SORBIFER DURULES Ferrous Sulfate 310mg Sustained Release Tablet 1's
RXDRUG-DR-XY25098-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
For the prevention and treatment of iron deficiency.
Dosage/Direction for Use
Adults: Ferrous Sulfate one tablet daily provides adequate therapy for the majority of patients. When a more rapid hemoglobin response is required, an extra dose in the morning is of advantage. If necessary, the dosage may be further increased by 1 to 2 tablets daily.
As prophylaxis during pregnancy: During the 1st to 6th month of pregnancy, 1 tablet daily. During the final months, the dosage should be increased to one tablet morning and evening.
Or as prescribed by the physician.
As prophylaxis during pregnancy: During the 1st to 6th month of pregnancy, 1 tablet daily. During the final months, the dosage should be increased to one tablet morning and evening.
Or as prescribed by the physician.
Overdosage
Symptoms: Acute iron overdosage can be divided into 4 stages.
Phase 1: Occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycemia and CNS depression ranging from lethargy to coma. Patients with mild to moderate poisoning do not generally pass this first phase.
Phase 2: May occur at 6-24 hours after ingestion and its characterised by a temporary remission or clinical stabilisation.
Phase 3: Gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycemia, coagulation disorders, oliguria or renal failure and pulmonary edema.
Phase 4: May occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment: Treatment consist of gastric lavage followed by the introduction of 5 g of desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases I.V. desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline catharthics (e.g. sodium sulfate 30 g for adults); milk and eggs with 5 g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory depression. Chelating agents (e.g. disodium calcium edetate) may be tried (500 mg/500 mL by continuous IV infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90 mg/kg I.M. followed by 15 mg/kg per hour I.V. until the serum iron is within the plasma binding capacity.
Phase 1: Occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycemia and CNS depression ranging from lethargy to coma. Patients with mild to moderate poisoning do not generally pass this first phase.
Phase 2: May occur at 6-24 hours after ingestion and its characterised by a temporary remission or clinical stabilisation.
Phase 3: Gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycemia, coagulation disorders, oliguria or renal failure and pulmonary edema.
Phase 4: May occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment: Treatment consist of gastric lavage followed by the introduction of 5 g of desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases I.V. desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline catharthics (e.g. sodium sulfate 30 g for adults); milk and eggs with 5 g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory depression. Chelating agents (e.g. disodium calcium edetate) may be tried (500 mg/500 mL by continuous IV infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90 mg/kg I.M. followed by 15 mg/kg per hour I.V. until the serum iron is within the plasma binding capacity.
Administration
May be taken with or without food: Swallow whole, do not suck/chew/keep in mouth.
Contraindications
Iron compounds should not be given to patients receiving repeated blood transfusions or to patients with anemias not produced by iron deficiency unless iron deficiency is also present.
Warnings
The patient should be warned that iron products can give rise to poisoning in infants.
Special Precautions
Care should be taken in patients with iron-storage or iron-absorption diseases such as hemochromatosis, hemoglobinopathies, or existing gastrointestinal diseases such as inflammatory bowel disease, intestinal structures and diverticulae.
Dental caries is a definite risk following long-term treatment with this product. Duration of treatment should generally not exceed 3 months after correction of anemia.
Due to the risk of mouth ulcerations and tooth discoloration, tablet should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Dental caries is a definite risk following long-term treatment with this product. Duration of treatment should generally not exceed 3 months after correction of anemia.
Due to the risk of mouth ulcerations and tooth discoloration, tablet should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Use In Pregnancy & Lactation
Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus, administration of iron during the first trimester, however, requires evidence. Prophylaxis of iron deficiency during remainder of pregnancy is justified.
Adverse Reactions
Allergic reactions have been reported. Other adverse drug reactions include upset stomach or abdominal pain, nausea and vomiting, diarrhea, constipation, darkening of stools and loss of appetite.
Drug Interactions
Iron salts are not well absorbed by mouth, and food may further impair their absorption.
