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Lipitor

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Overview

What is Lipitor?

LIPITOR 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)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (CHFNO)Ca∙3HO and its molecular weight is 1209.42. Its structural formula is:

Atorvastatin calcium 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.

LIPITOR Tablets for oral administration contain 10, 20, 40, or 80 mg of atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.



What does Lipitor look like?



What are the available doses of Lipitor?

Tablets: 10, 20, 40, and 80 mg of atorvastatin ().

What should I talk to my health care provider before I take Lipitor?

How should I use Lipitor?

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, LIPITOR can be started simultaneously with diet.

The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. LIPITOR can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of LIPITOR should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of LIPITOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.


What interacts with Lipitor?

Sorry No Records found


What are the warnings of Lipitor?

Sorry No Records found


What are the precautions of Lipitor?

Sorry No Records found


What are the side effects of Lipitor?

Sorry No records found


What should I look out for while using Lipitor?

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ().

Hypersensitivity to any component of this medication ().

Pregnancy (, , ).

Lactation (, ).


What might happen if I take too much Lipitor?

There is no specific treatment for LIPITOR 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 LIPITOR clearance.


How should I store and handle Lipitor?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. 10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters10 mg tablets NDC 0071-0155-23 bottles of 90 NDC 0071-0155-34 bottles of 5000NDC 0071-0155-40 10 × 10 unit dose blistersNDC 0071-0155-10 bottles of 100020 mg tabletsNDC 0071-0156-23 bottles of 90NDC 0071-0156-40 10 × 10 unit dose blistersNDC 0071-0156-94 bottles of 5000NDC 0071-0156-10 bottles of 100040 mg tablets : NDC 0071-0157-23 bottles of 90NDC 0071-0157-73 bottles of 500NDC 0071-0157-88 bottles of 2500NDC 0071-0157-40 10 × 10 unit dose blisters80 mg tablets :NDC 0071-0158-23 bottles of 90NDC 0071-0158-73 bottles of 500NDC 0071-0158-88 bottles of 2500NDC 0071-0158-92 8 × 8 unit dose blisters


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

LIPITOR is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, LIPITOR lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; LIPITOR also reduces LDL production and the number of LDL particles.

Non-Clinical Toxicology
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ().

Hypersensitivity to any component of this medication ().

Pregnancy (, , ).

Lactation (, ).

Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

Calcium channel blockers may also have an additive effect when given with atenolol (see ).

Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.

Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.

Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta blockers.

Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.

While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR and with other drugs in this class.

Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.

Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing LIPITOR. LIPITOR therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with LIPITOR and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs . Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

Prescribing recommendations for interacting agents are summarized in Table 2 .

Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine .

LIPITOR therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Rhabdomyolysis and myopathy

Liver enzyme abnormalities

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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