Sorbifer (international name – Ferrous sulfate + Ascorbic acid) belongs to the group of antianemic drugs that replenish iron deficiency. The drug is highly effective and safe, due to which it is prescribed during pregnancy and breastfeeding.
In this article we will look at why doctors prescribe Sorbifer Durules, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Sorbifer Durules can be read in the comments.
Composition and release form
The drug Sorbifer Durules is available in tablet form for oral administration. They have a round shape, a biconvex surface, and a yellow color. The drug contains several main active ingredients.
- One tablet contains: 320 mg ferrous sulfate (including 100 mg iron) and 60 mg ascorbic acid.
- Excipients: hypromellose, titanium dioxide, magnesium stearate, carbomer 934P, yellow iron oxide, paraffin, polyethylene powder, macrolog 6000 and povidone.
Clinical and pharmacological group: antianemic drug.
What is Sorbifer Durules used for?
Sorbifer Durules is used in the presence of iron deficiency anemia, when the amount of iron obtained from foods is too small, or there is a need to regularly replenish it during prolonged bleeding. And also as a preventive measure during pregnancy and lactation, with heavy menstruation and blood donors. The drug is also prescribed if there is a need for increased amounts of iron - for children and the elderly.
Pharmacodynamics and pharmacokinetics
The medicinal properties of the drug are due to the presence of iron in its composition in combination with ascorbic acid. Iron, in itself, is an integral part of the human body, its important functional unit. It is part of hemoglobin and takes part in oxidative reactions in tissues. Ascorbic acid improves the quality and affects the rate of absorption of iron by the body.
Durules is a special technology for manufacturing the drug, which allows iron ions to be evenly and gradually released in the intestines not under the influence of digestive juices, but as a result of peristalsis (wave-like movements of the intestinal walls). This gradual (over 6 hours) release of iron ions prevents the creation of an increased amount of them in the digestive organs and prevents the irritating effect of iron ions on the mucous membrane of the digestive tract.
Thanks to this technology, the absorption of the drug in the small intestine is high, 30% higher than that of other iron preparations. It is Ascorbic acid that increases its absorption.
Instructions for use
According to the instructions for use, I take Sorbifer Durules orally. Film-coated tablets should not be split or chewed. The tablet should be swallowed whole and washed down with at least half a glass of liquid. The duration of therapy is determined individually depending on the concentration of iron in the blood plasma. The average duration of treatment is 3–6 months.
- The standard dose is 1 tablet 2 times a day (morning/evening) 30 minutes before meals. The tablet should be swallowed whole with water (200 ml). If adverse reactions develop, the dose should be reduced by 50% (one tablet/day).
- During the first 6 months of pregnancy, the recommended dose is 1 tablet/day, in the last trimester of pregnancy, during lactation—1 tablet 2 times/day.
After normalization of hemoglobin levels, administration of the drug Sorbifer Durules should be continued until iron reserves are completely restored (about 2 months).
Contraindications
The drug should not be used in the following cases:
- Children under 12 years of age (due to lack of clinical data).
- Impaired iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia).
- Hypersensitivity to the components of the drug.
- Esophageal stenosis and/or obstructive changes in the digestive tract.
- Increased iron content in the body (hemosiderosis, hemochromatosis).
With caution: gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
Side effects
While taking Sorbifer Durules tablets, it is possible to develop a number of pathological negative reactions from various organs and systems:
- Allergic reactions - skin rash, itching, specific pathological changes in the form of swelling and rash, reminiscent of a nettle burn.
- Nervous system – dizziness, periodic headache.
- Digestive system - nausea, periodic vomiting, pain in the abdomen, bowel dysfunction (constipation or diarrhea).
- Rarely, ulcerative lesions of the walls of the stomach, duodenum, as well as narrowing (stenosis) of the esophagus can develop.
- Other: rarely - general weakness, skin hyperthermia.
