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Co-trimoxazole [Bactrim 400+80mg, 800+160mg Tablets]: Dosage and Administration

Co-trimoxazole: Reconstitution and Administration

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Co-trimoxazole [Bactrim 400+80mg, 800+160mg Tablets] is administered orally or by IV infusion. When oral therapy is not feasible or for severe infections, the drug may be administered IV. The drug should not be injected IM.

Co-trimoxazole for injection concentrate must be diluted prior to IV infusion. For IV infusion, each 5 mL of the concentrate for injection containing 80 mg of trimethoprim is usually diluted with 125 mL of 5% dextrose. In patients in whom fluid intake is restricted, each 5 mL of the concentrate may be diluted in 75 mL of 5% dextrose. ADD-Vantage® vials labeled as containing 80 or 160 mg of trimethoprim should be mixed with 5% dextrose injection according to the manufacturer's directions. IV solutions of the drug should be infused over a period of 60-90 minutes; rapid or direct IV injection must be avoided.

Co-trimoxazole: Dosage

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Dosage of co-trimoxazole is expressed in terms of the trimethoprim content of the fixed combination containing 5 mg of sulfamethoxazole to 1 mg of trimethoprim.

For the treatment of chronic or recurrent urinary tract infections (UTIs), prostatitis, enteritis caused by S. flexneri or S. sonnei, or bronchitis, the usual adult oral dosage of co-trimoxazole is 160 mg of trimethoprim (as co-trimoxazole) administered every 12 hours. Most clinicians recommend continuing co-trimoxazole treatment for 10-14 days for chronic or recurrent UTIs, for 3-6 months in men with prostatitis, for 5 days for enteritis, or for 14 days for bronchitis.

For the prophylaxis of chronic or recurrent UTIs, trimethoprim doses of 40-80 mg (as co-trimoxazole) have been administered daily or 3 times weekly for 3-6 months. For the treatment of otitis media, enteritis caused by S. flexneri or S. sonnei, or chronic or recurrent UTIs in children 2 months of age or older, the usual oral dosage is 8 mg/kg daily of trimethoprim (as co-trimoxazole), administered in 2 divided doses every 12 hours. The usual duration of co-trimoxazole therapy is 10 days for otitis media or chronic or recurrent UTIs or 5 days for enteritis.

For severe UTIs or enteritis caused by S. flexneri or S. sonnei in children 2 months of age or older and in adults, the usual IV dosage of trimethoprim is 8-10 mg/kg (as co-trimoxazole) daily, administered in 2-4 equally divided doses every 6, 8, or 12 hours for 5 days in the case of enteritis or up to 14 days for severe UTIs. The maximum recommended dosage is 960 mg of trimethoprim (as co-trimoxazole) daily.

Travelers' Diarrhea

For the treatment of travelers' diarrhea in adults, the usual oral dosage of co-trimoxazole is 160 mg of trimethoprim (as co-trimoxazole) every 12 hours for 3-5 days. A single oral dose of 320 mg of trimethoprim (as co-trimoxazole) has also been used for the treatment of travelers' diarrhea.

Although the use of anti-infective agents for prophylaxis of travelers' diarrhea generally is discouraged, an adult oral dosage of trimethoprim 160 mg (as co-trimoxazole) once daily during the period of risk has been used.

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

For the treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia (PCP) in adults and children older than 2 months of age, the usual oral or IV dosage of trimethoprim (as co-trimoxazole) is 15-20 mg/kg daily, given in 3 or 4 equally divided doses. An IV dosage of 10-15 mg/kg daily has also been suggested for the treatment of PCP in adults with normal renal function. The usual duration of co-trimoxazole for treatment of PCP is 14-21 days.

For both primary and secondary prevention of PCP in HIV-infected adults and adolescents, the Prevention and Opportunistic Infections Working Group of the US Public Health Service and the Infectious Disease Society of America (USPHS/IDSA) and other experts recommend an oral trimethoprim (as co-trimoxazole) dosage of 160 mg once daily; alternatively, an oral trimethoprim (as co-trimoxazole) dosage of 80 mg once daily also is recommended. In patients with acute lymphocytic leukemia undergoing induction and maintenance chemotherapy, co-trimoxazole therapy given on 3 consecutive days (e.g., Monday, Tuesday, and Wednesday) weekly appears to be as effective as daily therapy for the prevention of PCP and may be associated with a lower frequency of systemic fungal infections.

For primary or secondary prophylaxis of PCP in children, including HIV-infected children, the USPHS/IDSA and other clinicians recommend an intermittent regimen of trimethoprim 150 mg/m2 daily (as co-trimoxazole) in 2 divided doses for 3 consecutive days each week is recommended. Alternatively, the USPHS/IDSA states that 150 mg/m2 can be administered as a single daily dose for 3 consecutive days each week, in 2 divided doses daily, or in 2 divided daily doses 3 times a week on alternate days.

