atorvastatin calcium


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Related to atorvastatin calcium: rosuvastatin calcium

atorvastatin calcium

Lipitor

Pharmacologic class: HMG-CoA reductase inhibitor

Therapeutic class: Lipid-lowering agent

Pregnancy risk category X

Action

Inhibits HMG-CoA reductase, which catalyzes first step in cholesterol synthesis; this action reduces concentrations of serum cholesterol and low-density lipoproteins (LDLs), linked to increased risk of coronary artery disease (CAD). Also moderately increases concentration of high-density lipoproteins (HDLs), associated with decreased risk of CAD.

Availability

Tablets: 10 mg, 20 mg, 40 mg, 80 mg

Indications and dosages

Adjunct to diet for controlling LDL, total cholesterol, apo-lipoprotein B, and triglyceride levels and to increase HDL levels in patients with primary hypercholesterolemia and mixed dyslipidemia; primary dysbetalipoproteinemia in patients unresponsive to diet alone; adjunct to diet to reduce elevated triglyceride levels

Adults: Initially, 10 mg P.O. daily; increase to 80 mg P.O. daily if needed. Adjust dosage according to patient's cholesterol level.

Adjunct to other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia

Adults: 10 to 80 mg P.O. daily

Adjunct to diet to decrease total cholesterol, LDL, and apo-lipoprotein B levels in boys and postmenarchal girls ages 10 to 17 with familial and nonfamilial heterozygous hypercholesterolemia

Boys and girls: Initially, 10 mg P.O. daily; adjust dosage upward or downward based on lipid levels. Maximum dosage is 20 mg daily.

Prevention of cardiovascular disease in patients without clinically evident coronary heart disease (CHD) but with multiple CHD risk factors

Adults: 10 mg P.O. daily

Prevention of stroke and myocardial infarction in patients with type 2 diabetes who have multiple risk factors for CHD but without clinically evident CHD

Adults: Dosage individualized according to patient characteristics, such as goal of therapy and response according to National Cholesterol Education Program guidelines

Contraindications

• Hypersensitivity to drug or its components
• Active hepatic disease or unexplained, persistent serum transaminase elevations
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• hypotension, uncontrolled seizures, myopathy, alcoholism
• severe metabolic, endocrine, or electrolyte disorders
• concurrent use of cyclosporine, HIV protease inhibitors tipranavir or lopinavir plus ritonavir, hepatitis C protease inhibitor telaprevir, HMG-CoA reductase inhibitor gemfibrozil (avoid use)
• concurrent use of colchicine, fibric acid products, lipid-modifying doses (1 g/day or more) of niacin, clarithromycin and itraconazole (with atorvastatin dose above 20 mg), or grapefruit juice (more than 1.2 L/day)
• women of childbearing age
• children younger than age 18.

Administration

• Give with or without food.
• Don't give with grapefruit juice or antacids.
• If patient is also taking a CYP450 3A4 inducer (such as efavirenz or rifampin), give simultaneously with atorvastatin because delayed atorvastatin administration after rifampin administration has been associated with a significant reduction in atorvastatin plasma concentration.

Adverse reactions

CNS: amnesia, abnormal dreams, emotional lability, headache, hyperactivity, poor coordination, malaise, paresthesia, peripheral neuropathy, drowsiness, syncope, weakness

CV: orthostatic hypotension, palpitations, phlebitis, vasodilation, arrhythmias

EENT: amblyopia, altered refraction, glaucoma, eye hemorrhage, dry eyes, hearing loss, tinnitus, epistaxis, sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal cramps, abdominal or biliary pain, colitis, indigestion, dyspepsia, flatulence, stomach ulcers, gastroenteritis, melena, tenesmus, glossitis, mouth sores, dry mouth, dysphagia, esophagitis, pancreatitis, rectal hemorrhage

GU: hematuria, nocturia, dysuria, urinary frequency or urgency, urinary retention, cystitis, nephritis, renal calculi, abnormal ejaculation, decreased libido, erectile dysfunction, epididymitis

Hematologic: anemia, thrombocytopenia

Hepatic: jaundice, hepatic failure, hepatitis

Metabolic: hyperglycemia, hypoglycemia

Musculoskeletal: bursitis, joint pain, back pain, leg cramps, gout, muscle pain or aches, myositis, myasthenia gravis, neck rigidity, torticollis, rhabdomyolysis

