Pitavastatin Calcium, Pitavastatin Magnesium and Theraflu Sinus & Cold

• Generic Name: pitavastatin
• Dosage Forms: n.a.
• Other Brand Names: Livalo, Zypitamag

Available as pitavastatin calcium (e.g., Livalo) and pitavastatin magnesium (i.e., Zypitamag). FDA considers pitavastatin magnesium tablets to be a pharmaceutical alternative (as described in section 505[b][2] of the Federal Food, Drug, and Cosmetic Act) and not a pharmaceutical (generic) equivalent to pitavastatin calcium tablets, since both contain the same active moiety (pitavastatin) but have different salts. Clinical efficacy and safety expected to be similar between the 2 salt forms of the drug.

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia or mixed dyslipidemia. 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.

Reductions in LDL-cholesterol concentrations achieved with usual dosages (1–4 mg daily) of pitavastatin are similar to or greater than those achieved with low to medium dosages of certain other statins (i.e., atorvastatin, pravastatin, simvastatin).

Safety and efficacy not established in patients with Fredrickson type I, III, or V dyslipidemia. Effect on cardiovascular morbidity and mortality not established.

Prevention of Cardiovascular Events

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, pitavastatin may be used for primary or secondary prevention in adults when moderate-intensity statin therapy is indicated.

• Generic Name: acetaminophen / pheniramine / phenylephrine
• Dosage Forms: n.a.
• Other Brand Names: Flu & Severe Cold Night Time, Theraflu Flu & Sore Throat, Theraflu Nighttime Severe Cold, Theraflu Sinus & Cold, Theraflu Cold & Sore Throat, Theraflu Cold and Sore Throat, Theraflu Flu and Sore Throat

Acetaminophen is a pain reliever and a fever reducer.

Pheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Theraflu Sinus & Cold is a combination medicine used to treat headache, runny nose, sneezing, stuffy nose, sinus congestion, watery eyes, and pain or fever caused by allergies, the common cold, or the flu.

Theraflu Sinus & Cold may also be used for other purposes not listed in this medication guide.