Ipolipid (Tablets, Capsules) Instructions for Use

ATC Code

C10AB04 (Gemfibrozil)

Active Substance

Gemfibrozil (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Hypolipidemic agent

Pharmacotherapeutic Group

Hypolipidemic agent – fibrate

Pharmacological Action

A hypolipidemic agent, a fibric acid derivative. It reduces the concentration of triglycerides, total cholesterol, VLDL and, to a lesser extent, LDL in the blood.

The primary mechanism of action appears to be the activation of lipoprotein lipase. It suppresses peripheral lipolysis, increases the excretion of free fatty acids from the liver, thereby reducing the synthesis of triglycerides in the liver.

It reduces the incorporation of long-chain fatty acids into newly synthesized triglycerides, accelerates the turnover and removal of cholesterol from the liver and increases its excretion with bile. It inhibits the synthesis of VLDL and increases their clearance. It increases the formation of HDL, which have an antiatherogenic effect.

The onset of action is within 2-5 days, the maximum therapeutic effect develops after 4 weeks.

Pharmacokinetics

Gemfibrozil is well absorbed from the gastrointestinal tract after oral administration, C_max is reached within 1-2 hours.

T_1/2 after a single dose is 1.5 hours, after multiple doses it is 1.3 hours. It is excreted mainly by the kidneys (70%) unchanged; 6% is excreted with bile.

Indications

Hyperlipoproteinemia types IIb, IV and V, which are not corrected by special diet and physical exercise, especially in the presence of other risk factors; secondary hyperlipoproteinemia caused by diseases that are difficult to treat (diabetes mellitus, gout, hypothyroidism).

ICD codes

Dosage Regimen

Administer orally as tablets or capsules.

Take the standard dose of 600 mg twice daily, in the morning and evening.

Alternatively, administer a single 900 mg dose once daily in the evening.

Take each dose 30 minutes before a meal.

Continue treatment for several months; repeat courses if necessary based on clinical assessment.

Do not exceed the maximum daily dose of 1.5 grams.

Adverse Reactions

From the digestive system: dry mouth, decreased appetite, heartburn, nausea, vomiting, gastralgia, abdominal pain, flatulence, diarrhea or constipation, hyperbilirubinemia, increased activity of hepatic transaminases and alkaline phosphatase, cholelithiasis.

From the central and peripheral nervous system: dizziness, headache, excessive fatigue, fainting, paresthesia, drowsiness, depression.

From the musculoskeletal system: muscle pain, muscle weakness, arthralgia, synovitis, rhabdomyolysis.

From the hematopoietic system: leukopenia, anemia, bone marrow hypoplasia.

From laboratory parameters: hypokalemia.

Dermatological reactions: alopecia.

Allergic reactions: skin rash, dermatitis.

Other: visual impairment, decreased potency and/or libido.

Contraindications

Severe liver diseases (including primary biliary cirrhosis), cholelithiasis, chronic cholecystitis, severe renal failure, pregnancy, lactation, simultaneous use of lovastatin, hypersensitivity to gemfibrozil.

Use in Pregnancy and Lactation

Gemfibrozil is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe renal failure.

Use in Renal Impairment

Contraindicated in severe liver diseases (including primary biliary cirrhosis).

Pediatric Use

Should not be used in children and adolescents under 18 years of age.

Geriatric Use

Used according to indications.

Special Precautions

During treatment with gemfibrozil, it is necessary to systematically monitor blood lipid levels. If a 3-month course of treatment does not lead to a decrease in blood lipid levels, Gemfibrozil should be discontinued.

Drug Interactions

With simultaneous use with antacids, the absorption of gemfibrozil from the gastrointestinal tract decreases.

With simultaneous use, the effects of indirect anticoagulants and oral hypoglycemic agents of the sulfonylurea derivatives are enhanced.

With simultaneous use with atorvastatin, lovastatin, simvastatin, cerivastatin, the risk of developing severe myopathy increases, especially with simultaneous use with lovastatin or cerivastatin.

Cases of increased plasma concentration of carbamazepine have been described with simultaneous use, which may lead to an increase in its side effects.

With simultaneous administration of colestipol and gemfibrozil, the absorption of gemfibrozil decreases.

Cases of decreased absorption and plasma concentration of cyclosporine have been described with simultaneous use.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.