Tothema (Ferrous gluconate) 10ml 20 vials

The composition and form of issue: 

The oral solution. 10 ml contains:

iron (as gluconate) 50 mg

manganese (as gluconate) of 1.33 mg

copper (as gluconate) 0.7 mg

excipients: glycerol liquid glucose sucrose (3 g/amp.) citric acid anhydrous sodium citrate sodium benzoate Polysorbate 80 dye caramel TPS (Е150с) flavor “tutti – Frutti” water demineralized

in dark glass ampoules of 10 ml in cartons of 20 ampoules.

Description pharmaceutical form:

Dark brown liquid with a characteristic odor.

Pharmacokinetics:

Absorption of elements occurs in the proximal small intestine.

Description pharmacological action:

Iron is essential for the synthesis of heme, part of hemoglobin, myoglobin and other metalloproteins of the body, is involved in redox processes. Copper and manganese is an important part of enzyme systems involved in the major redox processes in the body.

While taking the drug there is a gradual regression of clinical and laboratory symptoms of anemia caused by a deficiency of these metals (trace elements).

Indications:

• treatment of iron deficiency anemia
• prevention of iron-deficiency States in individuals from high risk groups (pregnant women, children, adolescents, women of reproductive age, the elderly), in the case where there is no possibility to ensure a sufficient intake of iron from food.

Contraindications:

• hypersensitivity to the drug
• anaemia not related to iron deficiency
• iron overload (hemochromatosis, hemosiderosis)
• ulcers disease stomach and duodenal ulcer in the acute stage
• lead poisoning
• children under 3 years.

Side effects:

On the part of the digestive tract: the staining of stool in black, gastro-intestinal disorders — heartburn, nausea, vomiting, constipation or diarrhoea, epigastric pain, darkening of the tooth enamel.

Drug interactions:

The totem reduces the absorption of bisphosphonates, ciprofloxacin, tetracycline. Salts, oxides and hydroxides of magnesium, aluminum and calcium disrupt the absorption of iron salts. You should take the drug Totem no earlier than 2 h after administration of these drugs.

It is impossible to combine the Totem with other iron preparations, including parenterally administered.

Method of application and dose:

Inside, preferably before meals, previously the contents of the ampoule are dissolved in plain or sweetened water, or some other soft drink. Mode of ingestion, and dosage are adjusted depending on patient response. The contents of the vial should be used within 24 hours after opening it.

Treatment

Adults: 100-200 mg iron (2-4 amp.) a day.

Children older than 3 years at the rate of 3-7 mg/kg/day in 2-4 reception.

Prophylactic use: during pregnancy — 1 amp. a day in the last 6 months of pregnancy (from 4th month).

The duration of intake of the drug to restore the iron reserves in the body, usually 3-6 months.

Monitoring the effectiveness of treatment should be carried out not earlier than 3 months after the start of treatment.

Overdose:

Symptoms: nausea, vomiting, diarrhea, epigastric pain, described cases of necrosis of the gastrointestinal tract and shock.

Treatment: gastric lavage with 1% solution of baking soda with increasing of iron concentration in plasma over 5 mg/ml — appointment of deferoxamine. If you experience a state of shock — holding antishock therapy.

Special instructions:

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

Excessive consumption of tea inhibits iron absorption.

In order to avoid darkening of the enamel of the teeth is necessary to avoid long-term solution of the drug in the oral cavity.