Roxera (rozuvastatin) coated tablets 15 mg. №90

Description

Roxera (rozuvastatin) coated tablets 15 mg. №90

Composition

active ingredient: 1 film-coated tablet containing 5 mg or 10 mg or 15 mg or 20 mg or 30 mg or 40 mg of rosuvastatin (as rosuvastatin calcium);

excipients: microcrystalline cellulose, anhydrous lactose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate;

film shell: methacrylate copolymer, macrogol 6000, titanium dioxide (E 171), lactose monohydrate.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

• 5 mg: white, round, slightly convex, film-coated tablets with beveled edges and engraved “5” on one side;
• 10 mg: white, round, slightly convex, film-coated tablets with bevelled edges and engraved “10” on one side;
• 15 mg: white, round, slightly convex, film-coated tablets with beveled edges and engraved “15” on one side;
• 20 mg: white, round, film-coated tablets with a bevelled edge;
• 30 mg: white, biconvex, film-coated tablets in the form of a capsule with a notch on both sides;
• 40 mg: white, biconvex, film-coated tablets in the form of a capsule.

Pharmacological group

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

Pharmacological properties

It is a drug that lowers cholesterol and triglyceride levels in the blood. Refers to competitive inhibitors of HMG-CoA reductase.

Indications

Roxera coated tablets 15 mg is used:

• to reduce the risk of cardiovascular diseases (angina pectoris, stroke, myocardial infarction);
• with hyperlipidemia.

Contraindications

Roxera coated tablets 15 mg 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 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 coated tablets 15 mg 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

Overdose symptoms: rhabdomyolysis, liver dysfunction.
Treatment: gastric lavage, intake of adsorbents, symptomatic therapy.

Side effects:

• 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.