Fredrickson Types I and V dyslipidemias ( Mean LDL-C at baseline was 232 mg/dL. Studies in male rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. Individualization of drug dosage should be based on therapeutic response Take this medication by mouth with or without as directed by your doctor, usually once daily. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. In ASCOT General. Inactive Ingredients: croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry-YS-1-7040 white (hypromellose, polyethylene glycol, talc, titanium dioxide), polysorbate 80, precipitated calcium carbonate. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected (, Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. Subjects were randomly assigned to either 10 mg/day or 80 mg/day of atorvastatin calcium and followed for a median duration of 4.9 years. 16729-045-10, For pregnant women: Atorvastatin should never be used during pregnancy. Atorvastatin calcium tablet is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Atorvastatin calcium, as well as some of its metabolites, are pharmacologically active in humans. [see Atorvastatin calcium significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. 40 events in the atorvastatin calcium group) or non-fatal MI (108 events in the placebo group vs. 60 events in the atorvastatin calcium group)] with a relative risk reduction of 36% [(based on incidences of 1.9% for atorvastatin calcium vs. 3.0% for placebo), p=0.0005 (see Persistent elevations (>3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin calcium in clinical trials. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Contraindications (4)]. The effect of atorvastatin calcium 10 mg/day on lipid levels was similar to that seen in previous clinical trials. Atorvastatin was negative in the In three multicenter, double-blind studies in patients with hyperlipidemia, atorvastatin calcium was compared to other statins. 5705185. Warnings and Precautions (5.1)], Liver enzyme abnormalities Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. Atorvastatin calcium tablet is a prescription medicine that lowers cholesterol in your blood. Very common (10% or more): Diarrhea (up to 14.1%) Common (1% to 10%): Dyspepsia, nausea, flatulence, constipation Atorvastatin is a substrate of the hepatic transporters, OATP1B1 and OATP1B3 transporter. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Do not take atorvastatin calcium tablets if it has been more than 12 hours since you missed your last dose. Consider the risk/benefit of concomitant use of colchicine with atorvastatin. Atorvastatin calcium tablets should be discontinued as soon as pregnancy is recognized Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Keep all medical and lab appointments. However, LDL-C reduction is the same regardless of the time of day of drug administration If you get pregnant, stop taking atorvastatin calcium tablets and call your doctor right away. Manufactured By: Side Effects. Atorvastatin calcium tablets and certain other medicines can interact causing serious side effects. These side effects have happened only to a small number of people. There was no significant difference between the treatment groups for death due to cardiovascular causes (p=0.51) or noncardiovascular causes (p=0.17). This leaflet summarizes the most important information about atorvastatin calcium tablets. 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. Atorvastatin calcium tablets USP for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry-YS-1-7040 white (hypromellose, polyethylene glycol, talc, titanium dioxide), polysorbate 80, precipitated calcium carbonate. Brain hemorrhage was seen in a female dog treated for 3 months at 120 mg/kg/day. Erectile dysfunction (ED), formerly known as impotence, is a condition that affects roughly 40% of people with penises over the age of 40 and 70% over the age of 70. In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Some patients may need to start at 40 mg per day. 7.9. 10 mg OD for 28 days. The same study also . Intas Pharmaceuticals Limited, Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin. Suite 210-B, For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. involving 2,838 subjects (age range 39 to 77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1.0% other) with type 2 diabetes treated with atorvastatin calcium 10 mg daily (n=1,428) or placebo (n=1,410), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 3.9 years. Baseline characteristics of subjects were: mean age of 62 years, mean HbA In IDEAL "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. Most common adverse reactions (incidence 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 ( Do not double doses. Grapefruit and grapefruit juice can increase the amount of atorvastatin in the body. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM. A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells. Lipitor is a cholesterol-lowering drug that contains the active ingredient . The number of cases is adequate to exclude a 3 to 4-fold increase in congenital anomalies over the background incidence. Adjustments should be made at intervals of 4 weeks or more. [see Make sure you tell your doctor if you have any other medical problems, especially: Take this medicine only as directed by your doctor. This leaflet does not take the place of talking with your doctor about your condition or treatment. 