Fluxagal 50 mg — Detailed Description

Generic Name: Fluconazole
Brand Name: Fluxagal 50 mg
Manufacturer: Pristine Pharmaceuticals Ltd. (or similar reputable manufacturers depending on region)
Dosage Form: Capsule
Strength: 50 mg per capsule
Drug Class: Triazole antifungal agent

Pharmacological Profile

Fluxagal contains fluconazole, a synthetic antifungal from the triazole class. It works by selectively inhibiting the fungal cytochrome P450 enzyme 14-α-demethylase, which is responsible for converting lanosterol to ergosterol, a vital component of fungal cell membranes. Without ergosterol, the fungal cell membrane becomes permeable and dysfunctional, leading to inhibition of fungal growth or cell death.

Fluconazole exhibits fungistatic activity against many yeasts and fungicidal effects against some fungi. It has excellent oral bioavailability (over 90%), good tissue penetration including cerebrospinal fluid, and a long half-life (~30 hours), allowing once-daily dosing.

Indications

Fluxagal 50 mg is indicated for the treatment and prevention of various fungal infections, including:

• Candidiasis:

  • Vaginal candidiasis (acute and recurrent)

  • Oropharyngeal and esophageal candidiasis

  • Systemic candidiasis, including candidemia and disseminated candidiasis

• Cryptococcal meningitis:
  Treatment and maintenance therapy.

• Dermatophytic infections:

  • Tinea pedis (athlete's foot)

  • Tinea corporis (ringworm)

  • Tinea cruris (jock itch)

  • Tinea versicolor

  • Onychomycosis (fungal nail infections)

• Prophylaxis:
  Prevention of fungal infections in immunocompromised patients, such as those undergoing chemotherapy, bone marrow transplantation, or with AIDS.

Dosage and Administration

• For Vaginal Candidiasis:
  A single dose of 150 mg fluconazole is commonly used; however, for maintenance or recurrent infections, 50 mg daily or weekly doses may be prescribed based on physician's advice.

• Oropharyngeal Candidiasis:
  50 mg once daily for 7–14 days.

• Esophageal Candidiasis:
  Initially 100 mg daily, increased up to 400 mg daily depending on clinical response.

• Systemic Infections:
  Initial dose of 400 mg on day 1, followed by 200 mg daily.

• Cryptococcal Meningitis:
  400 mg daily, possibly higher doses as required.

• Dermatophytosis:
  50 mg daily for 2–4 weeks or longer depending on severity.

• Dose Adjustments:
  In patients with renal impairment, dose adjustment is required because fluconazole is primarily excreted unchanged in urine.

Contraindications

• Known hypersensitivity to fluconazole or other azole antifungals.

• Caution in patients with liver disease or severe renal impairment.

• Pregnancy: Not recommended unless benefits outweigh risks (especially high doses).

Side Effects

Common adverse effects:

• Headache

• Nausea, vomiting

• Abdominal pain, diarrhea

• Dizziness

• Skin rash

Serious but rare adverse effects:

• Hepatotoxicity (liver damage)

• Stevens-Johnson syndrome (severe skin reactions)

• QT prolongation and arrhythmias

• Anaphylaxis (rare allergic reactions)

Regular monitoring of liver function tests and ECG is advised during prolonged therapy.

Drug Interactions

Fluconazole inhibits CYP450 enzymes (mainly CYP2C9 and CYP3A4), potentially increasing plasma concentrations of:

• Warfarin (increasing bleeding risk)

• Phenytoin

• Sulfonylureas

• Cyclosporine

• Oral hypoglycemics

• Some benzodiazepines

Co-administration with drugs that prolong QT interval should be done cautiously.

Precautions and Warnings

• Use with caution in patients with hepatic or renal impairment.

• Monitor liver enzymes during therapy.

• Avoid use in pregnancy unless necessary.

• In immunocompromised patients, monitor closely for therapeutic response.

• Inform healthcare providers of all medications being taken to avoid interactions.

Pharmacokinetics

• Absorption: Rapid and nearly complete oral absorption.

• Distribution: Widely distributed in body fluids and tissues, including CSF.

• Metabolism: Minimal hepatic metabolism.

• Excretion: Primarily renal (80% excreted unchanged).

• Half-life: Approximately 30 hours.

Storage

• Store in a cool, dry place below 25°C.

• Keep out of reach of children.

• Protect from moisture and light.