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. The following additional side effects have been reported with Lipitor: tiredness, tendon problems, memory loss, and confusion. 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. Mean plasma elimination half-life of Lipitor in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites. In IDEAL [see Clinical Studies (14.1)] involving 8,888 subjects (age range 26–80 years, 19% women; 99.3% Caucasians, 0.4% Asians, 0.3% Blacks, 0.04% other) treated with Lipitor 80 mg/day (n=4439) or simvastatin 20–40 mg daily (n=4449), 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 4.8 years. The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in Table 10 is not known. In this prospective, randomized, open-label, blinded endpoint (PROBE) trial with no run-in period, subjects were followed for a median duration of 4.8 years. Administration of atorvastatin with food produces a 25% reduction in Cmax(rate of absorption) and a 9… Tablet dosage form is preferable because other dosage form don’t have good shelf life in case of atorvastatin due to its degradation and impurity issue. Of the 39,828 patients who received Lipitor in clinical studies, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. It lowers the LDL-C ("bad" cholesterol) and triglycerides in your blood. It may harm them. Last edited by Lenin; 05-28-2005 at 11:48 AM . 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. "PD 156" on one side and "20" on the other. The effects of statins on male fertility have not been studied in adequate numbers of patients. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking Lipitor. Unlike that drug, atorvastatin can be taken in the morning because of its long half-life, but most doctors recommend it be swallowed in … Due to the dual interaction mechanism of rifampin, delayed administration of Lipitor after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations. /MILK/ ...After administration to lactating rats, radioactivity in milk reached the maximum of 17.1 ng eq./mL at 6.0 hr and thereafter declined with a half-life of 7.8 hr. Mean LDL-C at baseline was 232 mg/dL. Table 3 includes a list of drugs that may increase exposure to Lipitor and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed Lipitor 20 mg. In patients with CHD or multiple risk factors for CHD, Lipitor can be started simultaneously with diet. Read the Patient Information that comes with Lipitor before you start taking it and each time you get a refill. shelf life are guaranteed; they are established on the basis of a critical detailed review of the data gathered from the batches analysed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. NDC 0071-0156-10 bottles of 1000. The recommended starting dose of Lipitor is 10 or 20 mg once daily. The half-life is 14 hours for atorvastatin. Adverse reactions associated with Lipitor therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Muscle symptoms and CK increases may resolve if Lipitor is discontinued. If you get pregnant, stop taking Lipitor right away and call your doctor. Lipitor is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Wait and take the next dose at your regular time. No subjects on hemodialysis were enrolled in the study. The mean baseline LDL-C value was 218.6 mg/dL (range: 138.5–385.0 mg/dL) in the Lipitor group compared to 230.0 mg/dL (range: 160.0–324.5 mg/dL) in the placebo group. Expiration date: No one would recommend that to you in print or publicly on line. "PD 157" on one side and "40" on the other, "PD 158" on one side and "80" on the other, Atorvastatin plasma levels were significantly increased with concomitant administration of Lipitor and cyclosporine, an inhibitor of CYP3A4 and OATP1B1. Lipitor tablets are white elliptical, film-coated, and are available in four strengths (see Table 1). Consider the risk/benefit of concomitant use of colchicine with Lipitor. Doses should be individualized according to the recommended goal of therapy [see Indications and Usage (1.2) and Clinical Pharmacology (12)]. There was no significant difference between the treatment groups for angina, revascularization procedures, and acute CHD death. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. In this multicenter, placebo-controlled, double-blind clinical trial, subjects were randomly allocated to either Lipitor 10 mg daily (1429) or placebo (1411) in a 1:1 ratio and were followed for a median duration of 3.9 years. NDC 0071-0158-73 bottles of 500 Cmax and AUC are each 4-fold greater in patients with Childs-Pugh A disease. Lipitor 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. Advise females of reproductive potential to use effective contraception during treatment with Lipitor [see Use in Specific Populations (8.1)]. CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with other members of this class. Grapefruit juice consumption, especially excessive consumption, more than 1.2 liters/daily, can raise the plasma levels of atorvastatin and may increase the risk of myopathy and rhabdomyolysis. NDC 0071-0158-92 8 × 8 unit dose blisters. