Totema, 10 ml 20 pcs.

Antianemic, replenishing iron deficiency.

Pharmacodynamics

A combined drug. It 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; it participates in a number of redox reactions.

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

The absorption of iron and trace elements occurs primarily 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

Low performance, Weakness and fatigue, Pale skin, Prevention of iron deficiency, Anemia

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

• bleeding;
• increased need for iron (pregnancy);
• insufficient iron intake with food or impaired iron absorption.

Active ingredient

Iron gluconate, Manganese gluconate, Copper gluconate

Composition

1 ampoule

• 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 µg

Associates:

Glycerol – 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 – 24 mg,
.

Caramel coloring TPS (E150c) – 50 mg,

Tutti-frutti flavoring – 20 µl,

Purified water – up to 10 ml.

How to take, the dosage

For treatment of anemia the preparation is prescribed at the rate of 100-200 mg of iron (2-4 ampoules)/day in adults; 5-7 mg/kg of body weight/day in 2-4 doses in children over 3 months.

The preparation is used under control of serum iron content and total serum iron-binding capacity before the start of treatment and at intervals of 1 every 2 months thereafter.

With prophylactic purpose for adults and pregnant women (from the 4th month of pregnancy) 50 mg (1 amp./day) is indicated. For children, depending on their age the drug is prescribed in a dose that is 1/4 to 1/2 of the daily therapeutic dose for adults.

The duration of treatment is determined individually. Average duration of preparation from 3 to 6 months (till restoration of iron reserves in a body).

The rules of administration of the drug

Shake before use.

Tear off on the dotted line a piece of cardboard from the package, bend it in half to break the tip of the ampoule safely. 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.

Interaction

The concomitant use of Totem® leads to decreased absorption of bisphosphonates, ciprofloxacin, tetracyclines when taken orally.

The salts, oxides and hydroxides of magnesium, aluminum and calcium impair absorption of iron salts. Totem® should not be taken earlier than 2 hours after taking these drugs.

The drug should not be combined with other iron preparations, including those given parenterally.

.

Special Instructions

The efficacy of treatment should not be monitored until at least 3 months after the start of treatment.

Ingestion of tea inhibits iron absorption.

To avoid darkening of tooth enamel, prolonged exposure of the solution in the mouth should be avoided.

Patients with diabetes need to be aware that 10 ml of the product contains 3 g of sucrose.

One ampoule of the product contains 1/4 IU, the maximum daily dose (4 ampoules of the product) is 1 IU.

Patients may present with black stools during treatment with iron preparations; however, this does not require medical intervention. Fecal occult blood tests may give false positives during treatment with iron preparations.

Influence on the ability to drive and operate machinery

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

.

Contraindications

• high sensitivity to the components of the drug;
• anemias not related to iron deficiency;
• Hemochromatosis, hemosiderosis;
• thalassemia;
• Gastric and duodenal ulcer in the acute stage;
• lead intoxication;
• copper or manganese intoxication, Wilson-Conoval disease;
• sugar/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

The drug should be prescribed with caution in diabetes mellitus.

.

Side effects

The digestive system:

• black stool coloring (normal);
• purging; nausea;
• vomiting;
• diarrhea;
• constipation;
• pigastric pain;
• darkening of dental enamel.

Others: allergic reactions.

.

Overdose

Symptoms: weakness, hyperthermia, seizures, nausea, vomiting, constipation, diarrhea, epigastric pain. Cases of gastrointestinal wall necrosis and shock have been described.

Treatment: gastric lavage with 1% sodium bicarbonate solution (drinking soda).

When the concentration of iron in the blood serum is more than 5 µg/ml, deferoxamine is administered v/v slowly: children – 15 mg/kg/h, adults – 5 mg/kg/h (up to 80 mg/kg/day); in mild poisoning v/v children – 1 g every 4-6 hours, adults – 50 mg/kg/h (up to 4 g/day); symptomatic therapy is carried out; in case of shock, antishock therapy is carried out.

.

Pregnancy use

The drug is allowed to be used during pregnancy and lactation when indicated in the recommended doses.

Pediatric use

Contraindication: children under 3 months of age.

.