Atorvastatin Calcium (Atorvastatin Calcium)

Trade Name : Atorvastatin Calcium

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 10 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 Mylan 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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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
  • Dosage and Administration, Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors ()u00a0u00a0u00a0u00a0u00a011/2019
  • Warnings and Precautions, Skeletal Muscle ()u00a0u00a0u00a0u00a0u00a011/2019
  • 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 HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to:
  • Limitations of Use:
  • Atorvastatin calcium tablets have not been studied in Types I and V dyslipidemias ().
  • No data
  • Atorvastatin Calcium Tablets, USP are available containing atorvastatin calcium, USP equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin.
  • Tablets: 10, 20, 40, and 80 mg of atorvastatin ().
  • No data
  • 4n- 8.1n- 8.3
  • 4n- 8.2
  • No data
  • 2.6n- 5.1n- 8.5
  • The following serious adverse reactions are discussed in greater detail in other sections of the label:
  • The most commonly reported adverse reactions (incidence u2265 2%) in patients treated with atorvastatin calcium tablets in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ().n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 and HCV protease inhibitors, and itraconazole) .
  • No data
  • 8.6n- 12.3
  • There is no specific treatment for atorvastatin calcium tablet 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 clearance.
  • Atorvastatin calcium tablets, USP are 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 Calcium (,)-2-(-fluorophenyl)-,-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl) pyrrole-1-heptanoate (1:2), trihydrate. The molecular formula of atorvastatin calcium is CHCaFNOu20223HO and its molecular weight is 1209. Its structural formula is:
  • Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.
  • Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: anhydrous lactose, anhydrous sodium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, L-Arginine, magnesium stearate and microcrystalline cellulose. The film coating of the tablets contains polyvinyl alcohol, talc and titanium dioxide, and may contain polyethylene glycol or lecithin and xanthan gum.
  • Meets USP Dissolution Test 4.
  • 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 (0-24) 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 (0-24) 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
  • In female rats, atorvastatin at doses up to 225 mg/kg (56 times the human exposure) did not cause adverse effects on fertility. 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 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 2 years.
  • No data
  • Atorvastatin Calcium Tablets, USP are available containing atorvastatin calcium, USP equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin.
  • The 10 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-3950-77bottles of 90 tablets
  • NDC 0378-3950-05bottles of 500 tablets
  • The 20 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-3951-77bottles of 90 tablets
  • NDC 0378-3951-05bottles of 500 tablets
  • The 40 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-3952-77bottles of 90 tablets
  • NDC 0378-3952-05bottles of 500 tablets
  • The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-3953-77bottles of 90 tablets
  • NDC 0378-3953-05bottles of 500 tablets
  • Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Advise the patient to read the FDA-approved patient labeling ().
  • 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 . Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium tablets.
  • Atorvastatin Calcium Tablets, USP(a toru2033 va statu2032 in kalu2032 see um)
  • Read the Patient Information that comes with atorvastatin calcium tablets before you start taking them 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 or treatment.
  • If you have any questions about atorvastatin calcium tablets, ask your doctor or pharmacist.
  • What are atorvastatin calcium tablets?
  • Atorvastatin calcium tablets are a prescription medicine that lowers cholesterol in your blood. They lower the LDL-C (u201cbadu201d cholesterol) and triglycerides in your blood. They can raise your HDL-C (u201cgoodu201d cholesterol) as well. Atorvastatin calcium tablets are for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.
  • 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:
  • Atorvastatin calcium tablets start to work in about 2 weeks. n
  • 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 tablet 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?
  • What should I avoid while taking atorvastatin calcium tablets?
  • What are the possible side effects of atorvastatin calcium tablets?
  • Atorvastatin calcium tablets can cause serious side effects. These side effects have happened only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or atorvastatin calcium tablets are stopped. These serious side effects 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 go away.
  • These are not all the side effects of atorvastatin calcium tablets. Ask your doctor or pharmacist for a complete list.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • 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 they were not prescribed. Do not give atorvastatin calcium tablets to other people, even if they have the same problem you have. They 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 information about atorvastatin calcium tablets that is written for health professionals. Or you can call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
  • What are the ingredients in atorvastatin calcium tablets?
  • Active Ingredient:
  • Inactive Ingredients:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • 75074582
  • Revised: 2/2020MX:ATOR:R13ppt/MX:PL:ATOR:R10p/MX:PL:ATOR:R10pt
  • PRINCIPAL DISPLAY PANEL - 10 mg
  • NDC 0378-3950-77
  • Atorvastatin n- Calciumn- Tablets, USPn- 10 mg*
  • Rx only 90 Tablets
  • *Each film-coated tablet containsatorvastatin calcium, USPequivalent to 10 mg of atorvastatin.
  • Usual Dosage:
  • Keep this and all medication out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RM3950MM2
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • PRINCIPAL DISPLAY PANEL - 20 mg
  • NDC 0378-3951-77
  • Atorvastatin n- Calciumn- Tablets, USPn- 20 mg*
  • Rx only 90 Tablets
  • *Each film-coated tablet containsatorvastatin calcium, USPequivalent to 20 mg of atorvastatin.
  • Usual Dosage:
  • Keep this and all medication out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RM3951MM3
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • PRINCIPAL DISPLAY PANEL - 40 mg
  • NDC 0378-3952-77
  • Atorvastatin n- Calciumn- Tablets, USPn- 40 mg*
  • Rx only 90 Tablets
  • *Each film-coated tablet containsatorvastatin calcium, USPequivalent to 40 mg of atorvastatin.
  • Usual Dosage:
  • Keep this and all medication out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RM3952MM2
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • PRINCIPAL DISPLAY PANEL - 80 mg
  • NDC 0378-3953-77
  • Atorvastatin n- Calciumn- Tablets, USPn- 80 mg*
  • Rx only 90 Tablets
  • *Each film-coated tablet containsatorvastatin calcium, USPequivalent to 80 mg of atorvastatin.
  • Usual Dosage:
  • Keep this and all medication out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RM3953MM2
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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