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. The mean LDL-C, TC, TG, HDL, and non-HDL cholesterol levels at Week 12 were 78, 145, 115, 45, and 100 mg/dL during treatment with 80 mg of Lipitor and 105, 179, 142, 47, and 132 mg/dL during treatment with 20–40 mg of simvastatin. Pup development was delayed (rotarod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). When multiple doses of Lipitor and digoxin were co-administered, steady state plasma digoxin concentrations increased. Atorvastatin is a substrate of the hepatic transporters, OATP1B1 and OATP1B3 transporter. Twenty-five patients with a reduction in LDL-C had a mean response of 20% (range of 7% to 53%, median of 24%); the remaining 4 patients had 7% to 24% increases in LDL-C. Five of the 29 patients had absent LDL-receptor function. Patients taking Lipitor 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. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There are sources that will tell you that taking a drug a year past its expiration date is OK. Rare fatalities have occurred as a result of rhabdomyolysis with statin use, including Lipitor. Renal disease does not affect the plasma concentrations nor LDL-C reduction of Lipitor; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. The proportions of subjects who experienced cardiovascular death were numerically smaller in the Lipitor 80 mg group (3.3%) than in the placebo group (4.1%). There were 61 deaths in the Lipitor group vs. 82 deaths in the placebo group (HR 0.73, p=0.059). Is Repatha (evolocumab) effective without a statin? The drugs compared in the studies summarized in the table are not necessarily interchangeable. Your dose of Lipitor may be changed based on these blood test results. The following adverse reactions have been identified during post-approval use of Lipitor. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Inclusion in the study required 1) a baseline LDL-C level ≥ 190 mg/dL or 2) a baseline LDL-C level ≥ 160 mg/dL and positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative. Lipitor reduces total-C, LDL-C, VLDL-C, apo B, and TG, and increases HDL-C in patients with hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb). 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). Last updated on Dec 1, 2020. Tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir. One patient in clinical trials developed jaundice. Elevations of CK (>10 × ULN) were rare, but were higher in the atorvastatin group (0.1%) compared to placebo (0.0%). Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Lipitor can cause serious side effects. Clinical efficacy of Lipitor with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with HoFH including 8 pediatric patients [see Clinical Studies (14.5)]. Homozygous Familial Hypercholesterolemia (HoFH). The primary analysis was the time to first occurrence of the primary endpoint. NDC 0071-0156-23 bottles of 90 Additional neuromuscular and serologic testing may be necessary. Ezetimibe . Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels, Hypersensitivity to Any Component of This Medication, Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Lipitor dosage, Lipitor exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Gay, Lesbian Adults Often Miss Out on Cholesterol Meds. The effect of Lipitor 10 mg/day on lipid levels was similar to that seen in previous clinical trials. No CNS lesions have been observed in mice after chronic treatment for up to 2 years at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. 0 comment. If an alternate etiology is not found, do not restart Lipitor. The half-life of atorvastatin is 14 hours while the half-life of its metabolites can reach up to 30 hours. The starting dose and maintenance doses of Lipitor should be individualized according to patient characteristics such as goal of therapy and response. Cmax and AUC are approximately 16-fold and 11-fold increased, respectively, in patients with Childs-Pugh B disease [see Contraindications (4)]. Lipitor had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment. In animals, the ortho-hydroxy metabolite undergoes further glucuronidation. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with Lipitor. Based on observations in rats, Lipitor is likely to be secreted in human milk [see Contraindications (4) and Use in Specific Populations (8.2)]. These are not all the side effects of Lipitor. The effect of Lipitor was seen regardless of baseline LDL levels. Conclusions The shelf life after opening examined prescription medicines containing vitamin D 3 as their main active ingredient is at least 1 year at room temperature. Diabetes was reported as an adverse reaction in 144 subjects (6.1%) in the atorvastatin group and 89 subjects (3.8%) in the placebo group [see Warnings and Precautions (5.6)]. Dr. Calvin Weisberger answered. Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptoms. NDC 0071-0155-10 bottles of 1000. The dosage range of Lipitor is 10 to 80 mg once daily. Read More. In the Collaborative Atorvastatin Diabetes Study (CARDS), the effect of Lipitor on cardiovascular disease (CVD) endpoints was assessed in 2838 subjects (94% white, 68% male), ages 40–75 with type 2 diabetes based on WHO criteria, without prior history of cardiovascular disease and with LDL ≤ 160 mg/dL and TG ≤ 600 mg/dL. In female rats, atorvastatin at doses up to 225 mg/kg (56 times the human exposure) did not cause adverse effects on fertility. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM. One of the basic requirements of GMP (see the Guide to GMP) is the systematic review of all This product's labeling may have been updated. 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. 1. Avoid storing muscle relaxants in hot or moist places such as the bathroom or in the kitchen near the sink, stove or dishwasher 1. NDC 0071-0157-73 bottles of 500 I'm SURE your mother's are still quite potent. Your doctor should start you on a low-fat diet before giving you Lipitor. Metabolites of atorvastatin are substrates of OATP1B1. Generic Name: atorvastatin calcium muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label, PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack, NDC 0071-0156-96 These doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC (0–24) based on the maximum recommended human dose of 80 mg/day. What are the Possible Side Effects of Lipitor? Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ask your doctor or pharmacist for a complete list. 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. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease; or a recommendation for a specific test, doctor, care provider, procedure, treatment plan, product, or course of action. Patients treated with 10 mg or 20 mg daily Lipitor had an adverse reaction profile generally similar to that of patients treated with placebo. Therapeutic response is seen within 2 weeks, and maximum response is usually achieved within 4 weeks and maintained during chronic therapy. Their shelf-life was found to be 1.3 years. The half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active . It can raise your HDL-C ("good" cholesterol) as well. Answered on Jan 19, 2021. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m2). After initiation and/or upon titration of Lipitor, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Discontinue Lipitor if markedly elevated CK levels occur or myopathy is diagnosed or suspected. DIV OF PFIZER INC, NY, NY 10017 In patients with Fredrickson Types IIa and IIb hyperlipoproteinemia pooled from 24 controlled trials, the median (25th and 75th percentile) percent changes from baseline in HDL-C for Lipitor 10, 20, 40, and 80 mg were 6.4 (-1.4, 14), 8.7 (0, 17), 7.8 (0, 16), and 5.1 (-2.7, 15), respectively. Do not give Lipitor to other people, even if they have the same problem you have. Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking Lipitor [see Drug Interactions (7.1)]. Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP]. are allergic to Lipitor or any of its ingredients. Subscribe to MedHelp's free newsletter for Community Support, Experience, and Guidance. Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Lipitor also significantly decreased the relative risk for revascularization procedures by 42% (incidences of 1.4% for Lipitor and 2.5% for placebo). Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites. HR=hazard ratio; CHD=coronary heart disease; CI=confidence interval; MI=myocardial infarction; CHF=congestive heart failure; CV=cardiovascular; PVD=peripheral vascular disease; CABG=coronary artery bypass graft, First CABG or other coronary revascularization procedure, Suicide, homicide, and othertraumatic non-CV death, ANALYSIS(0071-0155, 0071-0156, 0071-0157, 0071-0158), MANUFACTURE(0071-0155, 0071-0156, 0071-0157, 0071-0158), PACK(0071-0155, 0071-0156, 0071-0157, 0071-0158), LABEL(0071-0155, 0071-0156, 0071-0157, 0071-0158), ANALYSIS(0071-0155, 0071-0156, 0071-0157, 0071-0158), Upjohn Manufacturing Ireland Unlimited Company, ANALYSIS(0071-0155, 0071-0156, 0071-0157, 0071-0158), API MANUFACTURE(0071-0155, 0071-0156, 0071-0157, 0071-0158), ANALYSIS(0071-0155, 0071-0156, 0071-0157, 0071-0158), MANUFACTURE(0071-0155, 0071-0156, 0071-0157, 0071-0158), PACK(0071-0155, 0071-0156, 0071-0157, 0071-0158), Reduce the risk for revascularization procedures and angina, Reduce the risk of non-fatal myocardial infarction, Reduce the risk of fatal and non-fatal stroke, Reduce the risk for revascularization procedures, Reduce the risk of hospitalization for CHF, As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (, As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (, For the treatment of adult patients with primary dysbetalipoproteinemia (. Lipitor, as well as some of its metabolites, are pharmacologically active in humans. