Redistatin (rosuvastatin) coated tablets 10 mg. №30

Description

Redistatin (rosuvastatin) coated tablets 10 mg. №30

Composition

active substance: rosuvastatin;

1 film-coated tablet contains rosuvastatin calcium equivalent to rosuvastatin 10 mg or 20 mg;

excipients: microcrystalline cellulose; lactose, monohydrate; crospovidone; meglumine; magnesium stearate; Opadry II Pink 32 K540017 (titanium dioxide (E 171), red magic AC (E 129), indigo carmine (E 132), yellow sunset FCF (E 110)).

Medicinal form

Film-coated tablets.

The main physical and chemical properties:

10 mg tablets: light pink to pink biconvex, round, film-coated tablets, debossed with “10” on one side and “company logo symbol” on the other side;

20 mg tablets: light pink to pink biconvex, round, film-coated tablets, debossed with “20” on one side and “company logo symbol” on the other side.

Pharmacotherapeutic group

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

Pharmacological properties

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonate, a precursor of cholesterol. The primary site of action of rosuvastatin is the liver, a target organ for lowering cholesterol.

Rosuvastatin increases the number of hepatic low-density lipoprotein (LDL) receptors on the cell surface, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of very low-density lipoprotein (VLDL) synthesis, thereby reducing total LDL and LDL-C. Rosuvastatin reduces elevated LDL cholesterol (LDL-C), total cholesterol, triglycerides and increases high-density lipoprotein cholesterol (HDL-C). It also reduces apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (HDL-C), LDL-C, very low-density lipoprotein triglyceride (VLDL-TG), and increases apolipoprotein A-I (ApoA-I). Rosuvastatin also reduces the ratio of LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol and HDL-C, non-LDL-C/HDL-C, and the ApoB/ApoA-I ratio.

The therapeutic effect is achieved within 1 week after the start of therapy, and after 2 weeks of treatment the effect reaches 90% of the maximum possible. The maximum effect, as a rule, is achieved after 4 weeks and is constantly maintained after that.

Indications

Redistatin 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 prescribe Redistatin 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

Redistatin 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.