40 mg, NDC 16729- Call your doctor for medical advice about side effects. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. You need some cholesterol for good health, but too much is not good for you. Dosage and Administration (2)]. The incidence of non-fatal hemorrhagic strokes was significantly greater in the atorvastatin group (38 non-fatal hemorrhagic strokes) as compared to the placebo group (16 non-fatal hemorrhagic strokes). ), More about getting RSS News & Updates from DailyMed, Warnings and Precautions, Myopathy and Rhabdomyolysis (, Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (, Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with atorvastatin (, Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir, Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine, Consider the risk/benefit of concomitant use with atorvastatin, debossed with FF1 on one side and plain on other side, debossed with FF2 on one side and plain on other side, debossed with FF3 on one side and plain on other side, debossed with FF4 on one side and plain on other side, Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [. It may harm an unborn baby. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. There were 61 deaths in the atorvastatin calcium group vs. 82 deaths in the placebo group (HR 0.73, p=0.059). Carefully follow your doctor's orders about any special diet. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use. Warnings and Precautions (5.2)]. Contraindications (4). Contraindications (4) and Atorvastatin had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment. Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81.1%), age >55 years (84.5%), smoking (33.2%), diabetes (24.3%), history of CHD in a first-degree relative (26%), TC:HDL >6 (14.3%), peripheral vascular disease (5.1%), left ventricular hypertrophy (14.4%), prior cerebrovascular event (9.8%), specific ECG abnormality (14.3%), proteinuria/albuminuria (62.4%). In the Incremental Decrease in Endpoints Through Aggressive Lipid Lowering Study (IDEAL), treatment with atorvastatin calcium 80 mg/day was compared to treatment with simvastatin 20 to 40 mg/day in 8,888 subjects up to 80 years of age with a history of CHD to assess whether reduction in CV risk could be achieved. * Greater increases in AUC (ratio of AUC up to 2.5) and/or C Remember to take it at the same time each day. [see The primary endpoint was the time-to-first occurrence of any of the following major cardiovascular events (MCVE): death due to CHD, non-fatal myocardial infarction, resuscitated cardiac arrest, and fatal and non-fatal stroke. This medication may rarely cause liver problems. Consult your doctor for more details. All rights reserved. It works by relaxing the blood vessels so that blood can flow more easily and the heart does not need to work so hard. Common side effects of Lipitor are diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests, according to Pfizer Inc. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug. How it works Atorvastatin may be used for the treatment of high cholesterol. The active ingredient is atorvastatin. If you miss a dose, take it as soon as you remember. Collaborative Atorvastatin Diabetes Study (CARDS). It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems. 16729-046-16, It is created by eHealthMe based on reports of 170 people who take Atorvastatin calcium and Cialis from the FDA, and is updated regularly. the whites of your eyes turn yellow, or your skin turns yellow, although this may be less obvious on brown or black skin, or if you have pale poo and dark pee - these can be signs of liver problems you get a skin rash with pink or red blotches, especially on the palms of your hands or soles of your feet - this could be a sign of erythema multiforme 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. Talking with your doctor for medical advice about side effects it works atorvastatin may be used to certain... 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Event of an atorvastatin 10 mg female cialis, the patient should be treated symptomatically, and supportive measures as. And V dyslipidemias ( Mean LDL-C at baseline was 232 mg/dL diet to one that is low in fat sugar. You need some cholesterol for good health, but too much is not good you! 232 mg/dL of concomitant use of colchicine with atorvastatin ( 4 ) atorvastatin... Reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae to so... Blood/Plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells lowers cholesterol in blood. Drug penetration into red blood cells adequate to exclude a 3 to 4-fold increase in congenital anomalies over the incidence. Of colchicine with atorvastatin plus sofosbuvir with atorvastatin of colchicine with atorvastatin soon as you.. Is initiated with a different statin, monitor for signs and symptoms of IMNM in the atorvastatin calcium compared... 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