When taking an excessive dose of the drug, the following are possible: vomiting, abdominal pain, diarrhea mixed with blood, pallor of the skin, weakness or fatigue, paresthesia, cold clammy sweat, hyperthermia, acidosis, decreased blood pressure, weak pulse, rapid heartbeat; in severe cases - hypoglycemia, coagulopathy, signs of peripheral circulatory collapse, hyperthermia, renal failure, liver damage, muscle cramps and coma may appear after 6-12 hours.
tab., cover coated, 320 mg+60 mg: 30 or 50 pcs.Reg. No.: 4055/99/04/07/09/14 dated 06/12/2014 - Valid
Film-coated tablets yellow ocher coloured, lenticular, slightly biconvex, with a "Z" engraving on one side, with a characteristic odor.
Excipients: povidone (K-25), polyethylene powder, carbomer 934P, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), solid paraffin.
30 pcs. - dark glass bottles (1) - cardboard packs.
50 pcs. - dark glass bottles (1) - cardboard packs.
Description of the drug SORBIFER DURULES based on officially approved instructions for use of the drug and made in 2007. Update date: 03/06/2007
Iron supplement. Iron is an essential component of the body, necessary for the formation of hemoglobin and oxidative processes in living tissues. The drug is used to eliminate iron deficiency. Long-term release of iron ions is ensured by the film coating of the tablet.
Durules is a dosage form that gradually releases the active substance, ensuring a uniform supply of the drug. When taking Sorbifer Durules 100 mg 2 times a day, iron absorption is 30% greater compared to conventional dosage forms of iron preparations.
For adults and teenagers Usually 1 tablet is prescribed. morning and evening.
At iron deficiency anemia the dose can, if necessary, be increased to 3-4 tablets/day in 2 doses (morning and evening).
At pregnancy with for the purpose of prevention, 1 tablet/day is prescribed.
During treatment iron deficiency- 1 tab. morning and evening.
The tablet must not be split or chewed. The tablet should be swallowed whole with at least half a glass of liquid. Do not give tablets to a patient in a horizontal position.
Treatment should be continued until the optimal hemoglobin level is achieved. To further replenish the depot, you may need to continue taking the drug for another month.
Long-term therapy (continuously or intermittently) can be carried out if significant iron loss occurs regularly (for example, with heavy menstruation).
From the digestive system:>1% - nausea, abdominal pain, diarrhea, constipation;
The incidence of side effects from the digestive system increases with increasing doses and is 7-20% at doses of 100 to 400 mg of iron per day.
Dermatological reactions: <1% - сыпь.
During the use of iron supplements, darkening of the stool is possible.
The patient should be warned that iron supplements can cause poisoning in children.
Impact on the ability to drive vehicles and operate machinery
Sorbifer Durules does not affect the ability to drive a car or operate machinery, or this effect is insignificant.
Symptoms: abdominal pain, vomiting, diarrhea (sometimes bloody), dehydration, acidosis, drowsiness and shock. The patient's condition may improve, but after an asymptomatic period of 6-24 hours, symptoms may resume:
- coagulopathy, cardiovascular collapse (heart failure due to myocardial damage), hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma;
- risk of intestinal perforation. In the future, liver cirrhosis and pyloric stenosis may develop. Septicemia caused by Yersinia enterocolitica is possible.
Treatment: urgent measures - taking milk and raw eggs to form an iron-protein complex, inducing vomiting. Then you should do a gastric lavage, preferably with a 1% solution of sodium bicarbonate. Specific therapy is carried out with deferoxamine:
- gastric lavage at a concentration of 2 g/l, then 5-10 g of deferoxamine dissolved in 50-100 ml of drinking water is left in the stomach. To remove absorbed iron, deferoxamine is administered intramuscularly at 1-2 g. In severe cases, accompanied by the development of shock, a long-term intravenous infusion of deferoxamine is performed at a rate of 15 mg/kg/h (maximum 80 mg/kg in 24 hours), and also symptomatic therapy.
