Protrim Uses

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What is Protrim?

Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) is also used to prevent or treat Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) combination is an antibiotic. It works by eliminating the bacteria that cause many kinds of infections. Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) will not work for colds, flu, or other virus infections.

Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) is available only with your doctor's prescription.

Protrim indications

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Protrim and other antibacterial drugs, Protrim should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Urinary Tract Infections:

For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media:

For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, Protrim offers some advantage over the use of other antimicrobial agents. To date, there is limited data on the safety of repeated use of Protrim in pediatric patients under two years of age. Protrim is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults:

For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, Protrim offers some advantage over the use of a single antimicrobial agent.

Travelers' Diarrhea in Adults:

For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic E. coli.

Shigellosis:

For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis Carinii Pneumonia:

For the treatment of documented Pneumocystis carinii pneumonia. For prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.

How should I use Protrim?

Use Protrim suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Protrim suspension.

Uses of Protrim in details

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Use: Labeled Indications

Oral: Treatment of urinary tract infections (UTIs) due to

Escherichia coli, Klebsiella and Enterobacter spp, Morganella morganii, Proteus mirabilis, and Proteus vulgaris; acute otitis media; acute exacerbations of chronic obstructive pulmonary disease due to susceptible strains of Haemophilus influenzae or Streptococcus pneumoniae; treatment and prophylaxis of Pneumocystis pneumonia (PCP); traveler's diarrhea due to enterotoxigenic E. coli; treatment of shigellosis caused by Shigella flexneri or Shigella sonnei.

IV: Treatment of PCP; treatment of shigellosis caused by S. flexneri or S. sonnei; treatment of severe or complicated UTIs due to E. coli, Klebsiella and Enterobacter spp, M. morganii, P. mirabilis, and P. vulgaris.

Off Label Uses

Bite wound infection, prophylaxis or treatment (animal or human bite)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Protrim, in combination with an appropriate agent for anaerobic coverage, is an effective and recommended alternative for the prophylaxis and treatment of animal bite wounds.

Clinical experience suggests the utility of Protrim as an alternative agent for the prophylaxis and treatment of human bite wounds.

Toxoplasma gondii encephalitis (prophylaxis/treatment/chronic maintenance) in HIV-infected patients

Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, Protrim is an effective and recommended agent for primary prophylaxis of Toxoplasma gondii encephalitis and is an effective and recommended alternative agent for the treatment of or as chronic maintenance therapy of T. gondii encephalitis in HIV-infected patients.

Protrim description

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A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to pyrimethamine. The interference with folic acid metabolism may cause a depression of hematopoiesis. It is potentiated by sulfonamides and the Trimethoprim (Protrim)-Sulfamethoxazole (Protrim) combination is the form most often used. It is sometimes used alone as an antimalarial. Trimethoprim (Protrim) resistance has been reported.

Protrim dosage

Protrim Dosage

Generic name: Trimethoprim (Protrim) 80mg, Sulfamethoxazole (Protrim) 400mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Contraindicated in pediatric patients less than 2 months of age.

Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients and Acute Otitis Media in Pediatric Patients:

Adults: The usual adult dosage in the treatment of urinary tract infections is one Protrim DS (double strength) tablet, two Protrim tablets, or four teaspoonfuls (20 mL) Protrim Suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

Pediatric Patients: The recommended dose for pediatric patients with urinary tract infections or acute otitis media is 8 mg/kg Trimethoprim (Protrim) and 40 mg/kg Sulfamethoxazole (Protrim) per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this

Dosage:

Pediatric Patients: Two Months of Age or Older
Weight Dose-Every 12 Hours
lb kg Teaspoonfuls Tablets
22 10 1 (5 mL)
44 20 2 (10 mL) 1
66 30 3 (15 mL) 1 1/2
88 40 4 (20 mL) 2 (or 1 DS Tablet)

For Patients With Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:

Creatinine Recommended
Clearance Dosage
(mL/min) Regimen
Above 30 Use Standard Regimen
15-30 1/2 the Usual Regimen
Below 15 Use Not Recommended

Acute Exacerbations of Chronic Bronchitis in Adults:

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is one Protrim DS (double strength) tablet, two Protrim tablets, or four teaspoonfuls (20 mL) Protrim Suspension every 12 hours for 14 days.

