Pravastatin Sodium

Class: HMG-CoA Reductase Inhibitors
VA Class: CV350
Chemical Name: [1S - [1α(βS*,δS*),2α,6α,8β(R*),8aα]] - 1,2,6,7,8,8a - Hexahydro - β,δ,6 - trihydroxy - 2 - methyl - 8 - (2 - methyl - 1 - oxobutoxy) - 1 - naphthalene - heptanoic acid monosodium salt
CAS Number: 81131-70-6
Brands: Pravachol

Special Alerts:

[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as “Lou Gehrig's Disease.” The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins. For more information visit the FDA website at: and .

Introduction

Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).^{1 2 3 4 5 6}

Uses for Pravastatin Sodium

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Prevention of Cardiovascular Events

Adjunct to dietary therapy in patients with hypercholesterolemia without clinical evidence of CHD to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of cardiovascular mortality (with no increase in death from noncardiovascular causes).^{1 12}

Adjunct to dietary therapy in patients with clinical evidence of CHD to reduce the risk of total mortality by reducing coronary death, to reduce the risk of recurrent MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of stroke or TIA.¹

Adjunct to dietary therapy in patients with clinical evidence of CHD to slow the progression of atherosclerosis.^{1 13 14 16} Has been shown to slow the progression and/or induce regression of atherosclerosis in a few patients without clinical evidence of CHD† who had mild to moderate elevations of LDL-cholesterol concentrations.⁶¹

Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen).⁶⁹ Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis in patients with CHD.⁷⁰

Dyslipidemias

Adjunct to dietary therapy in adults to decrease elevated serum total and LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia (e.g., polygenic hypercholesterolemia).^{1 2 3 5 17}

Adjunct to dietary therapy and lifestyle modification in the management of heterozygous familial hypercholesterolemia in children 8 years of age and older who have a serum LDL-cholesterol concentration of 190 mg/dL or greater and in those who have a serum LDL-cholesterol concentration of 160 mg/dL or greater and either a family history of premature cardiovascular disease or multiple cardiovascular risk factors despite an adequate trial of dietary management.¹

Adjunct to dietary therapy in the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet.¹

Adjunct to dietary therapy in the treatment of patients with elevated serum triglyceride concentrations.¹

Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus† (diabetic dyslipidemia),^{51 62} cardiac† or liver† transplantation,^{19 63} or nephrotic syndrome† (nephrotic hyperlipidemia).²⁰

Pravastatin Sodium Dosage and Administration

General

• 
  

  Patients should be placed on a standard lipid-lowering diet before initiation of pravastatin therapy and should remain on this diet during treatment with the drug.¹

  
  

Administration

Oral Administration

Administer orally at any time of day without regard to meals.¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as pravastatin sodium; dosage expressed in terms of pravastatin.¹

Pediatric Patients

Dyslipidemias

Oral

Children 8–13 years of age: 20 mg once daily.¹ Dosages exceeding 20 mg daily have not been evaluated.¹

Adolescents 14–18 years of age: 40 mg once daily.¹ Dosages exceeding 40 mg daily have not been evaluated.¹

Re-evaluate in adulthood and modify therapy appropriately to achieve adult target LDL-cholesterol goals.¹

Adults

Dyslipidemias and Prevention of Cardiovascular Events

Oral

Initially, 40 mg once daily.¹ If antilipemic response is inadequate, increase dosage to 80 mg daily.¹ Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed.¹

Special Populations

Hepatic Impairment

Initially, 10 mg once daily in patients with a history of substantial hepatic impairment.¹

Use with caution in patients who consume substantial amounts of alcohol, in patients who have a history of liver disease, or in those with manifestations of liver disease (e.g., jaundice);¹ monitor such patients closely.¹ Contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.¹

Renal Impairment

Initially, 10 mg once daily in patients with a history of substantial renal impairment.¹

Cautions for Pravastatin Sodium

Contraindications

• 
  

  Active liver disease or unexplained, persistent elevations of serum aminotransferases.¹

  
  


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  Pregnancy or lactation.¹ Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.¹

  
  


• 
  

  Known hypersensitivity to pravastatin or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity and Mortality

Suppression of cholesterol biosynthesis could cause fetal harm.¹ Congenital anomalies following intrauterine exposure to statins reported rarely.¹

Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.¹ If the patient becomes pregnant while taking the drug, discontinue therapy and apprise the patient of the potential hazard to the fetus.¹

Hepatic Effects

Associated with increases in serum aminotransferase (AST, ALT) concentrations.¹

Pancreatitis,¹ hepatitis (including chronic active hepatitis),¹ cholestatic jaundice,¹ fatty change in liver,¹ abnormal liver function tests,¹ and, rarely, cirrhosis,¹ fulminant hepatic necrosis,¹ and hepatoma¹ have been reported.¹

Perform liver function tests before initiation of therapy or increase in dosage and thereafter as clinically indicated.¹

Patients who develop increased serum AST/ALT concentrations or manifestations of liver disease should have a second liver function evaluation to confirm the finding and should receive frequent liver function tests thereafter until the abnormalities return to normal.¹ If increases in AST or ALT concentrations of 3 times the upper limit of normal (ULN) or higher persist, discontinue therapy.¹

Musculoskeletal Effects

Myopathy (manifested as muscle pain, tenderness, or weakness and serum creatine kinase [CK, creatine phosphokinase, CPK] concentration increases >10 times the ULN) reported occasionally.¹

Rhabdomyolysis (characterized by muscle pain or weakness with marked increases [>10 times the ULN] in serum CK concentrations and increases in S_cr [usually accompanied by brown urine and urinary myoglobinuria]) with acute renal failure secondary to myoglobinuria has been reported.¹

Risk of myopathy increased in patients receiving higher doses of statins; in patients with multisystem disease (e.g., renal or hepatic impairment); in patients with concurrent serious infections or hypothyroidism; in patients (particularly women) of advanced age (especially >80 years of age); in patients with small body frame and frailty; and in patients undergoing surgery (i.e., during perioperative periods). Risk is increased by concomitant administration of certain statins with cyclosporine, erythromycin, niacin, or fibric acid derivatives (e.g., gemfibrozil).¹ (See Interactions.) Myopathy or substantial increases in serum CK concentrations were not observed in >100 transplant recipients receiving pravastatin (10–40 mg daily) and cyclosporine concomitantly for up to 2 years.¹ Myopathy was not reported in a limited number of patients receiving pravastatin concomitantly with niacin.¹ Myopathy also was not reported in patients receiving pravastatin (40 mg daily) concomitantly with gemfibrozil (1200 mg daily); however, marked serum CK elevations and discontinuance of therapy due to adverse musculoskeletal effects occurred more frequently in patients receiving combination therapy with gemfibrozil than in those receiving pravastatin alone.¹

Measure baseline serum CK concentrations prior to initiation of therapy, particularly in black men or in patients receiving concomitant therapy with fibric acid derivatives.

Obtain serum CK concentrations and compare with baseline concentrations in patients presenting with musculoskeletal symptoms suggestive of myopathy; because hypothyroidism may be a predisposing factor, thyrotropin (thyroid-stimulating hormone, TSH) concentrations also should be obtained in such patients.

Discontinue if serum CK concentrations increase markedly or if myopathy is diagnosed or suspected.¹

Monitor patients weekly if myalgia (muscle pain, tenderness) is present with either no CK elevation or a moderate elevation (3–10 times the ULN) until manifestations improve; discontinue if manifestations worsen.

Dosage reduction or temporary discontinuance may be prudent in patients with muscle discomfort and/or weakness in the presence of progressive elevation of CK concentrations on serial measurements.

Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).¹

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, hemolytic anemia, positive antinuclear antibody (ANA), increased erythrocyte sedimentation rate (ESR), arthritis, arthralgia, asthenia, photosensitivity, chills, malaise, toxic epidermal necrolysis, and erythema multiforme (including Stevens-Johnson syndrome) reported during postmarketing surveillance.¹

General Precautions

Role as Adjunct Therapy

Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.¹

CNS Effects

CNS vascular lesions (e.g., perivascular hemorrhage and edema, mononuclear cell infiltration of perivascular spaces) observed in animals.¹

Ocular Effects

Optic nerve degeneration observed in animals treated with certain statins.¹

Specific Populations

Pregnancy

Category X.¹ (See Contraindications and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Small amounts distributed into milk.¹ Use contraindicated.¹

Pediatric Use

Safety and efficacy not established in children <8 years of age.¹ Advise adolescent girls to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.¹

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults.¹

Caution in patients (particularly women) of advanced age (especially >80 years of age) and in those with small body frame and frailty.

