Methenyl tablets (5, 10, 20 and 40 mg): instructions for use

Mertenil is a drug for lowering cholesterol - so you can describe it in a simple way.

It is used as a supplement to a diet (not a substitute for it!) In the treatment of hypercholesterolemia and mixed dyslipidemic conditions. The active substance - rosuvastatin calcium - reduces the high cholesterol content of low-density lipoproteins, total cholesterol and triglycerides.

The therapeutic effect of Mortenil can be achieved within one week after the start of treatment, after 2 weeks 90% of the maximum possible effect is achieved. The maximum therapeutic effect is achieved after 4 weeks and is maintained with the further taking of tablets, Mortenil.

Clinical and pharmacological group

Lipid-lowering drug.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much does it cost? The average price in pharmacies is at the level of500 rubles.

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Form of issue and composition

Each tablet, film-coated, contains the active substance:

1. Film-coated tablets, 5 mg: rosuvastatin calcium, mg (equivalent to rosuvastatin 5 mg),
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2. Film-coated tablets, 10 mg: rosuvastatin calcium 1, mg (equivalent to rosuvastatin 10 mg),
3. Film-coated tablets, 20 mg: rosuvastatin calcium 2, mg (equivalent to rosuvastatin 20 mg),
4. Film-coated tablets, 40 mg: rosuvastatin calcium 4, mg (equivalent to rosuvastatin 40 mg);

Tablets are packed into 10-unit contour blisters.

Pharmacological effect

The active ingredient of Mertenil is rosuvastatin calcium, leading to a decrease in the level of total cholesterol and low-density lipoprotein cholesterol. Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, which is a precursor to cholesterol. This substance has an effect on the liver, synthesizing cholesterol and destroying low-density lipoproteins.

The patient observes the first effects from the application of Mertenil a week after starting the drug, the maximum positive changes are observed in a month.

Indications for use

What helps with Mortenil? Tablets are given to patients with the following pathological conditions:

1. Hereditary hypercholesterolemia;
2. Increased cholesterol in the blood;
3. Hypertriglyceridemia in the complex therapy together with diet;
4. Hypertriglyceridemia (type IV by Fredrickson) as a supplement to the diet;
5. The age of patients older than 60 years, who also suffer from excess weight;
6. High risk of atherosclerotic deposits on the walls of large blood vessels;
7. Prevention of cardiovascular pathology in patients with obesity, hypertension, a recent stroke or heart attack.

Contraindications

For tablets 5 mg, 10 mg and 20 mg:

• liver diseases in the active phase, including a persistent increase in hepatic transaminase activity, as well as any increase in serum transaminase activity by more than 3 times compared with VGN;
• hepatic failure (more than 9 on the Child-Pugh scale);
• severe renal dysfunction (KK less than 30 ml / min);
• myopathy;
• simultaneous administration of cyclosporine;
• in patients predisposed to the development of myotoxic complications;
• pregnancy;
• lactation period;
• in women of childbearing age who do not use reliable means of contraception;
• age under 18 years (effectiveness and safety not established);
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• increased sensitivity to rosuvastatin and other components of the drug.

For tablets 40 mg:

• hypothyroidism;
• myopathy;
• pregnancy;
• lactation period;
• age under 18 years (effectiveness and safety not established);
• patients of the Mongoloid race;
• personal or family anamnesis of muscular diseases;
• myotoxicity on the background of taking other inhibitors of HMG-CoA reductase or fibrates in anamnesis;
• in patients predisposed to the development of myotoxic complications;
• simultaneous administration of cyclosporine;
• simultaneous reception of fibrates;
• excessive use of alcohol;
• conditions that may lead to an increase in the concentration of rosuvastatin in the blood plasma;
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• liver diseases in the active phase, including a persistent increase in hepatic transaminase activity, as well as any increase in serum transaminase activity by more than 3 times compared with VGN;
• hepatic failure (more than 9 on the Child-Pugh scale);
• renal failure of moderate severity (CC less than 60 ml / min);
• increased sensitivity to rosuvastatin and other components of the drug.

