RiteMED Atorvastatin

RiteMED Atorvastatin

atorvastatin

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Reduction of LDL-cholesterol (LDL-C) apolipoprotein B & triglycerides & to increase HDL-cholesterol (HDL-C) in the treatment of hyperlipidemias. As adjunctive therapy in patients w/ homozygous familial hypercholesterolemia who have some LDL-receptor function & for primary prophylaxis of CV events in patients w/ multiple risk factors.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg w/ >15% reduction in LDL-C.
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. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
History of liver disease. Consumption of substantial quantities of alcohol. Perform liver function tests prior to & 12 wk following initiation of therapy & periodically thereafter. Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Discontinue use if markedly elevated creatine phosphokinase levels occurs or myopathy is diagnosed or suspected. Concomitant use w/ ketoconazole, spironolactone & cimetidine. Discontinue or temporary withheld in patients w/ severe acute infection, hypotension, majoy surgery, trauma, metabolic, endocrine & electrolyte disorders & uncontrolled seizures. Childn <18 yr.
Adverse Reactions
GI, resp, nervous, musculoskeletal, skin & appendages, urogenital, CV, hemic & lymphatic disorders; eye disorders & taste disturbances. Chest pain, face & generalized edema, fever, neck rigidity, malaise, photosensitivity reaction.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, gemfibrozil/fibric acid derivatives, erythromycin, azole antifungals or niacin. Increased plasma conc w/ CYP450 3A4 inhibitors (eg, macrolide antibiotics, grapefruit juice & PIs), substrates & other drugs metabolized by this isoenzyme. Increased risk of myopathy & bioavailability w/ P-glycoprotein inhibitors. May increase conc of digoxin, OC-containing norethisterone & ethinyl estradiol. Reduced plasma conc w/ colestipol, oral antacid susp containing Mg & Al hydroxides. Minimal decrease in 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
RiteMED Atorvastatin film-coated tab 10 mg
Packing/Price
100's (P16/film-coated tab, P1,600/box)
Form
RiteMED Atorvastatin film-coated tab 40 mg
Packing/Price
100's (P2,600/box, P26/film-coated tab)
Form
RiteMED Atorvastatin film-coated tab 20 mg
Packing/Price
100's (P1,900/box, P19/film-coated tab);30's (P19/film-coated tab)
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