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease; monitor such patients closely.¹

Contraindicated in patients with active liver disease or unexplained, persistent increases in liver function test results.¹

Renal Impairment

Small increase in plasma concentrations of inactive metabolite; closely monitor patients with renal impairment.¹

Common Adverse Effects

GI disturbances (e.g., nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain, heartburn), headache, fatigue, localized pain, rash, dizziness, urinary abnormality, chest pain, rhinitis, cough.¹

Interactions for Pravastatin Sodium

Minimally metabolized by CYP3A4; pharmacokinetic interaction unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral (e.g., warfarin)	Pharmacologic interaction (e.g., increased PT) unlikely1
Antileukotrienes (e.g., zileuton)	Increased risk of myopathy and/or rhabdomyolysis when used with certain statins
Bile acid sequestrants (i.e., cholestyramine, colestipol)	Possible decreased plasma pravastatin concentrations1	Administer pravastatin ≥ 1 hour before or at least 2–4 hours after the resin1
Cyclosporine	Possible increased pravastatin concentrations.1 (See Musculoskeletal Effects under Cautions.)	If pravastatin is used concomitantly, initiate pravastatin at 10 mg daily; pravastatin dosage should not exceed 20 mg daily.1
Digoxin	Increased plasma digoxin concentrations when used with certain statins
Erythromycin	Increased risk of myopathy and/or rhabdomyolysis when used with certain statins1
Fibric acid derivatives (e.g., gemfibrozil)	Possible decreased urinary excretion and protein binding of pravastatin1 (See Musculoskeletal Effects under Cautions.)	Concomitant use generally should be avoided unless benefits of combined therapy outweigh risks.1
Fluvoxamine	Increased risk of myopathy and/or rhabdomyolysis when used with another statins
Itraconazole	Increased pravastatin concentrations1
Metronidazole	Increased risk of myopathy and/or rhabdomyolysis when used with certain statins	Concomitant use generally should be avoided or undertaken with caution
Niacin	Increased risk of myopathy and/or rhabdomyolysis when used with certain statins1 (See Musculoskeletal Effects under Cautions.)
Troleandomycin	Increased risk of myopathy and/or rhabdomyolysis when used with certain statins

Pravastatin Sodium Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration; undergoes extensive first-pass metabolism in the liver.¹ Mean peak plasma concentrations occur at 1–1.5 hours.¹

Absolute bioavailability is 17%.¹

Evening administration of the drug is associated with a decrease in the extent of absorption;¹ however, the antilipemic activity remains unchanged and may be superior to the activity achieved with morning administration.¹

Onset

A therapeutic response to pravastatin is usually apparent within 1 week after initiating therapy, with a maximal response occurring within 4 weeks.¹

Food

Food appears to reduce the systemic bioavailability of pravastatin;¹ however, antilipemic effects are similar whether pravastatin is administered with or 1 hour prior to meals.¹

Distribution

Extent

Distributed mainly to the liver.¹

Distributed into milk in small amounts.¹

Plasma Protein Binding

Approximately 50%.¹

Elimination

Metabolism

Undergoes enzymatic and nonenzymatic biotransformation independent of the CYP enzyme system. The principal metabolites are pharmacologically inactive.

Elimination Route

Excreted in urine (20%) and feces (70%).¹

Half-life

0.5–3 hours.

Special Populations

Renal impairment may reduce clearance of pravastatin and/or active metabolites.¹

Hepatic impairment may reduce clearance of pravastatin and/or active metabolites.¹

Stability

Storage

Oral

Tablets

Tight containers at 25°C (may be exposed to 15–30°C); protect from light and moisture.¹

ActionsActions

• 
  

  Inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis.¹ Reduces serum concentrations of total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglycerides.¹

  
  


• 
  

  Statins may slow progression of and/or induce regression of atherosclerosis in coronary and/or carotid arteries, modulate blood pressure in hypercholesterolemic patients with hypertension, and possess anti-inflammatory activity.

