Trencedia 200mg Tablet

Brand Name:  Trencedia 200mg Tablet
Active Ingredient: Rifaximin
 

When is Trencedia 200 prescribed for?
Trencedia 200 is indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli.
 

How should you take Trencedia 200 Tablet?
The recommended dose is one 200 mg tablet taken orally three times a day for 3 days and can be administered orally, with or without food.
 

When you should not take Trencedia 200 Tablet?

  • Trencedia 200 should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
  • Trencedia 200  is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in Trencedia 200.

     

Special warning and precautions on using Trencedia 200 Tablet:      

Discontinue Trencedia if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered.

USE IN SPECIFIC POPULATIONS
Pediatric Use

The safety and effectiveness of Trencedia 200 mg in pediatric patients with travelers’ diarrhea less than 12 years of age have not been established.

Geriatric Use
No overall differences in safety or effectiveness were observed between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment
The pharmacokinetics of rifaximin in patients with impaired renal function has not been studied.

Hepatic Impairment
No dosage adjustment is recommended because rifaximin is presumably acting locally.

 

Possible Drug interaction with Trencedia 200 Tablet

In vitro drug interaction studies have shown that rifaximin at concentrations ranging from 2 to 200 ng/mL, did not inhibit human hepatic cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4.

Therefore, Trencedia 200 was not shown to significantly affect intestinal or hepatic CYP3A4 activity for the 200 mg three times a day dosing regimen.

 

Special information if you are pregnant or breastfeeding

Pregnancy
Pregnancy Category C
There are no adequate and well controlled studies in pregnant women. Trencedia 200 should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers
It is not known whether rifaximin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Trencedia 200, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

 

Possible Side effects with Trencedia 200 Tablet

  • The following adverse reactions for Trencedia 200mg three times daily that have been reported in < 2% of patients regardless of causal relationship to drug exposure: monocytosis, neutropenia, Ear pain, tinnitus, Abdominal distension, diarrhea , dry throat, fecal abnormality, gingival disorder inguinal hernia , dry lips, stomach discomfort, Chest pain, fatigue, malaise, pain, weakness, Dysentery, Anorexia, dehydration
  • Adverse reactions for Trencedia 200mg three times daily that occurred at a frequency ≥ 2% are: Flatulence, Headache, Abdominal pain, rectal tenesmus, Defecation urgency, Nausea, Constipation, pyrexia & Vomiting.