Rosuvast 5 mg 14 tablets

Rosuvast 5 mg 14 tablets

Composition:
Active ingredient:
Rosuvastatin calcium 5.217 mg equivalent to 5 mg rosuvastatin.
Excipients:
Microcrystalline cellulose, spray-dried lactose monohydrate, tribasic calcium phosphate, crospovidone, magnesium stearate, colloidal anhydrous silica, hypromellose, triacetin, titanium dioxide, red iron oxide.
Description:
ROSUVAST contains rosuvastatin, a selective HMG-CoA reductase inhibitor used to lower cholesterol and correct lipid disorders.
Indications for Use:
ROSUVAST is indicated as adjunct therapy to diet in:
- Hyperlipidemia and mixed dyslipidemia
- Pediatric heterozygous familial hypercholesterolemia (8-17 years)
- Pediatric homozygous familial hypercholesterolemia (7-17 years)
- Hypertriglyceridemia (adults)
- Primary dysbetalipoproteinemia (Type III)
- Adult homozygous familial hypercholesterolemia
- Slowing the progression of atherosclerosis
- Primary prevention of cardiovascular disease (stroke, MI, revascularization) in high-risk adults.
Dosage and Method of Administration:
Adults: 5-40 mg once daily.
Usual starting dose: 10-20 mg.
Homozygous familial hypercholesterolemia: 20 mg daily.
40 mg dose only if LDL-C goal not achieved on 20 mg.
Pediatric dosing:
- Heterozygous FH: - 5-10 mg (8-<10 years)
- 5-20 mg (10-17 years)
- Homozygous FH: 20 mg (7-17 years).
Special instructions:
- Severe renal impairment: start 5 mg; max 10 mg
- With cyclosporine or darolutamide: max 5 mg
- With gemfibrozil: max 10 mg
- With certain antivirals: max 10 mg
- Take once daily, any time, with or without food.
Swallow whole.
Contraindications:
- Hypersensitivity
- Active liver disease
- Pregnancy
- Lactation
- Hereditary galactose metabolism disorders
- Severe renal impairment without dose adjustment.
Precautions:
- Risk of myopathy and rhabdomyolysis
- Elevated CK
- Immune-mediated necrotizing myopathy
- Liver enzyme abnormalities
- INR increase with coumarin anticoagulants
- Proteinuria and hematuria-Increased glucose, possible onset of diabetes
- May worsen or induce myasthenia
- Caution with alcohol and liver disease
- Do not use during pregnancy or breastfeeding.
Side Effects:
Common:
- Headache
- Nausea
- Myalgia
- Weakness
- Constipation
- Abdominal pain
Other reported:
- Arthralgia
- Dizziness, insomnia
- Hypersensitivity reactions
- Increased CK, transaminases
- Pancreatitis
- Depression, sleep disorders
- Memory impairment
- Myasthenia, ocular myasthenia.
Pregnancy and Breastfeeding:
Pregnancy: contraindicated; may cause fetal harm.
Breastfeeding: contraindicated; drug passes into breast milk.
Storage Conditions:
Store below 30°C.
Keep out of reach of children.
Packaging:
A carton box containing 2 blisters, 7 tablets each and a leaflet.