Travelers' Diarrhea in Adults:

For the treatment of travelers' diarrhea, the usual adult dosage is one Protrim DS (double strength) tablet, two Protrim tablets, or four teaspoonfuls (20 mL) of Protrim Suspension every 12 hours for 5 days.

Pneumocystis Carinii Pneumonia:

Treatment:

Adults and Pediatric Patients: The recommended dosage for treatment of patients with documented Pneumocystis carinii pneumonia is 15 to 20 mg/kg Trimethoprim (Protrim) and 75 to 100 mg/kg Sulfamethoxazole (Protrim) per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. The following table is a guideline for the upper limit of this

Dosage:

Weight Dose – Every 6 Hours
lb kg Teaspoonfuls Tablets
18 8 1 (5 mL)
35 16 2 (10 mL) 1
53 24 3 (15 mL) 1 1⁄2
70 32 4 (20 mL) 2 (or 1 DS Tablet)
88 40 5 (25 mL) 2 1⁄2
106 48 6 (30 mL) 3 (or 1 1⁄2 DS Tablets)
141 64 8 (40 mL) 4 (or 2 DS Tablets)
176 80 10 (50 mL) 5 (or 2 1⁄2 DS Tablets)

For the lower limit dose (15 mg/kg Trimethoprim (Protrim) and 75 mg/kg Sulfamethoxazole (Protrim) per 24 hours) administer 75% of the dose in the above table.

Prophylaxis:

Adults: The recommended dosage for prophylaxis in adults is one Protrim DS (double strength) tablet daily.

Pediatric Patients: For pediatric patients, the recommended dose is 150 mg/m2/day Trimethoprim (Protrim) with 750 mg/m2/day Sulfamethoxazole (Protrim) given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 320 mg Trimethoprim (Protrim) and 1,600 mg Sulfamethoxazole (Protrim). The following table is a guideline for the attainment of this dosage in pediatric patients:

Body Surface Area Dose–every 12 hours
(m2) Teaspoonfuls Tablets
0.26 1⁄2 (2.5 mL)
0.53 1 (5 mL) 1⁄2
1.06 2 (10 mL) 1

More about Protrim (Sulfamethoxazole (Protrim) / Trimethoprim (Protrim))

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Other formulations

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Protrim interactions

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What other drugs will affect Protrim?

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Potential for Protrim to Affect Other Drugs

Trimethoprim (Protrim) is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole (Protrim) is an inhibitor of CYP2C9. Caution is recommended when Protrim is co-administered with drugs that are substrates of CYP2C8 and 2C9 or OCT2.

In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.

It has been reported that Protrim may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when Protrim is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.

Protrim may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). Protrim, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.

Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations.

There have been reports of marked but reversible nephrotoxicity with coadministration of Protrim and cyclosporine in renal transplant recipients.

Increased digoxin blood levels can occur with concomitant Protrim therapy, especially in elderly patients. Serum digoxin levels should be monitored.

Increased Sulfamethoxazole (Protrim) blood levels may occur in patients who are also receiving indomethacin.

Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if Protrim is prescribed.

The efficacy of tricyclic antidepressants can decrease when coadministered with Protrim.

Protrim potentiates the effect of oral hypoglycemics that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted.

In the literature, a single case of toxic delirium has been reported after concomitant intake of Protrim and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported.

In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of Protrim and an angiotensin converting enzyme inhibitor.

Drug/Laboratory Test Interactions

Protrim, specifically the Trimethoprim (Protrim) component, can interfere with a serum methotrexate assay as determined by the competitive binding protein technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA).

The presence of Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) may also interfere with the Jaffé alkaline picrate reaction assay for creatinine, resulting in overestimations of about 10% in the range of normal values.

