Proloprim (Trimethoprim) - Summary

PROLOPRIM SUMMARY

PROLOPRIM^® (trimethoprim)
-mg and 200-mg Scored Tablets

PROLOPRIM (trimethoprim) is a synthetic antibacterial available in tablet form for oral administration.

Proloprim (trimethoprim) is indicated for the following:

For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus.

Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.

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NEWS HIGHLIGHTS

Published Studies Related to Proloprim (Trimethoprim)

Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. [2015]
community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is unclear... CONCLUSIONS: We found no significant difference between clindamycin and TMP-SMX,

Itraconazole vs. trimethoprim-sulfamethoxazole: A comparative cohort study of 200 patients with paracoccidioidomycosis. [2014]
Paracoccidioidomycosis (PCM) is a systemic mycosis endemic to Latin America. Brazil accounts for approximately 80% of cases, where it represents a major public health issue due to its disabling impact and the number of premature deaths it causes... Although the results of this study show that itraconazole was the best treatment option for PCM patients, a double-blind, randomized, controlled trial is necessary to confirm this conclusion.

Short- and long-term cure rates of short-duration trimethoprim-sulfamethoxazole treatment in female dogs with uncomplicated bacterial cystitis. [2014]
BACKGROUND: Long-duration beta-lactam antibiotics are used for empirical treatment in female dogs with uncomplicated bacterial cystitis. However, women with bacterial cystitis are treated with short-duration potentiated sulfonamides because longer courses of beta-lactams result in lower cure and higher recurrence rates...

Comparative study of the efficacy and tolerability of dihydroartemisinin-piperaquine-trimethoprim versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Cameroon, Ivory Coast and Senegal. [2011.07.08]
BACKGROUND: The ACT recommended by WHO is very effective and well-tolerated. However, these combinations need to be administered for three days, which may limit adherence to treatment.The combination of dihydroartemisinin-piperaquine phosphate-trimethoprim (Artecom(R), Odypharm Ltd), which involves treatment over two days, appears to be a good alternative, particularly in malaria-endemic areas. This study intends to compare the efficacy and tolerability of the combination dihydroartemisinin-piperaquine phosphate-trimethoprim (DPT) versus artemether-lumefantrine (AL) in the treatment of uncomplicated Plasmodium falciparum malaria in Cameroon, Ivory Coast and Senegal... CONCLUSION: The overall efficacy and tolerability of DPT are similar to those of AL. The ease of taking DPT and its short treatment course (two days) may help to improve adherence to treatment. Taken together, these findings make this medicinal product a treatment of choice for the effective management of malaria in Africa.

Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. [2010.09]
STUDY OBJECTIVE: Community-associated methicillin-resistant Staphylococcus aureus is now the leading cause of uncomplicated skin abscesses in the United States, and the role of antibiotics is controversial. We evaluate whether trimethoprim-sulfamethoxazole reduces the rate of treatment failures during the 7 days after incision and drainage and whether it reduces new lesion formation within 30 days... CONCLUSION: After the incision and drainage of uncomplicated abscesses in adults, treatment with trimethoprim-sulfamethoxazole does not reduce treatment failure but may decrease the formation of subsequent lesions. Copyright (c) 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

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Clinical Trials Related to Proloprim (Trimethoprim)

Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers [Completed]
This study will be a two-part with an open-label, single oral dose, two-way crossover study design. Part A and Part B of the study are independent and may be conducted in parallel. The Part A of the study will assess the effect of an oral dose of GSK1278863 on the pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in order to determine the potential for clinically-significant drug interactions with CYP2C8 and OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites. Part A will be conducted in approximately 30 healthy subjects, having a randomized study design. There will be approximate 7-day washout period between each dosing period. Part B will be conducted in approximately 20 healthy subjects, having single sequence study design. Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The total duration of a subject's involvement in the part A of the study will be approximately 8 weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to Follow-up).

Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients [Recruiting]
Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents. Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.

Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus (MRSA) Osteomyelitis (VOTSMO) [Active, not recruiting]

Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations [Completed]
This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.

The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa [Completed]
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa.

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PATIENT REVIEWS / RATINGS / COMMENTS

Proloprim review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		acne
Dosage & duration:		100mg taken 2x daily initially, 1x daily maintenance for the period of over 4 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Dermatologist suggested trial of trimethoprim 2x per daily, once morning and once in the evening. Diminished acne resulted within the first month and more significantly for the following months. After 1 year, patient reduced to taking pill once per day.
Side effects:		Side effects were mild, but a similar derivative had significant side effects so this patient recommends trying another sulfur-based drug if this once poses problems. Side effects with trimethoprim included very mild sun sensitivity-simply use a sunscreen; occasional yeast infections once or twice per year; upset stomach if taken without food.
Comments:		Patient suffered acne for over 15 years and had been treated with various oral and topical medications. Oral medications included most typical antibiotics and Accutane. Results were less than ideal. D