Rovamed (rozuvastatin) coated tablets 20 mg. №30

Description

Rovamed (rozuvastatin) coated tablets 20 mg. №30

Composition

active substance: rosuvastatin;

1 film-coated tablet contains rosuvastatin calcium 5.21 mg equivalent to rosuvastatin 5 mg or rosuvastatin 10.419 mg equivalent to rosuvastatin 10 mg, or rosuvastatin calcium 20.838 mg equivalent to rosuvastatin 20 mg, or rosuvastatin calcium 41.676 mg equivalent to rosuvastatin 40 mg;

auxiliary substances: microcrystalline cellulose, type 101; colloidal anhydrous silicon dioxide; crospovidone, type A; microcrystalline cellulose, type 102; lactose, monohydrate; magnesium stearate;

film coating:

• Opadry II Yellow 33K12488 (НРМС 2910/hypromellose 6 сР; titanium dioxide (E 171); lactose, monohydrate; triacetin; iron oxide yellow) (5 mg tablets);
• Opadry II Pink 33K94423 (НРМС 2910/hypromellose 6 сР; titanium dioxide (E 171); lactose, monohydrate; triacetin; iron oxide red) (tablets of 10 mg);
• Opadry II Pink 33K94423 (НРМС 2910/hypromellose 6 сР; titanium dioxide (E 171); lactose, monohydrate; triacetin; iron oxide red) (20 mg tablets);
• Opadry II Pink 33K94424 (HPMS 2910/hypromellose 6 cR; titanium dioxide (E 171); lactose, monohydrate; triacetin; iron oxide red) (40 mg tablets).

Medicinal form

Film-coated tablets.

The main physical and chemical properties:

• tablets of 5 mg – yellow round, biconvex tablets, covered with a film shell, with the inscription “ROS” above “5” on one side, without inscriptions on the other side;
• tablets of 10 mg – pink, round, biconvex, film-coated tablets, with the inscription “ROS” above “10” on one side, without inscriptions on the other side;
• tablets of 20 mg – pink, round, biconvex, film-coated tablets, with the inscription “ROS” above “20” on one side, without inscriptions on the other side;
• tablets of 40 mg – pink, oval, biconvex, film-coated tablets, with the inscription “ROS” on one side and “40” on the other side.

Pharmacotherapeutic group

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

Pharmacological properties

This is a remedy that corrects fat metabolism. The active component 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, increased catabolism and seizure. It also slows down the production of VLDL, thereby reducing the total content of “bad fats” in the blood.

Indications

Rovamed 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 serious cardiovascular complications in adults at high risk of developing them.

Contraindications

You cannot appoint Rovamed 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

Rovamed 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, high cardiovascular diseases (for example, hereditary hypercholesterolemia), when it was not possible to achieve 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.