2010/06/16

Bagomet

Composition, structure and packing

Tablets, coated white, round, biconvex, with two cross-positioned risks on one side and logo - on the other, on the break - the rough surface of white. 1 tab. metformin hydrochloride 500 mg.

Excipients: sodium croscarmellose, povidone, stearic acid, starch, corn, lactose monohydrate, purified water. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, gipromellozy, titanium dioxide and triacetin at a ratio of 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of from gipromellozy and polyethylene glycol in the ratio of 90:10), purified water, sodium saccharin.

Long-acting tablets, coated blue kapsulovidnye, with risks on the one side and logo - on the other, on the break - the rough surface of white. 1 tab. metformin hydrochloride 850 mg. Excipients: gipromelloza, povidone, magnesium stearate, alcohol, lactose monohydrate, methylene chloride. The composition of the shell: Opadry White YS-30-18056 (ready mix for the shell, consisting of lactose, gipromellozy, titanium dioxide and triacetin in the ratio 40:40:10:10), Opadry clear YS 1-7006 (ready mix for the shell, consisting of from gipromellozy and polyethylene glycol in the ratio of 90:10), purified water, sodium saccharin, vanilla, food coloring Brilliant Blue.

Clinico-pharmacological group: oral hypoglycemic drug.

Pharmacological action

Hypoglycemic drug from the biguanide group. Hinders gluconeogenesis in the liver, reducing glucose absorption from the intestine, enhances the peripheral utilization of glucose and increases the sensitivity of tissues to insulin. It has no effect on the secretion of insulin β-cells of the pancreas. Bagomet reduces the level of TG and cholesterol in the blood.

It is easy anorectics effect, which helps patients in a diet, stabilize or reduce body weight. It improves the fibrinolytic properties of blood through the suppression of tissue plasminogen activator inhibitor type.

Pharmacokinetics

Absorption and distribution

After oral administration, metformin is absorbed from the gastrointestinal tract. Bioavailability after taking the standard dose is 50-60%. Cmax in plasma obtained 2 h after ingestion. Practically not bound to plasma proteins. Accumulates in the salivary glands, liver and kidneys.

Withdrawal

Provided in an unmodified form buds. T1 / 2 is approximately 6.5 hours

Pharmacokinetics in special clinical situations

When violations of kidney function is possible cumulation of the drug.

Statement
Type 2 diabetes patients without a tendency to ketoacidosis during inefficiency diet (especially in individuals with obesity).

Dosage regimen

Install individually depending on the level of glucose in the blood. The initial dose is 0.5-1 g / day. After 10-15 days, possibly a further gradual increase in the dose depending on the level of glucose in the blood. Maintenance dose is usually 1.5-2 g / day. Maximum dose - 3 g / day. To reduce the side effects on the digestive system, the daily dose should be divided into 2-3 reception.

In elderly patients the recommended daily dose should not exceed 1 g.

In severe violations of the metabolism of a dose

Bagometa should be reduced (due to increased risk of laktatsidoza),. Tablets should be taken entirely Bagometa during or immediately after a meal, washed down with a little liquid (a glass of water).

Side effect
On the part of the digestive system: nausea, vomiting, metallic taste in the mouth, anorexia, diarrhea, flatulence, abdominal pain.
On the part of the hemopoietic system: in some cases - megaloblastic anemia.
From the Endocrine: hypoglycemia (when used in inadequate doses), in rare cases, laktatsidoz (requires treatment).

Allergic reactions: skin rash.

Other: long-term use - hypovitaminosis B12 (due to malabsorption).

Contraindications
diabetic ketoacidosis;
diabetic precoma;
coma;
pronounced renal dysfunction;
liver problems;
cardiac and respiratory failure;
acute phase of myocardial infarction;
acute ischemic stroke;
dehydration;
laktatsidoz (including history);
chronic alcoholism and other conditions that may contribute to the development laktatsidoza;
major surgery and trauma (when shown an insulin);
acute alcohol poisoning;
application for at least 2 days before and within 2 days after the application of radioisotope iodine or radiopaque agents;
adherence to a strict diet (less than 1000 kcal / day).
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug.

Do not appoint a drug to persons over 60 years of performing heavy physical load (due to an increased risk of laktatsidoza).

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindications disturbancies liver function.

Application for violations of renal function

Contraindications disturbancies renal function.

Cautions

During the period of treatment should monitor renal function. Need to monitor lactate levels at least 2 times a year, as well as the appearance of myalgia.

Can be used Bagometa in combination with sulfonylurea derivatives. In this case, requires particularly careful monitoring of blood glucose.

At the use of ethanol in the background of

Bagometa may develop laktatsidoza.

Overdose

Symptoms: may develop laktatsidoza fatal (for reasons of development may also apply cumulation of the drug due to renal dysfunction). The early symptoms include nausea, vomiting, diarrhea, lowering of body temperature, abdominal pain and muscle, and in the future may be quickening of breath, dizziness, impaired consciousness and the development of coma.

Treatment: immediate repeal of the drug, the patient should be hospitalized immediately and determine the concentration of lactate. Most effective hemodialysis. If necessary, a symptomatic therapy.

Combined therapy with Bagometa Sulfonylureas possible hypoglycemia.

Drug Interactions

With the simultaneous use of derivatives sulfonylureas, acarbose, insulin, NSAIDs, inhibitors of MAO, oxytetracycline, ACE inhibitors, derivatives of clofibrate, cyclophosphamide, beta-blockers may be increased hypoglycemic action of metformin.

When applied simultaneously with the SCS, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormone, thiazide and loop "diuretics, phenothiazine derivatives, derivatives of nicotinic acid may decrease hypoglycemic action of metformin.

With simultaneous application of cimetidine slows the excretion of metformin, which increases the risk of laktatsidoza. With simultaneous use of metformin can reduce the effect of anticoagulants (coumarin derivatives).

Terms and Conditions of storage

List B. The drug should be stored in a dry, protected from light and the reach of children, at up to 25 ° C. Shelf life - 2 years.