Carefully

For tablets 5 mg, 10 mg and 20 mg

• liver disease in history;
• sepsis;
• arterial hypotension;
• extensive surgical interventions;
• injuries;
• severe metabolic, endocrine or electrolyte disorders;
• uncontrolled epilepsy;
• race (Mongoloid race);
• presence of risk of development of myopathy / rhabdomyolysis - renal failure, hypothyroidism;
• personal or family history of hereditary muscle diseases and a previous history of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates;
• excessive use of alcohol;
• conditions in which there was an increase in the plasma concentration of rosuvastatin;
• age over 65;
• simultaneous reception of fibrates.

For tablets 40 mg

• arterial hypotension;
• extensive surgical interventions;
• injuries;
• severe metabolic, endocrine or electrolyte disorders;
• the presence of a risk of myopathy / rhabdomyolysis - mild renal insufficiency (KK? 0 ml / min);
• age over 65;
• liver disease in history;
• sepsis;
• uncontrolled epilepsy.

Use in Pediatrics

The effectiveness and safety of the drug in children and adolescents under the age of 18 years is not established. Experience in the use of the drug in pediatric practice is limited to a small number of children (8 years and older) with family homozygous hypercholesterolemia.

Currently, Mertenil is not recommended for use in children and adolescents under the age of 18 years.

Use in pregnancy and lactation

Mertenil is contraindicated in pregnancy and lactation.

In the event of pregnancy, taking Mbenenil should be stopped immediately.

Data on the allocation of a drug with breast milk are not available. If it is necessary to prescribe tablets during lactation, breastfeeding should be discontinued.

Dosage and route of administration

The instructions for use indicate that before starting treatment with Mortenil, the patient should follow the standard diet using products with a low Xc content, which should be continued and during the whole period of treatment. Doses of the drug should be selected individually in accordance with the purpose of the treatment and therapeutic the patient's response to ongoing therapy, given current generally accepted recommendations on target levels lipids.

1. The drug is taken orally, at any time of the day, regardless of food intake. Tablets should not be chewed and crushed, they must be swallowed whole, washed down with water.
2. The recommended initial dose of the drug is 5 mg or 10 mg 1 time / day as for patients who have not previously taken statins, as well as for patients transferred to the drug after treatment with other inhibitors HMG-CoA reductase.
3. Choosing the initial dose of the drug, you should take into account the level of Xc in each individual patient, as well as Possible risk of developing cardiovascular complications and potential risk of side effects effects. If necessary, after 4 weeks, you can do a dose adjustment.

In connection with the possible development of side effects when taking a dose of 40 mg compared with lower doses of the drug, the final titration to a maximum dose of 40 mg should be given only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia), in whom a dose of 20 mg did not achieve the target cholesterol level, and which would be under the medical observation. When appointing a dose of 40 mg, a thorough observation of the doctor is recommended. Do not administer a dose of 40 mg to patients who have not previously consulted a doctor.

• The recommended initial dose for elderly patients (over 70 years) is 5 mg.

In patients with hepatic insufficiency7 points and lower on the Child-Pugh scale, no increase in the systemic concentration of rosuvastatin has been detected. However, in patients with hepatic insufficiency of 8 and 9 on the Child-Pugh scale, an increase in the systemic drug concentration was noted. These patients should be monitored for liver function against therapy. Data on the use of rosuvastatin in patients with hepatic insufficiency of more than 9 points on the Child-Pugh scale are absent. Patients with liver disease in the active phase of Mortenil is contraindicated.

In patients with mild or moderate renal insufficiency, dose adjustment is not required. The recommended initial dose of the drug is 5 mg for patients with moderate renal insufficiency (CC less than 60 ml / min). Patients with renal insufficiency of moderate severity of the appointment of the drug in a dose of 40 mg is contraindicated. The administration of the drug Mertenil in any dose is contraindicated in patients with severe renal insufficiency.

