Rifamycin

What is Rifamycin?

• Rifamycin (Aemcolo) is an antibacterial drug used for the treatment of travelers' diarrhea.

Rifamycin SV

Rifamycin B

Rifamycin SV stick 6BEB

What are the uses of this medicine?

• Rifamycin (Aemcolo) is used for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults.

Limitations of Use:

• Rifamycin is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aemcolo and other antibacterial drugs, Aemcolo should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

How does this medicine work?

• Rifamycin (rif" a mye' sin) is a semisynthetic derivative of rifampin specifically designed to have minimal gastrointestinal absorption (<0.1%).
• It is a broad spectrum antibiotic with activity against both aerobic and anaerobic organisms, both gram negative and gram positive.
• The antibiotic activity is attributed to rifamycin’s binding to bacterial RNA polymerases, preventing RNA and subsequent protein synthesis. Rifamycin is formulated with enteric coating and a multi-matrix technology that prevents the dissolving until it reaches the cecum where the higher pH (above 7) allows for the delivery of the drug throughout the colon.
• The delayed dissolution of the tablet prevents the antibacterial activity from acting on small bowel flora and targets it largely at the colon.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components in Aemcolo.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• No clinical Drug-Drug Interactions (DDIs) have been studied.

Is this medicine FDA approved?

• This delayed release formulation of rifamycin was approved for use as treatment of travelers’ diarrhea in 2018.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Aemcolo is 388 mg (two tablets) orally twice daily (in the morning and evening) for three days.

Administration:

• Rifamycin comes as a delayed-release tablet to take by mouth.
• It is usually taken twice daily with or without food for 3 days.
• Aemcolo can be taken with or without food.
• Swallow the tablets whole.
• Do NOT crush, break or chew the delayed-release tablets.
• Take each dose with a glass of liquid (6-8 ounces).
• Do NOT take Aemcolo concomitantly with alcohol.
• Take rifamycin until you finish the prescription, even if you feel better.
• If you stop taking rifamycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-Release Tablets: 194 mg rifamycin

This medicine is available in fallowing brand namesː

• Aemcolo

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache, constipation, dyspepsia

• Rare instances of hypersensitivity and Clostridium difficile-associated diarrhea have been described.

The most frequent adverse reactions leading to discontinuation of Aemcolo were:

• abdominal pain and pyrexia

What special precautions should I follow?

• Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. Discontinue use if diarrhea gets worse or persists more than 48 hours, and consider alternative antibacterial therapy.
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, specific antibacterial treatment of C. difficile, and/or surgical evaluation should be instituted as clinically indicated.
• Prescribing Aemcolo in the absence of a 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.
• Inform the patient being treated for travelers' diarrhea to discontinue Aemcolo if diarrhea persists more than 48 hours or worsens. Advise the patient to seek medical care for fever and/or blood in the stool
• Rifamycin has minimal oral absorption and has not been implicated in causing liver test abnormalities or clinically apparent liver injury.
• There is no information regarding the presence of Aemcolo in human milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• No specific information is available on the treatment of overdose with Aemcolo.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the case of overdose, discontinue Aemcolo, treat symptomatically, and institute supportive measures as required.

Can this medicine be used in pregnancy?

• There are no available data on Aemcolo use in pregnant women to inform any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Due to the negligible systemic exposure, it is not expected that maternal use of Aemcolo will result in fetal exposure to the drug.

Can this medicine be used in children?

• The safety and effectiveness of Aemcolo has not been established in pediatric patients less than 18 years of age with travelers' diarrhea.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• Rifamycin

Inactive Ingredients:

• Ammonio methacrylate copolymer type B
• Ascorbic Acid
• Glyceryl distearate
• LECITHIN, SOYBEAN
• Magnesium stearate
• MANNITOL
• METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER
• Polyethylene glycol
• SILICON DIOXIDE
• Talc
• Titanium Dioxide
• Triethyl citrate
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

Manufactured for:

• RedHill Biopharma Inc.
• Raleigh, NC

Manufactured by:

• Cosmo S.p.A.
• Lainate, Milan, Italy
• Made in Italy

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68 to 77°F) excursions permitted to 15 to 30°C (59° to 86°F).

• Dailymed label info on Rifamycin
• FDA Rifamycin