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Pravastatin

Generic name: pravastatin
Brand name: Pravachol
Drug class: Statins

Medically reviewed by  A Ras MD.

What is pravastatin used for?

Pravastatin is a prescription medicine that is used to lower bad cholesterol and raise good cholesterol (HDL). It is used to lower triglycerides. Pravastatin is also used to slow the progress of heart disease.

It is used to prevent heart attacks. It is used to prevent strokes. Pravastatin may be given to you for other reasons.

Description

Pravastatin is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.

Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-.

Structural formula:

Pravastatin Chemical Structure

Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether.

Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose and povidone. The 10 mg tablet also contains ferric oxide red, the 20 mg and 80 mg tablets also contain ferric oxide yellow, and the 40 mg tablet also contains D & C yellow No. 10 aluminum lake & FD & C blue No. l aluminum lake.

Mechanism of Action

Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, pravastatin reduces VLDL and TG and increases HDL-C.

Before taking pravastatin, tell your doctor:

  • If you are allergic to pravastatin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you are pregnant or may be pregnant. Do not take pravastatin if you are pregnant.
  • If you are breast-feeding. Do not breast-feed while you take pravastatin.
  • If you are taking gemfibrozil.
  • If you have any of these health problems: Active liver disease or a rise in liver enzymes.

This is not a list of all drugs or health problems that interact with pravastatin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pravastatin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take pravastatin?

  • Tell all of your health care providers that you take pravastatin. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow the diet and workout plan that your doctor told you about.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • If you take cholestyramine or colestipol, take them at least 4 hours before or 1 hour after pravastatin.
  • Avoid or limit drinking alcohol to less than 3 drinks a day. Drinking too much alcohol may raise your chance of liver disease.
  • If you are 65 or older, use pravastatin with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking pravastatin, call your doctor right away.
  • Use birth control that you can trust to prevent pregnancy while taking pravastatin.

How is pravastatin best taken?

Use pravastatin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking pravastatin as you have been told by your doctor or other health care provider, even if you feel well.
  • Take with or without food.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of pravastatin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain.
  • Change in eyesight.
  • Not able to pass urine or change in how much urine is passed.
  • This medicine may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call your doctor right away if you have muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call your doctor right away if you have muscle signs that last after your doctor has told you to stop taking pravastatin.
  • Very bad and sometimes deadly liver problems have happened with pravastatin. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of pravastatin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Dizziness.
  • Feeling tired or weak.
  • Diarrhea.
  • Upset stomach or throwing up.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out pravastatin?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

  • NDC 16729-008-15
  • Pravastatin Sodium Tablets USP
  • 10 mg : 90 Tablets Label
Pravastatin Sodium tablets 10mg
Imprint 0013 10 - pravastatin 10 mg
  • NDC 16729-009-15
  • Pravastatin Sodium Tablets USP
  • 20 mg : 90 Tablets Label
Pravastatin Sodium tablets 20mg
Imprint 0014 20 - pravastatin 20 mg
  • NDC 16729-010-15
  • Pravastatin Sodium Tablets USP
  • 40 mg : 90 Tablets Label
Pravastatin Sodium tablets 40mg
Imprint 0016 40 - pravastatin 40 mg

 

SRC: NLM .

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