Composition, form of production and packaging
The tablets covered with a film shell of white color, round, biconcave, with two cross-arranged risks on one side and the company logo on the other.
1 tab.
metformin hydrochloride 500 mg
Excipients: sodium croscarmellose - 15 mg, povidone - 40 mg, stearic acid - 3.5 mg, corn starch - 50 mg, lactose monohydrate - qs up to 700 mg.
Sheath composition: opedrai white YS-30-18056 - 14 mg (lactose monohydrate 40%, hypromellose 40%, titanium dioxide (E171) 10%, triacetin 10%), opadrai transparent YS 1-7006 - 3.5 mg (hypromellose 90% macrogol (polyethylene glycol) 10%), sodium saccharinate - 0.07 mg.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Bagomet В® inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin. In this case, it has no effect on the secretion of insulin by beta cells of the pancreas. Reduces the level of triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.
PHARMACOKINETICS
After ingestion, Bagomet В® is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. C max in blood plasma is achieved after 2 hours after ingestion. Virtually does not bind to plasma proteins. It accumulates in salivary glands, liver and kidneys. It is allocated in an invariable kind by kidneys. T1/2 is approximately 6.5 h.
With violations of kidney function, cumulation of the drug is possible.
INDICATIONS
- Type 2 diabetes mellitus without a tendency to ketoacidosis (especially in patients with obesity) with ineffective diet.
DOSING MODE
The dose of the drug is set by the doctor individually depending on the level of glucose in the blood.
The initial dose is 500-1000 mg / day. After 10-15 days, a further gradual increase in dose, depending on the level of glycemia, is possible. The maintenance dose of the drug is usually 1500-2000 mg / day. The maximum dose is 3000 mg / day. To reduce side effects from the gastrointestinal fact, the daily dose should be divided into 2-3 doses.
In elderly patients, the recommended daily dose should not exceed 1000 mg.
Tablets Bagometa should be taken entirely during or immediately after meals, squeezed a small amount of liquid (a glass of water).
Due to the increased risk of developing lactic acidosis, the dose of Baghomet should be reduced in case of severe metabolic disturbances.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, "metallic" taste in the mouth, lack of appetite, diarrhea, flatulence, abdominal pain.
From the side of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment); with prolonged treatment - hypovitaminosis B12 (impaired absorption).
On the part of the organs of hematopoiesis: in some cases - megaloblastic anemia.
On the part of the endocrine system: hypoglycemia (when used in inadequate doses).
Allergic reactions: skin rash.
CONTRAINDICATIONS
- diabetic ketoacidosis, diabetic precoma, coma;
- severe renal dysfunction;
- cardiac and respiratory failure, acute phase of myocardial infarction, acute disturbance of cerebral circulation, dehydration, chronic alcoholism and other conditions that may contribute to the development of lactic acidosis;
- pregnancy and the period of breastfeeding;
- hypersensitivity to the drug;
- Serious surgical operations and trauma, when insulin therapy is indicated;
- a violation of liver function, acute alcohol poisoning;
- lactic acidosis (including in the anamnesis);
- use for at least 2 days before and within 2 days after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast agent;
- adherence to a hypocaloric diet (less than 1000 calories / day).
It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe impairment of kidney function.
During the treatment it is necessary to monitor the kidney function. With violations of kidney function, cumulation of the drug is possible.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in violations of liver function.
APPLICATION IN ELDERLY PATIENTS
It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.
In elderly patients, the recommended daily dose should not exceed 1000 mg.
SPECIAL INSTRUCTIONS
During the treatment it is necessary to monitor the kidney function. At least 2 times a year, as well as the appearance of myalgia should determine the content of lactate in the plasma. It is possible to use Bagomet in combination with sulfonylurea derivatives. In this case, a particularly careful monitoring of blood glucose levels is necessary.
OVERDOSE
With an overdose of Bagomet, lactoacidosis can develop with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lower body temperature, abdominal pain, muscle pain, there may be more rapid breathing, dizziness, impaired consciousness and coma development.
Treatment: In case of signs of lactic acidosis, treatment with Bagometh must be stopped immediately, the patient should be hospitalized immediately and, having determined the concentration of lactate, confirm the diagnosis. The most effective measure to remove lactate and Bagomet from the body is hemodialysis. Conduct also symptomatic treatment.
With combined therapy of Bagomet with drugs of sulfonylureas, hypoglycemia can develop.
DRUG INTERACTION
When used simultaneously with derivatives of sulfonylurea, acarbose, insulin, non-steroidal anti-inflammatory agents, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, ОІ-adrenoblockers, hypoglycemic action of Bagomet may be increased. When used simultaneously with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormone preparations, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, hypoglycemic action of Bagomet can be reduced. Cimetidine slows the excretion of the baguette, which increases the risk of developing lactic acidosis.
The baguet can weaken the effect of anticoagulants (coumarin derivatives). With the simultaneous use of alcohol may develop lactic acidosis.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry place, protected from light and out of reach of children, at a temperature of up to 25 В° C.
Shelf life - 2 years. The drug can not be used after the expiration date indicated on the packag
