treatment of hypercholesterolemia Adults, adolescents, and children over 10 years of age with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) as an adjunct to a diet when dieting and other non-drug medications (such as exercise, weight loss) are insufficient. In homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (such as LDL apheresis) or in cases where such treatment is inappropriate. Prevention of cardiovascular disorders Prevention of significant cardiovascular disease in patients who are estimated to be at high risk of a first case of cardiovascular disease, in addition to correcting other risk factors. Contraindications. Doses of 5 mg, 10 mg, 15 mg and 20 mg are contraindicated: patients with hypersensitivity to rosuvastatin or to any inactive ingredient; patients with liver disease in the active phase, including unknown etiology, persistent increase in the level of transaminases in the blood serum and the level of any transaminase in the serum more than 3 times the upper limit of normal; patients with severe renal impairment (creatinine clearance <30 ml / min); patients with myopathy; patients who take cyclosporine along the way; patients with pre-existing factors for myotoxic complications; during pregnancy and breast-feeding, as well as women of reproductive age who do not use appropriate contraceptives; children under 10 years old. Doses of 30 mg and 40 mg are contraindicated: patients with hypersensitivity to rosuvastatin or to any inactive ingredient; patients with active liver disease, including an unclear, persistent increase in serum transaminases and any increase in serum transaminases more than 3 times the upper limit of normal; patients who take cyclosporine along the way; during pregnancy and breast-feeding, and women of reproductive age who do not use appropriate contraceptives; children; patients with myopathy or pre-existing factors for myopathy / rhabdomyolysis; such factors include: moderate renal impairment (creatinine clearance <60 ml / min) hypothyroidism a personal or family history of congenital muscle disorders, a history of muscle toxicity caused by another HMG-COA reductase or fibrate inhibitor, alcohol dependence; situations where there may be an increase in plasma levels (for example, severe hepatic insufficiency) azitske origin; simultaneous use of fibrates; age more than 70 years.
Composition and form of release
Active ingredient: rozuvastatin (5 mg).
Roxera is produced in pill form.
It is a drug that lowers cholesterol and triglyceride levels in the blood. Refers to competitive inhibitors of HMG-CoA reductase.
Roxera is used:
- to reduce the risk of cardiovascular diseases (angina pectoris, stroke, myocardial infarction);
- with hyperlipidemia.
Roxera’s drug is not used:
- with hypersensitivity to the active substance, auxiliary components;
- with liver disease in the active phase;
- with a persistent increase in the activity of liver transaminases, which is three times higher than the norm, of an unexplained cause.
Application during pregnancy and lactation
Roxera’s use is contraindicated in patients of reproductive age who do not use contraceptives.
Breastfeeding should be discontinued during the therapy period.
Method of administration and dosage
Roxera is used orally once a day every day (at any time of the day), regardless of food.
The dose must be selected in accordance with the baseline level of cholesterol, LDL, as well as the goal of treatment, clinical response.
The standard starting dose is 5-10 mg once a day. The dose can be increased (if necessary) after 4 weeks. Closer monitoring of patients receiving the 40 mg dose is recommended.
It is not recommended to take a dose of 40 mg or higher in patients who have not previously consulted a doctor.
After 2-4 weeks of admission and when the dose is increased, monitoring of lipid metabolism is required.
Overdose symptoms: rhabdomyolysis, liver dysfunction.
Treatment: gastric lavage, intake of adsorbents, symptomatic therapy.
- Hepatobiliary disorders: hepatitis, liver failure, cholestasis.
- Gastrointestinal disorders: abdominal discomfort, flatulence, belching, constipation, diarrhea, pancreatitis, nausea, vomiting.
- Musculoskeletal disorders: neck pain, back pain, musculoskeletal pain, increased muscle fatigue, myositis, myopathy, rhabdomyolysis, joint pain, tendon rupture, tendinopathy, joint swelling.
- Changes in laboratory parameters: fluctuations in liver function tests, increased transaminases, CPK activity, the level of alkaline phosphatase in the blood.
- Metabolic disorders: hypoglycemia, hyperglycemia, weight gain, anorexia.
- Neurological disorders: dizziness, paresthesia, dysgeusia, amnesia, hypesthesia, peripheral neuropathy, insomnia, headache, nightmares.
- Dermatological disorders: skin rashes, urticaria, pruritus, alopecia, angioedema, bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
- Respiratory disorders: sore throat, larynx, nosebleeds, nasopharyngitis.
- Ophthalmic disorders: blurred vision, blurred vision, other visual impairments.
- Genitourinary disorders: gynecomastia, leukocyturia.
- Otolaryngological disorders: hearing loss, tinnitus, ringing in the ears.
- Immune disorders: manifestations of allergies, incl. anaphylactic shock.
- Hematological disorders: thrombocytopenia.
- General: asthenia, pyrexia, malaise, peripheral edema, fatigue, chest pain.
Storage conditions and periods
Store Roxera at temperatures up to + 25 ° С for no more than 3 years.