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of informing patients about risks, especially rhabdomyolysis, associated with statins alone or combined with other drugs.¹ Importance of patients promptly reporting muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.¹

  
  


• 
  

  Importance of adhering to nondrug therapies and measures (i.e., therapeutic lifestyle changes, including dietary management, weight control, physical activity, and management of potentially contributory disease [e.g., diabetes mellitus]).

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Necessity for clinicians to advise women and adolescent girls to avoid pregnancy (i.e., using effective and appropriate contraceptive methods) during therapy and to advise pregnant women of risk to fetus.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pravastatin Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	10 mg (of pravastatin)	Pravachol (with povidone)	Bristol-Myers Squibb
		20 mg (of pravastatin)	Pravachol (with povidone)	Bristol-Myers Squibb
		40 mg (of pravastatin)	Pravachol (with povidone)	Bristol-Myers Squibb
		80 mg (of pravastatin)	Pravachol (with povidone)	Bristol-Myers Squibb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pravachol 10MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$119.99 or 90/$335.98

Pravachol 20MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$121.99 or 90/$349.98

Pravachol 40MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$169.98 or 90/$484.99

Pravachol 80MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$191.66 or 90/$529.09

Pravastatin Sodium 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$18.99 or 90/$46.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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42. Gardner SF, Marx MA, White LM et al. Combination of low-dose niacin and pravastatin improves the lipid profile in diabetic patients without compromising glycemic control. Ann Pharmacother. 1997; 31:677-82. [IDIS 387596] [PubMed 9184704]

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44. McPherson R, Bedard J, Connelly P et al. Comparison of the short-term efficacy and tolerability of pravastatin and pravastatin in the management of primary hypercholesterolemia. Clin Ther. 1992; 14:276-91. [PubMed 1611649]

45. Wiklund O, Angelin B, Bergman M et al. Pravastatin and gemfibrozil alone and in combination for the treatment of hypercholesterolemia. Am J Med. 1993; 94:13-20. [IDIS 308518] [PubMed 8420296]

46. Davignon J, Roederer G, Montigny M et al. Comparative efficacy and safety of pravastatin, nicotinic acid and the two combined in patients with hypercholesterolemia. Am J Cardiol. 1994; 73:339-45. [IDIS 326179] [PubMed 8109547]

47. The Simvastatin Pravastatin Study Group. Comparison of the efficacy, safety and tolerability of simvastatin and pravastatin for hypercholesterolemia. Am J Cardiol. 1993; 71:1408-14. [IDIS 315647] [PubMed 8517385]

48. The Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998; 339:1349-57. [IDIS 430942] [PubMed 9841303]

49. Lewis SJ, Moye LA, Sacks FM et al. Effect of pravastatin on cardiovascular events in older patients with myocardial infarction and cholesterol levels in the average range. Ann Intern Med. 1998; 129:681-9. [IDIS 413781] [PubMed 9841599]

50. Lewis SJ, Sacks FM, Mitchell JS et al. Effect of pravastatin on cardiovascular events in women after myocardial infarction: the Cholesterol and Recurrent Events (CARE) Trial. J Am Coll Cardiol. 1998; 32:120-6.

51. Goldberg RB, Mellies MJ, Sacks FM et al. Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels: subgroup analyses in the Cholesterol and Recurrent Events (CARE) Trial. Circulation. 1998; 98:2513-9. [IDIS 419462] [PubMed 9843456]

52. Flaker GC, Warnica JW, Sacks FM et al. Pravastatin prevents clinical events in revascularized patients with average cholesterol concentrations. J Am Coll Cardiol. 1999; 34:106-12. [IDIS 433897] [PubMed 10399998]

53. Bertrand ME, McFadden EP, Fruchart JC et al. Effect of pravastatin on angiographic restenosis after coronary balloon angioplasty. J Am Coll Cardiol. 1997; 30:863-9. [IDIS 410414] [PubMed 9316510]

54. Plehn JF, Davis BR, Sacks FM et al. Reduction of stroke incidence after myocardial infarction with pravastatin: the Cholesterol and Recurrent Events (CARE) Study. Circulation. 1999; 99:216-23. [IDIS 422099] [PubMed 9892586]

55. van Boven AJ, Jukema JW, Zwinderman AH et al. Reduction of transient myocardial ischemia with pravastatin in addition to the conventional treatment in patients with angina pectoris. Circulation. 1996; 94:1503-5. [IDIS 374413] [PubMed 8840836]

