Atorwin

Atorwin

atorvastatin

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Hypercholesterolemia. Prevention of CV disorders.
Dosage/Direction for Use
Individualized dosage. Usual starting dose: 10 mg once daily. Adjust dose at ≥4 wk intervals. Max: 80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once a day. Heterozygous familial hypercholesterolemia Initially 10 mg daily. Dose should be individualized & may be adjusted every 4 wk to 40 mg daily. May be increased to a max of 80 mg daily or a bile acid sequestrant may be combined w/ atorvastatin 40 mg once daily. Homozygous familial hypercholesterolemia 10-80 mg daily. Prevention of CV disorders 10 mg/day.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases (>3 x ULN); myopathy. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Perform liver function test prior to treatment & periodically thereafter, monitor patients who develop increased transaminase levels until abnormalities resolve. Reduce dose or withdraw treatment if transaminase increase is >3 x ULN. May affect skeletal muscle & cause myalgia, myositis, myopathy that may progress to rhabdomyolysis. Patients w/ predisposing factors for rhabdomyolysis; measure CPK prior to treatment in patients w/ renal impairment, hypothyroidism, history of hereditary muscular disorder, toxicity w/ statin or fibrate, liver disease &/or substantial alcohol consumption & elderly >70 yr. Do not start treatment if CPK >5 x ULN. Discontinue use if creatinine phosphokinase (CPK) levels elevated to >10 x ULN or rhabdomyolysis is diagnosed or suspected. Concomitant use w/ ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-PIs may increase risk of rhabdomyolysis. Immune-mediated necrotizing myopathy (rarely). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Constipation, flatulence, dyspepsia, nausea, diarrhea; allergic reactions; insomnia; headache, dizziness, paraesthesia, hypoesthesia; skin rash, pruritus; myalgia, arthralgia; asthenia, chest & back pain, peripheral edema.
Drug Interactions
Increased risk of myopathy w/ ciclosporin, fibric acid derivatives, boceprevir, macrolide antibiotics including erythromycin, azole antifungals, niacin, telaprevir, combination of tipranavir/ritonavir may result to rhabdomyolysis. Increased plasma conc w/ CYP450 3A4 inhibitors eg, ciclosporin, macrolide antibiotics including erythromycin & clarithromycin, nefazodone, azole antifungals including itraconazole & HIV-PIs. Increased bioavailability w/ P-glycoprotein inhibitors (eg, ciclosporin). Increased AUC w/ itraconazole. Increased plasma conc w/ erythromycin, clarithromycin, PIs, grapefruit juice & OCs (norethindrone & ethinyl oestradiol). Increased risk of atorvastatin-induced myopathy w/ gemfibrozil/fibric acid derivatives. May increase conc of digoxin. Decreased plasma conc w/ colestipol, oral antacid susp containing Mg & Al hydroxide. Slight decrease in prothrombin time w/ warfarin. Cases of myopathy w/ colchicine.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atorwin FC tab 10 mg
Packing/Price
30's (P607/box)
Form
Atorwin FC tab 40 mg
Packing/Price
30's (P907/box)
Form
Atorwin FC tab 20 mg
Packing/Price
30's (P801/box)
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