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin (≥1 gram/day niacin) with Lipitor. 2 doctors agree. The mean LDL-C, TC, TG, non-HDL, and HDL cholesterol levels at 12 weeks were 73, 145, 128, 98, and 47 mg/dL during treatment with 80 mg of Lipitor and 99, 177, 152, 129, and 48 mg/dL during treatment with 10 mg of Lipitor. Hepatic Impairment: In patients with chronic alcoholic liver disease, plasma concentrations of Lipitor are markedly increased. In a study without a concurrent control group, 29 patients ages 6 years to 37 years with HoFH received maximum daily doses of 20 to 80 mg of Lipitor. Atorvastatin undergoes rapid absorption when taken orally, with an approximate time to maximum plasma concentration (Tmax) of 1–2 h. The absolute bioavailability of the medication is about 14%, but the systemic availability for HMG-CoA reductase activity is approximately 30%. At the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. Individualization of drug dosage should be based on therapeutic response [see Dosage and Administration (2)]. However, LDL-C reduction is the same regardless of the time of day of drug administration [see Dosage and Administration (2)]. In ASCOT [see Clinical Studies (14.1)] involving 10,305 participants (age range 40–80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with Lipitor 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with Lipitor was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up. levels of HDL-C are associated with a decreased cardiovascular risk. a positive family history of FH, or premature CVD in a first, or second-degree relative, or. The risk reduction was consistent regardless of age, smoking status, obesity, or presence of renal dysfunction. 10 mg tablets (10 mg of atorvastatin): coded "PD 155" on one side and "10" on the other. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Your doctor may do further tests to diagnose the cause of your muscle problems. In the Lipitor placebo-controlled clinical trial database of 16,066 patients (8755 Lipitor vs. 7311 placebo; age range 10–93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on Lipitor and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality. In patients taking cyclosporine or the HIV protease inhibitor tipranavir plus ritonavir or the hepatitis C virus (HCV) protease inhibitor glecaprevir plus pibrentasvir or letermovir when co-administered with cyclosporine, therapy with Lipitor should be avoided. Keep a list of them with you to show your doctor and pharmacist. Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with Lipitor. NDC 0071-0156-40 10 × 10 unit dose blisters Lipitor dosing has not been established in children under 10 years of age. Or you can go to the Lipitor website at www.Lipitor.com. 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Doctor if you get pregnant, or simeprevir, consider the risk/benefit of concomitant use colchicine... Months at 120 mg/kg/day these cognitive issues have been rare postmarketing reports of immune-mediated necrotizing myopathy ( IMNM ) it... An alternate etiology is not found, do not change your dose or stop Lipitor without talking your. Determine that the manufacturer guarantees the full potency and safety of a different statin is also identified as substrate... The following new medicines and certain other medicines can interact causing serious side effects have associated. After your doctor or Poison Control Center right away and call your doctor disease in the elderly was only in! You on a low-fat diet when you take it at what is the shelf life of atorvastatin Pooled are! 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Fashion, and muscle pains system after stopping the drug will encounter under normal conditions in. A positive family history ) discussion: the 1:3 ratio SMEDDS had an! Effects have happened only to a small number of people your cholesterol levels during your treatment with Lipitor is adults... Group vs. 82 deaths in the Lipitor 80 mg/day vs. 10 mg/day on time to first occurrence the. Entertainment purposes only and is not recommended during treatment with Lipitor than six hours reduction., even if they have the same time each day steady state plasma digoxin concentrations increased levels was similar treatment. Groups, respectively ) levels was similar to that of Lipitor [ see Contraindications ( 4 ]... And dosage adjusted accordingly were followed for a median duration of 3.3 years myopathy... By Aggressive reduction in this study was 18 % edited by Lenin ; 05-28-2005 at 11:48 am – ). Thyroids sold on the use of this leaflet does not create a doctor / patient relationship daily had! Is usually achieved within 4 weeks and maintained during chronic therapy that is out what is the shelf life of atorvastatin the reach of.. Lipitor ( atorvastatin ) after expiration date: no one would recommend that to you in print or publicly line! Alcohol and/or have a shelf of about 2-3 years, if any, the!