ferrous sulphate dosage  for the treatment of iron deficiency:

• Infants, Children, and Adolescents:

  • 3 to 6 mg/kg/day in three divided doses
  • The maximum daily dose is 200 mg per day.

Ferrous sulphate pregnancy Risk Factor: B

• Pregnancy is a time when iron requirements are higher
• Except in extreme cases of anemia, sufficient fetal iron can be maintained regardless of maternal iron status.
• If left untreated, iron deficiency can cause adverse events such as low birth weight, preterm births, or increased perinatal mortality.
• Iron deficiency can be treated in the same way for non-pregnant antenatal females.
• Most studies show iron therapy causes improvement in maternal hematologic parameters. However, data on clinical outcomes for the mother and the neonate are limited.
• If a female is unable to tolerate oral iron, has a history of iron deficiency or has a history of malabsorption, parenteral iron therapy may be indicated.
• Iron sulfate in pregnancy is the best iron supplement.
• Enteric-coated and slow/sustained-release preparations are found to be less effective.

Ferrous sulfate use during breastfeeding:

• Breast milk contains iron.
• Increased iron supplementation is required for breastfeeding women (IOM 2001).
• Iron is still present in breast milk in women with mild to moderate iron deficiencies. However, this is markedly reduced in severe iron deficiency.
• Breast milk with higher iron content is likely to be produced by mothers who have used ferrous sulfate.
• Breastfeeding infants were not exposed to adverse events, even when the mother used ferrous sulfate in supplemental dosages.
• In various trials, ferrous sulfate was evaluated for the treatment of iron deficiency anemia postpartum.
• The compatibility of ferrous salts used to treat anemia with breastfeeding has been shown by the WHO 2002.
• According to WHO guidelines, postpartum women who are at high risk for gestational anemia (whether they are nursing or not) should take oral iron pulse/folic acid 6-12 weeks after giving birth to lower the chance of developing anemia. (WHO 2016c).

Ferrous sulfate dose in Kidney disease:

• No specific dosage adjustment has been mentioned.
• A trial of oral iron replacement is justified and can be continued if the patient is responding (in iron-deficient individuals).
• intravenous iron may be preferred especially in patients who are intolerant or who do not respond to a trial of oral iron replacement.

Ferrous Sulphate Dose in Liver disease:

• Dose adjustment in patients with liver disease has not been mentioned.
• However, it can be administered in liver disease if no contraindications exist.

Ferrous sulfate Side Effects:

• Gastrointestinal:

  • Darkening Of Stools
  • Abdominal Pain
  • Heartburn
  • Nausea
  • Constipation
  • Flatulence
  • Vomiting
  • Diarrhea

Contraindication to Ferrous sulfate:

• Hypersensitivity to iron salts and any component of the formula
• hemochromatosis,
• Hemolytic anemia can be a contraindication to iron salts prescribing.

Warnings and precautions

• Gastrointestinal Disease:

  • It is not recommended for patients with peptic ulcers, enteritis, and ulcerative colitis.

Ferrous sulfate: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

Iron deficient anemia:

• Hemoglobin and hematocrit/ RBC count/ RBC indices/ serum ferritin/ transferrin saturation, total iron-binding capacity/ serum iron concentration/ erythrocyte protoporphyrin concentration should be monitored.

Cancer and chemotherapy-induced anemia:

• Serum iron/ total iron-binding capacity/ transferrin saturation/ ferritin levels (baseline and periodic) are recommended to check.

Chronic kidney disease associated anemia (patients not on dialysis):

• Hemoglobin/ serum ferritin/ transferrin saturation is required to evaluate response to iron.

How to administer Ferrous sulfate?

• Extended-release oral preparations should not be chewed or crushed.
• The tablet should be taken with water or juice on an empty stomach.

Ferrous sulfate Mechanism of Action:

• Ferrous sulphate is a form of iron that can be replaced by hemoglobin/myoglobin/ enzymes.
• This allows for oxygen transport via hemoglobin.

Start of action

• After oral administration, the hemologic response is approximately 3-10 days.

Peak effect:

• Reticulocytosis can be seen in between 5-10 days. Hemoglobin levels increase within 2-4 weeks

Absorption:

• Iron is absorbed in the upper and duodenum. 10% of the oral dose is absorbed by people who have normal iron stores.
• This is increased to 20%-30% for patients with depleted iron. Food and achlorhydria decrease absorption.

Protein binding:

• To transferrin.

Excretion:

• Urine and sweat. Sloughing of intestinal mucosa. Menses.

Ferrous sulfate Brand Names (International):

• BProtected Pedia Iron
• Fer-In-Sol
• Fer-Iron
• FeroSul
• Ferro-Bob
• FerrouSul
• Iron Supplement Childrens
• Iron Supplement
• Slow Fe
• Slow Iron
• PMS-Ferrous Sulfate
• Aktiferrin
• Brisofer
• Conferon
• Duroferon
• Eribell
• Femas
• Feosol
• Feospan
• Feospan Z
• Fer-In-Sol
• Ferglobin
• Ferlea
• Fero-Gradumet
• Feroba
• Feromin
• Feromin Oral Drops
• Ferro Duretter
• Ferro-grad
• Ferro-Gradumet
• Ferro-Liquid
• Ferrogamma
• Ferrogard
• Ferrograd
• Ferrograd C
• Ferrogradumet
• Ferrolent
• Ferrophor
• Ferroplex ”Era”
• Ferrostatin
• Ferrosterol
• Fersulph
• Haemoprotect
• Hemobion
• Iberol Drops
• Inshel
• Irovit
• Kdiron
• Kidiron
• Liquifer
• Microfer
• Mol-Iron
• Pediafer
• Pharmafer
• Plastufer
• Plexafer
• Retafer
• Slow-Fe
• Sorbifer
• Tardyferon
• Valdefer

Ferrous Sulphate Brand Names in Pakistan: