Romazik (rozuvastatine) coated tablets 20 mg. №30

Description

Romazik (rozuvastatine) coated tablets 20 mg. №30

Composition

active substance: rosuvastatin;

1 film-coated tablet contains rosuvastatin 5 mg or 10 mg or 20 mg or 40 mg, which is equivalent to 5.2 mg or 10.4 mg or 20.8 mg or 41.6 mg of rosuvastatin calcium;

excipients: lactose monohydrate, type 1; lactose monohydrate, type 2; microcrystalline cellulose; sodium citrate; crospovidone type B; silicon colloidal anhydrous; magnesium stearate; shell (dye Opadry II white 33G28523, hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E 171)).

Medicinal form

Film-coated tablets.

The main physical and chemical properties:

• 5 mg: round, biconvex, film-coated tablets, white or almost white in color, embossed with “5” on one side;
• 10 mg: round, biconvex, film-coated tablets, white or almost white in color, embossed with “10” on one side;
• 20 mg: round, biconvex, film-coated tablets, white or almost white in color, embossed with “20” on one side;
• 40 mg: oblong, biconvex, film-coated tablets, white or almost white in color.

Pharmacotherapeutic group

Hypolipidemic agents. HMG-CoA reductase inhibitors.
ATX code C10A A07.

Pharmacological properties

This is a remedy that corrects fat metabolism. The active ingredient selectively and competitively inhibits the HMG-CoA reductase enzyme, 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 “bad fats” in the blood.

Indications

Romazik tablets 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

You can not appoint Romazik tablets:

• 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.

Application during pregnancy and lactation

Not applicable.

Method of administration and dosage

Romazik tablets 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.