56. Simons LA, Nestel PJ, Clifton P et al. Treatment of primary hypercholesterolaemia with pravastatin: efficacy and safety over three years. Med J Aust. 1992; 157:584-9. [IDIS 308181] [PubMed 1406416]

57. MacMahon S, Sharpe N, Gamble G et al. Effects of lowering average or below-average cholesterol levels on the progression of carotid atherosclerosis: results of the LIPID atherosclerosis substudy. Circulation. 1998; 97:1784-90. [IDIS 406511] [PubMed 9603532]

58. Morimoto S, Koh E, Fukuo K et al. Long-term effects of pravastatin on serum lipid levels in elderly patients with hypercholesterolemia. Clin Ther. 1994; 16:793-803. [IDIS 338776] [PubMed 7859238]

59. Mellies MJ, DeVault AR, Kassler-Taub K et al. Pravastatin experience in elderly and non-elderly patients. Atherosclerosis. 1993; 101:97-110. [PubMed 8216507]

60. Tamura A, Mikuriya Y, Nasu M for the Coronary Artery Regression Study (CARS) Group. Effect of pravastatin (10 mg/day) on progression of coronary atherosclerosis in patients with serum total cholesterol levels from 160 to 220 mg/dL and angiographically documented coronary artery disease. Am J Cardiol. 1997; 79:893-6. [IDIS 385104] [PubMed 9104901]

61. Pitsavos CE, Aggeli KI, Barbetseas JD et al. Effects of pravastatin on thoracic atherosclerosis in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 1998; 82:1484-8. [IDIS 421062] [PubMed 9874052]

62. Krempf M, Berthezene F, Wemeau JL et al. Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus. Diabetes Metab. 1997; 23:131-6. [PubMed 9137901]

63. Imagawa DK, Dawson S, Holt CD et al. Hyperlipidemia after liver transplantation. Transplantation. 1996; 62:934-42. [IDIS 375996] [PubMed 8878387]

64. Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285:2486-97. [IDIS 464555] [PubMed 11368702]

65. Anon. Choice of lipid-regulating drugs. Med Lett Drugs Ther. 2001; 43:43-8. [PubMed 11378632]

66. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Adult Treatment Panel III Report. From AHA web site.

67. The ALLHAT officers and coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002; 288:2998-3007. [IDIS 490722] [PubMed 12479764]

68. Pasternak RC. The ALLHAT lipid lowering trial—less is less. JAMA. 2002; 288:3042-4. [IDIS 490724] [PubMed 12479771]

69. Cannon CP, Braunwald E, McCabe CH et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004; 350: 1495-504. [IDIS 514118] [PubMed 15007110]

70. Nissen SE, Tuzcu EM, Schoenhagen P et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA. 2004; 291: 1071-80. [IDIS 511905] [PubMed 14996776]

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Compare Pravastatin Sodium with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
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• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL
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Amoxil Syrup Sucrose-Free / Dye-Free 250mg / 5ml

1. Name Of The Medicinal Product

Amoxil® Syrup Sucrose-Free/Dye-Free 250 mg/5 ml

2. Qualitative And Quantitative Composition

Amoxil Syrup SF/DF 250 mg contains 250 mg amoxicillin per 5 ml dose.

The amoxicillin is present as the trihydrate.

3. Pharmaceutical Form

Amoxil Syrup SF/DF 250 mg/5 ml: citrus-flavoured sucrose-free/Dye Freesuspension in a sorbitol base. Presented as powder in bottles for preparing 100 ml.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Osteomyelitis

Dental abscess (as an adjunct to surgical management)

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Gram-positive Gram-negative

Streptococcus faecalis Haemophilus influenzae

Streptococcus pneumoniae Escherichia coli

Streptococcus pyogenes Proteus mirabilis

Streptococcus viridans Salmonella species

Staphylococcus aureus Shigella species

(penicillin-sensitive) Bordetella pertussis

Clostridium species Brucella species

Corynebacterium species Neisseria gonorrhoeae

Bacillus anthracis Neisseria meningitidis

Listeria monocytogenesVibrio cholerae

Pasteurella septica

4.2 Posology And Method Of Administration

Treatment of Infection:

Adult dosage (including elderly patients):

Oral:

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

Injectable:

500 mg IM eight hourly (or more frequently if necessary) in moderate infections. (This dose may be given by slow IV injection if more convenient.)

