Oral Prophylaxis of folic acid deficiency in pregnancy, Prophylaxis of iron deficiency in pregnancy
Adult: Available preparations:
Ferrous fumarate 305 mg and folic acid 0.35 mg cap
Ferrous fumarate 310 mg and folic acid 0.35 mg tab
Ferrous fumarate 322 mg and folic acid 0.35 mg tab
1 tab or cap daily.
Contraindications
Anaemia other than those due to Fe deficiency, megaloblastic anaemia due to vitamin B12 deficiency, paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, haemoglobinopathies, inflammatory bowel disease including regional enteritis, ulcerative colitis, intestinal strictures, and diverticulae; active peptic ulcer. Patients requiring repeated blood transfusion. Concomitant use with parenteral Fe.
Special Precautions
Patient with folate-dependent tumours, erythropoietic protoporphyria, treated or controlled peptic ulceration. Not indicated for the prevention of anaemia in children, men and non-pregnant women. Pregnancy and lactation.
Adverse Reactions
Gastrointestinal disorders: Constipation, diarrhoea, black stool, nausea, vomiting, gastrointestinal discomfort. Immune system disorders: Rarely, allergic reactions.
Overdosage
Symptoms: Nausea, vomiting, abdominal pain, diarrhoea, haematemesis, rectal bleeding, lethargy, circulatory collapse, hypoglycaemia, and metabolic acidosis. Severe cases: Hypothermia, hypotension, hepatocellular necrosis, renal failure, diffuse vascular congestion, pulmonary oedema, anuria, coagulopathy, convulsions, and/or coma. Management: Induce emesis and perform gastric lavage with desferrioxamine solution (2 g/L). Administer desferrioxamine 5 g in 50-100 mL water to be retained in the stomach following gastric emptying. May induce small bowel emptying with mannitol or sorbitol. In case of shock or coma with high Fe serum levels (>142 micromole/L), immediate supportive measures and slow IV infusion of desferrioxamine (5 mg/kg/hour up to Max of 80 mg/kg/24 hours) should be instituted. In case of less severe and symptomatic conditions, administer IM desferrioxamine 50 mg/kg up to Max 4 g. Monitor serum Fe levels.
Drug Interactions
Ferrous fumarate: Fe chelates with tetracyclines, absorption of both agents may be impaired; it also chelates with acetohydroxamic acid, reducing the absorption of both. May reduce the absorption of penicillamine, fluoroquinolones, levodopa, carbidopa, entacapone, bisphosphonates, thyroid hormones (e.g. levothyroxine), mycophenolate, cefdinir, Zn, and eltrombopag. Reduced absorption with antacids and PPIs, neomycin, colestyramine, Ca, oral Mg salts and other mineral supplements, Zn and trientine. May form insoluble complexes with bicarbonates, carbonates, oxalates, or phosphates, thus absorption is impaired. Increased absorption with ascorbic or citric acid. Chloramphenicol delays plasma clearance and incorporation of Fe into RBC by interfering with erythropoiesis. May reduce the hypotensive effect of methyldopa. May form toxic complexes with dimercaprol. Increased risk of Fe overload with parenteral Fe.
Folic acid: May reduce serum levels of anticonvulsants (e.g. phenobarbital, phenytoin, primidone). Decreased serum level with sulfasalazine. May diminish the therapeutic effect of raltitrexed.
Food Interaction
Reduced absorption with food (e.g. tea, coffee, cereals, eggs, and milk).
Lab Interference
May interfere with tests used for detection of occult blood in the stool.
Action
Description: Mechanism of Action: Ferrous fumarate is an Fe compound that replaces the Fe found in Hb, myoglobin, and enzymes which is beneficial in the prevention and treatment of Fe deficiency anaemia. It also allows the transportation of oxygen via Hb.
Folic acid is necessary for purine and pyrimidine synthesis, nucleoprotein synthesis, and maintenance of erythropoiesis. It also stimulates the production of WBC and platelet in folate deficiency anaemia. Onset: Ferrous fumarate: Haematologic response: Approx 3-10 days. Pharmacokinetics: Absorption: Ferrous fumarate: Absorbed in the duodenum and jejunum. Food decreases absorption.
Folic acid: Rapidly absorbed mainly from the proximal part of the small intestine. Bioavailability: Approx 100% (folic acid supplement); 50% (dietary folate). Time to peak plasma concentration: 1 hour. Distribution: Ferrous fumarate: Enters breast milk.
Folic acid: Enters breast milk. Plasma protein binding: Extensive. Metabolism: Folic acid: Metabolised in the liver and plasma into the active form 5-methyltetrahydrofolate; undergoes enterohepatic circulation. Excretion: Ferrous fumarate: Via urine, sweat, menses, and sloughing of the intestinal mucosa.
Folic acid: Mainly via urine.