Pravastatin Sodium and Rybix ODT

• Generic Name: pravastatin
• Dosage Forms: n.a.
• Other Brand Names: Pravachol

ACC/AHA cholesterol management guideline recommends statins as first-line therapy for prevention of atherosclerotic cardiovascular disease (ASCVD) in adults; extensive evidence demonstrates that statins can substantially reduce ASCVD risk when used for secondary prevention or primary prevention (in high-risk patients). Relative reduction in ASCVD risk is correlated with degree of LDL-cholesterol lowering; therefore, use maximum tolerated statin intensity to achieve optimum ASCVD benefits. According to ACC/AHA, pravastatin may be used for primary or secondary prevention in adults when moderate-intensity statin therapy is indicated. (See Prevention of Cardiovascular Events under Dosage and Administration.)

Adjunct to nondrug therapies (i.e., lifestyle modifications) in patients with hypercholesterolemia without clinical evidence of CHD to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of cardiovascular mortality (with no increase in death from noncardiovascular causes). Consider benefits, adverse effects, drug interactions, and patient preferences before initiating statin therapy for primary prevention.

Adjunct to nondrug therapies (i.e., lifestyle modifications ) in patients with clinical evidence of CHD to reduce the risk of total mortality by reducing coronary death, to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of stroke or TIA. Unless contraindicated, statins are considered first-line therapy in patients 21–75 years of age with clinical ASCVD (i.e., acute coronary syndromes; history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). Addition of a nonstatin drug (i.e., niacin) to statin-based therapy (i.e., simvastatin with or without ezetimibe) in patients with established cardiovascular disease not shown to provide incremental ASCVD risk reduction benefit beyond that provided by statin monotherapy.

Adjunct to nondrug therapies (i.e., lifestyle modifications ) in patients with clinical evidence of CHD to slow the progression of coronary atherosclerosis. Has been shown to slow the progression and/or induce regression of atherosclerosis in a few patients without clinical evidence of CHD who had mild to moderate elevations of LDL-cholesterol concentrations.

Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen). Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis in patients with CHD.

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) in adults to decrease elevated serum total and LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia or mixed dyslipidemia (Fredrickson type IIa or IIb). Also used in combination with fenofibrate to decrease triglyceride concentrations and increase HDL-cholesterol concentrations in patients with mixed dyslipidemia and CHD (or CHD risk equivalents) who are on optimal statin therapy; however, no incremental benefit on cardiovascular morbidity and mortality beyond that provided by statin monotherapy.

Adjunct to dietary therapy and lifestyle modification in the management of heterozygous familial hypercholesterolemia in children ≥8 years of age who, despite an adequate trial of dietary management, have a serum LDL-cholesterol concentration of ≥190 mg/dL or a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular risk factors.

Adjunct to nondrug therapies (e.g., dietary management) in the treatment of primary dysbetalipoproteinemia (Fredrickson type III) in patients who do not respond adequately to diet.

Adjunct to nondrug therapies (e.g., dietary management) in the treatment of elevated serum triglyceride concentrations (Fredrickson type IV). However, fibric acid derivatives provide greater benefit in patients with elevated triglyceride concentrations compared with statins.

Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus (diabetic dyslipidemia), cardiac or liver transplantation, or nephrotic syndrome (nephrotic hyperlipidemia).

• Generic Name: tramadol
• Dosage Forms: tablet, orally disintegrating
• Other Brand Names: ConZip, Ultram, Ultram ER, Rybix ODT, Ryzolt

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release capsules or tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain.

When tramadol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.