Mertenil (rosuvastatin) coated tablets 20 mg. №30

Description

Mertenil composition
active substance: rosuvastatin;
1 tablet contains rosuvastatin 20 mg, which is equivalent to 20.8 mg of rosuvastatin calcium;
excipients: lactose monohydrate, microcrystalline cellulose, magnesium hydroxide, crospovidone, magnesium stearate; film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc.

Dosage form
Film-coated tablets.

Pharmacological properties
This is a remedy that corrects fat metabolism. The active component selectively and competitively inhibits the enzyme HMG-CoA reductase, which catalyzes the conversion of HMG-CoA into a cholesterol precursor in the liver. Promotes an increase in the number of LDL receptors on the surface of liver cells, increasing catabolism and seizure. It also slows down the production of VLDL, thereby reducing the total content of “harmful fats” in the blood.

Indications
Mertenil is prescribed:

• with homozygous hereditary hypercholesterolemia – as an addition to diet, other lipid-lowering pharmaceuticals;
• for the treatment of primary hypercholesterolemia (type IIa, including heterozygous hereditary hypercholesterolemia);
• for the treatment of mixed dyslipidemia (type IIb) – as an addition to the diet when non-pharmacological methods are ineffective;
• for the prevention of cardiovascular complications;
• to reduce the risk of developing severe cardiovascular complications in adults at high risk of developing them.

Contraindications:

• with intolerance to the components of the drug;
• with hepatobiliary diseases in the active phase;
• with chronic kidney disease at stages 4-5 (creatinine excretion rate <30 ml / minute);
• during pregnancy / lactation, planning pregnancy;
• with pathology of muscle tissue;
• while taking cyclosporine;
• with a predisposition to myopathy, rhabdomyolysis.

Children
The use of the drug in children should be performed only by a specialist.
Used for children and adolescents aged 10 to 17 years (boys in stage II and above Tanner and girls whose menstruation began at least a year ago).
The usual starting daily dose for children and adolescents with hypercholesterolemia is 5 mg to 20 mg once daily. The dose should be increased according to the child’s individual response to treatment and tolerability of the drug, following the recommendations for the treatment of children. Before starting rosuvastatin therapy, children and adolescents should be prescribed a standard hypocholesterolemic diet, which patients should follow during treatment. The safety and efficacy of the drug at doses greater than 20 mg in this population have not been studied.
40 mg tablets are not used in children.
Children under 10 years.
Experience in the treatment of children under 10 years of age is limited to the use of the drug in a small number of patients (aged 8 to 10 years) with homozygous familial hypercholesterolemia. The drug is not recommended for use in children under 10 years of age.

Application during pregnancy and lactation
Not applicable.

Method of administration and dosage
Mertenil is taken orally whole, without chewing, with water, regardless of the meal.
The standard starting dose for the treatment of hypercholesterolemia is 5 mg or 10 mg once a day. If necessary, it is allowed to increase the dose after 4 weeks. Due to the high likelihood of side effects, increasing the dose to 40 mg should be considered only in patients with severe hypercholesterolemia, a high risk of cardiovascular complications (for example, hereditary hypercholesterolemia), when it was not possible to achieve the target values ​​when using lower doses.
For the prevention of cardiovascular complications, 20 mg per day is indicated.

Overdose
Symptomatic therapy, control of hepatic parameters, CPK level is recommended.

Side effects:

• Blood test changes: thrombocytopenia.
• Immune disorders: allergies, including angioedema.
• Endocrine disorders: diabetes mellitus.
• Mental Disorders: Depression.
• Neurological disorders: headache, polyneuropathy, insomnia, dizziness, peripheral neuropathy, amnesia, nightmares.
• Respiratory disorders: shortness of breath, cough.
• Digestive Disorders: Pancreatitis, abdominal pain, nausea, constipation / diarrhea.
• Hepatobiliary disorders: jaundice, hepatitis, increased activity of liver transaminases.
• Dermatological disorders: rash, Stevens-Johnson syndrome, urticaria, pruritus.
• Musculoskeletal disorders: myalgia, rhabdomyolysis, myopathy, myositis, arthralgia, tendon rupture, immune-mediated necrotizing myopathy.
• Urinary disorders: hematuria.
• Sexual disorders: gynecomastia.
• General disorders: edema, asthenic syndrome.

Storage conditions and periods
It is required to store Mertenil at room temperature (15-25 ° C) for no more than 3 years.