Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
New Drug Approvals
- Aemcolo (rifamycin SV*), approved for the treatment of travelers' diarrhea caused by non-invasive strains of E. coli in adults. Rifamycin SV is a poorly absorbed member of the rifamycin (technically ansamycin) class of antibiotics that was actually the first to be used in clinical practice (1963). In theory the product's MMX (multimatrix) technology allows for release of active antibiotic only after it reaches intestinal pH levels of ≥7 in the distal small bowel and colon, with an additional 1 hour delay upon reaching this pH. The recommended dosage is 388 mg po bid x3 days, with or without food (but not with alcohol). Tablets should be swallowed whole (not crushed, chewed, or broken) with 6-8 ounces of fluid. Rifamycin SV interacts with many CYP450 and transporter proteins, but because of negligible systemic rifamycin concentrations no clinically relevant drug interactions are expected. Product availability: 194 mg tablets.
- Temixys* (lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg), approved (in combination with other antiretroviral agents) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. This product is a generic formulation that has essentially the same activity and safety profile as Truvada (emtricitabine + tenofovir disoproxil fumarate). The recommended dosage is one tablet once daily, with or without food.
New or Updated Treatment Guidelines
- Updated clinical practice guidelines for the management of outpatient parenteral antimicrobial therapy from the Infectious Diseases Society of America (Clin Infect Dis 2018 Nov 13 [Epub ahead of print]). These guidelines update the 2004 version and are available on the IDSA website.
Drug Shortages (US)
- Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- [New on the list]: Nystatin oral suspension
- [Shortage recently resolved]: Cefpodoxime oral suspension, Mafenide powder for solution
- [Continue to be in reduced supply]:
- Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
- Carbapenems: Meropenem injection
- Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
- Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
- Glyco-, glycolipo-, lipopeptides: Dalbavancin injection, Daptomycin injection, Vancomycin injection
- Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
- Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
- Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
- Antifungal drugs: Fluconazole injection
- Antiparasitic drugs: None
- Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
- Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
- Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
- Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
- For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages