RiteMED Atorvastatin

Adjunct to diet for treatment of patients w/ elevated total cholesterol, LDL-C, Apo B & triglycerides & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types Ila & 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/ HoFH when response to diet & other non-pharmacological measures are inadequate.

10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH Most patients responded to 80 mg.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Women of childbearing potential not using adequate contraception. Pregnancy & lactation.

Discontinue use if markedly elevated CPK levels occur or myopathy is diagnosed or suspected; in any patient w/ acute, serious condition suggestive of myopathy or w/ risk factor predisposing to development of renal failure secondary to rhabdomyolysis eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures. Rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Patients who consume substantial quantities of alcohol &/or w/ history of liver disease. Perform LFTs prior to & at 12 wk following both initiation of therapy & any elevation of dose, & periodically (eg, semiannually) thereafter. Concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone, & cimetidine; cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals. Treatment period >52 wk in patients <18 yr. Childn <10 yr & premenarchal girls.

Chest pain, face & generalized edema, fever, neck rigidity, malaise, photosensitivity reaction; nausea, gastroenteritis, abnormal LFTs, colitis, vomiting, gastritis, dry mouth, rectal & gum hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal & stomach ulcer, dysphagia, enteritis, melena, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice; bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis; insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, decreased libido, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia; arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis; pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer; UTI, hematuria, albuminuria, urinary frequency, incontinence, retention & urgency, cystitis, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vag & uterine hemorrhage, breast enlargement, metrorrhagia, nephritis, abnormal ejaculation; amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss & perversion; palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, HTN; peripheral edema, hyperglycemia, increased creatine phosphokinase, gout, wt gain, hypoglycemia; ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, erythromycin, azole antifungals, or niacin. Concomitant use w/ CYP450 3A4 substrates (eg, immunomodulators, many antiarrhythmics, some Ca channel antagonists & some benzodiazepines) may lead to possible change in plasma drug levels of either drug. Concomitant use w/ CYP450 3A4 inhibitors eg, certain macrolide antibiotics & azole antifungals. Increased & decreased plasma levels of phenytoin. Bioavailability may be increased & thereby increase risk of dose-related side effects (eg, myopathy) w/ P-gp inhibitors eg, cyclosporine. May increase risk of atorvastatin-induced myopathy w/ fibric acid derivatives. Increased plasma conc of digoxin; norethisterone & ethinyl estradiol. Higher plasma conc w/ erythromycin or clarithromycin. Lowered plasma conc & greater lipid effects w/ colestipol. Decreased plasma conc w/ Mg & Al hydroxide-containing oral antacid susp. Minimal decrease in prothrombin time w/ warfarin. Increased AUC w/ large quantities of grapefruit juice. Increased plasma conc w/ PIs.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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