Cefazolin Sodium and Pitavastatin Calcium, Pitavastatin Magnesium

• Generic Name: cefazolin
• Dosage Forms: n.a.
• Other Brand Names: Ancef, Kefzol

Treatment of biliary tract infections caused by susceptible Escherichia coli, Klebsiella, Proteus mirabilis, Staphylococcus aureus, or various streptococci.

Treatment of bone and joint infections caused by susceptible S. aureus.

Treatment of endocarditis caused by susceptible Streptococcus pyogenes. AHA recommends cefazolin as an alternative for treatment of staphylococcal endocarditis or endocarditis caused by viridans streptococci, S. bovis, S. pneumoniae, S. pyogenes, or groups B, C, and G streptococci in penicillin-allergic individuals; should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis in individuals undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk. Oral amoxicillin is usual drug of choice for such prophylaxis; cefazolin (or ceftriaxone) is an alternative in penicillin-allergic individuals or when an oral anti-infective cannot be used. Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions). Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis.

Treatment of respiratory infections caused by susceptible S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), S. aureus (including penicillin-resistant strains), Klebsiella, or Haemophilus influenzae.

Treatment of septicemia caused by susceptible S. pneumoniae, S. aureus (including penicillinase-producing strains), E. coli, Klebsiella, or P. mirabilis.

Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. pyogenes, or other streptococci.

Treatment of UTIs caused by susceptible E. coli, P. mirabilis, Klebsiella, some strains of Enterobacter, or some strains of enterococci.

Treatment of prostatitis or epididymitis caused by susceptible E. coli, Klebsiella, P. mirabilis, or some strains of enterococci.

Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease (early-onset neonatal GBS disease) in penicillin-allergic pregnant women who do not have immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions).

Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is indicated in women identified as GBS carriers during routine prenatal GBS screening (vaginal and rectal cultures) performed at 35–37 weeks during the current pregnancy, women who have GBS bacteriuria identified at any time during the current pregnancy, and women with a previous infant diagnosed with invasive GBS disease.

Prophylaxis also indicated in women with unknown GBS status at onset of labor (i.e., culture not done, incomplete, or results unknown) if delivery is at <37 weeks of gestation, duration of amniotic membrane rupture is ≥18 hours, intrapartum temperature is ≥38°C, or woman has a positive intrapartum GBS nucleic acid amplification test (NAAT).

Perioperative prophylaxis to reduce incidence of infection in patients undergoing certain cardiac surgery, noncardiac thoracic surgery, vascular surgery, head and neck surgery, neurosurgery, orthopedic surgery, GI surgery, GU surgery, and gynecologic and obstetric surgery.

Drug of choice for perioperative prophylaxis for a wide variety of contaminated or potentially contaminated surgical procedures. Also recommended as drug of choice for perioperative prophylaxis for heart, lung, heart-lung, pancreas, and pancreas-kidney transplantation.

For perioperative prophylaxis in patients undergoing certain GI procedures (e.g., colorectal surgery, appendectomy) that might involve exposure to Bacteroides fragilis or other anaerobic bowel bacteria or in patients undergoing head and neck surgery involving incisions through oral or pharyngeal mucosa; used in conjunction with metronidazole to provide anaerobic coverage.

Consult published guidelines and protocols for perioperative prophylaxis for recommendations regarding specific procedures.

• 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.