Tovastin

Tovastin

atorvastatin

Manufacturer:

T. O. Chemicals

Distributor:

T. O. Chemicals
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to nondrug therapies, which include adherence to a heart-healthy diet, regular exercise, avoidance of tobacco products, & maintenance of a healthy wt, for prevention of CV events & for the management of dyslipidemias. Reduce risk of MI, stroke or angina & to reduce the risk of undergoing revascularization procedures in patient w/o clinical evidence of CHD who have multiple risk factors eg, age, smoking, HTN, low HDL-C conc & family history of early CHD. Reduce risk of MI or stroke in patient w/o CHD who have type 2 DM & multiple risk factors for CHD eg, retinopathy, albuminuria, smoking, HTN. Reduction of total-C, LDL-C, apoB & triglyceride & the increment of HDL in patients w/ primary hypercholesterolaemia (heterozygous familial & nonfamilial hypercholesterolemia), mixed hyperlipidemia (Fredrickson types IIa & IIb), & patient w/ primary dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Elevated triglyceride in patient w/ hypertriglyceridemia (Fredrickson type IV) & reduced total-C & LDL-D in patient w/ homozygous familial hypercholesterolemia.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolaemia (heterozygous familial & non-familial) & mixed hyperlipidemia 10 mg once daily. Ped patient 10-17 yr Initially 10 mg once daily. Max dose: 20 mg daily. Homozygous familial hypercholesterolaemia (as adjunct to other lipid-lowering therapies or when such therapies are unavailable) 10-80 mg once daily. In concomitant use w/ other medicinal compd (cyclosporine, telaprevir, or combination tipranavir/ritonavir) Max dose: 10 mg.
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
History of hypersensitivity. Patient w/ active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 x ULN. Women of child-bearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use in patients w/ musculoskeletal disorder eg, muscles, back or limb pain. Monitor liver function test in 6- & 12-wk before & after therapy; monitor every 6 mth during therapy. Concomitant use w/ digoxin, warfarin; azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone; colchicines (especially elderly or w/ renal impairment). Patients w/ renal or hepatic impairment, alcoholism, or hypothyroidism. Risk of myopathy & hyperglycemia. Promptly interrupt if serious liver injury w/ clinical manifestations &/or hyperbilirubinemia or jaundice occurs. Measure baseline CK conc before initiation of therapy; routine monitoring for muscle toxicity in childn & adolescents receiving statin therapy. DM; concomitant use w/ drug that may decrease the conc or activity of endogenous steroid hormones eg, spironolactone, & cimetidine. Recent stroke or transient ischemic attack.
Adverse Reactions
Diarrhea; arthralgia; nasopharyngitis. Hemorrhagic stroke; insomnia; hyperglycemia; nausea, dyspepsia; allergic reaction; headache; pharyngolaryngeal pain; abnormal liver function test, increased serum transaminases; myalgia, muscle spasm, limb pain.
Drug Interactions
Increased plasma conc & increased risk of myopathy may occur w/ CYP3A4 inhibitors eg, cyclosporine, clarithromycin, itraconazole, & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir. Variable reductions in plasma conc may occur w/ CYP450 3A4 inducers eg, efavirenz, rifampin, St. John's wort. Increased peak plasma conc & AUC w/ clarithromycin, erythromycin, itraconazole & grapefruit juice. Decreased peak plasma conc & AUC w/ rifampin. Increased risk of myopathy including rhabdomyolysis w/ fibric acid derivatives eg, gemfibrozil, fenofibrate; colchicine. Decreased levels w/ Al hydroxide/Mg hydroxide susp. Decreased plasma conc w/ colestipol. Increase peak plasma conc & AUC of digoxin, ethinyl estradiol, norethindrone.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Tovastin FC tab 10 mg
Packing/Price
3 × 10's
Form
Tovastin FC tab 20 mg
Packing/Price
3 × 10's
Form
Tovastin FC tab 40 mg
Packing/Price
10 × 10's;3 × 10's
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