Xarator

Xarator

atorvastatin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to diet for the treatment of patients w/ elevated total cholesterol, LDL-C, Apo B & triglycerides to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total cholesterol & LDL-C in patients w/ homozygous familial hypercholesterolemia. In patients w/o clinically evident CV disease & w/ or w/o dyslipidemia but w/ multiple risk factors for CHD, fatal & non-fatal MI, stroke, revascularization procedures & angina pectoris. Reduce the risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF, angina in patients w/ clinically evident CHD; CV disease in patients w/ diabetes w/ moderately decreased eGFR; major CV events including stroke in patients w/ clinically evident CHD & chronic kidney disease (CKD) not requiring dialysis. Reduce the rate of GFR decline & progression of CKD in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total-C, LDL-C & apo-B levels in boys & post-menarchial girls & in ped patients (10-17 yr) w/ heterozygous familial hypercholesterolemia.
Dosage/Direction for Use
10-80 mg once daily. Dose adjustment according to lipid levels analyzed w/in 2-4 wk after initiation &/or upon titration. Heterozygous familial hypercholesterolemia Ped patients 10-17 yr Initially 10 mg/day. Max: 20 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 exceeding 3x ULN. Pregnancy & lactation.
Special Precautions
Alcohol &/or history of liver disease. Discontinue use in patients w/ acute, serious condition suggestive of a myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Hemorrhagic stroke. Increased HbA1c & fasting serum glucose.
Adverse Reactions
Nasopharyngitis, hyperglycemia, pharyngolaryngeal pain, epistaxis, diarrhea, dyspepsia, nausea, flatulence, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling, abnormal LFT, increased blood creatinine phosphokinase.
Drug Interactions
Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP450 3A4 inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP450 3A4 inhibitors (eg, cyclosporine, erythromycin/clarithromycin, PIs, diltiazem HCl, cimetidine, itraconazole, grapefruit juice). Reduced plasma conc w/ CYP450 3A4 inducers (eg, efavirenz, rifampin). Antacids, colestipol, digoxin, oral OCs, colchicines, fusidic acid.
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
Xarator tab 10 mg
Packing/Price
100's;30's
Form
Xarator tab 20 mg
Packing/Price
100's;30's
Form
Xarator tab 40 mg
Packing/Price
100's;30's
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