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Atorvastatin Calcium (Atorvastatin Calcium)

Trade Name : ATORVASTATIN CALCIUM

Marlex Pharmaceuticals Inc

TABLET, FILM COATED

Strength 10 mg/1

ATORVASTATIN CALCIUM 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 Marlex Pharmaceuticals Inc. It is available in strength of 10 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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About GNH

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
  • 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.u00a0In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
  • Atorvastatin calcium tablets is an inhibitor of HMG-CoA reductase (statin) indicate d as an adjunct therapy to die t to: () Re duce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors ().
  • Limitations of Use:
  • Atorvastatin calcium tablets has not beenu00a0studied in Fredrickson Types I and V dyslipidemias. ()
  • Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors ().n
  • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors ()n
  • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD ().n
  • Reduceu00a0elevated total-C, LDL-C, apou00a0B, andu00a0TG levels and increaseu00a0HDL-C in adult patientsu00a0with primaryu00a0hyperlipidemia (heterozygousu00a0familial and nonfamilial) and mixed dyslipidemia ().n
  • Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (). n
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) ().n
  • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy ()u00a0
  • Dose range: 10 to 80 mg once daily (). ()
  • Recommended start dose: 10 or 20 mg once daily (). ()
  • Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily (). ()
  • Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (). ()
  • Atorvastatin calcium tablets are yellow, oval shape, biconvex, film coated, and are available in four strengths (see Table 1).
  • u00a0u00a0u00a0u00a0u00a0n- Table 1: Atorvastatin Calcium Tablet Strengths and Identifying Features
  • Tablets: 10, 20, and 40 mg of atorvastatin (). (3)
  • Active liver n- disn- easn- e, n- which n- may n- include unexplained n- persn- isn- tent elevations n- in n- Hepatic n- Transn- aminasen- u00a0n- Levels
  • Hypersn- ensn- itivity n- to n- any n- Component ofn- u00a0n- this n- Medication
  • Pregnancyn- u00a0
  • Lactationn- u00a0
  • Activeu00a0liveu00a0ru00a0disease,u00a0which may includeu00a0unexplainedu00a0persistentu00a0elevationsu00a0inu00a0hepatic transaminaseu00a0levelsu00a0().n
  • Hypersensitivityu00a0tou00a0anyu00a0component ofu00a0thisu00a0medicationu00a0().n
  • Pregnancy (,u00a0,u00a0)n
  • Lactation (,u00a0)
  • No data
  • 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 factorsu00a0include 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 (, ). n
  • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter (). n
  • 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 ().
  • The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy [see Warnings and Precautions ()]
  • Liver enzyme abnormalities [see Warnings and Precautions ()]
  • Theu00a0mostu00a0commonlyu00a0reportedu00a0adverseu00a0reu00a0actionsu00a0(incidenceu00a0u2265u00a02%)u00a0inu00a0patientsu00a0treatedu00a0withu00a0atorvastatinu00a0calciumu00a0inu00a0placebo controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ().u00a0()
  • 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 Warnings and Precautions () and Clinical Pharmacology ()].
  • Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying dose s (u22651 g/day) of niacin increases the risku00a0ofu00a0adverseu00a0skeletalu00a0muscleu00a0effects.u00a0Cautionu00a0shouldu00a0beu00a0usedu00a0whenu00a0preu00a0scribingu00a0withu00a0atorvastatinu00a0calciumu00a0().n
  • Digoxin:u00a0Patientsu00a0should beu00a0monitored appropriatelyu00a0().n
  • Oralu00a0Contraceptiveu00a0s:u00a0Valueu00a0su00a0foru00a0norethindroneu00a0andu00a0ethinylu00a0estradiolu00a0may beu00a0increasedu00a0().n
  • Rifampinu00a0shouldu00a0beu00a0simultaneouslyu00a0co-administeredu00a0withu00a0atorvastatinu00a0calciumu00a0().u00a0()
  • No data
  • Hepatic impairment:u00a0Plasma concentrationsu00a0markedlyu00a0increasedu00a0inu00a0patientsu00a0withu00a0chronic alcoholic liveu00a0ru00a0diseaseu00a0(,u00a0).n
  • Femalesu00a0ofu00a0reproductiveu00a0potential:u00a0Adviseu00a0femaleu00a0su00a0ofu00a0reu00a0productiveu00a0potentialu00a0tou00a0useu00a0effectiveu00a0contraceptionu00a0during treatmentu00a0with atorvastatin calcium (). ()
  • 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*,u00a0R*)]-2-(4-fluorophenyl)-u00df,u03b4-dihydroxy-5-(1-methylethyl)-3-phenyl-4- [(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The empirical formula of atorvastatin calcium is CHCaFNOu00a0and its molecular weight is 1155.36. Its structural formula is:
  • Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below.
  • Atorvastatin calcium tablets for oral administration contain 10, 20 or 40mg atorvastatin and the following inactive ingredients: anhydrous lactose, NF; colloidal silicon dioxide, NF; copovidone, NF; croscarmellose sodium, NF; magnesium stearate, NF; mannitol, USP; silicified microcrystalline cellulose, NF; sodium bicarbonate, USP; sodium carbonate anhydrous, NF; sodium lauryl sulfate, NF; lecithin, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, xanthan gum and iron oxideu00a0yellow.
  • 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 highdose 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 oralu00a0dose.
  • In vitro, atorvastatin was not mutagenic or clastogenic in the following tests with and without metabolic activation: the Ames test with Salmonella typhimurium and Escherichia coli, the HGPRT forward mutation assay in Chinese hamster lung cells, and the chromosomal aberration assay in Chinese hamster lung cells. Atorvastatin was negative in the in vivo mouse micronucleusu00a0test.