INN: Ascorbic acid, Ferrous sulfate
Manufacturer: CJSC "EGIS Pharmaceutical Plant", licensed by Astra Zeneca, Sweden
Anatomical-therapeutic-chemical classification: Iron preparations (ferrous) for oral administration
Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 005192
Instructions
Trade name
Sorbifer® Durules®
International nonproprietary name
Dosage form
Film-coated tablets
Compound
One tablet contains
active substances: dry iron (II) sulfate 320 mg (equivalent to 100 mg iron (II)), ascorbic acid 60 mg,
excipients: povidone (K-25), polyethene powder, carbomer 934 R, magnesium stearate,
shell composition: hypromellose, macrogol 6000, titanium dioxide E 171, iron (III) yellow oxide E 172, solid paraffin.
Description
Tablets are lenticular-shaped, slightly biconvex, ocher-coated, yellow in color, engraved “Z” on one side, with a characteristic odor.
Pharmacotherapeutic group
Hematopoiesis stimulants. Iron supplement. Fe++ preparations for oral administration.
ATX code B03AA
Pharmacological properties
Pharmacokinetics
“Durules” is a special production technology that ensures a gradual, long-term release of the active substance (iron ions) and a uniform supply of the drug.
Iron is absorbed primarily in the duodenum and proximal jejunum.
The absorption of heme-bound iron is about 20%, and that of non-heme-bound iron is about 10%. For effective absorption, iron must be in the form of Fe(II). After oral administration, ascorbic acid is completely absorbed from the gastrointestinal tract. Hydrochloric acid of the stomach and ascorbic acid stimulate the absorption of iron, reducing it from Fe 3+ to Fe 2+. The presence of ascorbic acid in the drug creates more favorable conditions for the absorption of iron in the intestines and improves the bioavailability of the drug. Iron Fe 2+ (ferro form) entering the intestinal epithelial cells undergoes intracellular oxidation to Fe 3+ (ferri form), which binds to apoferritin. Part of apoferritin enters the blood, the other part temporarily remains in the intestinal epithelial cells in the form of ferritin, which enters the blood after 1-2 days or is excreted from the body in feces during the desquamation of epithelial cells.
About 1/3 of the iron entering the blood binds to apotransferrin, the molecule of which is converted into transferrin. The iron-transferrin complex is transported to target organs and, after binding to receptors located on the surface of their cells, enters the cytoplasm via endocytosis. In the cytoplasm, iron dissociates from transferrin and recombines with apoferritin. Apoferritin oxidizes iron to Fe 3+, and flavoproteins participate in the reduction of iron.
There are no data on the pharmacokinetics of the drug in patients with impaired liver or kidney function.
Pharmacodynamics
Iron is an essential component of the body, necessary for the formation of hemoglobin and the implementation of oxidative processes in living tissues. The active substance is contained in a biologically indifferent plastic matrix with a spongy structure. When passing through the gastrointestinal tract from the porous matrix of the tablets (within 6 hours), a continuous release of ferrous ions occurs. The film coating of the tablet and the porous matrix provide long-term release of iron ions. The film coating of the tablet, which completely disintegrates under the action of intestinal peristalsis and releases the active ingredient, helps prevent the tablet from dissolving in the stomach. The slow release of iron ions does not lead to the creation of a high local concentration, which avoids irritation of the mucous membrane of the gastrointestinal tract.
Iron is deposited in significant amounts as myoglobin in muscles.
Ascorbic acid slows down the breakdown of ferritin by blocking autophagy of ferritin by ferritin lysosomes and transformation into hemosiderin.
Ascorbic acid accelerates the absorption of iron in the gastrointestinal tract, reducing unbound heme iron (III) to iron (II) in the stomach.
Indications for use
Prevention and treatment of iron deficiency anemia
Directions for use and doses
The tablet should be taken whole, without chewing, and at least half an hour before meals, with half a glass of water.
You should not take the tablets while lying down.
Adults and teenagers over 12 years old:
For patients with grade II-III iron deficiency anemia, if necessary, on the recommendation of a doctor, the dose can be increased to 3-4 tablets 2 times a day (morning and evening).
