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Pravigard Pac Side Effects

Generic name: aspirin / pravastatin

Note: This document contains side effect information about aspirin / pravastatin. Some dosage forms listed on this page may not apply to the brand name Pravigard Pac.

Applies to aspirin / pravastatin: oral tablet.

Warning

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 aspirin and pravastatin if you are pregnant or breast-feeding, or if you have liver disease, asthma with nasal polyps, or aspirin-sensitive asthma or other allergic reactions.

Before taking aspirin and pravastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, congestive heart failure, a muscle disorder, a recent history of stomach or intestinal bleeding, a bleeding or blood clotting disorder, or if you drink 3 or more alcoholic beverages per day.

Avoid eating foods that are high in fat or cholesterol. Aspirin and 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 aspirin and pravastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking aspirin and pravastatin.

Read the label of any other medicine you are using to see if it contains aspirin. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin.

There are many other drugs that can interact with aspirin and 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.

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

Less serious side effects include:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to aspirin / pravastatin: oral tablet.

Cardiovascular

A 29-year-old female with a history of migraine developed chest pain, tachycardia and orthopnea following aspirin consumption at doses of 1500 mg per day for several days. After discontinuation of aspirin therapy, the patient's symptoms promptly resolved. The patient consented to a pharmacological challenge test which once again triggered the symptoms.[Ref]

Cardiovascular side effects of aspirin have been reported rarely and have included salicylate-induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity. In addition, at least one case of fluid retention simulating acute congestive heart failure has been reported during aspirin therapy.[Ref]

Dermatologic

Dermatologic side effects associated with aspirin have been reported rarely and include Stevens-Johnson syndrome and a lichenoid eruption. Dermatologic side effects of pravastatin have included rash (0.9% to 4.0%) and a case report of bullous erythematous lesions. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, and alopecia have occurred with HMG-CoA reductase inhibitors.[Ref]

Endocrine

Endocrine side effects associated with aspirin therapy have included hypoglycemia (which has been reported in children) and hyperglycemia. Endocrine side effects of gynecomastia and thyroid function abnormalities have been reported during pravastatin therapy.[Ref]

Gastrointestinal

Gastrointestinal side effects of aspirin are common and include epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations. Gastrointestinal side effects of pravastatin have included nausea and vomiting (0.5% to 7.3%), diarrhea (2.0% to 6.2%), abdominal pain (0.3% to 5.4%), constipation, flatulence, and heartburn. Gastrointestinal side effects reported with HMG-CoA reductase inhibitors have included pancreatitis and anorexia.[Ref]

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin.

Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin-containing rectal suppositories. One case-controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

Gastrointestinal side effects have been among the most common symptoms reported by patients on pravastatin. These symptoms tended to be mild and transient in nature and resolved with continued therapy.[Ref]

General

In general, many side effects noted with aspirin use are dose-related.[Ref]

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) include increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.

Hematologic side effects including hemolytic anemia, thrombocytopenia, and leukopenia have occurred with some HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.[Ref]

Hepatic

Hepatic side effects associated with aspirin therapy including hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely. Hepatic side effects of pravastatin have included elevations in liver function tests (1.3%). HMG-CoA reductase inhibitors have reported hepatic side effects of hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, and fulminant hepatic necrosis.[Ref]

Persistent elevations in liver function tests three times normal values have been reported in up to 1.3% of patients in clinical trials. In one review of 1,142 patients, elevations in serum transaminases led to discontinuation of pravastatin in 1% of patients. Clinical monitoring of hepatic function is recommended and pravastatin should be discontinued in patients with persistent, significant elevations (three times normal) in liver function parameters.[Ref]

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin-sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps). Hypersensitivity reactions have rarely occurred with HMG-CoA reductase inhibitors. Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, and dyspnea have been reported.[Ref]

The mechanism of aspirin-induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).[Ref]

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has been reported in a patient on hemodialysis. Salicylates have also been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]

Musculoskeletal

HMG-CoA inhibitors have been associated with rare cases of severe myopathy and rhabdomyolysis. This has been accompanied by elevations in creatine kinase, myoglobinuria, and proteinuria, as well as renal failure. Concomitant use with gemfibrozil, niacin, cyclosporine, or erythromycin may increase the incidence and severity of musculoskeletal side effects. One case of myopathy and one of dermatomyositis associated with pravastatin have been reported in the literature. Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured and if markedly elevated, pravastatin should be discontinued. The value of routine monitoring of creatine kinase is not known.[Ref]

Musculoskeletal side effects of rhabdomyolysis have occurred during aspirin therapy. Musculoskeletal side effects of pravastatin have included elevations in creatine kinase, myopathy, and a case report of dermatomyositis. Musculoskeletal side effects reported with HMG-CoA reductase inhibitors have included rhabdomyolysis and arthralgia. In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.[Ref]

Nervous system

Some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.[Ref]

Nervous system side effects including agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy and seizures have occurred in patients receiving aspirin. Tinnitus and subjective hearing loss (or both) may occur. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise. Nervous system side effects of pravastatin have included headache (0.6% to 6.2%), dizziness, drowsiness, and weakness. Cranial nerve dysfunction, tremor, vertigo, memory loss, paresthesias, peripheral neuropathy, and peripheral nerve palsy have been reported with HMG-CoA reductase inhibitors.[Ref]

Ocular

Ocular side effects including cases of localized periorbital edema have rarely been reported during aspirin therapy. Ocular side effects of HMG-CoA reductase inhibitors have included progression of cataracts and ophthalmoplegia. There are no data associating pravastatin with lens opacities in humans.[Ref]

Oncologic

Oncologic side effects of aspirin may be beneficial ones. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found such a beneficial effect. Oncologic side effects including hepatocellular carcinomas and malignant lymphomas have been associated with pravastatin in animal studies. Long-term clinical trials are needed to define the cancer risk in humans.[Ref]

Other

Other side effects include Reye's syndrome has rarely been associated with aspirin use in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults.[Ref]

Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]

Renal

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure. Renal side effects of HMG-CoA reductase inhibitors have included myoglobinuria and acute renal failure secondary to rhabdomyolysis.[Ref]

The mechanism of an aspirin-induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.[Ref]

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.[Ref]

Genitourinary

Genitourinary side effects of HMG-CoA reductase inhibitors have been limited to erectile dysfunction.[Ref]

Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient lead to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.[Ref]

Immunologic

Immunologic side effects of HMG-CoA reductase inhibitors have included a lupus-like syndrome, positive ANA, elevated ESR, polymyalgia rheumatica, and vasculitis.[Ref]

Psychiatric

Psychiatric side effects of pravastatin have included insomnia and other sleep disturbances. Psychiatric side effects reported with HMG-CoA reductase inhibitors have included depression, decreased libido, and anxiety.[Ref]

References

1. Product Information. Pravigard Pac (aspirin-pravastatin). Bristol-Myers Squibb. 2003.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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