Compounds containing calcium and magnesium, including antacids and mineral supplements, and bicarbonates, carbonates, oxalates, or phosphates, may impair the absorption of iron by the formation of insoluble complexes. Similarly, the absorption of both iron salts and tetracyclines is diminished when taken together orally. If treatment with both drugs is required, a time interval of about 2 to 3 hours should be allowed between them. A suitable interval is also advised if an iron supplement is needed in patients given trientine. Zinc salts may decrease the absorption of iron. Iron is chelated by acetohydroxamic acid, reducing the absorption of both. Iron should not be given with dimercaprol as toxic complexes may form.
The response to iron may be delayed in patients receiving systemic chloramphenicol.
Some agents, such as ascorbic acid and citric acid, may actually increase the absorption of iron.
In addition to those already mentioned, iron salts can also decrease the absorption of other drugs and thus reduce their bioavailability and clinical effect. Drugs affected include cefdinir, bisphosphonates, entacapone, fluoroquinolones, levodopa, methyldopa, mycophenolate mofetil, and penicillamine.
Compounds containing calcium and magnesium, including antacids and mineral supplements, and bicarbonates, carbonates, oxalates, or phosphates, may impair the absorption of iron by the formation of insoluble complexes. Similarly, the absorption of both iron salts and tetracyclines is diminished when taken together orally. If treatment with both drugs is required, a time interval of about 2 to 3 hours should be allowed between them. A suitable interval is also advised if an iron supplement is needed in patients given trientine. Zinc salts may decrease the absorption of iron. Iron is chelated by acetohydroxamic acid, reducing the absorption of both. Iron should not be given with dimercaprol as toxic complexes may form.
The response to iron may be delayed in patients receiving systemic chloramphenicol.
Some agents, such as ascorbic acid and citric acid, may actually increase the absorption of iron.
In addition to those already mentioned, iron salts can also decrease the absorption of other drugs and thus reduce their bioavailability and clinical effect. Drugs affected include cefdinir, bisphosphonates, entacapone, fluoroquinolones, levodopa, methyldopa, mycophenolate mofetil, and penicillamine.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics and Pharmacokinetics: Iron is regularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach and by some dietary acids (such as ascorbic acid) and occurs more readily when the iron is in the ferrous state or is part of the haem complex (haem-iron). Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if the body stores are overloaded. Normally, only about 5% to 15% of the iron ingested in food is absorbed.
Most absorbed of the iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin; the remainder is contained within the storage forms, ferritin or haemosiderin, or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
Only very small amounts of iron are excreted as the majority released after the destruction of haemoglobin molecule is re-used. This conservation of body iron, and lack of an excretory mechanism for excess iron, is the reason for the development of iron overload with excessive iron therapy or repeated transfusions.
Properties: Durules provide continuous release of active substance. Studies using the double-isotope technique have shown that iron administered in the form of Ferrous Sulfate Durules is better utilized by the body than iron in ordinary tablets. This good absorption does not result in increased side effects. The occurrence of nausea and gastric pain is less with Ferrous Sulfate Durules than with conventional tablets.
Most absorbed of the iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin; the remainder is contained within the storage forms, ferritin or haemosiderin, or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
Only very small amounts of iron are excreted as the majority released after the destruction of haemoglobin molecule is re-used. This conservation of body iron, and lack of an excretory mechanism for excess iron, is the reason for the development of iron overload with excessive iron therapy or repeated transfusions.
Properties: Durules provide continuous release of active substance. Studies using the double-isotope technique have shown that iron administered in the form of Ferrous Sulfate Durules is better utilized by the body than iron in ordinary tablets. This good absorption does not result in increased side effects. The occurrence of nausea and gastric pain is less with Ferrous Sulfate Durules than with conventional tablets.
MedsGo Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
Features
Brand
Sorbifer Durules
Full Details
Dosage Strength
310mg
Drug Ingredients
- Iron
Drug Packaging
Sustained Release Tablet 1's
Generic Name
Ferrous Sulfate
Dosage Form
Sustained Release Tablet
Registration Number
DR-XY25098
Drug Classification
Prescription Drug (RX)
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