Product image of Fidaxomicin 200 mg/1 (Fidaxomicin) 200 mg/1 TABLET, FILM COATED supplied by GNH India

Fidaxomicin 200 mg/1

Active Ingredient:
Fidaxomicin
Form:
TABLET, FILM COATED
Brand:
Fidaxomicin
Origin:
USA

Fidaxomicin 200 mg/1 (Fidaxomicin TABLET, FILM COATED) 200 mg/1

Fidaxomicin, the active ingredient in Fidaxomicin, is a macrocyclic antibiotic presented as a 200 mg film-coated tablet for oral use. It is indicated for the treatment of Clostridioides difficile infection in adults.

GNH India supplies Fidaxomicin as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

200 mg/1

Pack Size

20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)

Manufacturer / TM Owner

Teva Pharmaceuticals, Inc.

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Indications & Clinical Uses

Fidaxomicin is a macrocyclic antibiotic used to treat infections caused by Clostridioides difficile.

  • Clostridioides difficile infection: Treats diarrhea caused by this bacterium, reducing symptoms and preventing recurrence.
  • Clostridioides difficile-associated diarrhea: Effective in managing diarrhea specifically linked to C. difficile infections.
  • C. difficile colitis: Helps in the treatment of inflammation of the colon due to C. difficile.

How It Works

  • Fidaxomicin works by inhibiting bacterial DNA-dependent RNA polymerase, which leads to the suppression of protein synthesis and ultimately results in bacterial cell death. This mechanism is particularly effective against Clostridioides difficile, making it a targeted treatment for infections caused by this bacterium.

Side Effects

Fidaxomicin may cause various side effects, ranging from common to serious.

Common Side Effects

  • Nausea: A feeling of sickness in the stomach.
  • Abdominal pain: Discomfort or pain in the stomach area.
  • Diarrhea: Loose or watery stools.
  • Vomiting: The act of expelling the contents of the stomach through the mouth.
  • Malaise: A general feeling of discomfort or uneasiness.
  • Headache: Pain or discomfort in the head or neck area.

Serious or Rare Side Effects

  • Clostridium difficile infection: Recurrence or persistence of the infection.
  • Disease recurrence: The return of the original condition after treatment.
  • Treatment failure: Inadequate response to the medication.
  • Death: Rarely reported but possible in severe cases.

Precautions & Warnings

Fidaxomicin should be used with caution and under medical supervision.

  • Pregnancy: Safety in pregnancy is unknown; consult a healthcare provider.
  • Breastfeeding: Safety during breastfeeding is unknown; consult a healthcare provider.
  • Allergies: Avoid if allergic to fidaxomicin or any of its components.
  • Drug interactions: Inform your healthcare provider about all medications you are taking.
  • Renal impairment: Use with caution in patients with kidney problems.
  • Hepatic impairment: Use with caution in patients with liver problems.
  • Store below 25°C: Keep in the original pack, protect from moisture.

Avoid Interactions

Fidaxomicin may interact with other medications, potentially affecting its efficacy or increasing the risk of side effects.

Major Interactions (Avoid)

  • None identified.

Moderate Interactions (Monitor Closely)

  • Antacids: May reduce the absorption of fidaxomicin.
  • Cholestyramine: May reduce the effectiveness of fidaxomicin.
  • Proton pump inhibitors: May alter the gut microbiota, affecting fidaxomicin's action.
  • H2 blockers: May alter the gut microbiota, affecting fidaxomicin's action.
  • Antidiarrheal agents: May interfere with the treatment of Clostridioides difficile infection.

Frequently Asked Questions

Fidaxomicin is a macrocyclic antibiotic primarily used to treat infections caused by Clostridioides difficile, including Clostridioides difficile-associated diarrhea and colitis. It is effective in reducing symptoms and preventing the recurrence of these infections.

Fidaxomicin works by inhibiting bacterial DNA-dependent RNA polymerase, which suppresses protein synthesis and leads to the death of bacterial cells. This mechanism is particularly effective against Clostridioides difficile, making it a targeted treatment for infections caused by this bacterium.

The usual dose of Fidaxomicin is determined by a healthcare provider based on the patient's condition. It is typically administered as one 200 mg tablet orally twice daily for 10 days. Always follow the prescribed dosage and consult your healthcare provider for personalized advice.

The safety of Fidaxomicin during pregnancy and breastfeeding is unknown. It is important to consult a healthcare provider before using Fidaxomicin if you are pregnant, planning to become pregnant, or breastfeeding, to weigh the potential benefits and risks.

To order Fidaxomicin from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then provide pricing, availability, shipping, and the necessary import paperwork.

Fidaxomicin is a targeted treatment for Clostridioides difficile infection, offering a different mechanism of action compared to other antibiotics like vancomycin. It is particularly effective in reducing the recurrence of infections, making it a preferred choice in certain clinical scenarios.

Fidaxomicin should be stored below 25°C, kept in the original pack, and protected from moisture. Ensure that the medication is stored in a cool, dry place away from direct sunlight and out of reach of children. Always follow the storage instructions provided on the packaging.

Fidaxomicin is administered orally as a film-coated tablet. It can be taken with or without food. The typical dosage is one 200 mg tablet taken twice daily for 10 days, as prescribed by a healthcare provider. Always follow the administration instructions provided by your healthcare professional.

The most serious risks associated with Fidaxomicin include the recurrence of Clostridioides difficile infection, treatment failure, and in rare cases, death. It is important to monitor for signs of persistent or worsening symptoms and to consult a healthcare provider if any severe side effects occur.

Fidaxomicin should not be used by individuals who are allergic to fidaxomicin or any of its components. It should be used with caution in patients with kidney or liver problems. Always consult a healthcare provider to determine if Fidaxomicin is suitable for you, especially if you have pre-existing medical conditions or are taking other medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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