If side effects occur, the dose can be reduced by half (1 tablet per day).
Duration of treatment:
The duration of treatment is determined individually, based on the results of laboratory data on iron metabolism.
Treatment should be carried out until hemoglobin levels normalize, under the control of Fe levels in the blood, and continue until the iron depot is completely saturated for another 2 months. For severe iron deficiency, the average duration of treatment is 3-6 months.
Side effects
Often (>1/100)
Nausea, abdominal pain, diarrhea, constipation
Rarely (<1/100)
- ulcerative lesions of the esophagus, stenosis of the esophagus
Frequency unknown (not determined from available data):
Hypersensitivity reactions (eg, rash, anaphylactic reaction, angioedema)
Reports of suspected adverse reactions
Providing data on suspected adverse drug reactions is very important to enable continuous monitoring of the risk/benefit ratio of the drug. Health care professionals should provide information about any suspected adverse reactions to the contacts listed at the end of the instructions, as well as through the national reporting system.
Contraindications
Hypersensitivity to the active or any other inactive component of the drug
Esophageal stenosis and/or other obstructive changes in the digestive tract
Increased iron content in the body (hemosiderosis, hemochromatosis)
Repeated blood transfusions
Other types of anemia not associated with iron deficiency, unless another type of anemia also develops iron deficiency
Children under 12 years of age (due to lack of clinical data)
Drug interactions
- ciprofloxacin: Concomitant use reduces the absorption of ciprofloxacin by approximately 50%, so there is a risk that the plasma levels of ciprofloxacin will be lower than necessary for a therapeutic effect.
- levofloxacin: simultaneous use reduces the absorption of levofloxacin.
-moxifloxacin: Concomitant use reduces the bioavailability of moxifloxacin by almost 40%, therefore, if simultaneous use is required, it is necessary to ensure the longest possible period between taking moxifloxacin and Sorbifer Durules.
- norfloxacin: Concomitant use reduces the absorption of norfloxacin by approximately 75%.
- ofloxacin: Concomitant use reduces the absorption of ofloxacin by approximately 30%.
When using the drug Sorbifer Durules simultaneously with the following drugs, dosage adjustment of these drugs may be required. The recommended minimum time interval between taking Sorbifer Durules and these drugs should be at least 2 hours:
- calcium or dietary supplements containing magnesium carbonate, as well as aluminum or calcium hydroxide, antacids containing magnesium carbonate, together with iron salts they form a complex that reduces the absorption of each other.
- captopril: Concomitant use reduces the area under the plasma concentration-time curve for captopril by approximately 37%, presumably due to chemical reactions in the gastrointestinal tract.
- zinc: simultaneous use reduces the absorption of zinc salts.
- clodronate: research in vitro showed that preparations containing iron form a complex compound with clodronate; simultaneous use may reduce the absorption of clodronate.
- deferoxamine: with simultaneous use, the absorption of deferoxamine and iron is reduced due to the formation of a complex compound.
- levodopa: When used concomitantly, ferrous sulfate reduces the bioavailability of single doses of levodopa by approximately 50% and of single doses of carbidopa by 75%, possibly due to the formation of a chelate complex.
- methyldopa: When used concomitantly with iron salts (ferrous sulfate or gluconate), the bioavailability of methyldopa is reduced, possibly due to the formation of a chelate complex.
- penicillamine: Concomitant use of penicillamine and iron salts reduces their absorption, possibly due to the formation of a chelate complex.
- risedronate: carried out in vitro Studies have shown that preparations containing iron form complex compounds with risedronate. Although no drug interaction studies have been conducted in vivo, it can be assumed that the simultaneous use of these drugs reduces the absorption of risedronate.
- tetracyclines: with simultaneous use, the absorption of tetracyclines and iron is reduced. If simultaneous use is necessary, the recommended minimum time interval between taking Sorbifer Durules and these drugs should be at least 3 hours. When taken orally, iron inhibits the enterohepatic circulation of oxytetracyxine (doxycycline), as well as when administered intravenously.
