Eulexin 125 mg/1
Flutamide · CAPSULE · Waylis Therapeutics LLC
Eulexin is a capsule containing flutamide at 125 mg/1, taken oral. Manufactured by Waylis Therapeutics LLC.
Key Facts
- Brand Name
- Eulexin
- Generic Name
- Flutamide
- NDC Code (Product)
80725-600- Manufacturer
- Waylis Therapeutics LLC
- Strength
- 125 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075298
- Drug Class
- Androgen Receptor Inhibitor [EPC]
- Marketing Start
- 11/12/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended dosage is 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg.
Warnings
WARNINGS Hepatic Injury SEE BOXED WARNINGS Use in Women Eulexin ® capsules are for use only in men. This product has no indication for women and should not be used in this population, particularly for nonserious or nonlife-threatening conditions. Fetal toxicity Eulexin ® may cause fetal harm when administered to a pregnant woman (see Pregnancy ). Aniline toxicity One metabolite of Eulexin ® is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia and cholestatic jaundice have been observed in both animals and humans after Eulexin ® administration. In patients susceptible to aniline toxicity (e.g. persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease and smokers), monitoring of methemoglobin levels should be considered.
Contraindications
CONTRAINDICATIONS Eulexin ® capsules are contraindicated in patients who are hypersensitive to Eulexin ® or any component of this preparation. Eulexin ® capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).
Drug Interactions
Drug Interactions Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin ® was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin ® capsules are administered concomitantly with warfarin.
Adverse Reactions
ADVERSE REACTIONS Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below: Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both …
Frequently Asked Questions
What is Eulexin used for?
Eulexin contains Flutamide. It is a capsule taken oral. Consult your doctor for specific uses.
Is Eulexin a controlled substance?
Eulexin is not classified as a controlled substance by the DEA.
What is the generic name for Eulexin?
The generic name for Eulexin is Flutamide. There are no other listed brand versions of Flutamide.
What is the NDC code for Eulexin 125 mg/1?
The NDC (National Drug Code) for Eulexin 125 mg/1 is 80725-600, listed by Waylis Therapeutics LLC.
Other Eulexin Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)