Pitavastatin Calcium, Pitavastatin Magnesium and Triaminic Softchews Cough & Sore Throat (pseudoephedrine)

• 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 / dextromethorphan / pseudoephedrine
• Dosage Forms: n.a.
• Other Brand Names: Alka-Seltzer Plus Flu Liquigels, Comtrex Non-Drowsy, Dayquil Liquicaps, Daytime Cold, Non-Drowsy Daytime, Robitussin Honey Flu Non-Drowsy, Theraflu Daytime Severe Cold, Theraflu Severe Cold & Congestion Non-Drowsy, Triaminic Cough & Sore Throat, Triaminic Softchew Throat Pain and Cough, Triaminic Softchews Cough & Sore Throat, EQL Severe Cold, GNP Day Time D Cold/Flu, PX Daytime Multi-Symptom, RA Acetaminophen Flu Cold

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

Triaminic Softchews Cough & Sore Throat (pseudoephedrine) is a combination medicine used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Triaminic Softchews Cough & Sore Throat (pseudoephedrine) will not treat a cough that is caused by smoking, asthma, or emphysema.

Triaminic Softchews Cough & Sore Throat (pseudoephedrine) may also be used for purposes not listed in this medication guide.