- thyroid hormones: with the simultaneous use of iron and thyroxine preparations, a decrease in the absorption of thyroxine is possible, which reduces the effectiveness of replacement therapy.
- cimetidine: with simultaneous use, a decrease in gastric juice production caused by cimetidine reduces iron absorption. Therefore, the intervals between taking these drugs should be at least 2 hours.
- chloramphenicol: When taken simultaneously, the clinical effect of iron treatment may be delayed.
When taking the drug simultaneously with tea, coffee, eggs, dairy products, wheat bread, porridge or foods rich in plant fiber, iron absorption may be reduced.
Interactions associated with ascorbic acid:
Increases concentration salicylates in the blood (increases the risk of developing crystalluria), ethinyl estradiol, benzylpenicillin, And tetracyclines. - reduces concentration oral contraceptives.
Increases activity norepinephrine.
Reduces anticoagulant effect derivatives of coumarin, heparin.
Improves the absorption of iron preparations in the intestines, as well as iron from food (due to the conversion of Fe 3+ to Fe 2+).
Increases overall clearance ethyl alcohol.
May affect effectiveness disulfiram in the treatment of chronic alcoholism.
Simultaneous use of ascorbic acid and deferoxamine increases iron excretion.
Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drinks reduce the absorption and absorption of ascorbic acid.
Special instructions
When using the drug, darkening of the stool appears, which has no clinical significance.
The drug is used with caution for gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease), chronic liver and kidney diseases.
Comprehensive laboratory and instrumental monitoring of the effectiveness of treatment is recommended to be carried out every 7-14 days, depending on the course of anemia.
The drug is effective only for iron deficiency. Before starting treatment, it is necessary to confirm the diagnosis of iron deficiency (low iron content in serum, high total iron-binding capacity of serum).
The drug is ineffective for other types of anemia not caused by iron deficiency (infectious anemia, anemia associated with chronic diseases, thalassemia).
Pregnancy and lactation
The drug can be used during pregnancy and lactation in therapeutic doses.
Features of the effect of the drug on the ability operate a vehicle or potentially dangerous machinery.
No effect.
Overdose
Relatively low amounts of iron can cause symptoms of intoxication. There is evidence that an iron content equivalent to 20 mg/kg can already cause some symptoms of intoxication, and with an iron content exceeding 60 mg/kg, the development of such symptoms is expected. Iron content equivalent to 200-250 mg/kg can be fatal.
Symptoms:
Less than 3 mcg/ml - mild poisoning
3-5 mcg/ml - moderate poisoning
> 5 mcg/ml - severe poisoning
The maximum concentration of iron is determined 4-6 hours after ingestion of iron.
Mild to moderate poisoning: Vomiting and diarrhea may occur within 6 hours of ingestion.
Severe poisoning: severe vomiting and diarrhea, lethargy, metabolic acidosis, shock, gastrointestinal bleeding, coma, convulsions, hepatotoxicity, later gastrointestinal stenosis. Severe toxicity also causes liver necrosis and jaundice, hypoglycemia, bleeding disorders, oliguria, renal failure and pulmonary edema.
An overdose of iron salts is especially dangerous in children at an early age.
Overdose of vitamin C can cause severe acidosis and hemolytic anemia in susceptible individuals (glucose-6-phosphate dehydrogenase deficiency).
Treatment:
Milk or vomiting inducers inside.
Gastric lavage with 5% sodium bicarbonate solution and saline laxatives (for example, sodium sulfate, at a dose of 30 g for adults); milk and eggs combined with 5 g of bismuth carbonate as emollients.
After gastric lavage, 5 g of deferoxamine dissolved in 50-100 ml of water is administered, and this solution is left in the stomach. To stimulate intestinal activity, adult patients can be given a solution of mannitol or sorbitol orally. Causing diarrhea in children, especially at a young age, can be dangerous and is not recommended. Patients should be carefully monitored to prevent aspiration.
