
Flugal50 mg
Square Pharmaceuticals PLC.

Xeroder 50 mg is a broad-spectrum triazole antifungal agent indicated for the treatment and prevention of a wide range of fungal infections caused by susceptible Candida species, Cryptococcus neoformans, and dermatophytes. It is available in oral (capsule, tablet, suspension) and intravenous formulations, making it suitable for both superficial and life-threatening systemic fungal infections.
Triazole Antifungal Agents / Drugs for Subcutaneous and Systemic Mycoses
Xeroder 50 mg is a member of the bis-triazole class of synthetic antifungal agents. It has a broad spectrum of antifungal activity against most clinically important pathogenic fungi and is distinguished by its excellent oral bioavailability, favorable pharmacokinetic profile, and good penetration into the central nervous system and other difficult-to-reach body compartments.
Xeroder 50 mg exerts its antifungal effect by selectively inhibiting fungal cytochrome P-450 14α-demethylase (also known as lanosterol 14α-demethylase, encoded by the CYP51 gene in fungi). This enzyme is an essential component of the fungal cytochrome P-450 enzyme system and is responsible for the conversion of lanosterol to ergosterol — the principal sterol in the fungal cell membrane, analogous to cholesterol in mammalian cell membranes.
By blocking this enzymatic step, Xeroder 50 mg causes:
Selectivity: Xeroder 50 mg has high selectivity for fungal over mammalian cytochrome P-450 enzymes (approximately 10,000-fold greater affinity for fungal CYP51), which accounts for its relatively favorable safety profile compared to older antifungals like amphotericin B. However, Xeroder 50 mg does have some inhibitory activity on human liver CYP enzymes — particularly CYP2C9 and CYP3A4 — which is responsible for its clinically important drug-drug interactions.
The dose of Xeroder 50 mg depends on the type, site, and severity of the fungal infection, the patient's immune status, age, body weight, and renal function. Always follow your registered physician's prescribed dose. Do not self-medicate.
Normal loading doses should be given on Days 1 and 2. From Day 3 onwards, adjust the dosing interval or daily dose based on creatinine clearance:
Note: No adjustment is required for single-dose therapy (e.g., 150 mg for vaginal candidiasis) in patients with renal impairment.
The normal dose should be used if there is no evidence of renal impairment. In elderly patients with renal impairment, dose adjustment as per the creatinine clearance table above is required.
Xeroder 50 mg is a significant inhibitor of hepatic cytochrome P-450 enzymes — particularly CYP2C9 and CYP3A4 — and to a lesser extent CYP2C19. This results in multiple clinically important drug interactions where Xeroder 50 mg raises the plasma concentrations of co-administered drugs metabolized by these enzymes. The following interactions require careful management:
Xeroder 50 mg inhibits CYP2C9, which is primarily responsible for the metabolism of the S-enantiomer of warfarin (the active form). Co-administration results in increased warfarin plasma levels and a measurable prolongation of prothrombin time (INR). Even a modest increase in INR (observed to be approximately 12% in controlled studies) can clinically increase bleeding risk. Close monitoring of INR/prothrombin time is mandatory when Xeroder 50 mg is initiated, changed in dose, or discontinued in patients on warfarin. Warfarin dose reduction may be required.
Xeroder 50 mg prolongs the serum half-life of oral sulfonylurea antidiabetic agents including chlorpropamide, glibenclamide (glyburide), glipizide, and tolbutamide by inhibiting their CYP2C9-mediated metabolism. This can lead to significantly elevated plasma sulfonylurea levels and prolonged, potentially severe hypoglycemia. Xeroder 50 mg and oral sulfonylureas may be co-administered in diabetic patients, but blood glucose must be carefully monitored and sulfonylurea dose reduction may be necessary.
Concomitant administration of Xeroder 50 mg and phenytoin may increase phenytoin plasma levels to a clinically significant degree, potentially causing phenytoin toxicity (nystagmus, ataxia, confusion, seizures). Regular monitoring of phenytoin plasma concentrations is essential when these drugs are co-administered. Phenytoin dose adjustment may be required.
