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Sulfamethoxazole/Trimethoprim (sulfamethoxazole/trimethoprim)

OTHER BRAND NAMES

Bactrim, Bactrim DS, Sulfatrim

THERAPEUTIC CLASS

Sulfonamide/tetrahydrofolic acid inhibitor

DEA CLASS

RX

INDICATIONS

Treatment of Pneumocystis jiroveci pneumonia. Treatment of enteritis and urinary tract infections (UTIs) caused by susceptible strains of microorganisms. (Sus/Tab) Treatment of acute otitis media (pediatric patients), acute exacerbations of chronic bronchitis (AECB) (adults), and traveler's diarrhea (adults) caused by susceptible strains of microorganisms. Prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

ADULT DOSAGE

Traveler's Diarrhea

Sus/Tab:
Usual: One 800mg/160mg tab or two 400mg/80mg tabs or 4 tsp sus q12h for 5 days

Urinary Tract Infections

Inj:
Severe Infections: 8-10mg/kg/day (based on the trimethoprim component) given in equally divided doses q6h, q8h, or q12h for up to 14 days
Max: 60mL/day

Sus/Tab:
Usual: One 800mg/160mg tab or two 400mg/80mg tabs or 4 tsp (20mL) sus q12h for 10-14 days

Acute Bacterial Exacerbation of Chronic Bronchitis

Usual: One 800mg/160mg tab or two 400mg/80mg tabs or 4 tsp sus q12h for 14 days

Shigellosis

Inj:
8-10mg/kg/day (based on the trimethoprim component) given in equally divided doses q6h, q8h, or q12h for up to 5 days
Max: 60mL/day

Sus/Tab:
Usual: One 800mg/160mg tab or two 400mg/80mg tabs or 4 tsp (20mL) sus q12h for 5 days

Pneumonia

Pneumocystis jiroveci pneumonia (PCP)Treatment:
Inj:

15-20mg/kg/day (based on the trimethoprim component) given in 3 or 4 equally divided doses q6-8h for up to 14 days
Sus/Tab:
 75-100mg/kg sulfamethoxazole and 15-20mg/kg trimethoprim per 24 hrs given in equally divided doses q6h for 14-21 days

PCP Prophylaxis in Immunosuppressed Patients:
Sus/Tab:
One 800mg-160mg tab or 4 tsp sus daily

PEDIATRIC DOSAGE

Pneumonia

Pneumocystis jiroveci pneumonia (PCP)Treatment:
≥2 Months of Age:
Inj:

15-20mg/kg/day (based on the trimethoprim component) given in 3 or 4 equally divided doses q6-8h for up to 14 days
Sus/Tab:
75-100mg/kg sulfamethoxazole and 15-20mg/kg trimethoprim per 24 hrs given in equally divided doses q6h for 14-21 days

PCP Prophylaxis in Immunosuppressed Patients:
Sus/Tab:
750mg/m2/day sulfamethoxazole w/ 150mg/m2/day trimethoprim given in equally divided doses bid, on 3 consecutive days/week. Not to exceed 1600mg/day sulfamethoxazole and 320mg/day trimethoprim

Acute Otitis Media

Use only when sulfamethoxazole/trimethoprim could offer some advantage over the use of a single antimicrobial agent
≥2 Months of Age:
Sus/Tab:
40mg/kg sulfamethoxazole and 8mg/kg trimethoprim per 24 hrs, given in 2 divided doses q12h for 10 days

Shigellosis

≥2 Months of Age:
Inj:
8-10mg/kg/day (based on the trimethoprim component) given in equally divided doses q6h, q8h, or q12h for up to 5 days
Max: 60mL/day

Sus/Tab:
40mg/kg sulfamethoxazole and 8mg/kg trimethoprim per 24 hrs, given in 2 divided doses q12h for 5 days

Urinary Tract Infections

≥2 Months of Age:

Inj:
Severe Infections: 8-10mg/kg/day (based on the trimethoprim component) given in equally divided doses q6h, q8h, or q12h for up to 14 days
Max: 60mL/day
Sus/Tab:
40mg/kg sulfamethoxazole and 8mg/kg trimethoprim per 24 hrs, given in 2 divided doses q12h for 10 days