Protrim side effects

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What are the possible side effects of Protrim?

The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, OTHER BLOOD DYSCRASIAS, AND HYPERSENSITIVITY OF THE RESPIRATORY TRACT.

Hematologic:

Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

Allergic:

Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch- Schönlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

Gastrointestinal:

Hepatitis, including cholestatic jaundice and hepatic necrosis, elevation of serum transaminase and bilirubin, pseudo-membranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

Genitourinary:

Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, and crystalluria.

Metabolic:

Hyperkalemia, hyponatremia.

Neurologic:

Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

Psychiatric:

Hallucinations, depression, apathy, nervousness.

Endocrine:

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

Musculoskeletal:

Arthralgia and myalgia. Isolated cases of rhabdomyolosis have been reported with Protrim, mainly in AIDS patients.

Respiratory System:

Cough, shortness of breath, and pulmonary infiltrates.

Miscellaneous:

Weakness, fatigue, insomnia.

Protrim contraindications

See also:
What is the most important information I should know about Protrim?

Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) is contraindicated in patients with a known hypersensitivity to Trimethoprim (Protrim), USP or sulfonamides, in patients with a history of drug-induced immune thrombocytopenia with use of Trimethoprim (Protrim), USP and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency.

Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) is contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole (Protrim) and Trimethoprim (Protrim) is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.

Active ingredient matches for Protrim:

Sulfamethoxazole/Trimethoprim in Mexico.

Co-trimoxazole in Mexico.


List of Protrim substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Sulfamethoxazole 400 mg; Trimethoprim 80 mg (Pro doc)
Tablets; Oral; Sulfamethoxazole 400 mg; Trimethoprim 80 mg (Pro doc)
Tablet; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
Tablets; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
Pymeprim Forte 2 Blister x 10 Tablet
Pymeprim Forte 6 Blister x 10 Tablet
Pymeprim 1 Blister x 20 Tablet
Pymeprim 2 Blister x 10 Tablet
Pymeprim 10 Blister x 10 Tablet
RANCOTRIM SUSPENSION 1 bottle / 50 ML suspension each (Ranbaxy)$ 0.15
Rancotrim Suspension (Ranbaxy)$ 0.15
Suspension; Oral; Sulfamethoxazole 200 mg; Trimethoprim 40 mg / 5 ml (Alphapharm)
Tablet; Oral; Sulfamethoxazole 400 mg; Trimethoprim 80 mg (Alphapharm)
Tablets; Oral; Sulfamethoxazole 400 mg; Trimethoprim 80 mg (Alphapharm)
Tablet; Oral; Sulfamethoxazole 500 mg; Trimethoprim 160 mg
Tablet; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
Tablets; Oral; Sulfamethoxazole 500 mg; Trimethoprim 160 mg
Tablets; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
RiteMED Cotrimoxazole 100's (RiteMED)$ 38.89
RiteMED Cotrimoxazole 60 mL (RiteMED)$ 2.49
RiteMED Cotrimoxazole 200 mg/40 mg/5 mL oral susp 60 mL x 1's (RiteMED)
RiteMED Cotrimoxazole 400 mg/80 mg tab 100's (RiteMED)
RiteMED Cotrimoxazole 800 mg/160 mg tab 100's (RiteMED)
Tablet; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
Tablets; Oral; Sulfamethoxazole 800 mg; Trimethoprim 160 mg
Rizol DS Sulfamethooxazole800mg, Trimethoprim 160mg TAB / 10 (Bombay Tablet)$ 0.14
10's (Bombay Tablet)$ 0.14
Rizol DS Sulfamethooxazole800mg, Trimethoprim 160mg TAB / 10 (Bombay Tablet)$ 0.14
RIZOL DS tab 10's (Bombay Tablet)$ 0.14
Rotrace 100's (Ace)$ 41.67

References

  1. DailyMed. "SULFAMETHOXAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "trimethoprim". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Protrim are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Protrim. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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3 consumers reported age

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46-602
66.7%
6-151
33.3%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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