Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
Available formulation in Zambia: Injection: SMX 80 mg + TMP16 mg/ml in 5 ml and 10 ml ampoules. Oral liquid: SMX 200 mg/5 ml + TMP 40 mg/5 ml. Tablet: SMX/TMP 100 + 20 mg; 400 + 80 mg.
PCP treatment: 5 mg/kg (TMP component) q6h: <60kg three 400/80 mg tabs q6h x 21 days; >60 kg four 400/80 mg tabs q6h x 21 days.
PCP prophylaxis: 1-2 tabs (400/80 mg) once daily. If Toxo IgG+, SMX/TMP 800/160 mg once daily.
Toxoplasmosis: 1600/320 mg q12h (5 mg/kg q12h TMP component) x 4weeks, then 800/160 mg q12h x 12 weeks. Consider induction for 6 weeks, then ½ dose for maintenance.
- UTI prophylaxis: SMX/TMP 400/80 mg qhs
- High level of SMX/TMP resistance observed in strains of non-typhoidal Salmonellae, S. flexneri, and S. dysenteriae in tertiary hospital in Zambia.
Zambia Information Author: Paul A. Pham Pharm.D.
- Acute exacerbation of chronic bronchitis
- Otitis media (in S. pneumoniae sensitive cases only)
- Traveler's diarrhea, shigellosis
- Urinary tract infections
Toxoplasmosis treatment and prophylaxis
- Bacterial cystitis prophylaxis
- MSSA and community-acquired MRSA soft tissue infections
- Legionellosis treatment (2nd line)
Listeriosis treatment (2nd line for PCN allergic pts)
| Bactrim or Septra|| Trimethoprim-sulfamethoxazole (TMP-SMX) ||Generic manufacturers||oral |
400 mg/80 mg (SS)
800 mg/160 mg (DS)
80 mg/16 mg per ml (30ml)
|$19.49 /30 ml
200-40 mg/5 ml (473 ml bottle)
|$58.10/473 ml bottle
*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP).
AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's
information, and the McKesson database.
^Dosage is indicated in mg unless otherwise noted.
PCP treatment: 5 mg/kg (TMP component) IV or PO q8h x 21d (usually 5-6 DS/d but must dose based on weight using TMP component).
PCP prophylaxis: 1 DS or 1 SS PO once-daily or 1 DS 3x/wk (alternative).
Toxoplasmosis prophylaxis: 1 DS PO once-daily.
Toxoplasmosis treatment: 5 mg/kg (TMP component) PO or IV q12h x 6 wks, then 1/2 dose for maintenance (sulfadiazine + pyrimethamine preferred).
- UTI: 1 DS PO twice-daily x 3-14 d, (3d recommended for uncomplicated cystitis in women).
- Traveler's diarrhea, Salmonella, Shigella, E. coli, and Cyclospora: 1 DS PO twice-daily x 5-7 d.
- Skin and soft tissue infections (including CA-MRSA): 1-2 DS PO q12h.
Nocardia: 2-3 DS PO twice-daily x >6 mos.
Isospora: 1 DS PO twice-daily x 7-10 d, then 1 DS 3x/wk.
- Gradual dose escalation over 6 d may improves long-term tolerability of TMP/SMX compared to direct rechallenge, but dosing may be impractical for some pts. Start with 12.5% of SS TMP/SMX (10 mg TMP component), then increase by 12.5%/d until target dose of 1 SS TMP/SMX on day 6 (J Infect Dis. 2001;184:992-7).
- Acute exacerbations of chronic bronchitis (bacterial): 1 DS twice-daily x 14 d
GFR 10-30 ml/min: 5 mg/kg IV q12h; oral 50% of dose.
Manufacturer recommends avoiding. For severe PCP or serious infections, authors recommend 5-7.5 mg/kg/d in 2-3 divided doses (1/2-1/3 standard dose) for GFR <10ml/min. HD: 5-7.5 mg/kg/d (1/2-1/3 standard dose). PCP prophylaxis: consider 1 SS po once-daily.
Dialyzed out, consider 5-7.5mg/kg/d in 2-3 divided doses (dose post-HD on days of dialysis). PCP prophylaxis: consider 1 SS PO qday.
Not dialyzed out. PCP prophylaxis: consider 1 DS PO q48h. PCP treatment: consider 5 mg/kg/d.
CVVH and CVVHD: limited data. Consider 5 mg/kg IV q 8h-12h.
Generally well tolerated in the immunocompetent host. HIV+ pts at increased risk for developing SMX-TMP-associated ADRs.
- GI intolerance with nausea and vomiting (in 20-50% receiving high dose >15 mg/kg).
- Rash and pruritus (usually 7-14 d after starting SMX/TMP).
- Continue treatment if Sx not disabling.
- Pseudo elevation in serum creatinine (an average increase of18%) [Kainer et al. Chemotherapy. 1981;27:229-32].
- Reversible hyperkalemia (with higher TMP doses +/- chronic renal insufficiency ).
- Bone marrow suppression (anemia with folate deficiency, thrombocytopenia, and leukopenia; more common with higher doses).
- Serum sickness and drug fever.
- Hepatitis (may be cholestatic).
- Methemoglobinemia (with severe G6PD deficiency). African-American pts with mild to moderate G6PD deficiency can tolerate TMP-SMX.
- Crystalluria with azotemia, urolithiasis and oliguria (more common with sulfadiazine).
- Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN)
- Aseptic meningitis
- Neurologic toxicity (tremor, ataxia, apathy, and ankle clonus)
- Interstitial nephritis
T. gondii, P. jiroveci , CA-MRSA, Gram-negative bacilli
- Cyclosporine: may decrease cyclosporine serum levels. Monitor cyclosporine serum levels.
- Folinic acid: possible antagonism. Avoid co-administration.
- Para-aminobenzoic acid (PABA) and derivatives (such as benzocaine, procaine, tetracaine): theoretical antagonism.
- Phenytoin: may increase phenytoin serum levels. Monitor free phenytoin levels with co-administration.
- Porfimer: may increase the risk of photosensitivity reaction. Avoid co-administration.
- Sulfonylurea: may increase hypoglycemia. Monitor closely with co-administration.
- Warfarin: may increase INR. Monitor closely.
E. coli: (urine isolates) certain regions in US and world-wide >20% resistance
S. pneumoniae: 15-30% resistance
P. jiroveci: increasing rates of mutations in the dihydropteroate synthase (DHPS) gene of P. jiroveci associated with resistance to sulfonamide and dapsone but not clinically significant since clinical outcome was not worse with DHPS mutation in a prospective trial (Lancet 2001;358:545-9).
- CA-MRSA: low resistance rates to TMP-SMX
First line agent for PCP prophylaxis and treatment. Active against other pathogens (T. gondii, Listeria, Legionella, 70% of S. pneumoniae, many S. aureus including CA-MRSA, and H. influenzae) which may protect patients against CAP and soft tissue infections. Although generally well tolerated in immunocompetent host, there is higher incidence of intolerance requiring discontinuation in HIV+ pts.
- National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA);
Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents ;
2008 ; Vol.
Basis for recommendation
Comments:TMP-SMX usage recommendations in HIV patients. TMP-SMX is the preferred agent for PCP prophylaxis and treatment.