Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

PRAVASTATIN/BUFFERED ASPIRIN - ORAL

(PRAV-uh-stat-in/BUFF-erd ASP-er-in)

COMMON BRAND NAME(S): Pravigard PAC

WARNING: Children and teenagers should not use aspirin, aspirin-containing or aspirin-related medications for flu symptoms or chickenpox without first consulting a doctor. A rare but serious illness known as Reye's syndrome may occur.

Uses

The medications in this product are a "statin" (HMG-CoA reductase inhibitor) and aspirin. Pravastatin works by lowering cholesterol (LDL) and fat (triglycerides) levels in your blood. Aspirin in low doses acts as a "blood thinner" preventing blood clots. When used along with a cholesterol-lowering diet, these medications reduce the risk of heart attacks and strokes. In general, pravastatin is prescribed after non-drug treatment options have not been fully successful at lowering cholesterol (e.g., diet change, increase in exercise, weight loss if overweight).

How To Use

Take these medicines by mouth usually once daily or as directed by your doctor. Pravastatin is best taken in the evening, with or without food. The buffered aspirin may be taken with food if stomach upset occurs. Also, you should take the aspirin with a full glass of water (8 oz or 240 ml) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking it. Dosage is based on your medical condition, response to therapy, and use of certain interacting medicines. Many of the drugs listed in the Drug Interactions section may increase the chances of muscle injury when used with pravastatin. Consult your doctor or pharmacist for more details. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take pravastatin at least 1 hour before or 4 hours after these drugs. The antacids in the buffered aspirin may decrease the absorption of other medicines if taken at the same time. Take the following medications at least 2 hours before or after this product: delavirdine, gabapentin, levothyroxine, quinidine, or tetracyclines (e.g., tetracycline, minocycline). If you are taking a quinolone antibiotic (e.g., ciprofloxacin, levofloxacin), check with your pharmacist for the exact amount of time to separate the doses of the quinolone and the buffered aspirin. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 4 weeks before the full benefit of this drug takes effect. Do not stop taking this medication without checking with your doctor. It is important to continue taking these medications even if you feel well. Most people with high cholesterol or triglycerides do not feel sick. This medication comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions you may have about this medicine.

Side Effects

Heartburn, headache, dizziness, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This drug may infrequently cause muscle damage (which can rarely lead to a very serious condition called rhabdomyolysis). Stop taking this drug and tell your doctor immediately if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these unlikely but serious side effects occur: difficulty hearing/ringing in the ears, easy bruising or bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, persistent nausea, severe stomach/abdominal pain, black stool, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

These medications should not be used if you have certain medical conditions. Before using these medicines, consult your doctor or pharmacist if you have: active liver disease, allergies to aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen, celecoxib). Before using these medications, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use, blood disorders, bleeding problems, ulcers, any allergies in addition to those listed above (especially to other "statins"). The rare development of severe muscle damage (see Side Effects) infrequently can lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Aspirin or daily use of alcohol may increase your risk for stomach bleeding or other serious side effects (e.g., liver damage). Check with your doctor or pharmacist for more information. Aspirin that has a very strong vinegar-like odor is too old and should not be used. Pravastatin may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially muscle damage. These medications must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that women of child-bearing age use effective birth control measures while taking these drugs since this product may cause fetal harm. These medications pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using these drugs. Consult your doctor before breast-feeding.

Drug Interactions

See also the How to Use section. This drug should not be used with the following medications because very serious interactions may occur: mifepristone. If you are currently using any of these medications, tell your doctor or pharmacist before starting pravastatin/buffered aspirin. Use caution if the following drugs are combined with pravastatin because serious side effects such as muscle injury (myopathy) infrequently could occur: fibrates (e.g., gemfibrozil, fenofibrate), high-dose niacin (1 gram or more per day). Before using these medications, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: acetazolamide, atazanavir, azole antifungals (e.g., itraconazole, ketoconazole), "blood thinners" (e.g., heparin, warfarin), cholestyramine, colestipol, corticosteroids (e.g., prednisone), cyclosporine, delavirdine, gabapentin, gingko biloba, levothyroxine, medication for gout or diabetes, methotrexate, NSAIDs (e.g., ibuprofen, naproxen), quinidine, quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), tetracycline antibiotics (e.g., tetracycline, minocycline), ticlopidine, valproic acid. Check the labels on all your medicines because they may contain aspirin or aspirin-like NSAIDs (e.g., ibuprofen, naproxen, ketoprofen). Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe vomiting, severe stomach pain, or fast breathing.

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood cholesterol levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. For best results, this medication should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight. Also to help reduce your risk of heart attacks and strokes, check your blood pressure regularly, seek medical treatment if your blood pressure is high, and stop smoking. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68 and 77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.