DOSING CONSIDERATIONS

Renal Impairment
Inj/Sus/Tab:
CrCl 15-30mL/min: 1/2 the usual regimen
CrCl <15mL/min: Use not recommended

ADMINISTRATION

IV/Oral route

Inj
Administer by IV infusion over 60-90 min; avoid rapid infusion or bolus inj
Do not mix w/ other drugs or sol

IV Preparation/Dilution
Dilute prior to administration
Each 5mL of sulfamethoxazole/trimethoprim should be added to 125mL D5W; use w/in 6 hrs after dilution and do not refrigerate
If 5mL/100mL D5W dilution is desired, use w/in 4 hrs
If fluid restriction is desired, each 5mL of sulfamethoxazole/trimethoprim may be added to 75mL D5W; administer w/in 2 hrs
Multidose vials must be used w/in 48 hrs after initial entry into vial

Compatible Infusion Systems
Unit-dose glass containers
Unit-dose polyvinyl chloride and polyolefin containers

Sus
Shake well before using
Refer to PI for specific weight-dose recommendations for sus/tab use in pediatrics

HOW SUPPLIED

Sulfamethoxazole-/Trimethoprim (SMX/TMP) Inj: 80mg/16mg/mL [5mL, 10mL]; Sus: (Sulfatrim) 200mg/40mg/5mL [473mL]; Tab: (Bactrim) 400mg/80mg*, (Bactrim DS) 800mg/160mg* *scored

CONTRAINDICATIONS

Documented megaloblastic anemia due to folate deficiency, history of drug-induced immune thrombocytopenia with use of TMP and/or sulfonamides, and pediatrics <2 months of age. (Inj/Sus) Pregnant and nursing women. (Sus/Tab) Marked hepatic damage, and severe renal insufficiency when renal function status cannot be monitored.

WARNINGS/PRECAUTIONS

Fatalities, although rare, have occurred due to severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, thrombocytopenia, and other blood dyscrasias; d/c at the 1st appearance of skin rash or any sign of adverse reaction. Cough, SOB, and pulmonary infiltrates reported. Do not use for treatment of group A β-hemolytic streptococcal infections. Clostridium difficile-associated diarrhea (CDAD) reported; d/c if CDAD is suspected or confirmed. May result in bacterial resistance if used in the absence of proven or suspected bacterial infection or a prophylactic indication. Caution with hepatic/renal impairment, possible folate deficiency (eg, in the elderly, chronic alcoholics, those receiving anticonvulsant therapy, with malabsorption syndrome, and in malnutrition states), severe allergies or bronchial asthma, porphyria, and thyroid dysfunction. Hematological changes indicative of folic acid deficiency may occur in the elderly, or with preexisting folic acid deficiency or kidney failure; effects are reversible by folinic acid therapy. Hemolysis may occur in patients with G6PD deficiency. Cases of hypoglycemia in nondiabetic patients reported rarely. TMP may impair phenylalanine metabolism. AIDS patients may not tolerate or respond to therapy in the same manner as non-AIDS patients; increased incidence of side effects, particularly rash, fever, leukopenia, elevated transaminase values, and hyperkalemia, in AIDS patients being treated for P. jiroveci pneumonia; reevaluate therapy if skin rash or any sign of adverse reaction develops. May cause hyperkalemia in patients receiving high dosage of TMP, with underlying disorders of K+ metabolism, with renal insufficiency, or when used concomitantly with drugs known to induce hyperkalemia; closely monitor serum K+. Ensure adequate fluid intake and urinary output during treatment to prevent crystalluria. Slow acetylators may be more prone to idiosyncratic reactions to sulfonamides. D/C if a significant reduction in the count of any formed blood element is noted. Lab test interactions may occur. (Inj) Contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Contains benzyl alcohol, which has been associated with an increased incidence of neurological and other complications (sometimes fatal) in newborns. Local irritation and inflammation due to extravascular infiltration of the infusion reported; d/c infusion and restart at another site if these occur. (Tab) Severe and symptomatic hyponatremia may occur, particularly in patients treated for P. jiroveci pneumonia; evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complications. Use during pregnancy may be associated with an increased risk of congenital malformations.

