Rosuvast 10 mg 14 tablets
Chemipharm
Chemipharm
Composition
Active ingredient
Rosuvastatin calcium 10.434 mg (equivalent to 10 mg rosuvastatin).
Excipients
Lactose monohydrate 45 mg, microcrystalline cellulose, tribasic calcium phosphate, crospovidone, magnesium stearate, hypromellose, titanium dioxide, triacetin, red iron oxide.
Description
A lipid-lowering statin used to reduce LDL cholesterol and total cholesterol in the blood.
Indicated for management of dyslipidemia, reduction of atherosclerotic and cardiovascular risk in high-risk patients, and treatment of familial hypercholesterolemia.
Indications
- Primary hypercholesterolemia (Type IIa including heterozygous familial) and mixed dyslipidemia (Type IIb).
- Homozygous familial hypercholesterolemia (as adjunct to diet or other LDL-lowering methods).
- Prevention of major cardiovascular events in high-risk patients.
Dosage and Method of Administration
- Initial dose: 5-10 mg once daily, with or without food.
- Dose adjustment after 4 weeks.
- Maximum dose: 20 mg, selected patients up to 40 mg under specialist supervision.
Special populations
- Elderly ≥70 years: 5 mg start.
- Moderate renal impairment: 5 mg start. 40 mg contraindicated.
- Severe renal impairment: contraindicated.
- Active liver disease: contraindicated.
- Asian ancestry: start 5 mg; 40 mg contraindicated.
Contraindications
- Hypersensitivity to components.
- Active liver disease or transaminase elevation >3×ULN.
- Severe renal impairment.
- Myopathy.
- Concomitant ciclosporin.
- Concomitant sofosbuvir/velpatasvir/voxilaprevir.
- Pregnancy and breastfeeding.
- 40 mg is contraindicated with risk factors for myopathy.
Precautions
- Risk of myopathy/rhabdomyolysis increases with dose and interacting drugs.
- Reports of myasthenia gravis and ocular myasthenia.
- Proteinuria possible at higher doses.
- Dose-related transaminase elevation possible.
- Risk of interstitial lung disease with long-term therapy.
- Statins can increase blood glucose and unmask diabetes.
- Systemic fusidic acid is contraindicated (severe rhabdomyolysis risk).
Side Effects
Common (≥1/100-<1/10)
Headache, Dizziness, Myalgia, Decreased haemoglobin, Elevated triglycerides, Elevated total and LDL cholesterol, Decreased HDL cholesterol, Somnolence, Dry mouth, Extrapyramidal symptoms.
Uncommon (≥1/1000-<1/100)
Constipation, nausea, Elevated liver enzymes, Proteinuria, Hematuria, Fatigue, Rash, pruritus.
Rare (≥1/10 000-<1/1000)
Myopathy, myositis, Rhabdomyolysis, Hypersensitivity reactions, Pancreatitis.
Very rare (<1/10 000)
Peripheral neuropathy, Jaundice, hepatitis.
Not known
- Myasthenia gravis
- Ocular myasthenia
- Sexual dysfunction
- Interstitial lung disease
- Severe cutaneous reactions: SJS, DRESS
- Immune-mediated necrotising myopathy
- Muscle pain, weakness, cramps
- CK elevations >10×ULN
- Rhabdomyolysis with fusidic acid combinations.
Pregnancy and Lactation
Contraindicated.
Discontinue immediately if pregnancy occurs.
Contraindicated during breastfeeding.
Storage
Store below 30°C in a dry place.
Keep out of reach of children.
Packaging
Carton box containing 2 blisters of 7 tablets each and leaflet.