Pravastatin

What is Pravastatin?

• Pravastatin (Pravachol) is an HMG-CoA reductase inhibitor (statin) used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.
• It is also used to reduce the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol in the blood.

Pravastatin

What are the uses of this medicine?

Pravastatin (Pravachol) is used as an adjunctive therapy to diet to:

• Reduce the risk of myocardial infarction (MI), revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident coronary heart disease (CHD).
• Reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
• Reduce elevated serum TG levels in patients with hypertriglyceridemia.
• Treat patients with primary dysbetalipoproteinemia (Fredrickson Type III) who are not responding to diet.
• Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Limitations of use:

• Pravastatin sodium tablets have not been studied in Fredrickson Types I and V dyslipidemias.

How does this medicine work?

• The sodium salt of pravastatin with cholesterol-lowering and potential antineoplastic activities.
• Pravastatin competitively inhibits hepatic hydroxymethyl-glutaryl coenzyme A (HMG-CoA) reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate, a key step in cholesterol synthesis.
• This agent lowers plasma cholesterol and lipoprotein levels, and modulates immune responses by suppressing MHC II (major histocompatibility complex II) on interferon gamma-stimulated, antigen-presenting cells such as human vascular endothelial cells.
• In addition, pravastatin, like other statins, exhibits pro-apoptotic, growth inhibitory, and pro-differentiation activities in a variety of tumor cells; these antineoplastic activities may be due, in part, to inhibition of the isoprenylation of Ras and Rho GTPases and related signaling cascades.

Pravastatin Sodium

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to any component of this medication.
• Active liver disease or unexplained, persistent elevations of serum transaminases
• pregnancy
• Nursing Mothers

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antacids
• antifungals such as fluconazole (Diflucan) and ketoconazole (Nizoral)
• boceprevir (Victrelis)
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• colchicine (Colcrys)
• cyclosporine (Neoral, Sandimmune)
• digoxin (Lanoxin)
• diltiazem (Cardizem, Cartia, Taztia, Tiazac)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan)
• ritonavir (Norvir) taken with darunavir (Prezista)
• spironolactone (Aldactone)
• verapamil (Calan, Covera, Verelan)
• warfarin (Coumadin)

If you are taking cholestyramine or colestipol, take them 4 hours before or 1 hour after pravastatin.

Is this medicine FDA approved?

• Pravastatin was approved for use in the United States in 1991 and continues to be widely used with more than 9 million prescriptions filled yearly. Current indications are for treatment of hypercholesterolemia in persons at high risk for coronary, cerebrovascular and peripheral artery disease.

How should this medicine be used?

Recommended dosage:

Adult Patients:

• The recommended starting dose is 40 mg once daily.
• If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended.

Pediatric Patients: Children (Ages 8 to 13 Years, Inclusive):

• The recommended dose is 20 mg once daily in children 8 to 13 years of age.
• Doses greater than 20 mg have not been studied in this patient population.

Adolescents (Ages 14 to 18 Years):

• The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age.
• Doses greater than 40 mg have not been studied in this patient population.

Dosage in Patients Taking Cyclosporine:

• In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. \
• Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day.

Dosage in Patients Taking Clarithromycin:

• In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily.

Administration:

• Pravastatin comes as a tablet to take by mouth.
• It is usually taken once a day with or without food.
• Take pravastatin at around the same time every day.
• Your doctor may start you on a low dose of pravastatin and gradually increase your dose, not more than once every 4 weeks.
• Continue to take pravastatin even if you feel well.
• Do not stop taking pravastatin without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Pravastatin Sodium Tablets: 10 mg, 20 mg, 40 mg and 80 mg

This medicine is available in fallowing brand namesː

• Pravachol

What side effects can this medication cause?

The most common side effects of this medicine include:

• Edema
• Fatigue
• Chest Pain
• Weight Gain
• Weight Loss
• Musculoskeletal Pain
• Muscle Cramp
• Musculoskeletal Traumatism
• Dizziness
• Sleep Disturbance
• Anxiety/Nervousness
• Paresthesia
• Urinary Tract Infection
• Upper Respiratory Tract Infection
• Cough
• Influenza
• Pulmonary Infection
• Sinus Abnormality
• Tracheobronchitis
• Vision Disturbance (includes blurred vision, diplopia)
• Viral Infection

Less common side effects may include:

• scalp hair abnormality (including alopecia), urticaria
• sexual dysfunction, libido change
• flushing
• allergy, edema head/neck
• muscle weakness
• vertigo, insomnia, memory impairment, neuropathy (including peripheral neuropathy)
• taste disturbance

What special precautions should I follow?

• Skeletal muscle effects (e.g., myopathy and rhabdomyolysis)may occur. Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to report promptly any symptoms of myopathy. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected.
• Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
• It is associated with mild, asymptomatic and self-limited serum aminotransferase elevations during therapy, and rarely with clinically apparent acute liver injury.
• Statins interfere with cholesterol synthesis and lower circulating cholesterol levels and, as such, might theoretically blunt adrenal or gonadal steroid hormone production. Caution should also be exercised if a statin or other agent used to lower cholesterol levels is administered to patients also receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may diminish the levels or activity of steroid hormones.
• Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
• It is recommended that liver enzyme tests be performed before the initiation of pravastatin sodium, and thereafter when clinically indicated. All patients treated with pravastatin sodium should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
• A small amount of pravastatin is excreted in human breastmilk. Because of the potential for serious adverse reactions in nursing infants, women taking pravastatin sodium should not nurse.
• Ask your doctor about the safe use of alcoholic beverages while you are taking pravastatin. Alcohol can increase the risk of serious side effects.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Safety in pregnant women has not been established.
• Therefore, it is not known whether pravastatin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Pravastatin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus and patients have been informed of the potential hazards.

Can this medicine be used in children?

• The safety and effectiveness of pravastatin sodium in children and adolescents from 8 to 18 years of age have been evaluated.
• Doses greater than 40 mg have not been studied in this population.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PRAVASTATIN SODIUM

Inactive ingredients:

• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• POLYOXYL 35 CASTOR OIL
• SODIUM CARBONATE
• CELLULOSE, MICROCRYSTALLINE
• ANHYDROUS LACTOSE

Who manufactures and distributes this medicine?

Manufactured by:

• Cadila Healthcare Ltd.
• Ahmedabad, India

Distributed by:

• Zydus Pharmaceuticals USA Inc.
• Pennington, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25° C (68° to 77° F).
• Keep tightly closed (protect from moisture).
• Protect from light.

Lipid lowering medications

• Bile Acid Resins/Sequestrants

• • Cholestyramine
  • Colesevelam
  • Colestipol

• Fibrates
  • Clofibrate
  • Fenofibrate
  • Gemfibrozil

• Monoclonal Antibodies - Anti-PCSK9
  • Alirocumab
  • Evolocumab

• Niacin (Nicotinic Acid)

• • Omega-3 Fatty Acids,
  • Icosapent Ethyl
  • Omega-3 Acid Ethyl Esters
  • Omega-3 Carboxylic Acids

• Statins
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

• Miscellaneous
  • Ezetimibe
  • Lomitapide
  • Mipomersen

• Dailymed label info on Pravastatin
• FDA Pravastatin

Pravastatin Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

Pravastatin Resources
Latest articles Most recent articles Ongoing trials	Wikipedia