Sorbifer Douroules, 30 pcs.

Pharmacotherapeutic group: iron drug

ATX code: B03A A07 Pharmacological properties

Pharmacodynamics

Iron is an essential component of the body needed for the formation of hemoglobin and oxidation processes in living tissues. The drug is used to eliminate iron deficiency. Durules technology provides gradual release of active ingredient (iron ions) over a long period of time.

The plastic matrix of Sorbifer Durules tablets is completely inert in digestive juices, but completely disintegrates under the influence of intestinal peristalsis, when the active ingredient is completely released.

Pharmacokinetics

Durules is a technology that provides a gradual release of the active ingredient (iron ions), a uniform intake of the drug. Intake of 100 mg twice a day provides 30% higher iron absorption from Sorbifer Durules in comparison with common iron preparations.

Absorption and bioavailability of iron are high. Iron is absorbed mainly in the duodenum and proximal part of the jejunum. Binding to plasma proteins is 90% and more. It is deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the system of phagocytic macrophages, a minor amount is deposited in the form of myoglobia in muscles. The elimination half-life is 6 hours.

Indications

Iron deficiency anemia.
Iron deficiency.
Prophylactic use during pregnancy, lactation and in blood donors.

Pharmacological effect

Pharmacotherapeutic group: iron preparation

ATX code: B03A A07 PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

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.

Pharmacokinetics

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 twice a day provides 30% greater absorption of iron from Sorbifer Durules compared to conventional iron supplements.

Absorption and bioavailability of iron are high. Iron is absorbed primarily in the duodenum and proximal jejunum. Plasma protein binding -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 myoglobia in muscles. The half-life is 6 hours.

Special instructions

It is effective only for iron deficiency anemia and is ineffective for anemia of other etiologies.

Active ingredient

Ferrous sulfate, [Ascorbic acid]

Composition

1 tablet contains iron sulfate 320 mg, which is equivalent to Fe2+ 100 mg; ascorbic acid (vit. C) 60 mg.

Excipients:

magnesium stearate,

povidone K-25,

polyethene powder,

carbomer 934R.

Shell composition:

hypromellose,

macrogol 6000,

titanium dioxide,

iron oxide yellow,

paraffin paraffin

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).
Impaired iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia).
Children under 12 years of age (due to lack of clinical data).
With caution: peptic ulcer of the stomach and duodenum,
inflammatory bowel diseases (enteritis, diverticulitis, ulcerative
colitis, Crohn’s disease).

Side Effects

Nausea, vomiting, abdominal pain, diarrhea, constipation.

The incidence of gastrointestinal side effects may increase as the dose increases from 100 to 400 mg.

Rarely (<1/100), the following side effects may occur: ulcerative lesions of the esophagus, esophageal stenosis, allergic reactions (itching, rash), skin hyperthermia, headache, dizziness, weakness.

Interaction

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, where the minimum interval should be 3 hours. Sorbifer Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.

Overdose

Symptoms: abdominal pain, vomiting and diarrhea mixed with blood, fatigue or weakness, hyperthermia, parasthesia, pale 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 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.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 20 °C.

Shelf life

3 years.

Manufacturer

EGIS, Hungary