  • In female rats, atorvastatin at doses up to 225 mg/kg (56 times the human exposure) did not cause adverseu00a0effects Onu00a0fertility. Studies in male rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. There was aplasia and as permia 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 80mg dose); testis weights were significantly lower at 30 and 100mg/kg and epididymal weight was lower at 100mg/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 causedu00a0no adverse effects on semen parameters, or reproductive organ histopathology in dogs given doses of 10, 40, or 120 mg/kg for twou00a0years.
  • No data
  • 10 mg tablets:
  • Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 152 on other side. Bottles of 1000 NDC 10135-0649-10
  • 20 mg tablets:
  • Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 153 on other side. Bottles of 500 NDC 10135-0650-05
  • 40 mg Tablets:
  • Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 154 on other side. Bottles of 1000 NDC 10135-0651-10
  • 80 mg Tablets:
  • Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 155 on other side. Bottles of 500 NDC 10135-0653-05
  • Storage
  • Store at 20u00b0C to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Patients taking atorvastatin calcium 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 Warnings and Precautions (n- Arrayn- )]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium.
  • PATIENT INFORMATION
  • Atorvastatin Calcium Tablets
  • (a toru2033 va statu2032 in kalu2032 see um)
  • Read the Patient Information that comes with atorvastatin calcium tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition oru00a0treatment.
  • If you have any questions about atorvastatin calcium tablets, ask your doctor or pharmacist.
  • What is Atorvastatin Calcium Tablet?
  • Atorvastatin calcium tablets is a prescription medicine that lowers cholesterol in your blood. It lowers the LDL-C (u201cbadu201d cholesterol) and triglycerides in your blood. It can raise your HDL-C (u201cgoodu201d cholesterol) as well. Atorvastatin calcium tablets are for adults and children over 10 whose cholesterolu00a0does not come down enough with exercise and a low-fat dietu00a0alone.
  • Atorvastatin calcium tablets can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as:
  • Atorvastatin calcium tablets can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:
  • What is Cholesterol?
  • Cholesterol and triglycerides are fats that are made in your body. They are also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol and triglycerides can clog your blood vessels. It is especially important to lower your cholesterol if you have heart disease, smoke, have diabetes or high blood pressure, are older, or if heart disease starts early in your family.
  • Who Should Not Take Atorvastatin Calcium Tablets?
  • Do not take Atorvastatin Calcium Tablets if you:
  • Atorvastatin calcium tablets dosing has not been established in children under 10 years of age.
  • Before You Start Atorvastatin Calcium Tablets
  • Tell your doctor if you:
  • Some medicines should not be taken with atorvastatin calcium tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for:
  • Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.
  • How Should I Take Atorvastatin Calcium Tablets?
  • Donu2019t break atorvastatin calcium tablets before taking.
  • What Should I Avoid While Taking Atorvastatin Calcium Tablets?
  • What are the Possible Side Effects of Atorvastatin Calcium Tablets?
  • Atorvasn- tatin n- calcium tablets n- can n- causn- en- u00a0n- sn- erious n- sn- ide n- effectsn- . n- Thesn- e sn- ide n- effects n- have n- happened n- only n- to n- a small n- number n- of n- people. n- Your n- doctor n- can n- monitor n- you n- for them. n- Thesn- e sn- ide n- effects n- usn- ually n- go n- away n- if n- your n- dosn- e n- is n- lowered n- or n- atorvasn- tatin n- calcium tablets are sn- topped. n- Thesn- en- u00a0n- sn- erious n- sn- ide n- effectsn- u00a0n- include:
  • Call your doctor right away if you have:
  • In clinical studies, patients reported the following common side effects while taking atorvastatin calcium tablets: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.
  • The following additional side effects have been reported with atorvastatin calcium tablets: tiredness, tendon problems, memory loss, and confusion.
  • Talk to your doctor or pharmacist if you have side effects that bother you or that will not gou00a0away.
  • These are not all the side effects of atorvastatin calcium tablets. Ask your doctor or pharmacist for a complete list.
  • How do I store Atorvastatin Calcium Tablets
  • General Information About Atorvastatin Calcium Tablets
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use atorvastatin calcium tablets for a condition for which it was not prescribed. Do not give atorvastatin calcium tablets to other people, even if they have the same problem you have. It may harm them.
  • This leaflet summarizes the most important information about atorvastatin calcium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for informationu00a0about atorvastatin calcium tablets that is written for health professionals.
  • What are the Ingredients in Atorvasn- tatin Calcium Tabletsn- ?
  • Active Ingredient:
  • Inactive Ingredients :
  • Manufactured for & Distributed by:
  • NDC 10135-0649-10Atorvastatin Calcium Tablets10 mg1000 TABLETSRx Only
  • NDC 10135-0650-05Atorvastatin Calcium Tablets20 mg500 TABLETSRx Only
  • NDC 10135-0651-10Atorvastatin Calcium Tablets40 mg1000 TABLETSRx Only
  • NDC 10135-0653-05Atorvastatin Calcium Tablets80 mg500 TABLETSRx Only

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