Rifampicin is a potent inducer of CYP enzymes and significantly increases the metabolism of Xeroder 50 mg. Co-administration of rifampicin results in approximately a 25% decrease in the AUC and a 20% shorter half-life of Xeroder 50 mg — substantially reducing its antifungal efficacy. An increase in the Xeroder 50 mg dose should be considered in patients receiving concurrent rifampicin therapy. Alternative antifungal agents may need to be considered in some settings.
Xeroder 50 mg can increase cyclosporin plasma concentrations, primarily at higher doses (200 mg/day). The interaction is dose-dependent — 100 mg/day may not affect cyclosporin levels, while 200 mg/day has been shown to slowly increase them in renal transplant patients. Cyclosporin plasma concentration monitoring is recommended in all patients receiving both drugs, and cyclosporin dose adjustment may be required to avoid nephrotoxicity and other cyclosporin-related adverse effects.
Xeroder 50 mg 200 mg administered for 14 days has been shown to reduce the mean plasma clearance of theophylline by approximately 18%, resulting in elevated theophylline plasma concentrations. Patients taking higher theophylline doses or those already at increased risk for theophylline toxicity (nausea, palpitations, seizures) should be monitored for signs of toxicity when Xeroder 50 mg is added to therapy. Theophylline dose adjustment may be needed.
Co-administration of multiple doses of hydrochlorothiazide with Xeroder 50 mg increased Xeroder 50 mg plasma concentrations by approximately 40%. While this magnitude of change does not normally necessitate a change in the Xeroder 50 mg dose regimen, clinicians should be aware of potentially higher-than-expected Xeroder 50 mg levels in patients on concurrent diuretic therapy.
At standard doses (50 mg daily), Xeroder 50 mg does not have a relevant effect on estrogen or progestogen levels in combined oral contraceptives. At 200 mg daily, the AUC of ethinyl estradiol was increased by approximately 40% and levonorgestrel by approximately 24%. At these higher doses, co-administration may theoretically increase the risk of estrogen-related side effects. At standard antifungal doses, no clinically significant impairment of contraceptive efficacy is expected.
Xeroder 50 mg inhibits CYP3A4 and can increase plasma levels of drugs that prolong the QTc interval, potentially increasing the risk of torsades de pointes. Exercise caution when co-administering Xeroder 50 mg with drugs known to prolong the QT interval, including certain antihistamines (astemizole, terfenadine — contraindicated), antiarrhythmics, antipsychotics, and macrolide antibiotics.
Interaction studies have shown no clinically significant pharmacokinetic interactions between oral Xeroder 50 mg and the following: phenacetin, theophylline (at low doses), caffeine, propranolol, metoprolol, cyclosporin (100 mg/day), lidocaine, quinidine, estradiol, amoxicillin, antacids, cimetidine, food, alcohol, or following total body irradiation. No interactions have been demonstrated with piroxicam, diclofenac, or naproxen — making Xeroder 50 mg compatible with NSAID therapy.
Xeroder 50 mg is contraindicated in the following situations:
Xeroder 50 mg is generally well tolerated, particularly at the lower doses used for superficial fungal infections. Most adverse effects are dose-dependent and occur more frequently at higher doses used for systemic infections. The following adverse effects have been reported:
Important: If a rash develops in a patient being treated for a superficial fungal infection (e.g., tinea, vaginal candidiasis) that is attributable to Xeroder 50 mg, the drug should be discontinued. In patients with invasive/systemic fungal infections who develop a rash, they should be monitored closely; Xeroder 50 mg should be discontinued if bullous lesions or erythema multiforme develop.
Xeroder 50 mg should not be used during pregnancy and should not be used in women of childbearing potential unless adequate contraception is employed. Here is the evidence basis:
Xeroder 50 mg is found in human breast milk at concentrations similar to plasma concentrations. Because of this substantial transfer into breast milk and the potential for adverse effects on the nursing infant (including exposure of the infant to therapeutic drug levels), Xeroder 50 mg is not recommended during breastfeeding. If Xeroder 50 mg treatment is considered essential for the mother, breastfeeding should be discontinued during therapy.
Experience with Xeroder 50 mg indicates that therapy is unlikely to impair a patient's ability to drive or operate machinery. Occasional dizziness has been reported; patients should assess their individual response before driving.
