Dosing & Uses
Dosage Forms & Strengths
tablet, delayed-release
- 194mg
Traveler’s Diarrhea
Minimally absorbed antibiotic indicated for traveler’s diarrhea caused by noninvasive strains of Escherichia coli, not complicated by fever or blood in the stool
388 mg (2 tablets) PO BID x 3 days
Dosage Modifications
Renal or hepatic impairment: Not studied; no dosage adjustment required owing to minimal systemic absorption
Dosing Considerations
Limitations of use: Not indicated or shown effective in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of E coli
To reduce the development of drug-resistant bacteria and maintain effectiveness of antibiotics, rifamycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria
<18 years: Safety and efficacy not established
Adverse Effects
1-10%
Constipation (3.5%)
Headache (3.3%)
Dyspepsia (<2%)
Warnings
Contraindications
Known hypersensitivity to rifamycin or any of the other rifamycin-class antimicrobial agents
Cautions
Not effective for diarrhea complicated by fever and/or bloody stool; discontinue use if diarrhea gets worse or persists >48 hr; consider alternative antibacterial therapy
Consider Clostridium difficile-associated diarrhea (CDAD) in all patients who present with diarrhea following antibacterial drug use; CDAD can occur over 2 months after antibiotic discontinued
Prescribing rifamycin without proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
Owing to minimal systemic rifamycin concentrations observed, clinically relevant drug interactions are not expected
Pregnancy
Pregnancy
There are no available data regarding use in pregnant women
Systemic absorption in humans is negligible following PO administration; not expected that maternal use results in fetal exposure
Lactation
There are no available data regarding presence in human milk
Systemic absorption in humans is negligible following PO administration; exposure to breastfed infants through breastmilk is expected to be negligible
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Oral nonabsorbable antibiotic that can be used for the treatment of bacterial infections of the colon
Belongs to the ansamycin antibacterial drug class and acts by inhibiting the beta-subunit of bacterial DNA-dependent RNA polymerase, blocking 1 of the DNA transcription steps; this results in bacterial synthesis inhibition and consequently bacterial growth
Absorption
Bioavailability: <0.1%
Distribution
Protein bound: ~80%
Metabolism
CYP-based metabolism not observed in vitro
Elimination
Excretion: 86% feces
Administration
Oral Administration
Take each dose with full glass of liquid (6-8 oz)
Do not take concomitantly with alcohol
May take with or without food
Swallow delayed-release tablet whole; do not crush, break, or chew
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Aemcolo oral - | 194 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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