Toxoplasmosis

For primary prophylaxis against toxoplasmosis in HIV-infected adults and adolescents, the USPHS/IDSA recommends an oral trimethoprim dosage of 160 mg (as co-trimoxazole) once daily. Alternatively, an oral dosage of trimethoprim of 80 mg once daily (as co-trimoxazole) may be used. For primary prophylaxis against toxoplasmosis in HIV-infected children, the dosage recommended by USPHS/IDSA is trimethoprim 150 mg/m2 (as co-trimoxazole) daily in 2 divided doses.

Granuloma Inguinale (Donovanosis)

For the treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis, the CDC recommends that oral trimethoprim (as co-trimoxazole) be given in a dosage of 160 mg twice daily for at least 3 weeks. If lesions do not respond within the first few days, addition of a parenteral aminoglycoside (1 mg/kg of gentamicin IV every 8 hours) to the regimen should be considered; addition of the aminoglycoside should be strongly considered when treating donovanosis in patients with human immunodeficiency virus (HIV) infection and in pregnant and lactating women. Despite effective anti-infective therapy, donovanosis may relapse 6-18 months later.

Brucellosis

For the treatment of brucellosis, some clinicians recommend that pediatric patients receive a dosage of oral trimethoprim (as co-trimoxazole) of 10 mg/kg daily (maximum 480 mg/daily) given for 4-6 weeks.

Pertussis

Although the optimum dosage and duration of co-trimoxazole for the treatment or prevention of pertussis have not been established, an oral dosage of trimethoprim (as co-trimoxazole) of 40 mg/kg daily in children or 320 mg daily in adults, given in 2 divided doses daily, has been recommended. Because of reports of prophylaxis failures and delays or failure in eradication with shorter courses of anti-infective therapy in this infection, the US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and some clinicians recommend that a 14-day course of therapy be employed for the treatment or prevention of pertussis.

Plague

For anti-infective prophylaxis of individuals with close exposure to pneumonic plague or an exceptionally high risk of exposure to plague, the CDC recommends an oral trimethoprim (as co-trimoxazole) dosage of 320-640 mg daily in 2 equally divided doses for 7 days or a dosage of 8 mg/kg daily in 2 equally divided doses for 7 days in children at least 2 months of age.

Cholera

For the treatment of cholera, the usual oral dosage of trimethoprim (as co-trimoxazole) is 4-5 mg/kg twice daily for 3 days in children or 160 mg twice daily for 3 days in adults, in conjunction with fluid and electrolyte replacement.

Co-trimoxazole: Other Uses

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For the treatment of sepsis in granulocytopenic adults, trimethoprim (as co-trimoxazole) has been administered in a dosage of 2.5 mg/kg IV 4 times daily. For prophylaxis of gram-negative bacteremias in granulocytopenic adults, oral trimethoprim (as co-trimoxazole) dosages of 80-160 mg twice daily have been used.

For the treatment of Nocardia infections, an average adult oral dosage of trimethoprim (as co-trimoxazole) of 640 mg daily has been administered for an average of 7 months.

If oral co-trimoxazole is used as an alternative agent for the treatment of uncomplicated pharyngeal gonorrhea in prepubertal children 1 month of age or older, the AAP recommends a dosage of trimethoprim (as co-trimoxazole) of 720 mg once daily for 5 days.

For the treatment of isosporiasis, some clinicians recommend that adults receive an oral trimethoprim dosage (as co-trimoxazole) of 160 mg 4 times daily for 10 days and that children receive a dosage of oral trimethoprim (as co-trimoxazole) of 5 mg/kg twice daily for 10 days. However, immunocompromised patients should receive this dosage regimen for an additional 3 weeks.

For the treatment of Cyclospora infection, the usual oral dosage of trimethoprim (as co-trimoxazole) is 160 mg twice daily for 7-10 days in adults or 5 mg/kg twice daily for 7-10 days in children. However, HIV-infected patients may require higher dosage and longer-term therapy.

Co-trimoxazole: Dosage in Renal Impairment

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In patients with impaired renal function, doses and/or frequency of administration of co-trimoxazole must be modified in response to the degree of renal impairment, severity of the infection, susceptibility of the causative organism, and serum concentrations of the drug. The manufacturers recommend that the usual adult daily dosage of co-trimoxazole be reduced 50% in patients with creatinine clearances of 15-30 mL/minute. Although the manufacturers recommend not using the drug in patients with creatinine clearances less than 15 mL/minute, some clinicians suggest using the drug in reduced dosages in these patients.

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