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

Reduced performance, Weakness and fatigue, Anemia, Prevention of iron deficiency

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

Active ingredient

Iron sulfate, ascorbic acid

Composition

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

Associates:

magnesium stearate,

povidone K-25,

polythene powder,

carbomer 934P.

Composition of the shell:

Hypromellose,

MacroGol 6000,

titanium dioxide,

iron oxide yellow,

paraffin hard.

How to take, the dosage

Coated tablets are taken orally.
They should not be divided or chewed.
Tablet should be swallowed whole and drink at least half a glass of liquid. Adults and adolescents:

1 tablet 1-2 times a day. If necessary, for patients with iron deficiency anemia, the dose can be increased to 3-4 tablets a day in two doses (morning and evening) for 3-4 months (until the replenishment of iron depot in the body).

During pregnancy and lactation:

Prevention: 1 tablet a day.

Therapeutic dose: 1 tablet 2 times a day (morning and evening). The treatment should be continued until the optimal level of hemoglobin is achieved. For further depot replenishment it may be necessary to continue taking the drug for another 2 months.

Interaction

Durules may reduce absorption of concomitantly used enoxacin, clodronate, grepafloxacin, levodopa, levofloxacin, methyldopa, penicillamine, tetracyclines and thyroid hormones.

Simultaneous administration of Sorbifer Durules and antacids containing aluminum hydroxide and magnesium carbonate may decrease iron absorption.

The longest possible interval between taking Sorbifer Durules and any of these drugs should be observed.

The recommended minimum 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.

Special Instructions

Effective only in iron deficiency anemia and ineffective in anemia of other etiologies.

Contraindications

• High sensitivity to the ingredients of the drug.
• Oesophageal stenosis and/or obstructive changes in the digestive tract.
• Elevated iron levels in the body (hemosiderosis, hemochromatosis).
• Iron utilization disorders (lead anemia, sideroblastic anemia, hemolytic anemia).
• children under 12 years of age (due to lack of clinical data).

With caution: gastric and duodenal ulcer, inflammatory bowel disease (enteritis, diverticulitis, ulcerative colitis, Crohn’s disease).

Side effects

Nausea, vomiting, abdominal pain, diarrhea, constipation.

The frequency of gastrointestinal side effects may increase with increasing doses from 100 to 400 mg.

Rarely (<1/100) the following side effects may be observed: esophageal ulceration, esophageal stenosis, allergic reactions (itching, rash), skin hyperthermia, headache, dizziness, weakness.

Overdose

Symptoms: abdominal pain, vomiting and diarrhea with blood admixture, fatigue or weakness, hyperthermia, parasthesias, pale skin, cold clammy sweat, acidosis, weak pulse, decreased blood pressure, palpitation.

In severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma may occur in 6-12 hours.

Treatment:In case of overdose seek immediate medical attention. It is necessary to flush the stomach, ingestion of raw egg, milk (to bind iron ions in the gastrointestinal tract); administer deferoxamine. Symptomatic therapy.