In carriers of the genotypes SLC01B1 (OATP1B1) p.521SS and ABCG2 (BCRP) p.421AA, the increase in the exposure (AUC) of rosuvastatin was noted in comparison with the carriers of genotypes SLCO1B1 p.521TT and ABCG2 p.421S. For patients carrying genotypes с.521СС or с.421АА the recommended maximum dose of the drug Мертенил is 20 mg 1 time / day.

In patients of the Mongoloid race an increase in the systemic concentration of rosuvastatin was noted. When administered at doses of 10 mg and 20 mg, the recommended initial dose of the drug for patients in this group is 5 mg. The use of the drug in a dose of 40 mg in such patients is contraindicated.

• When administered at doses of 10 mg and 20 mg, the recommended initial dose of the drug for patients with a predisposition to myopathy is 5 mg. The use of the drug in a dose of 40 mg in such patients is contraindicated.

Rosuvastatin binds to various transport proteins (in particular, to OATP1B1 and BCRP). When the drug is jointly used with medicinal preparations (such as cyclosporin, some HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increasing the concentration of rosuvastatin in plasma due to interaction with transport proteins, may increase the risk of myopathy (including rhabdomyolysis).

In such cases, the possibility of prescribing alternative therapy or temporarily stopping the drug Mertenil should be evaluated. If the use of the above drugs is necessary, the ratio of benefit and risk of concomitant therapy with Mertenil should be assessed and the possibility of reducing its dose should be considered.

Side effects

With the use of the drug Mortenil, the following side effects on the part of systems and organs are possible:

1. Urinary system: proteinuria; very rarely - hematuria;
2. Endocrine system: often - type 2 diabetes mellitus;
3. Respiratory system: frequency unknown - dyspnea, cough;
4. Nervous system: often - headache, dizziness; very rarely - memory loss, polyneuropathy;
5. Allergic reactions: rarely - hypersensitivity reactions, including angioedema;
6. Skin: rarely - rash, hives, itching; frequency unknown - Stevens-Johnson syndrome;
7. Musculoskeletal system: often - myalgia; rarely - rhabdomyolysis, myopathy (including myositis); very rarely - arthralgia;
8. Digestive system: often - abdominal pain, nausea, constipation; rarely - pancreatitis, increased activity of hepatic transaminases; very rarely - hepatitis, jaundice; frequency unknown - diarrhea;
9. Laboratory indicators: increased bilirubin concentration, glucose, impaired thyroid function, increased activity of alkaline phosphatase (AP) and gamma-glutamyl transferase (GGT);
10. Other: often - asthenic syndrome; frequency unknown - peripheral edema.

The side effects of the drug Mertenil, as a rule, are weakly expressed and quickly pass.

According to available data, some statins cause the following side reactions: sleep disturbances (nightmares, insomnia), depression, sexual dysfunction. Single cases of interstitial lung disease were also reported.

Overdose

Specific treatment for overdose does not exist.

In case of an overdose, it is recommended to carry out symptomatic treatment and supportive measures. It is necessary to monitor the liver function and the degree of activity of CK. Hemodialysis in this case is probably ineffective.

special instructions

In case of sudden appearance of spasms, muscle weakness or pain, especially in combination with fever or malaise, it is necessary to consult a doctor.

At the time of taking Mertenil in all doses (especially when taking in a dose of more than 20 mg), myopathy, myalgia and, in rare cases, rhabdomyolysis developed. In very rare cases, rhabdomyolysis occurs with simultaneous administration with ezetimibe (this combination requires caution).

The development of proteinuria, mainly of tubular origin, is usually observed with high doses Mertenyl (especially - 40 mg), but in most cases this violation was periodic or short-term. The development of proteinuria during the treatment of acute or progressive development of an existing kidney disease does not mean. The frequency of serious functional disorders of the kidneys increases with the use of rosuvastatin 40 mg.