ADVERSE REACTIONS

GI disturbances (N/V, anorexia), allergic skin reactions (eg, rash, urticaria).

DRUG INTERACTIONS

Increased incidence of thrombocytopenia with purpura reported in elderly concurrently receiving certain diuretics, primarily thiazides. May prolong PT with warfarin; caution with anticoagulants. May inhibit the hepatic metabolism of phenytoin; monitor for possible excessive phenytoin effect. May increase MTX concentrations. Marked but reversible nephrotoxicity reported with cyclosporine in renal transplant recipients. May increase digoxin levels, especially in the elderly; monitor digoxin levels. Increased SMX levels with indomethacin. Megaloblastic anemia may develop if used in patients receiving pyrimethamine as malaria prophylaxis in doses >25mg/week. May decrease efficacy of TCAs. Potentiates the effect of oral hypoglycemics. Toxic delirium reported with amantadine. Hyperkalemia in elderly patients reported after concomitant use with an ACE inhibitor. (Inj/Tab) Treatment failure and excess mortality reported when used concomitantly with leucovorin for the treatment of HIV positive patients with P. jiroveci pneumonia; avoid coadministration during treatment of P. jiroveci pneumonia. (Tab) Caution with drugs that are substrates of CYP2C8 (eg, pioglitazone, repaglinide, rosiglitazone), CYP2C9 (eg, glipizide, glyburide), or OCT2 (eg, memantine, metformin).

PREGNANCY AND LACTATION

(Inj/Sus) Category C, not for use in nursing. (Tab) Category D, caution in nursing.

MECHANISM OF ACTION

SMX: Sulfonamide; inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid. TMP: Tetrahydrofolic acid inhibitor; blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the required enzyme, dihydrofolate reductase. Thus, this combination blocks 2 consecutive steps in biosynthesis of nucleic acids and proteins essential to many bacteria.

PHARMACOKINETICS

Absorption: (PO) Rapid. Tmax=1-4 hrs. (Inj) SMX: Cmax=46.3mcg/mL. TMP: Cmax=3.4mcg/mL. Distribution: Crosses placenta; found in breast milk. Plasma protein binding (70% [SMX], 44% [TMP]). Metabolism: SMX: N4-acetylation. TMP: 1- and 3-oxides, 3'- and 4'-hydroxy derivatives (major metabolites). Elimination: (PO) Urine (84.5% total sulfonamide [30% as free SMX and remaining as N4-acetylated metabolite], 66.8% free TMP). SMX: T1/2=10 hrs. TMP: T1/2=8-10 hrs. (Inj) Urine (7-12.7% free SMX, 17-42.4% free TMP, 36.7-56% total SMX). SMX: T1/2=12.8 hrs. TMP: Refer to PI for T1/2.

ASSESSMENT

Assess for hypersensitivity to the drug, megaloblastic anemia, history of drug-induced immune thrombocytopenia, hepatic/renal impairment, folate deficiency, severe allergies, bronchial asthma, G6PD deficiency, porphyria, thyroid dysfunction, underlying disorders of K+ metabolism, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for hypersensitivity and other fatal reactions, CDAD, folate deficiency, hypoglycemia, hyperkalemia, and other adverse reactions. Monitor hydration status. Perform CBC frequently, and urinalyses with careful microscopic exam and renal function tests. (Inj) Monitor for infusion reactions. (Tab) Monitor for hyponatremia.

PATIENT COUNSELING

Counsel that therapy should only be used to treat bacterial, not viral (eg, common cold), infections. Instruct to take exactly ud even if patient feels better early in the course of therapy. Inform that skipping doses or not completing the full course of therapy may decrease effectiveness of treatment and increase bacterial resistance. Instruct to maintain an adequate fluid intake. Inform that diarrhea is a common problem caused by therapy, which usually ends when therapy is discontinued. Instruct to immediately contact physician if watery and bloody stools (with or without stomach cramps and fever) occur, even as late as ≥2 months after having taken the last dose.

STORAGE

20-25°C (68-77°F). (Inj) Do not refrigerate. (Sus) Protect from light.

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