Properties
What is it?
International Nonproprietary Name - Ferrous gluconate Trade Name: Tot'hema®. Dosage Form: Oral solution in ampoules. Composition: Active substances: Ferrous gluconate, quantity corresponding to 50 mg of elemental iron, manganese gluconate, quantity corresponding to 1.33 mg of elemental manganese, copper gluconate, quantity corresponding to 0.70 mg of elemental copper. Excipients: Glycerol, liquid glucose, sucrose (3 g/ampoule), anhydrous citric acid, sodium citrate, sodium benzoate, polysorbate 80, caramel color TPS 150c, "tutti-frutti" flavoring, demineralized water. Description: Dark brown liquid with a characteristic odor. Pharmacotherapeutic Group: Iron-containing preparation. Indications: Treatment of iron-deficiency anemia. Prevention of iron-deficiency anemia in at-risk patients (pregnant women, premature infants, twins, newborns born to mothers with iron-deficiency anemia) when iron intake from food is insufficient. Contraindications: Anemia not caused by iron deficiency; hemochromatosis, hemosiderosis; peptic ulcer disease of the duodenum and stomach during exacerbation; zinc poisoning; hypersensitivity to any component of the preparation; children under three years of age. Dosage regimen: Treatment: Adults: 100-200 mg iron - 2-4 ampoules per day. Children over 3 years of age: 3-7 mg elemental iron/kg body weight/day in 2-4 divided doses. Prophylactic treatment: Pregnant women: 1 ampoule per day for the last six months (starting from 4 months). Treatment efficacy should be checked three months after the start of treatment. Method of administration: The ampoule heads are broken off by hand without the use of a file. For safety, use the cardboard part of the box. The contents of the preparation should be dissolved in clean or sweetened water, or any other non-alcoholic beverage (juice, etc.). It is best to take the preparation before meals, but the timing of administration and possibly the dosage regimen should be chosen considering the patient's individual tolerance. The medicinal solution should be used within 24 hours after opening. Side effects: Possible complaints from the gastrointestinal system (heartburn, constipation or diarrhea), black stools are considered a normal event, darkening of tooth enamel. Overdose: Symptoms: nausea, vomiting, diarrhea, epigastric pain. Cases of gastrointestinal tract necrosis and shock have been described. Treatment: gastric lavage with a 1% sodium bicarbonate solution. If blood iron concentration exceeds 5 mg/ml, deferoxamine should be administered. In case of shock, anti-shock therapy should be carried out. Interactions with other drugs: Tot'hema® reduces the absorption of bisphosphonates, ciprofloxacin, tetracyclines. Magnesium, calcium, and aluminum salts reduce the absorption of iron salts. Simultaneous treatment with these drugs with Tot'hema® is not recommended, or if these drugs are taken, a 2-hour interval should be observed. Simultaneous use of Tot'hema® and other injectable iron preparations is not recommended. Special instructions: High intake of tea and coffee during treatment reduces iron absorption; to avoid darkening of tooth enamel, do not hold the preparation in the mouth for a long time; consider that one ampoule contains 3 g of sucrose. Dosage form: One cardboard box contains 20 ampoules, each containing 10 ml of medicinal solution and instructions for use. Dispensing: By prescription. Storage conditions: Store the preparation in a dry, cool place at room temperature not exceeding 250C. Keep out of reach of children.