On an x-ray, the tablets give a shadow, so using an x-ray of the abdomen, you can identify the tablets remaining after gastric lavage and induced vomiting. It is advisable to prescribe an intravenous infusion of chelated compounds (sodium, calcium edetate, 500 mg/500 ml in the form of a long infusion). Dimercaprol should not be used as it forms toxic complexes with iron. Desferoxamine is a specific drug that forms a chelate complex with iron. In case of acute, severe poisoning in children, desferoxamine should always be prescribed at a dose of 90 mg/kg intramuscularly, then 15 mg/kg intravenously, until the iron content in the blood serum corresponds to the iron-binding capacity of the serum. If the infusion rate is too high, hypotension may develop. In less severe cases of intoxication, desferoxamine is prescribed intramuscularly at a dose of 50 mg/kg, up to a maximum dose of 4 g. In severe intoxication: in a state of shock and/or coma and in case of increased serum iron levels (> 90 mmol/l in children, > 142 mmol/l in adults), intensive supportive care should be started immediately. Blood or plasma transfusions are performed for shock, and oxygen therapy is prescribed for respiratory failure. After elimination of intoxication, it is recommended to monitor the level of iron in the blood serum throughout the course of treatment.
Release form and packaging
30 and 50 tablets are placed in brown glass bottles with an FG-7 polyethylene cap, tamper evident and equipped with an accordion shock absorber. The bottle, together with instructions for medical use in the state and Russian languages, is placed in a cardboard box.
Storage conditions
Sorbifer Durules (iron sulfate + vitamin C) is a stimulator of the hematopoietic process, used in the treatment of iron deficiency anemia, to compensate for the lack of iron in the body - the most important element, without which hemoglobin synthesis and the normal course of oxidative processes in cells and tissues are impossible. “Durules” in the name of the drug means a unique technology for its production. And these are not loud words from just another manufacturer on the pharmaceutical market: this exclusive technology ensures a gradual release of the active substance from the “tight embrace” of the dosage form over a long period of time (the so-called controlled release). The tablet has a plastic base, which is completely inactive in the presence of digestive enzymes, but at the same time completely decomposes under the influence of wave-like contractions of the intestinal walls. This ensures the release of iron ions and the uniformity of their entry into the systemic circulation. The second component of the drug - vitamin C - improves the absorption of iron in the digestive tract. Conventional iron supplements look rather pale compared to Sorbifer Durules: the latter provides 30% better absorption and bioavailability of iron. Absorption occurs mainly in the duodenum and upper small intestine. The half-life of the drug is six hours. The tablets should only be swallowed whole: they should not be divided and/or chewed. The volume of liquid used to wash down the tablet must be at least 100 ml. Single dose - 1 tablet.
The frequency of administration is 1-2 times a day. According to indications, the dose can be doubled. The duration of taking the drug depends on the time it takes to reach an acceptable hemoglobin level. Sorbifer Durules has a favorable safety profile and rarely exhibits side effects. And if they develop, then most often they affect the digestive system (dyspeptic symptoms and, very rarely, esophageal ulcers) and the central nervous system. Sorbifer Durules is contraindicated for use in cases of narrowing of the esophagus or any other part of the digestive tract, excess iron in the body (including due to impaired iron utilization), and individual intolerance to the components of the drug. Pregnancy and lactation are not a contraindication to taking Sorbifer Durules: on the contrary, during this period its use is often necessary to prevent the possible development of iron deficiency anemia. In pediatric practice, the drug is approved for use in patients over 12 years of age. To prevent an overdose, you need to know its main symptoms: pain in the abdomen, diarrhea and vomiting streaked with blood, increased fatigue, pale skin, cold sweat, bradycardia. If one or more signs of iron overdose appear, you should immediately consult a doctor. Sorbifer Durules is not recommended to be combined with individual antibacterial drugs: ciprofloxacin (Tsipraxil, Rocil, Tsifratsid, Tsiprolet, Ecotsifol), doxycycline (Unidox, Xedocin, Vidoccin), norfloxacin (Norilet, Norfacin, Norbactin) and ofloxacin (Ashof, Ofloxin).
