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Atorvastatin Calcium (Atorvastatin Calcium)

Trade Name : Atorvastatin Calcium

Aidarex Pharmaceuticals LLC

TABLET, FILM COATED

Strength 20 mg/1

ATORVASTATIN CALCIUM TRIHYDRATE HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atorvastatin Calcium (Atorvastatin Calcium) which is also known as Atorvastatin Calcium and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 20 mg/1 per ml. Read more

Atorvastatin Calcium (Atorvastatin Calcium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration (2.6) tttt 10/2012
  • Warnings and Precautions (5.1) tttt 10/2012
  • Drug Interactions (7) tttttt 02/2012
  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
  • Atorvastatin calcium tablets are an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:
  • Limitations of Use
  • Atorvastatin calcium tablets have not been studied in Types I and V dyslipidemias.
  • Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1).
  • Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
  • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
  • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
  • Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
  • Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2).
  • Dose range: 10 to 80 mg once daily (2.1).
  • Recommended start dose: 10 or 20 mg once daily (2.1).
  • Patients requiring large LDL-C reduction (> 45%) may start at 40 mg once daily (2.1).
  • Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (2.2).
  • White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium, USP.
  • 10, 20, 40, and 80 mg tablets (3).
  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4.1).
  • Women who are pregnant or may become pregnant (4.3).
  • Nursing mothers (4.4).
  • Hypersensitivity to any component of this medication (4.2).
  • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected (5.1, 8.5).
  • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter (5.2).
  • A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium 80 mg group vs. placebo (5.5).
  • The following serious adverse reactions are discussed in greater detail in other sections of the label:
  • Rhabdomyolysis and myopathy [see ]
  • Liver enzyme abnormalities [see ]
  • The most commonly reported adverse reactions (incidence u2265 2%) in patients treated with atorvastatin calcium in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).
  • To report SUSPECTED ADVERSE REACTIONS, contact Ranbaxy Pharmaceuticals Inc. at (1-888-Ranbaxy (726-2299)) or FDA at 1-800-FDA-1088 or .
  • The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole) [see and ].
  • Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (2.6, 5.1, 7, 12.3)
  • Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (u2265 1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with atorvastatin calcium (7).
  • Digoxin: Patients should be monitored appropriately (7.8).
  • Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.9).
  • Rifampin should be simultaneously co-administered with atorvastatin calcium (7.7).
  • No data
  • Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease (12.3).
  • There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.
  • Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
  • Atorvastatin calcium is [R-(R,R)]-2-(4-fluorophenyl)-u00df, u03b4-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (CHFNO)Cau20223HO and its molecular weight is 1209.42. Its structural formula is:
  • Atorvastatin calcium, USP is a white to off-white crystalline powder. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble to insoluble in water and pH 7.4 phosphate buffer; insoluble in acetonitrile; slightly soluble to very slightly soluble in ethanol; and freely soluble to slightly soluble in methanol.
  • Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; candelilla wax, FCC; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide.
  • No data
  • In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose females: in one, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. This dose represents a plasma AUC (0 to 24) value of approximately 16 times the mean human plasma drug exposure after an 80 mg oral dose.
  • A 2-year carcinogenicity study in mice given 100, 200, or 400 mg/kg/day resulted in a significant increase in liver adenomas in high-dose males and liver carcinomas in high-dose females. These findings occurred at plasma AUC (0 to 24) values of approximately 6 times the mean human plasma drug exposure after an 80 mg oral dose.
  • In vitro,
  • Salmonella typhimurium
  • Escherichia coli,
  • in vivo
  • Studies in rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. There was aplasia and aspermia in the epididymis of 2 of 10 rats treated with 100 mg/kg/day of atorvastatin for 3 months (16 times the human AUC at the 80 mg dose); testis weights were significantly lower at 30 and 100 mg/kg and epididymal weight was lower at 100 mg/kg. Male rats given 100 mg/kg/day for 11 weeks prior to mating had decreased sperm motility, spermatid head concentration, and increased abnormal sperm. Atorvastatin caused no adverse effects on semen parameters, or reproductive organ histopathology in dogs given doses of 10, 40, or 120 mg/kg for two years.
  • No data
  • 1
  • Pediatrics.
  • Atorvastatin calcium tablets 20 mg are white, elliptical, film-coated tablets, debossed with u2018 n on one side and plain on the other side. They are supplied as follows:
  • NDC 33261-0972-30 Bottles of 30
  • NDC 33261-0972-90 Bottles of 90
  • Storage
  • Store at 20 - 25u00b0 C (68 - 77u00b0 F) [See USP Controlled Room Temperature].
  • Dispense in tight containers (USP).
  • Patients taking atorvastatin calcium tablets should be advised that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.
  • Patients should be advised about substances they should not take concomitantly with atorvastatin see . Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking n- atorvastatin calcium tablets.
  • 33261-0972-30
  • ATORVASTATIN CALCIUM TABLETS
  • 20 mg
  • Rx only 30 Tablet
  • 33261-0972-90
  • ATORVASTATIN CALCIUM TABLETS
  • 20 mg
  • Rx only 90 Tablet

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