In the presence of risk factors for the development of myopathy / rhabdomyolysis, Mertenil can be prescribed only after the ratio of the benefits of therapy to the possible risk. During treatment it is necessary to conduct constant clinical observation.

With an increase in the creatine phosphokinase before the start of therapy above the upper limit of the norm more than 5 times, after 5-7 days, a second measurement should be carried out. If the initial indicator of creatine phosphokinase is confirmed upon repeated measurement, therapy should not be started.

To prescribe Mortenil to patients with severe, acute illnesses suggesting the presence of myopathy, or with the possible development of secondary renal failure (eg, arterial hypertension, sepsis, trauma, surgery, electrolyte disorders, metabolic syndrome, endocrine disorders, seizures) are not follows.

Mertenil should be used with extreme caution in patients who have a history of liver disease or abusing alcohol.

In patients with secondary hypercholesterolemia due to hypothyroidism, nephrotic syndrome, treatment of the underlying disease should be performed before the drug is started.

Simultaneous administration of Mertenil with protease inhibitors is not recommended.

If necessary, during the administration of the drug to drive a vehicle or other mechanisms, it must be taken into account that dizziness may develop during therapy.

Diagnosis of liver function is recommended before and 3 months after the start of therapy. In cases where the activity of hepatic transaminases in the serum exceeds the upper limit of the norm by 3 times, treatment should be stopped or the dose taken lowered. The frequency of pronounced functional disorders of the liver (associated in most cases with an increase in the activity of hepatic transaminases) increases with the intake of 40 mg of Mbertenil.

Drug Interactions

The use of martenil or an analog at the same time with drugs that reduce lipid levels, provokes an increase in the concentration of rosuvastatin in the blood.

Erythromycin reduces the concentration of the active substance in the blood, so the interval between taking these drugs should be at least 2 hours.

Nicotinic acid, gemfibrozil and fenofibrate with simultaneous application with rosuvastatin increase the risk of myopathy.

Reviews

We picked up some reviews of people taking the drug Mertenil:

1. Lilya. While you take Mertenil, the cholesterol level falls. But as soon as you stop, it grows again, although you stick to the diet. Directly some dependence on the drug. It turns out that with his help from the disease can not get rid of. And, incidentally, very affects the liver. Be careful.
2. Tatyana. To me the cardiologist has written out 3 months ago Ro-statin of 10 mg a day to drink. I do not know what's going on with someone with a liver - the other day I took biochemistry and it's all right. There are no problems on the part of the liver. And cholesterol keeps at a level, mmol / l. I am very pleased with the results. Experienced before the analysis, tk. the drug is new and did not know whether there will be an effect or not. Now she is calm. The drug works. and even the doctor gave a prescription, according to which in the pharmacy, two packs of the drug. What a good savings!
3. Love. Mertenil has no direct effect on lowering the pressure, allergies can give at least that!!! This is individual. Influence on the liver is much less than when taking other statins (simvastatin really beats on the liver, can and atorvastatin raise-Atori, then you drank) was dead-rosuvastatin-in practice did not raise! transaminase. So drink, once the show, do it regularly, no breaks.

Analogues

The drug is a rosuvastatin generic, therefore the full structural analogues of the Mertenil by the active substance are the following drugs, the list:

• Suvardio.
• Rosewood.
• Akorta.
• Ro-statin.
• Tevastor.
• Roxer.
• Rosulip.
• Rosart.
• Cross-country.
• Rosuvastatin.
• Rustor.
• Rosistark.

Before using analogues, consult your doctor.

Storage conditions and shelf life

Mortenil refers to the number of lipid-lowering medications of prescription leave with a shelf life of up to 24 months, subject to standard storage conditions (at temperatures up to 30 degrees Celsius).

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