Aemcolo 194mg Tablets
It is used to treat travelers' diarrhea.
Drug Class
Antibiotic, Gastrointestinal
Pharmacologic Class
Rifamycin derivative, RNA polymerase inhibitor
Pregnancy Category
Not available
FDA Approved
Nov 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aemcolo is an antibiotic used to treat traveler's diarrhea in adults. It works mainly in your gut to kill the bacteria causing the diarrhea, with very little of the medicine getting into your bloodstream.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to take it with a full glass of liquid. Avoid taking it with alcohol. Swallow the medication whole - do not chew, break, or crush it. Continue taking the medication as directed, even if your symptoms improve.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to take it with a full glass of liquid. Avoid taking it with alcohol. Swallow the medication whole - do not chew, break, or crush it. Continue taking the medication as directed, even if your symptoms improve.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Stay hydrated by drinking plenty of fluids (water, clear broths, oral rehydration solutions) to prevent dehydration caused by diarrhea.
- Avoid foods that may worsen diarrhea, such as spicy foods, fatty foods, dairy products, and excessive fiber, until symptoms improve.
- Practice good hand hygiene to prevent the spread of infection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
388 mg (two 194 mg tablets) orally twice daily for 3 days
Dose Range:
388 - 388 mg
Condition-Specific Dosing:
Traveler's Diarrhea (TD) caused by noninvasive strains of Escherichia coli:
388 mg (two 194 mg tablets) orally twice daily for 3 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific recommendations; minimal systemic absorption
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Pharmacology
Mechanism of Action
Rifamycin is a non-systemic antibiotic that inhibits bacterial RNA synthesis by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase. This binding prevents transcription, leading to inhibition of bacterial protein synthesis and cell death. Its action is primarily localized to the gastrointestinal tract due to minimal systemic absorption.
Pharmacokinetics
Absorption:
Bioavailability:
<0.4% (systemic)
Tmax:
~4.5 hours (for systemic absorption, but primary action is local)
FoodEffect:
Food decreases Cmax and AUC slightly, but not considered clinically significant for its local action.
Distribution:
Vd:
Not well characterized due to minimal systemic absorption
ProteinBinding:
Not available
CnssPenetration:
Limited/No (due to minimal systemic absorption)
Elimination:
HalfLife:
~10 hours (systemic, for the small amount absorbed)
Clearance:
Not available
ExcretionRoute:
Primarily fecal (as unchanged drug)
Unchanged:
>99% (excreted unchanged in feces)
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours (clinical improvement for TD)
PeakEffect:
Not applicable (local action)
DurationOfAction:
Maintained for the 3-day treatment course
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps. This could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD), which may occur during or after treatment with antibiotics.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you manage any concerns.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps. This could be a sign of a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD), which may occur during or after treatment with antibiotics.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Diarrhea that worsens or does not improve after 24-48 hours of treatment.
- Fever or bloody stools (Aemcolo is not for these types of diarrhea).
- Signs of dehydration (e.g., decreased urination, dry mouth, excessive thirst, dizziness).
- Severe abdominal pain or cramping.
- New or worsening side effects like severe nausea, vomiting, or headache.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are experiencing diarrhea accompanied by fever or blood in your stool.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are experiencing diarrhea accompanied by fever or blood in your stool.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as using this drug for an extended period may increase the risk of a second infection. If you experience diarrhea that persists for more than 48 hours or worsens, contact your doctor immediately. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, overdose symptoms are unlikely to be severe systemically.
- Possible gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, amiodarone, verapamil, quinidine): May theoretically increase systemic absorption of rifamycin, though clinical significance is low due to already minimal absorption.
- P-glycoprotein (P-gp) substrates (e.g., digoxin, dabigatran): Rifamycin is a weak P-gp inhibitor in vitro, so it could theoretically alter absorption of P-gp substrates, but clinical relevance is low due to minimal systemic exposure.
Monitoring
Routine Monitoring
Clinical response to therapy (resolution of diarrhea symptoms)
Frequency: Daily during treatment
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 24-48 hours may indicate need for alternative therapy or evaluation for invasive pathogens.
Adverse effects (e.g., nausea, headache, constipation)
Frequency: Daily during treatment
Target: Absence or mild, tolerable effects
Action Threshold: Severe or persistent adverse effects warrant discontinuation or re-evaluation.
Symptom Monitoring
- Frequency and consistency of bowel movements
- Abdominal pain or cramping
- Nausea/vomiting
- Fever
- Bloody stools (Aemcolo is not indicated for TD with fever or bloody stools)
Special Patient Groups
Pregnancy
Aemcolo is not systemically absorbed to a significant extent. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk not ruled out; animal studies have shown some developmental toxicity at high doses, but systemic exposure in humans is minimal.
Second Trimester:
Risk not ruled out.
Third Trimester:
Risk not ruled out.
Lactation
It is unknown if rifamycin is excreted in human milk. Due to minimal systemic absorption in the mother, infant exposure is expected to be low. However, caution should be exercised when Aemcolo is administered to a nursing woman.
Infant Risk:
Low risk due to minimal maternal systemic absorption, but potential for alteration of infant gut flora or theoretical risk of direct effects on infant is unknown.
Pediatric Use
Safety and effectiveness of Aemcolo in pediatric patients (under 18 years of age) have not been established for traveler's diarrhea.
Geriatric Use
No dosage adjustment is necessary in elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but minimal systemic absorption suggests no significant differences.
Clinical Information
Clinical Pearls
- Aemcolo (rifamycin) is a non-systemic antibiotic, meaning it primarily acts within the gastrointestinal tract with very little absorbed into the bloodstream.
- It is specifically indicated for traveler's diarrhea caused by noninvasive *E. coli* and is not effective for systemic infections.
- Do not use Aemcolo if the patient has fever or bloody stools, as these symptoms may indicate an invasive bacterial infection requiring different treatment.
- Patients should be advised to stay well-hydrated during treatment for diarrhea.
- Complete the full 3-day course of treatment, even if symptoms improve sooner, to ensure eradication of the bacteria.
Alternative Therapies
- Rifaximin (Xifaxan) - another non-systemic rifamycin for TD
- Azithromycin - often used for TD, especially in areas with high fluoroquinolone resistance
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - historically used for TD, but resistance is increasing, limiting their utility in many regions.
Cost & Coverage
Average Cost:
Varies, typically $1000-$1500+ per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Brand-name drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.