Rosuvast 10 mg 14 tablets

Rosuvast 10 mg 14 tablets

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.