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COL-ALPHAR (PRAVACHOL) INDICATIONS

Col-alphar is used for lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with an appropriate diet. It is also used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to slow blood vessel blockage and to reduce the need for medical procedures to open blocked blood vessels. Col-alphar is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

COL-ALPHAR (PRAVACHOL) INSTRUCTIONS

Use Col-alphar as directed by your doctor.

  • Take Col-alphar by mouth with or without food.
  • If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Col-alphar.
  • Continue to take Col-alphar even if you feel well. Do not miss any dose.
  • If you miss a dose of Col-alphar, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Col-alphar.

COL-ALPHAR (PRAVACHOL) STORAGE

Store Col-alphar at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Col-alphar out of the reach of children and away from pets.

COL-ALPHAR (PRAVACHOL) MORE INFO:

Active Ingredient:Pravastatin sodium.

Do NOT use Col-alphar if:

  • you are allergic to any ingredient in Col-alphar
  • you have liver problems or unexplained abnormal liver function tests
  • you are pregnant or breast-feeding.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Col-alphar. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood pressure, a serious infection, kidney problems, diabetes, muscle pain or tenderness, or a history of seizures
  • if you have metabolism, hormonal, or electrolyte problems
  • if you drink alcohol, have jaundice (yellowing of the skin or eyes), or have a history of liver problems or alcohol abuse
  • if you have recently had major surgery or a serious injury
  • if you have a certain type of high cholesterol (homozygous familial hypercholesterolemia).

Some medicines may interact with Col-alphar. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole), fibrates (eg, gemfibrozil, clofibrate), fluconazole, HIV protease inhibitors (eg, ritonavir), immunosuppressants (eg, cyclosporine), macrolides (eg, erythromycin), niacin, non-nucleoside reverse transcriptase inhibitors (eg, delavirdine), telithromycin, or voriconazole because they may increase the risk of muscle or kidney problems
  • Cimetidine or spironolactone because the risk of their side effects may be increased by Col-alphar.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Col-alphar may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Col-alphar may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Col-alphar with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Drinking alcohol daily or in large amounts may increase the risk of liver problems with Col-alphar. Check with your doctor before drinking alcohol while you are taking Col-alphar.
  • Follow the diet and exercise program given to you by your health care provider.
  • Tell your doctor or dentist that you take Col-alphar before you receive any medical or dental care, emergency care, or surgery.
  • Women who may become pregnant should use effective birth control while taking Col-alphar. Check with your doctor if you have questions about using birth control.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.
  • Lab tests, including blood cholesterol levels and liver function tests, may be performed while you use Col-alphar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Col-alphar should be used with extreme caution in children younger 8 years and in those who have not reached puberty; safety and effectiveness in these children have not been confirmed.
  • Pregnancy and breast-feeding: Do not use Col-alphar if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Col-alphar is found in breast milk. Do not breastfeed while you are taking Col-alphar.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Headache; heartburn.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; muscle pain, tenderness, or weakness (with or without fever or fatigue); pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; vision changes; yellowing of the eyes or skin.
 This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.



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