Tothema, ampoules, 10 ml, 20 pcs.

Composition

1 amp.

• iron (elemental, in the form of iron gluconate dihydrate) 50 mg
• manganese (elemental, in the form of manganese gluconate) 1.33 mg
• copper (elemental, in the form of copper gluconate) 700 mcg

Auxiliary substances:

glycerol is 2.52 g,

dextrose (glucose) – 80 mg,

sucrose 3 g

citric acid anhydrous – 27.4 mg,

sodium citrate dihydrate – 30 mg,

sodium benzoate,20 mg,

Polysorbate 80 and 24 mg,

TPS caramel coloring (E150 a) – 50 mg,

flavoring “tutti-Frutti” – 20 µl

distilled water up to 10 ml.

Pharmacological action

Antianemic, replenishing iron deficiency.

Pharmacodynamics

Combined drug. Contains iron, which is necessary for the synthesis of heme, which is part of hemoglobin, myoglobin, flavoproteins, iron — ferritin and iron — transferrin complexes, various enzymes; participates in a number of redox reactions.

Copper and manganese are trace elements and are cofactors of some enzymes.

Absorption of iron and trace elements occurs mainly in the duodenum and upper jejunum. Absorption is more intense, the greater the iron deficiency in the body.

When taking the drug, there is a gradual regression of clinical and laboratory symptoms of anemia.

Indications

Prevention and treatment of iron deficiency anemia in adults and children from 3 months of age, caused by various causes:

• bleeding;
• increased need for iron (pregnancy);
• insufficient intake of iron from food or a violation of its absorption.

Use during pregnancy and lactation

It is allowed to use the drug during pregnancy and lactation according to indications in the recommended doses.

Use in children

Contraindication: children under 3 months of age.

Contraindications

• hypersensitivity to the components of the drug;
• anemia, not associated with iron deficiency;
• hemochromatosis, hemosiderosis;
• thalassemia;
• peptic ulcer of the stomach and duodenum in the acute stage;
• lead intoxication;
• intoxication with copper or manganese, Wilson’s disease-Konovalov;
• sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution, the drug should be prescribed for diabetes mellitus.

Side effects

From the digestive system: 

• fecal staining in black (is the norm);
• heartburn; nausea;
• vomiting;
• diarrhea;
• constipation;
• epigastric pain;
• darkening of tooth enamel.

Other services: allergic reactions.

Interaction

Concomitant administration of Tothema reduces the absorption of bisphosphonates, ciprofloxacin, and tetracyclines when taken orally.

Salts, oxides and hydroxides of magnesium, aluminum and calcium disrupt the absorption of iron salts. You should take Tothema® not earlier than 2 hours after taking these medications.

Do not combine the drug with other iron preparations, including those administered parenterally.

How to take, course of administration and dosage

For the treatment of anemia, adults are prescribed the drug at the rate of 100-200 mg of iron (2-4 amp. )/day; children older than 3 months-at the rate of 5-7 mg/kg of body weight/day in 2-4 receptions.

The use of the drug is carried out under the control of the iron content in the blood serum, the total iron-binding ability of the serum before the start of treatment and in the future with a frequency of 1 time in 2 months.

For preventive purposes for adults and pregnant women (starting from the 4th month of pregnancy) assign 50 mg (1 amp. )/day. Children, depending on their age, are prescribed the drug at a dose of 1/4 to 1/2 of the daily therapeutic dose of adults.

The duration of treatment is determined individually. The average duration of taking the drug is from 3 to 6 months (until iron reserves in the body are restored).

Rules for the use of the drug

Shake thoroughly before use.

You should tear a piece of cardboard from the pack along the dotted line, bend it in half to safely break the tip of the ampoule. Break the ampoule on both sides, pour the contents of the ampoule into a glass, dissolve in plain or sweetened water.

Take orally, before meals.

Overdose

Symptoms: weakness, hyperthermia, convulsions, nausea, vomiting, constipation, diarrhea, epigastric pain. Cases of necrosis of the gastrointestinal tract walls and shock are described.

Treatment: gastric lavage with a 1% solution of sodium bicarbonate (baking soda).

When the concentration of iron in the blood serum is more than 5 mcg/ml, deferoxamine is administered intravenously slowly: children – 15 mg / kg / h, adults-5 mg / kg / h (up to 80 mg/kg/day); with mild poisoning in/m: children – 1 g every 4-6 hours, adults – 50 mg/kg (up to 4 g/day); symptomatic therapy is performed; if shock occurs, anti-shock therapy is performed.

Special instructions

Monitoring of the effectiveness of treatment should be carried out no earlier than 3 months after the start of treatment.

Excessive tea consumption suppresses iron absorption.

To avoid darkening of the tooth enamel, avoid prolonged exposure of the drug solution in the oral cavity.

Patients with diabetes should take into account that 10 ml of the drug contains 3 g of sucrose.

In 1 ampoule of the drug contains 1/4 XE, in the maximum daily dose (in 4 ampoules of the drug) 1 XE.

During treatment with iron preparations, patients may experience black feces, but this does not require medical intervention. During treatment with iron preparations, a stool test for hidden blood can give a false positive result.

Influence on the ability to drive motor vehicles and manage mechanisms

There are no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.

Form of production

Solution

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Iron gluconate, Manganese gluconate, Copper gluconate

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral administration

Description

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children older than 3 months, Adults as prescribed by a doctor

Indications

Anemia, Iron Deficiency Prevention

Weight

Weight: 394 g.