Respiratory: dyspnea, pneumonia, bronchitis

Skin: alopecia, acne, contact dermatitis, eczema, dry skin, pruritus, rash, urticaria, skin ulcers, seborrhea, photo-sensitivity, diaphoresis, toxic epidermal necrolysis

Other: taste loss, gingival bleeding, fever, facial paralysis, facial or generalized edema, flulike symptoms, infection, appetite changes, weight gain, allergic reaction, Stevens-Johnson syndrome

Interactions

Drug-drug.Antacids, colestipol, CYP450 3A4 (such as efavirenz, rifampin): decreased atorvastatin blood level

Azole antifungals, colchicine, cyclosporine, erythromycin, fibric acid derivatives, HIV protease inhibitors, lipid-modifying doses of niacin, other HMG-CoA reductase inhibitors, strong CYP3A4 inhibitors (such as clarithromycin, itraconazole): protease inhibitors: increased risk of myopathy or rhabdomyolysis

Digoxin: increased digoxin level, greater risk of toxicity

Hormonal contraceptives: increased levels of these drugs

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, creatine kinase: increased levels

Drug-food.Grapefruit juice: increased drug blood level, greater risk of adverse effects

Patient monitoring

• Monitor patient for signs and symptoms of allergic response.

Evaluate for muscle weakness (a symptom of myositis and possibly rhabdomyolysis).
• Be aware that reduction in dosage and periodic monitoring of creatine kinase level may be considered for patients taking drugs that may increase atorvastatin level.
• Monitor liver function test results and blood lipid levels.

Patient teaching

• Tell patient he may take drug with or without food.

Advise patient to immediately report allergic response, irregular heart beats, unusual bruising or bleeding, unusual tiredness, yellowing of skin or eyes, or muscle weakness.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.
• Inform patient taking hormonal contraceptives that drug increases estrogen levels. Instruct her to tell all prescribers she's taking drug.
• Tell men that drug may cause erectile dysfunction and abnormal ejaculation. Encourage them to discuss these issues with prescriber.
• Tell patient he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

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References in periodicals archive ?
The company stated that ATORVASTATIN CALCIUM TABLETS are the bioequivalent generic version of LIPITOR (atorvastatin calcium) tablets.
Reddy's Atorvastatin Calcium Tablets in 10 mg, 20 mg, 40 mg and 80 mg are available in bottle count sizes of 90 and 500.
is conducting a voluntary recall for Atorvastatin calcium tablets, in connection with its 10mg 20mg and 40mg dosage strengths, packaged in 90's and 500 count bottles and only with respect to certain select lot numbers.
A portion of the profits from Ranbaxy's sales of Atorvastatin Calcium Tablets during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva.
29 Atorvastatin Calcium Mylan 00378395177 7,496,375
The company added that Atorvastatin Calcium is the generic equivalent to Pfizer's Lipitor Tablets, which is indicated for the prevention of cardiovascular disease and hypercholesterolemia.
The Atorvastatin Calcium Tablets are the generic version of Pfizer's (NYSE:PFE) Lipitor Tablets.
The company added the Amlodipine Besylate and Atorvastatin Calcium tablets are the generic version of Pfizer's Caduet Tablets, which are used in the treatment of hypertension.
Pharmaceutical company Teva Pharmaceutical Industries Ltd (Nasdaq:TEVA) reported on Thursday the receipt of tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets as updated from a previous announcement.
Reddy's Laboratories (NYSE: RDY) announced today that it has entered into a settlement agreement with Pfizer which will resolve litigation related to Lipitor[R] Tablets, 10 mg, 20 mg, 40 mg, and 80 mg, known generically as Atorvastatin Calcium tablets.
Pharmaceutical company Teva Pharmaceutical Industries Ltd (Nasdaq:TEVA) announced today that under an agreement between its subsidiary, Teva Pharmaceuticals USA Inc, and Ranbaxy Laboratories Limited, a portion of the profits from Ranbaxy's sales of Atorvastatin Calcium Tablets during Ranbaxy's 180-day first-to-file exclusivity period, will be paid to Teva.
20 May 2010 - US-based specialty pharmaceutical company Watson Pharmaceuticals Inc (NYSE: WPI) announced yesterday that its subsidiary Cobalt Pharmaceuticals has received a Notice of Compliance from Health Canada to market Atorvastatin Calcium Tablets in the 10, 20, 40 and 80 mg strengths.