In some patients — particularly those with serious underlying diseases such as AIDS or cancer — abnormalities in hepatic function tests have been observed during Xeroder 50 mg treatment. In very rare cases, severe hepatic reactions including hepatic necrosis have been reported, primarily in severely ill patients receiving multiple concomitant potentially hepatotoxic medications or with underlying conditions that could independently cause liver damage. The risk-benefit ratio of continued Xeroder 50 mg treatment should be reassessed in any patient in whom a significant rise in liver enzymes occurs. Xeroder 50 mg should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to Xeroder 50 mg.
Patients have rarely developed serious exfoliative cutaneous reactions — including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) — during Xeroder 50 mg treatment. Patients with HIV/AIDS are more prone to the development of severe cutaneous reactions to many drugs, including Xeroder 50 mg. The following rules apply:
Cases of QT prolongation and torsades de pointes have been reported during post-marketing surveillance in patients receiving Xeroder 50 mg, predominantly in patients with serious underlying conditions or co-medications that may contribute to QTc prolongation. Use with extreme caution — or avoid — in patients with:
Since Xeroder 50 mg is predominantly excreted unchanged in the urine, dose adjustment is required in patients with significant renal impairment receiving multiple-dose therapy. Normal loading doses should be administered on Days 1 and 2, followed by adjusted dosing intervals or doses based on creatinine clearance (see Dosage section). Failure to adjust the dose in renally impaired patients may lead to drug accumulation and toxicity.
Xeroder 50 mg is a potent inhibitor of CYP2C9 and CYP3A4 enzymes. Review all concurrent medications before initiating Xeroder 50 mg, particularly anticoagulants, antiepileptics, immunosuppressants, antidiabetics, and QT-prolonging drugs. Many drug-drug interactions may be clinically significant even at low Xeroder 50 mg doses.
Xeroder 50 mg resistance has been increasingly reported, particularly in non-albicans Candida species. Candida krusei is intrinsically resistant, and Candida glabrata often shows dose-dependent susceptibility or frank resistance. Culture and susceptibility testing is recommended for treatment failures, recurrent infections, or invasive infections to guide appropriate therapy.
Extra vigilance is required in patients with AIDS, organ transplantation, or malignancy. These patients are more susceptible to both severe fungal infections and adverse drug reactions (particularly hepatic and cutaneous). More frequent monitoring of liver function tests, renal function, and complete blood counts is advisable.
There is no specific antidote for Xeroder 50 mg overdose. Reported cases of Xeroder 50 mg overdose have described hallucinations and paranoid behavior as potential symptoms. In general, Xeroder 50 mg overdose management follows these principles:
In the event of suspected Xeroder 50 mg overdose, contact a poison control center or seek emergency medical care immediately.
The normal adult dose should be used in elderly patients who show no evidence of renal impairment. Since renal function frequently declines with age, renal function (creatinine clearance) should be assessed before initiating and during multiple-dose Xeroder 50 mg therapy. Dose adjustment per the renal impairment guidelines should be applied in elderly patients with creatinine clearance below 40 mL/min. Elderly patients are also at higher risk for drug-drug interactions due to polypharmacy.
Xeroder 50 mg is approved for use in children over 1 year of age at weight-based doses. Renal clearance in children may be proportionately more rapid than in adults. Doses up to 12 mg/kg/day may be used in serious life-threatening infections in children aged 5–13 years (maximum 400 mg/day). The oral suspension formulation is preferred for young children. The safety of Xeroder 50 mg in neonates (under 1 year) has not been fully established, though it is used in this age group in specialist settings under close clinical supervision.
Since Xeroder 50 mg is excreted predominantly in the urine as unchanged drug, renal impairment significantly affects drug accumulation and elimination. No adjustment is needed for single-dose therapy. For multiple-dose therapy, normal loading doses should be administered on Days 1 and 2, followed by dose adjustment based on creatinine clearance (see Dosage section). In patients on regular hemodialysis, one full dose should be given after each dialysis session since a 3-hour hemodialysis session removes approximately 50% of plasma Xeroder 50 mg. Peritoneal dialysis removes Xeroder 50 mg less efficiently.