1 g IV six hourly in severe infections.

Children's dosage (up to 10 years of age):

Oral:

Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

Amoxil Paediatric Suspension is recommended for children under six months of age.

Prophylaxis of endocarditis:

CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE	NOTES
Dental procedures : prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	Under 10: half adult dose. Under 5: quarter adult dose.	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lignocaine solution (see Administration ).
Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
Dental procedures : patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	Under 10: the doses of 'Amoxil' should be half the adult dose; the dose of gentamicin should be 2 mg/kg.   Under 5: the doses of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
Genitourinary Surgery or Instrumentation : prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia.   In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.	See Notes 2, 3 and 4 above.
Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves.	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	Under 10: half adult dose.   Under 5: quarter adult dose.	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	Under 10: the dose of 'Amoxil' should be half the adult dose; the gentamicin dose should be 2 mg/kg.   Under 5: the dose of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Notes 2, 3, 4 and 5 above.

In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Injectable:

50-100 mg/kg body weight a day, in divided doses.

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.

In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

Prophylaxis of endocarditis: see table on previous page.

Administration:

Oral

4.3 Contraindications

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

4.4 Special Warnings And Precautions For Use

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose).

Dosage should be adjusted in patients with renal impairment (see 4.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Use in pregnancy:

Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxycillin and may occur when using other pencillins.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Blood and lymphatic system disorders

Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction)

Immune system disorders

Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.

If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders

Clinical Trial Data

*Common: Diarrhoea and nausea.

*Uncommon: Vomiting.

Post-marketing Data

Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).

Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Hepato-biliary disorders

Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common: Skin rash

*Uncommon: Urticaria and pruritus

Post-marketing Data

Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)

(See also Immune system disorders).

Renal and urinary tract disorders

Very rare: Interstitial nephritis.

Very rare: Crystalluria (see Section 4.9 Overdose).

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amoxil is a broad spectrum antibiotic.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

5.2 Pharmacokinetic Properties

Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Amoxil Syrup SF/DF 250 mg / 5ml

The powder contains disodium edetate, sodium benzoate (E211), saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420).

6.2 Incompatibilities

None.

6.3 Shelf Life

Amoxil Syrup SF/DF 250 mg / 5 ml

60M (once reconstituted: 14 days)

6.4 Special Precautions For Storage

Store powder in a dry place. Once dispensed, Amoxil Syrup SF/DF should be used within 14 days. If dilution of the reconstituted SF/DF product is required, water should be used.

6.5 Nature And Contents Of Container

Amoxil Syrup SF/DF 250 mg/5 ml: Original Pack of 100 ml with Patient InformationLeaflet.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

Great West Road, Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

And/or

Bencard or SmithKline Beecham Pharmaceuticals all at Mundells Welwyn Garden City, Hertfordshire AL7 1EY

8. Marketing Authorisation Number(S)

Amoxil Syrup SF/DF 250 mg/5 ml

0038/0327

9. Date Of First Authorisation/Renewal Of The Authorisation

14 May 1985 / 16 January 1998

10. Date Of Revision Of The Text

5^th July 2005

11. Legal Status

POM

Plan B

levonorgestrel

Dosage Form: tablet
FULL PRESCRIBING INFORMATION

Indications and Usage for Plan B

Plan B® One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.

Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.

Plan B One-Step is not indicated for routine use as a contraceptive.

Plan B Dosage and Administration

Take Plan B One-Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. Plan B One-Step can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

Dosage Forms and Strengths

The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side.

Contraindications

Plan B One-Step is contraindicated for use in the case of known or suspected pregnancy.

Warnings and Precautions

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.

A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step.

Existing Pregnancy

Plan B One-Step is not effective in terminating an existing pregnancy.

Effects on Menses

Some women may experience spotting a few days after taking Plan B One-Step. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.

If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.

STI/HIV

Plan B One-Step does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Physical Examination and Follow-up

A physical examination is not required prior to prescribing Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step.

 Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with Plan B One-Step for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Plan B One-Step to ensure ongoing prevention of pregnancy.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, 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 clinical practice.