Pharmacology
Iron is an essential component of the body, necessary for the formation of hemoglobin and the occurrence of oxidative processes in living tissues. The drug is used to eliminate iron deficiency.
Durules technology provides a gradual release of the active ingredient (iron ions) over a long period of time. The plastic matrix of Sorbifer Durules tablets is completely inert in the digestive juice, but completely disintegrates under the action of intestinal peristalsis, when the active ingredient is completely released.
Ascorbic acid helps improve iron absorption.
Pharmacokinetics
Suction
Durules is a technology that ensures a gradual release of the active substance (iron ions) and a uniform supply of the drug. Taking 100 mg 2 times a day provides 30% greater absorption of iron from Sorbifer Durules compared to conventional iron preparations.
Absorption and bioavailability of iron are high. Iron is absorbed primarily in the duodenum and proximal jejunum.
Distribution
Connection with plasma proteins - 90% or more. Deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in muscles.
Removal
T 1/2 is 6 hours.
Release form
Light yellow, round, biconvex, film-coated tablets, engraved with “Z” on one side; at the break there is a gray kernel with a characteristic odor.
Excipients: magnesium stearate, povidone K-25, polyethylene powder, carbomer 934R.
Shell composition: hypromellose, macrogol 6000, titanium dioxide, yellow iron oxide, solid paraffin.
30 pcs. - dark glass bottles (1) - cardboard packs.
50 pcs. - dark glass bottles (1) - cardboard packs.
Dosage
I take the drug orally. Film-coated tablets should not be split or chewed. The tablet should be swallowed whole and washed down with at least half a glass of liquid.
Adults and adolescents are prescribed 1 tablet. 1-2 times/day. If necessary, for patients with iron deficiency anemia, the dose can be increased to 3-4 tablets/day in 2 doses (morning and evening) for 3-4 months (until the iron depot in the body is replenished).
During pregnancy and lactation, for the purpose of prevention, 1 tablet/day is prescribed; For treatment, 1 tablet is prescribed. 2 times/day (morning and evening).
Treatment should be continued until the optimal hemoglobin level is achieved. To further replenish the depot, you may need to continue taking the drug for another 2 months.
Overdose
Symptoms: abdominal pain, vomiting and diarrhea mixed with blood, fatigue or weakness, hyperthermia, paresthesia, pale skin, cold clammy sweat, acidosis, weak pulse, decreased blood pressure, palpitations. In case of severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma may appear after 6-12 hours.
Treatment: in case of overdose, consult a doctor immediately. It is necessary to rinse the stomach, inside - a raw egg, milk (to bind iron ions in the gastrointestinal tract); deferoxamine is administered. Symptomatic therapy.
Interaction
Sorbifer Durules may reduce the absorption of concomitantly administered enoxacin, clodronate, grepafloxacin, levodopa, levofloxacin, methyldopa, penicillamine, tetracyclines and thyroid hormones.
The simultaneous use of Sorbifer Durules and antacid preparations containing aluminum hydroxide and magnesium carbonate may reduce the absorption of iron. The maximum possible time interval should be maintained between taking Sorbifer Durules and any of these drugs. The recommended minimum time interval between doses is 2 hours, except when taking tetracyclines, when the minimum interval should be 3 hours.
Sorbifer Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.
- esophageal stenosis and/or other obstructive changes in the digestive tract;
- increased iron content in the body (hemosiderosis, hemochromatosis);
- impaired iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia);
- children under 12 years of age (due to lack of clinical data);
- hypersensitivity to the components of the drug.
The drug should be used with caution in case of gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).
Features of application
Use during pregnancy and breastfeeding
It is possible to use the drug Sorbifer Durules during pregnancy and lactation according to indications.
Use in children
The drug is contraindicated in children and adolescents under 12 years of age.Special instructions
When using the drug, darkening of the stool is possible, which has no clinical significance.
Ferrous sulfate + Ascorbic acid
