Pravachol

DRUG DESCRIPTION

PRAVACHOL® (pravastatin sodium) 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, 1,2,6,7,8,8ahexahydro-?,?,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1?(?S*,?S*),2?,6?,8?(R*),8a?]]-.

Structural formula:

PRAVACHOL® (pravastatin sodium) Structural Formula Illustration

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.

PRAVACHOL (pravastatin sodium) is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg and 80 mg tablets also contain Yellow Ferric Oxide, and the 40 mg tablet also contains Green Lake Blend (mixture of D&C Yellow No. 10-Aluminum Lake and FD&C Blue No. 1-Aluminum Lake).

What are the possible side effects of pravastatin (Pravachol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pravastatin and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Pravachol »

What are the precautions when taking pravastatin sodium (Pravachol)?

Before taking pravastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with pravastatin. Ask your doctor or pharmacist for more information.

Older adults may be...

Read All Potential Precautions of Pravachol »


Pravachol Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pravastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with pravastatin. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

This medication must not be used during pregnancy. Pravastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Pravachol Patient Information Including Side Effects

Brand Names: Pravachol

Generic Name: pravastatin (Pronunciation: PRAV a STAT in)

  • What is pravastatin (Pravachol)?
  • What are the possible side effects of pravastatin (Pravachol)?
  • What is the most important information I should know about pravastatin (Pravachol)?
  • What should I discuss with my healthcare provider before taking pravastatin (Pravachol)?
  • How should I take pravastatin (Pravachol)?
  • What happens if I miss a dose (Pravachol)?
  • What happens if I overdose (Pravachol)?
  • What should I avoid while taking pravastatin (Pravachol)?
  • What other drugs will affect pravastatin (Pravachol)?
  • Where can I get more information?

What is pravastatin (Pravachol)?

Pravastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Pravastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Pravastatin is used to treat high cholesterol. Pravastatin is also used to lower the risk of stroke, heart attack, or other heart complications in people with coronary heart disease.

Pravastatin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pravastatin (Pravachol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pravastatin and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • mild stomach pain, constipation, diarrhea;
  • heartburn, gas, bloating, upset stomach;
  • tired feeling;
  • headache, dizziness;
  • stuffy nose, cold or flu symptoms;
  • skin rash; or
  • general pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pravastatin (Pravachol)?

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take pravastatin if you have liver disease, or if you are breast-feeding.

Before taking pravastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or if you drink 3 or more alcoholic beverages per day.

Avoid eating foods that are high in fat or cholesterol. Pravastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol while taking pravastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking pravastatin.

There may be other drugs that can interact with pravastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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