Plan B One-Step was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Plan B One-Step group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step group and 1.4% in Plan B group were lost to follow-up.

The most common adverse events (>10%) in the clinical trial for women receiving Plan B One-Step included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Plan B One-Step users.

Table 1. Adverse Events in > 4% of Women, by % Frequency

Most Common Adverse Events (MedDRA)	Plan B One-Step N = 1359 (%)
Heavier menstrual bleeding	30.9
Nausea	13.7
Lower abdominal pain	13.3
Fatigue	13.3
Headache	10.3
Dizziness	9.6
Breast tenderness	8.2
Delay of menses (> 7 days)	4.5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions

Fatigue

Nervous System Disorders

Dizziness, Headache

Reproductive System and Breast Disorders

Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

Drug Interactions

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

• barbiturates


• bosentan


• carbamazepine


• felbamate


• griseofulvin


• oxcarbazepine


• phenytoin


• rifampin


• St. John’s wort


• topiramate

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.

USE IN SPECIFIC POPULATIONS

Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.

Nursing Mothers

In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.

Pediatric Use

Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Plan B  One-Step emergency contraception before menarche is not indicated.

Geriatric Use

This product is not intended for use in postmenopausal women.

Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step.

Drug Abuse and Dependence

Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B One-Step.

Overdosage

There are no data on overdosage of Plan B One-Step, although the common adverse event of nausea and associated vomiting may be anticipated.

Plan B Description

The Plan B One-Step tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

C21H28O2

Plan B - Clinical Pharmacology

Mechanism of Action

Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B  One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.

Pharmacokinetics

Absorption

Following a single dose administration of Plan B One-Step in 30 women under fasting conditions, maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.

Table 2. Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B One-Step (levonorgestrel) tablet 1.5 mg to 30 Healthy Female Volunteers under Fasting Conditions

* N=29 † median (range)
	Mean (± SD)
	Cmax (ng/mL)	AUCt (ng·hr/mL)*	AUCinf (ng·hr/mL)*	Tmax (hr)†	t1/2 (hr)
Levonorgestrel	19.1 ( 9.7)	294.8 ( 208.8)	307.5 ( 218.5)	1.7 (1.0-4.0)	27.5 ( 5.6)
Cmax = maximum concentration AUCt = area under the drug concentration curve from time 0 to time of last determinable concentration AUCinf = area under the drug concentration curve from time 0 to infinity Tmax = time to maximum concentration t1/2 = elimination half life

Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan B One-Step has not been evaluated.

Distribution

The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.

Metabolism

Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Excretion

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.

Specific Populations

Pediatric

This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.

Geriatric

This product is not intended for use in postmenopausal women, and pharmacokinetic data are not available for this population.

Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see USE IN SPECIFIC POPULATIONS (8.6)].

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step.

Drug-Drug Interactions

No formal drug-drug interaction studies were conducted with Plan B One-Step [see DRUG INTERACTIONS (7)].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 µg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 µg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.

Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.

Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.

Clinical Studies

A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg of levonorgestrel (Plan B One-Step) was administered to women allocated into group 1. Two doses of 0.75 mg levonorgestrel 12 hours apart (Plan B) were administered to women in group 2. In the Plan B One-Step group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20 pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. Among women receiving Plan B One-Step, 84% of expected pregnancies were prevented and among those women taking Plan B, 79% of expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B One-Step.

Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE (1)].

In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens. More than half of the women had menses within two days of the expected time; however, 31% of women experienced change in their bleeding pattern during the study period; 4.5% of women had menses more than 7 days after the expected time.

How Supplied/Storage and Handling

The Plan B One-Step (levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is almost white, round, and marked G00 on one side.

NDC 51285-942-88  (1 tablet unit of use package)

Store Plan B One-Step at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Patient Counseling Information

Information for Patients

• Take Plan B One-Step as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.


• If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.


• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One-Step, in order to be evaluated for an ectopic pregnancy.


• After taking Plan B One-Step, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.


• Do not use Plan B One-Step as routine contraception.


• Plan B One-Step is not effective in terminating an existing pregnancy.


• Plan B One-Step does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.


• For women younger than age 17 years, Plan B One-Step is available only by prescription.

 

Mfg. by Gedeon Richter, Ltd., Budapest, Hungary

for Duramed Pharmaceuticals, Inc.

