Lucius LuciFida Fidaxomicin 200mg

Product Information

• Product name: LuciFida Fidaxomicin 200mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Fidaxomicin
• Current strength: 200mg
• SKU: LU-ITEM-60
• Site category: other cancer

Product Summary

LuciFida Fidaxomicin 200mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Fidaxomicin is the active ingredient used for this product page. Public prescribing information for Fidaxomicin was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Fidaxomicin is an antibacterial drug .

Reference Indications

Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. difficile-associated diarrhea (CDAD). When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Pediatric use information is approved for Cubist Pharmaceuticals LLC’s DIFICID ® (Fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

Reference Dosage and Administration

Recommended dosage for adults is one 200 mg Fidaxomicin tablet orally twice daily for 10 days. administered orally with or without food.

With this 200mg product, that corresponds to 1 x 200mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue Fidaxomicin tablets. Fidaxomicin tablets is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of Fidaxomicin. Fidaxomicin tablets should only be used for the treatment of C. difficile -associated diarrhea. Development of drug-resistant bacteria: Only use Fidaxomicin tablets for infection proven or strongly suspected to be caused by C. If a severe hypersensitivity reaction occurs, Fidaxomicin tablets should be discontinued and appropriate therapy should be instituted. Some patients with hypersensitivity reactions to Fidaxomicin tablets also reported a history of allergy to other macrolides.

Common Adverse Reactions and Monitoring

Adults The safety of Fidaxomicin 200 mg tablets taken twice a day for 10 days was evaluated in 564 adult patients with CDAD in two active-controlled trials with 86.7% of patients receiving a full course of treatment. The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the Fidaxomicin tablets and vancomycin patients in Phase 3 trials. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Drug Interactions and Special Populations

Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. When cyclosporine was co-administered with Fidaxomicin tablets, plasma concentrations of Fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range . Concentrations of Fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of Fidaxomicin-treated adult patients in controlled clinical trials. Based on these results, Fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Fidaxomicin public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.