Rostatin

Rostatin

rosuvastatin

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma

Marketer:

Atlantic Pharma
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Used w/ dietary therapy for hyperlipidemias to reduce elevations in total cholesterol, LDL, apolipoprotein B in adult patients w/ primary hypercholesterolemia (type IIa including heterezygous familial hypercholesterolemia), mixed dyslipidemia (type IIb), or homozygous familial hypercholesterolemia who have not responded adequately to diet & other appropriate measures. Reduction of atherosclerosis progression in adult patients w/ elevated total- or LDL-cholesterol conc, & for primary prevention of CV disease in those at high risk. Heterozygous familial hypercholesterolemia in patients 10-17 yr.
Dosage/Direction for Use
Individualized dose. Adult Initially 10 mg once daily. Patients w/ severe hyperlipidemia (LDL >190 mg/dL) & aggressive lipid targets 20 mg once daily. Patients requiring less aggressive treatment or predisposed to myopathy (including Asian descent) 5 mg once daily. Titration After 2 wk, may be increased by 5-10 mg once daily. Dosing range: 5-40 mg/day. Max: 40 mg once daily. Homozygous familial hypercholesterolemia Initially 20 mg once daily. Max: 40 mg/day. Patients 10-17 yr (female >1 yr post menarche) Heterozygous familial hypercholesterolemia 5-20 mg once daily. Max: 20 mg/day. Dosage adjustment w/ concomitant medications: Cyclosporine Max: 5 mg/day, gemfibrozil Max: 10 mg/day, if cannot be avoided, atazanavir/ritonavir or lopinavir/ritonavir Max: 10 mg/day. Renal impairment (CrCl <30 mL/min/1.73 m2) Initially 5 mg/day. Max: 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease; unexplained persistent elevations of serum transaminases (>3x ULN). Pregnancy & lactation.
Special Precautions
Discontinue therapy if becomes pregnant while taking Rostatin. Perform liver functions tests before & at 12-wk after initiation of therapy or any increase in dosage & periodically thereafter. Reduce dose or discontinue if increases in AST or ALT conc of 3x ULN or higher persist. Increased risk of myopathy in patients ≥65 yr, particularly women, hypothyroidism, receiving dose exceeding recommended dose range of 5-40 mg daily, Asian patients, & renal impairment. Concomitant use w/ cyclosporine, niacin, fibric-acid derivatives, macrolide antibiotics, certain azole antifungals & alcohol; ketoconazole, spironolactone, cimetidine. Discontinue use if serum CK conc elevation or myopathy occurs. Temporarily withhold therapy in acute; serious condition suggestive of myopathy or acute renal failure predisposing development secondary to rhabdomyolysis (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, uncontrolled seizures. Attempt vigorously control of serum cholesterol prior to therapy.
Adverse Reactions
Myalgia, myopathy, myositis, rhabdomyolysis; GI disturbances, sleep disturbance, headache, dizziness, depression, paraesthesia, asthenia, peripheral neuropathy, amnesia, fatigue, sexual dysfunction, thrombocytopenia, arthralgia, visual disturbance, alopecia, hypersensitivity reactions.
Drug Interactions
Decreased plasma conc w/ antacids. Enhanced effect on total- & LDL-cholesterol w/ bile acid sequestrants. Increased Cmax & AUC w/ cyclosporine. Increased risk of musculoskeletal effects w/ gemfibrozil & risk of myopathy w/ atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, & saquinavir. Increase plasma conc of ethinyl estradiol & norgestrel. Increased INR w/ warfarin.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Rostatin FC tab 10 mg
Packing/Price
2 × 14's
Form
Rostatin FC tab 20 mg
Packing/Price
2 × 14's
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