Subsidiary of Barr Pharmaceuticals, Inc.

Pomona, New York 10970

Phone: 1-800-330-1271

Website: www.PlanBOneStep.com

Revised: August 2009

11001524

PRINCIPAL DISPLAY PANEL - clinic carton

FOR CLINIC USE ONLY. NOT FOR RESALE.

NDC 51285-963-19

Plan B

One-Step®

(levonorgestrel) tablet, 1.5 mg

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control)

Not for regular birth control.

Rx only for women

younger than age 17

One Tablet

One Dose

•Take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better Plan B One-Step® will work.

1 Tablet Levonorgestrel 1.5mg

•Not for regular birth control.

Plan B One-Step® should be used only in emergencies.

•Does not protect against HIV/AIDS or other STDs.

Drug Facts

Active ingredient                              Purpose

Levonorgestrel 1.5mg........................Emergency contraceptive

Use reduces chance of pregnancy after unprotected sex

(if a contraceptive failed or if you did not use birth control)

Warnings

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

Do not use

■ if you are already pregnant (because it will not work)

■ for regular birth control

When using this product you may have

■ menstrual changes

■ nausea

■ lower stomach (abdominal) pain

■ tiredness

■ headache

■ dizziness

■ breast pain

■ vomiting

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Directions

■ women 17 years of age or older:

      ■ take tablet as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.

      ■ if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose

■ prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

Other information

■ before using this product read the enclosed consumer information leaflet for complete directions and information

■ this product is not recommended for regular birth control. It does not work as well as most other birth control methods used correctly.

■ this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).

■ when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS. See condom labeling for additional STD information.

■ tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

■ store at 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

Questions or comments?

For more information or to speak to a healthcare professional,

call 1-800-330-1271, 24 hours a day/7 days a week.

Visit our Web site at www.PlanBOneStep.com

PRINCIPAL DISPLAY PANEL- trade Carton

NDC 51285-942-88

Plan B

One-Step®

(levonorgestrel) tablet, 1.5 mg

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex (if a regular birth control method fails or after sex without birth control)

Not for regular birth control.

Rx only for women

younger than age 17

One Tablet

One Dose

•Take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better Plan B One-Step® will work.

1 Tablet Levonorgestrel 1.5mg

• Not for regular birth control.

Plan B One-Step® should be used only in emergencies.

• Does not protect against HIV/AIDS or other STDs.

Drug Facts

Active ingredient                             Purpose

Levonorgestrel 1.5mg........................Emergency contraceptive

Use reduces chance of pregnancy after unprotected sex

(if a contraceptive failed or if you did not use birth control)

Warnings

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

Do not use

■ if you are already pregnant (because it will not work)

■ for regular birth control

When using this product you may have

■ menstrual changes

■ nausea

■ lower stomach (abdominal) pain

■ tiredness

■ headache

■ dizziness

■ breast pain

■ vomiting

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Directions

■ women 17 years of age or older:

      ■ take tablet as soon as possible within 72 hours (3 days) after unprotected sex. The  sooner you take it the better it will work.

      ■ if you vomit within 2 hours of taking the medication, call ahealthcare professional to  find out if you should repeat the dose

■ prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

Other information

■ before using this product read the enclosed consumer information leaflet for complete directions and information

■ this product is not recommended for regular birth control. It does not work as well as most other birth control methods used correctly.

■ this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).

■ when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS. See condom labeling for additional STD information.

■ tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

■ store at 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

Questions or comments?

For more information or to speak to a healthcare professional,

call 1-800-330-1271, 24 hours a day/7 days a week.

Visit our Web site at www.PlanBOneStep.com

Plan B ONE-STEP  levonorgestrel  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51285-942 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 1.5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   STARCH, CORN   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, POTATO   TALC

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code G00 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51285-942-88 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (51285-942-88)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021998	07/10/2009

Plan B ONE-STEP  levonorgestrel  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51285-963 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 1.5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   STARCH, CORN   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   STARCH, POTATO   TALC

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code G00 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51285-963-19 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (51285-963-19)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021998	07/10/2009

Labeler - Duramed Pharmaceuticals, Inc. (017038951)

Revised: 08/2009Duramed Pharmaceuticals, Inc.

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