Xeroder 50 mg undergoes minimal hepatic metabolism and is primarily renally eliminated. However, caution should be exercised in patients with severe hepatic impairment. Liver function tests should be monitored during Xeroder 50 mg therapy in patients with pre-existing hepatic disease. If significant liver enzyme elevations occur during treatment, the risk-benefit ratio of continued therapy must be reassessed. Xeroder 50 mg should be discontinued if clinical liver disease attributable to the drug develops.
Immunocompromised patients frequently require higher doses, longer treatment durations, and long-term suppressive (maintenance) therapy. They are at greater risk of both invasive fungal infections requiring aggressive treatment and serious adverse drug reactions. Careful monitoring of hepatic, renal, and hematological parameters is essential during prolonged therapy. Culture and susceptibility testing is particularly important in this population to detect antifungal resistance.
Drugs for subcutaneous and mycoses
Xeroder 50 mg is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.
Use in the elderly: The normal dose should be used if there is no evidence of renal impairment. In patients with renal impairment, (creatinine clearance less than 40 ml/min) the dosage intervales or orally dosage should be adjusted as described below.Use in renal impairment: Xeroder 50 mg is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required. In multiple dose therapy of patients with renal impairment, normal dose should be given on days 1 and 2 of treatment and thereafter the dosage intervals or daily dosage should be modifed in accordance with creatinine clearance as follows. CrCl >40: Dosage interval 24 hours (normal dosage regimen) CrCl 21-40: Dosage interval 48 hours or half normal daily dose CrCl 10-20: Dosage interval 72 hours or one-third normal daily dose Patients receiving regular haemodialysis: One dose after every dialysis session
What is Xeroder 50 mg used for?
Xeroder 50 mg is a broad-spectrum triazole antifungal agent indicated for the treatment and prevention of a wide range of fungal infections caused by susceptible Candida species, Cryptococcus neoformans , and dermatophytes. It is available in oral (capsule, tablet, suspension) and intravenous formulations, making it suitable for both superficial and life-threatening systemic fungal infections. Can…
What is the dosage of Xeroder 50 mg?
The dose of Xeroder 50 mg depends on the type, site, and severity of the fungal infection, the patient's immune status, age, body weight, and renal function. Always follow your registered physician's prescribed dose. Do not self-medicate. Adults — Oral and IV Indication Loading Dose (Day 1) Maintenance Dose Duration Route Vaginal Candidiasis (uncomplicated) 150 mg as a single dose Single dose Oral…
What are the side effects of Xeroder 50 mg?
Xeroder 50 mg is generally well tolerated, particularly at the lower doses used for superficial fungal infections. Most adverse effects are dose-dependent and occur more frequently at higher doses used for systemic infections. The following adverse effects have been reported: Gastrointestinal Effects (Most Common — Approximately 5–10%) Nausea — the most frequently reported adverse effect Abdominal…
Who should not take Xeroder 50 mg?
Xeroder 50 mg is contraindicated in the following situations: Known hypersensitivity to Xeroder 50 mg or to any other triazole antifungal compound (e.g., itraconazole, voriconazole, posaconazole). Patients with known azole hypersensitivity should not receive Xeroder 50 mg due to the risk of cross-reactivity. Concurrent use with terfenadine in patients receiving multiple doses of Xeroder 50 mg ≥400…
What precautions should be taken with Xeroder 50 mg?
Hepatotoxicity Monitoring In some patients — particularly those with serious underlying diseases such as AIDS or cancer — abnormalities in hepatic function tests have been observed during Xeroder 50 mg treatment. In very rare cases, severe hepatic reactions including hepatic necrosis have been reported, primarily in severely ill patients receiving multiple concomitant potentially hepatotoxic medic…
Is Xeroder 50 mg safe during pregnancy and breastfeeding?
Pregnancy Xeroder 50 mg should not be used during pregnancy and should not be used in women of childbearing potential unless adequate contraception is employed. Here is the evidence basis: Animal studies: Adverse fetal effects (embryotoxicity and teratogenicity including skeletal malformations) have been observed in animal studies, but only at dose levels many times in excess of those recommended …
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