Universal reference book for medicines
Product name: FORMIN PLIVA FORMIN PLIVA

Active substance: metformin

Type: Oral hypoglycemic drug

Manufacturer: PLIVA HRVATSKA (Croatia) manufactured by DRAGENOPHARM APOTHEKER PUSCHL (Germany)
Composition, form of production and packaging
The tablets, coated with a
white film membrane , biconvex, oblong, on both sides with risks along which the sloping notches, on one side of the tablet, the notch is more pronounced.

1 tab.

metformin hydrochloride 1 g

Excipients: hypromellose 15000 CPS, povidone, magnesium stearate.

Sheath composition: hypromellose 5 CPS, macrogol 6000, titanium dioxide (E171).

15 pcs.
- blisters (2) - packs of cardboard.
15 pcs.
- blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Hypoglycemic agent for oral administration from the biguanide group.

Metformin 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 LDL in the blood.
Stabilizes or reduces body weight. Has a fibrinolytic effect by suppressing the inhibitor of the tissue plasminogen activator.
PHARMACOKINETICS

Suction

After ingestion, metformin is absorbed from the digestive tract.
Bioavailability after taking a standard dose is 50-60%. C max in blood plasma is achieved 2 hours after ingestion. Eating reduces C max by 40% and slows its achievement by 35 min.
Distribution

It is able to accumulate in red blood cells.
Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys.
Excretion

T 1/2 is 6.5 hours.

INDICATIONS

- Type 2 diabetes mellitus without a tendency to ketoacidosis (especially when combined with obesity) with dietary inefficacy.

DOSING MODE

The dose of the drug Formin Pliva is set individually, taking into account the level of glucose in the blood.

The initial dose is, as a rule, 500-1000 mg (1 / 2-1 tab. / Day).
A further gradual increase in dose is possible depending on the effectiveness of therapy.
The maintenance daily dose is 1-2 g (1-2 tablets / day).
The maximum daily dose is 3 g (3 tab). The use of the drug in higher doses does not improve the effectiveness of treatment.
The course of treatment is long.

In severe metabolic disorders, the dose of the drug should be reduced because of the increased risk of developing lactic acidosis.

Tablets of the drug Formin Pliva should be taken with food, squeezed a small amount of liquid (a glass of water).

SIDE EFFECT

On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea, flatulence, lack of appetite, change in taste (in these cases, usually no cessation of treatment is required, and the symptoms pass independently without changing the dose of the drug);
rarely - abnormal abnormalities of hepatic samples or hepatitis that disappear after discontinuation of the drug. The frequency and severity of side effects from the digestive system may decrease with a gradual increase in the dose of metformin or by dividing the daily dose by 2-3 doses.
On the part of the endocrine system: hypoglycemia (mainly when used in inadequate doses and / or in combination with other hypoglycemic drugs).

From the side of metabolism: rarely - lactic acidosis (discontinuation of treatment is required);
at long treatment - a hypovitaminosis In 12 (infringement of absorption).
On the part of the hematopoiesis system: in some cases - megaloblastic anemia.

Allergic reactions: skin rash, itching.

CONTRAINDICATIONS

- diabetic ketoacidosis, diabetic precoma, coma;

- severe renal dysfunction;

- laktatsidoz (including in the anamnesis);

- cardiac and respiratory insufficiency, acute phase of myocardial infarction, acute disturbance of cerebral circulation, dehydration, chronic alcoholism, severe infectious diseases, shock and other conditions that may contribute to the development of lactic acidosis;

- Pregnancy;

- lactation (breastfeeding);

- Serious surgical operations and trauma, when insulin therapy is shown;

- liver failure;

- Acute alcohol poisoning;

- 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 medium;

- adherence to a hypocaloric diet (less than 1000 calories / day);

- Hypersensitivity to the drug.

With caution should be used in patients over 60 years of age, performing heavy physical work, which is associated with an increased risk of developing lactic acidosis.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in the violation of kidney function (due to the increased risk of hypoglycemia and lactic acidosis).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in the violation of liver function (due to the increased risk of hypoglycemia and lactic acidosis).

APPLICATION FOR CHILDREN

The drug is contraindicated in childhood.

APPLICATION IN ELDERLY PATIENTS

With caution and after assessing the relationship between benefit and the risk of use, Plamin Plamin should be prescribed to elderly patients (over 65 years of age).Such patients need to determine the clearance of creatinine before it is appointed, tk.
an increase in the level of serum creatinine is not a reliable indicator of renal dysfunction in patients of this age group.
SPECIAL INSTRUCTIONS

During the treatment it is necessary to monitor the kidney function.

At least 2 times a year, and also with the appearance of myalgia, a determination of the lactate content in the plasma should be carried out.

Possible use of the drug Formin Pliva in combination with derivatives of sulfonylureas or insulin.
In this case, a very careful monitoring of blood glucose levels is necessary.
Large surgical interventions and trauma, extensive burns, infectious diseases with febrile syndrome may require the abolition of oral glycemic drugs and the administration of insulin.

During treatment with the drug Formina Pliva should avoid drinking alcohol.

Influence on ability to drive vehicles and work with mechanisms

When used as a monotherapy, the drug does not affect the ability to drive vehicles and work with mechanisms.
When metformin is combined with other hypoglycemic agents (including those with sulfonylureas, insulin), hypoglycemic conditions may develop, in which the ability to drive vehicles and other potentially dangerous activities that require increased attention and rapid psychomotor reactions deteriorates.
OVERDOSE

Symptoms: Lactic acidosis with lethal outcome is possible.
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, the drug should be immediately canceled, the patient needs urgent hospitalization, to confirm the diagnosis, a determination of the concentration of lactate should be carried out.
To remove from the body lactate and metformin most effective hemodialysis. Symptomatic therapy is indicated.
With combined therapy with Formin Pliva with sulfonylureas, hypoglycemia may develop.

DRUG INTERACTION

With simultaneous use with sulfonylurea derivatives, salicylates, acarbose, insulin, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate derivatives, cyclophosphamide, beta-adrenoblockers, hypoglycemic action of metformin may be enhanced.

With simultaneous use (systemic and local) with GCS, oral contraceptives,
sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.
Nifedipine increases absorption, C max in blood plasma, slows the excretion of metformin from the body.

Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene and vancomycin) secreted in tubules compete for tubular transport systems and, with prolonged therapy, can increase C max of metformin by 60%.

Metformin can weaken the effect of anticoagulants (coumarin derivatives).

With the simultaneous administration of ethanol, the development of lactic acidosis is possible.

Possible cumulation of metformin and development of lactic acidosis with intravascular injection of iodine-containing contrast agents.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
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