Product Overview
Structure
1 tablet contains 320 mg iron sulfate, which is equivalent to a Fe 2+ content of 100 mg; ascorbic acid (vit. C) 60 mg.
Excipients:
magnesium stearate,
povidone K-25,
polyethylene powder
carbomer 934��.
Shell composition :
hypromellose,
macrogol 6000,
titanium dioxide
iron oxide yellow,
hard paraffin.
pharmachologic effect
Pharmacotherapeutic group:
iron preparation
ATX code:
B03A A07
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Iron is an irreplaceable component of the body necessary for the formation of hemoglobin and the course of oxidative processes in living tissues. The drug is used to eliminate iron deficiency. Durules technology provides a phased release of the active ingredient (iron ions) for a long time.
The plastic matrix of Sorbifer Durules tablets is completely inert in the digestive juice, but completely disintegrates under the action of intestinal motility, when the active ingredient is completely released.
Pharmacokinetics
Durules is a technology that provides a gradual release of the active substance (iron ions), a uniform flow of the drug. Reception of 100 mg twice a day provides 30% greater absorption of iron from the drug Sorbifer Durules compared with conventional iron preparations.
The absorption and bioavailability of iron are high. Iron is absorbed predominantly in the duodenum 12 and the proximal jejunum. Communication with plasma proteins -90% or more. It is deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the phagocytic macrophage system, a small amount in the form of muscle myoglobia. The half-life is 6 hours.
Indications
- Iron-deficiency anemia.
- Iron deficiency.
- Prophylactic use in pregnancy, lactation and in blood donors.
Contraindications
- 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).
- Violation of iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia).
- Children under 12 years of age (due to lack of clinical data).
Side effects
Nausea, vomiting, abdominal pain, diarrhea, constipation.
The frequency of side effects from the gastrointestinal tract may increase with increasing doses from 100 to 400 mg.
Rarely (<1/100) can the following side effects be observed: peptic ulcer of the esophagus, esophageal stenosis, allergic reactions (itching, rash), skin hyperthermia, headache, dizziness, weakness.
Interaction
Durules can reduce the absorption of the simultaneously used enoxacin, clodronate, grefafloxacin, levodopa, levofloxacin, methyldopa, penicillamine, tetracyclines and thyroid hormones.
The simultaneous use of the drug Sorbifer Durules and antacids containing aluminum hydroxide and magnesium carbonate can reduce iron absorption.
Between taking Sorbifer Durules and any of these drugs should withstand the maximum possible time interval.
The recommended minimum time interval between doses is 2 hours, except for cases of 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.
The simultaneous use of the drug Sorbifer Durules and antacids containing aluminum hydroxide and magnesium carbonate can reduce iron absorption.
Between taking Sorbifer Durules and any of these drugs should withstand the maximum possible time interval.
The recommended minimum time interval between doses is 2 hours, except for cases of 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.
How to take, course of administration and dosage
Coated tablets are taken orally.
They can not be divided or chewed.
The tablet should be swallowed whole and washed down with at least half a glass of liquid. Adults and teenagers:
1 tablet 1-2 times a day. If necessary, patients with iron deficiency anemia, the dose can be increased to 3-4 tablets per day for two doses (morning and evening) for 3-4 months (until the iron depot in the body is replenished).
During pregnancy and lactation:
Prevention: 1 tablet per day.
Therapeutic dose: 1 tablet 2 times a day (morning and evening). Treatment should be continued until an optimal hemoglobin level is achieved. For further replenishment of the depot, you may need to continue taking the drug for another 2 months.
They can not be divided or chewed.
The tablet should be swallowed whole and washed down with at least half a glass of liquid. Adults and teenagers:
1 tablet 1-2 times a day. If necessary, patients with iron deficiency anemia, the dose can be increased to 3-4 tablets per day for two doses (morning and evening) for 3-4 months (until the iron depot in the body is replenished).
During pregnancy and lactation:
Prevention: 1 tablet per day.
Therapeutic dose: 1 tablet 2 times a day (morning and evening). Treatment should be continued until an optimal hemoglobin level is achieved. For further replenishment of the depot, you may need to continue taking the drug for another 2 months.
Overdose
Symptoms: abdominal pain, vomiting and diarrhea with an admixture of blood, fatigue or weakness, hyperthermia, parasthesia, pallor of the skin, cold clammy sweat, acidosis, weak pulse, decreased blood pressure, palpitations.
In severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma can occur 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 digestive tract); deferoxamine is administered. Symptomatic Therapy
In severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma can occur 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 digestive tract); deferoxamine is administered. Symptomatic Therapy
Special instructions
It is effective only for iron deficiency anemia and ineffective for anemia of another etiology.
Avoid concurrent administration with other iron-containing drugs (risk of overdose).
Storage conditions
In a dry, dark place at a temperature of no higher than 20 ° C.
Shelf life
3 years.