Simgal

Simgal has a hypolipidemic effect by slowing down the activity of HMG-CoA reductase.

The drug helps to reduce the amount of unhealthy fats in the blood (LDL with triglycerides and VLDL) and total cholesterol, and at the same time increases the levels of fats that are good for the body (HDL). [ 1 ]

The drug is used in cases of disorders in which an increased level of fats in the blood is observed (when physical exercise and diet do not demonstrate the necessary effect). [ 2 ]

Indications Simgal

It is used for hypercholesterolemia (primary type or hereditary form of homozygous nature), as well as mixed-type dyslipidemia. In addition, it is prescribed to prevent the development of cardiovascular diseases in people with atherosclerosis or diabetics.

Release form

The therapeutic agent is released in tablets of 10, 20 or 40 mg. There are 14 such tablets inside a blister pack; there are 2 or 6 such packs inside a box.

In addition, tablets (28 pieces) can be released in bottles.

Pharmacodynamics

When administered orally, simvastatin is involved in hydrolysis with the formation of a derivative that significantly slows the action of HMG-CoA reductase. This results in a decrease in low-density cholesterol levels by weakening its binding and enhancing catabolism.

In addition, there is a decrease in triglyceride levels with apolipoprotein and a slight increase in high-density cholesterol. This leads to a change in the proportions of LDL and HDL levels. [ 3 ]

Pharmacokinetics

The drug is well absorbed, regardless of whether it is taken with or without food. It reaches Cmax after 1-2 hours.

Transformation into a form with therapeutic activity occurs inside the liver. About 5% of the administered dose of the drug penetrates into the systemic circulation from the liver. There is no accumulation of the drug. At least 95% of simvastatin with its active metabolic elements undergoes protein synthesis.

Excretion occurs over a period of 96 hours – together with feces (60%) and urine (13%).

Dosing and administration

The medicine is taken in a minimum dose of 10-20 mg/maximum of 80 mg per day. It is usually taken once in the evening. It is recommended not to take it with food. If the tablet needs to be divided in half, it is not broken by hand, but cut with a knife.

The dosage is selected by the attending physician, taking into account the established diagnosis, age and health status, as well as the nature of the treatment (monotherapy or combination with other medications).

• Application for children

During the use of the drug in adolescents, no effects on the processes of sexual development and growth were observed. Studies in younger individuals were not conducted.

Use Simgal during pregnancy

There is no information regarding whether Simgal may affect fetal development and whether it is excreted in breast milk.

When planning conception, during pregnancy, and during breastfeeding, the use of the drug is prohibited.

Contraindications

Main contraindications:

• severe intolerance associated with the components of the drug;
• liver disease in the active phase;
• persistent increase in serum transaminase values;
• use of potent inhibitors of hemoprotein CYP3A4 activity (for example, nelfinar, telithromycin with erythromycin, itraconazole and clarithromycin with nefazodone).

Side effects Simgal

Sometimes the use of drugs causes the following side effects: memory or sleep disorders (nightmares and insomnia), sexual dysfunction and depression.

Rarely, dizziness, paresthesia, convulsions and headaches occur, as well as polyneuropathy or anemia. In addition, stomach pain, vomiting, bowel and digestive disorders, jaundice, hepatitis or pancreatitis are occasionally possible. Myositis, myopathy, asthenia, muscle spasms also occur occasionally. Rarely, itching, rashes, alopecia and severe intolerance syndrome (vasculitis, photophobia, arthritis, weakness, rheumatic polymyalgia, Quincke's edema, eosinophilia, thrombocytopenia and dyspnea) occur, as well as an increase in the values of alkaline phosphatase and transaminases.

A single dose of Simgal causes pulmonary interstitial processes or renal failure.

Overdose

There is currently no information about fatal poisoning by Simgal. Recovery from intoxication was without complications for all.

The medicine has no antidote. In case of overdose, symptomatic actions are performed.

Interactions with other drugs

Administration of the drug with bosentan leads to a decrease in the level of simvastatin with its derivatives. Dosage adjustment is required taking into account cholesterol levels.

The combination with danazol, amiodarone, cyclosporine, niacin and gemifibrozil requires a reduction in the dose of the drug to prevent the occurrence of myopathy.

Combination with telithromycin, itraconazole, clarithromycin, as well as erythromycin, posaconazole, fluconazole and other potent inhibitors of the CYP3A4 component is prohibited. If there is an urgent need for treatment using the above drugs, the use of Simgal is temporarily canceled.

Storage conditions

Simgal should be stored in a place protected from sunlight. Temperature should be within the range of 10-25°C.

Shelf life

Simgal is approved for use within a 4-year period from the date of manufacture of the therapeutic product.

Analogues

Analogues of the drug are the medicines Vabadin, Vasta, Aldesta and Zosta with Vasostat-Zdorovye, as well as Atrolin, Simvakard, Simvostat and Simvageksal with Simva Tad. In addition, the list includes Cardak, Simvalimit, Vastatin with Simvakol, Vazilip and Zocor.

Reviews

Simgal receives good reviews from patients – its high efficiency and good tolerability when used correctly are noted.