Atoris

Atoris

atorvastatin

Manufacturer:

KRKA

Distributor:

Uni Drug
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides in patients w/ primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & those w/ dysbetalipoproteinemia (Fredrickson type III) when response to diet & other non-pharmacological measures is inadequate. Raises HDL-cholesterol & lowers LDL/HDL & total cholesterol/HDL ratios. Adjunct to diet & other nondietary measures in reducing elevated total cholesterol, LDL-cholesterol & apolipoprotein B in patients w/ homozygous familial hypercholesterolemia when response to these measures is inadequate. Reduces the risk of MI in adult hypertensive patients w/o clinically evident CHD, but w/ at least 3 additional risk factors for CHD eg, age ≥55 yr, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6 or premature family history of CHD. Reduces the risk of MI or stroke in patients w/ type 2 diabetes & w/o clinically evident CHD, but w/ multiple risk factors for CHD eg, retinopathy, albuminuria, smoking or HTN. Reduces the risk of nonfatal MI, fatal & nonfatal stroke, revascularization procedures, hospitalization for CHF & angina in patients w/ clinically evident CHD.
Dosage/Direction for Use
Initially 10 mg once daily. Dose may be adjusted at intervals of ≥4 wk. Max: 80 mg daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily for 2-4 wk. Homozygous familial hypercholesterolemia 80 mg. Prevention of CV disease Primary: 10 mg daily.
Administration
May be taken with or without food: May take w/o regard to time of day. Avoid excessive consumption (>1 L/day) of grapefruit juice. 
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3 times the upper limit of normal (ULN); myopathy. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Perform liver function tests prior to initiation of treatment & periodically thereafter. Haemorrhagic stroke or lacunar infarct. Measure creatine phosphokinase (CPK) prior to treatment in patients w/ renal impairment, hypothyroidism; history of hereditary muscular disorders, muscular toxicity w/ statins or fibrates, liver disease &/or substantial alcohol consumption, elderly >70 yr. Discontinue use if significant CPK elevation (>5 times ULN) or if muscular symptoms are severe even if the CPK levels are elevated to ≤5 times ULN, or if clinically significant elevation of CPK levels (>10 times ULN) occurs or if rhabdomyolysis is diagnosed or suspected. Temporarily w/hold or discontinue treatment in patients w/ acute, serious condition suggestive of a myopathy or w/ risk factor predisposing to renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures). Concomitant use w/ ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivatives or HIV-PIs; ezetimibe. Patients <18 yr (for treatment periods >52 wk). Childn <10 yr & premenarchal girls. Long-term effects on cognitive development, growth & pubertal maturation. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Abdominal pain, constipation, flatulence, dyspepsia, nausea, diarrhoea; allergic reactions; insomnia; headache, dizziness, paraesthaesia, hypoesthesia; skin rash, pruritus; myalgia, arthralgia, back pain; asthenia, chest pain, peripheral oedema.
Drug Interactions
Increase on the following: Risk of myopathy w/ ciclosporin, gemfibrozil/fibric acid derivatives, macrolides including erythromycin, azole antifungals, HIV-PIs or niacin, ezetimibe; plasma conc w/ CYP3A4 inhibitors (eg, clarithromycin, nefazodone, itraconazole); systemic exposure w/ OATP1B1 & P-glycoprotein transporter inhibitors; AUC w/ ritonavir + saquinavir, or w/ diltiazem or grapefruit juice; exposure w/ verapamil, amiodarone, amlodipine. Variable reductions in plasma conc w/ CYP3A4 inducers eg, efavirenz, rifampin, St. John's wort. Increases digoxin conc, norethindrone, ethinyl oestradiol. Decreased plasma conc but greater lipid effects w/ colestipol. Decreased plasma conc w/ Mg- & Al hydroxide-containing antacids. May affect prothrombin time w/ warfarin.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atoris FC tab 10 mg
Packing/Price
30's
Form
Atoris FC tab 20 mg
Packing/Price
30's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in