Metformin, 1000 mg 60 pcs

Special Instructions

Lactoacidosis

Lactoacidosis is a rare but serious (high mortality if not treated urgently) complication that can occur due to metformin cumulation. Cases of lactoacidosis when taking metformin have occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

The risk of lactoacidosis should be considered if nonspecific signs, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain, and marked asthenia, are present. Lactoacidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia, followed by coma. Diagnostic laboratory indicators are decreased blood pH (less than 7.25), plasma lactate content over 5 mmol/l, elevated anion gap and lactate/pyruvate ratio.

If metabolic acidosis is suspected, discontinue the drug and see a physician immediately.

Surgical surgeries

The use of metformin should be discontinued 48 hours before elective surgical procedures and may be continued no earlier than 48 hours after, provided that renal function has been found to be normal during examination.

The drug Metformin should be changed to another hypoglycemic drug (e.g., insulin) 48 hours before an IV radiology exam and continued for another 48 hours after that exam.

Renal function

Because metformin is excreted by the kidneys, CK should be determined before treatment and regularly thereafter: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, and in patients with CK at the lower end of normal.

Particular caution should be exercised if renal function may be impaired in elderly patients, if hypotensive drugs, diuretics, or nonsteroidal anti-inflammatory drugs are used concomitantly.

Application in children and adolescents

The diagnosis of type 2 diabetes must be confirmed before starting treatment with metformin.

In 1-year clinical trials, metformin has not been shown to affect growth and puberty. However, because of the lack of long-term data, close monitoring of the subsequent effects of metformin on these parameters in children, especially during puberty, is recommended. The most careful monitoring is necessary in children aged 10-12 years.

Other precautions

Patients are advised to continue on a diet with an even carbohydrate intake throughout the day. Patients who are overweight are recommended to continue on a hypocaloric diet (but at least 1000 kcal/day).

It is recommended that regular standard laboratory tests be performed to control diabetes.

The drug is not recommended if there is a risk of dehydration.

Metformin does not cause hypoglycemia during monotherapy, but caution is recommended when using it in combination with insulin or other hypoglycemic agents (e.g., sulfonylurea derivatives, repaglinide). In case of concomitant treatment it is necessary to control blood glucose concentration carefully.

Influence on driving and operating machinery

Monotherapy with the drug does not cause hypoglycemia and therefore does not affect driving and operating machinery. Patients should be cautioned about the risk of hypoglycemia when using metformin in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide, etc.), which impair the ability to drive vehicles and engage in other potentially dangerous activities that require increased alertness and quick psychomotor reactions.

Synopsis

Dosage 1000 mg: film-coated tablets, white or almost white, oblong, biconvex with a ridge on one side.

Contraindications

• High sensitivity to metformin and/or any excipient of the drug;
• diabetic ketoacidosis, diabetic precoma, coma;
• renal insufficiency (creatinine clearance (CK) less than 60 ml/min);
• disordered liver function;
• clinical manifestations of acute and chronic diseases that may lead to tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction);
application less than 48 hours before and within 48 hours after radioisotopic or radiological studies with iodine-containing contrast agent;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• chronic alcoholism, acute alcohol poisoning;
• hypocaloric diet (less than 1000 kcal/d);
lactoacidosis (including anamnesis);
• acute conditions with risk of renal dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
• extensive surgical operations and trauma when insulin therapy is indicated (see
• pregnancy
• children under 10 years of age.

Cautions

The drug should be used in persons over 60 years of age who have heavy physical work because of increased risk of lactoacidosis; during breastfeeding.

Side effects

The frequency of side effects of the drug is rated as follows: very frequently: > 1/10; frequently: 1/10-1/100; infrequently: 1/100-1/1000; rarely: 1/1000-1/10000; very rarely: < 1/10000.

Metabolic and nutritional disorders

Very rare: lactoacidosis (see section “Special Precautions”).

Long-term use of metformin may result in decreased absorption of vitamin B12. If megaloblastic anemia is detected, the possibility of this etiology should be considered.

Nervous system disorders

Often: impaired taste.

Gastrointestinal disorders

Very common: nausea vomiting diarrhea lack of appetite abdominal pain.

These side effects often occur during the initial period of treatment and in most cases go away spontaneously when continued. To reduce side effects, it is recommended that the drug be taken with or after meals. Slowly increasing the dose may improve gastrointestinal tolerance.

Hepatic and biliary tract disorders

Very rare: impaired liver function and hepatitis. After withdrawal of metformin, these adverse events disappear completely.

Skin and subcutaneous tissue disorders

Very rare: skin reactions such as erythema pruritus rash.

Published post-marketing data and controlled clinical studies in a limited pediatric population in the 10-16 year age group show that side effects in children are similar in nature and severity to those in adult patients.

Overdose

Symptoms: when using metformin at a dose of 85 g (42.5 times the maximum daily dose) hypoglycemia was not observed, but the development of lactoacidosis was noted. Significant overdose of metformin or associated risk factors may lead to the development of lactoacidosis (see “Cautionary Note”). Treatment: in case of signs of lactocidosis, the drug treatment should be stopped immediately, the patient should be urgently hospitalized and, after determining the lactate concentration, the diagnosis should be specified. The most effective measure for lactate and metformin elimination from the body is hemodialysis. Symptomatic treatment is also carried out.

Pregnancy use

Decompensated diabetes mellitus during pregnancy is associated with an increased risk of birth defects and perinatal mortality.

Limited data suggest that metformin administration in pregnant women does not increase the risk of birth defects in children.

If pregnancy is planned or if pregnancy occurs while taking metformin for prediabetes or type 2 diabetes, the drug should be withdrawn and insulin therapy should be prescribed. Plasma glucose levels should be maintained as close to normal as possible to reduce the risk of fetal malformations.

Metformin passes into breast milk. No adverse effects have been observed in infants during breastfeeding while taking metformin. However, due to the limited data, it is not recommended to use the drug during breastfeeding. The decision to discontinue breastfeeding should be made taking into account the benefits of breastfeeding and the potential risk of side effects in the baby.

Similarities

Siofor 500, Siofor 850, Metformin-Teva, Siofor 1000, Glucofage Long, Formetin, Metformin, Merifatin