Romestin (rozuvastatin) coated tablets 20 mg. №30

Description

Romestin (rozuvastatin) coated tablets 20 mg. №30

Composition

active substance: rosuvastatin;

1 tablet contains rosuvastatin calcium in terms of rosuvastatin 5 mg, 10 mg or 20 mg;

excipients:

5 mg: microcrystalline cellulose; anhydrous calcium hydrogen phosphate; lactose, monohydrate; croscarmellose sodium; crospovidone; talc; stearic acid; dye Instacoat sol (hypromellose, polyethylene glycol, talc, titanium dioxide (E 171)); diamond blue (E 133); erythrosine (E 127);

10 mg: microcrystalline cellulose; anhydrous calcium hydrogen phosphate; lactose, monohydrate; croscarmellose sodium; crospovidone; talc; stearic acid; dye Instacoat sol (hypromellose, polyethylene glycol, talc, titanium dioxide (E 171)); quinoline yellow (E 104);

20 mg: microcrystalline cellulose; anhydrous calcium hydrogen phosphate; lactose, monohydrate; croscarmellose sodium; crospovidone; talc; stearic acid; dye Instacoat sol (hypromellose, polyethylene glycol, talc, titanium dioxide (E 171)); diamond blue (E 133); tartrazine (E 102)

Medicinal form

Film-coated tablets.

The main physical and chemical properties:

• tablets of 5 mg: light purple round biconvex film-coated tablets with a line on one side;
• tablets of 10 mg: light yellow round biconvex tablets covered with a film cover;
• tablets of 20 mg: light green to green, round, biconvex, film-coated tablets.

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

Romestin 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 Romestin 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

Romestin 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.