Canazole 50 mg

Description

Canazole (Fluconazole) – Product Description

Indications
Canazole is prescribed for the treatment and prevention of various fungal infections, including:

• Vaginal Candidiasis
• Oropharyngeal Candidiasis
• Esophageal Candidiasis
• Tinea infections (Tinea corporis, Tinea cruris, Tinea pedis, and other Tinea)
• Kerion
• Pityriasis Versicolor
• Onychomycosis
• Invasive candidal and cryptococcal infections, including meningitis
• Prevention of cryptococcal meningitis
• Prevention of fungal infections in immunocompromised patients
• Systemic Candidiasis and Cryptococcal infections
• Superficial Candidiasis

Other Indications:

• Fungal infections of the urinary tract
• Disseminated Candidiasis
• Fungal infection prophylaxis in neutropenic cancer patients
• Acute treatment of systemic fungal infections such as coccidioidomycosis and histoplasmosis

Use this medication as per the advice of a registered physician.

Pharmacology
Fluconazole is a triazole antifungal agent that inhibits fungal cytochrome P-450 dependent enzymes. These enzymes play a crucial role in ergosterol synthesis, an essential component of the fungal cell membrane. By disrupting this process, Fluconazole effectively combats fungal infections.

Dosage & Administration

For Adults:

• Vaginal Candidiasis: 150 mg as a single dose
• Oropharyngeal Candidiasis: 200 mg on the first day, followed by 100 mg daily for 14 days
• Esophageal Candidiasis: 200 mg on the first day, followed by 100 mg daily for 14-30 days
• Tinea Infections (Tinea corporis, Tinea cruris, Tinea pedis, and others): 150 mg weekly for 4-6 weeks
• Kerion: 50 mg daily for 20 days
• Pityriasis Versicolor: 400 mg as a single dose
• Onychomycosis: 150 mg weekly for up to 12 months
• Invasive Candidal and Cryptococcal Infections (including Meningitis): 400 mg on the first day, then 200-400 mg daily (oral or IV)
• Prevention of Cryptococcal Meningitis: 200 mg daily (oral or IV)
• Prevention of Fungal Infections in Immunocompromised Patients: 50-400 mg daily (oral or IV)

For Children (Over 1 Year):

• Superficial Candidiasis: 1-2 mg/kg daily
• Systemic Candidiasis & Cryptococcal Infections: 3-6 mg/kg daily
• Severe Life-Threatening Infections: Up to 12 mg/kg daily (Maximum 400 mg/day)

Pediatric Dosage Guidelines:

• 1 year (9 kg): ½ measuring spoonful
• 1-2 years (12 kg): 1 measuring spoonful
• 2-3 years (14 kg): 1½ measuring spoonful
• 3-4 years (16 kg): 2 measuring spoonfuls
• 4-6 years (20 kg): 2½ measuring spoonfuls

Use in Special Populations

Elderly Patients:

• Standard dosage applies unless renal impairment is present.

Patients with Renal Impairment:

• Single-dose therapy requires no adjustment.
• In multiple-dose therapy, the standard dose is given on days 1 and 2, with adjustments based on creatinine clearance:

  • 41 ml/min: 24-hour interval

  • 21-40 ml/min: 48-hour interval
  • 10-20 ml/min: 72-hour interval
  • Regular dialysis patients: One dose after each dialysis session

Drug Interactions

• Warfarin: Fluconazole may increase prothrombin time; careful monitoring is required.
• Sulfonylureas (Chlorpropamide, Glibenclamide, Glipizide, Tolbutamide): May prolong half-life, potentially causing hypoglycemia.
• Hydrochlorothiazide: May increase Fluconazole plasma concentration by 40%.
• Phenytoin: Fluconazole may elevate phenytoin levels to clinically significant levels.
• Rifampicin: May reduce Fluconazole levels by 25%, requiring dose adjustment.
• Oral Contraceptives: At 200 mg daily, Fluconazole increases ethinyl estradiol and levonorgestrel levels slightly but does not significantly impact contraceptive efficacy.
• Cyclosporine: Monitoring is recommended when co-administered with Fluconazole.
• Theophylline: Fluconazole may reduce the clearance of theophylline, increasing toxicity risk.
• Food, Antacids, and Cimetidine: Do not significantly affect Fluconazole absorption.

Contraindications

• Hypersensitivity to Fluconazole or related triazole compounds.

Side Effects
Canazole is generally well tolerated. Common side effects include:

• Nausea
• Abdominal discomfort
• Diarrhea
• Flatulence

Rare side effects:

• Skin rash (incidence <1%)
• Anaphylaxis (in extremely rare cases)

Pregnancy & Lactation

• Fluconazole has shown fetal effects in animal studies at high doses.
• Use during pregnancy is not recommended unless absolutely necessary with adequate contraception.
• It is excreted in breast milk; therefore, its use is discouraged in nursing mothers.

Precautions & Warnings

• Patients with serious underlying conditions (AIDS, cancer) may experience abnormal liver, kidney, or blood function test results.
• Rare cases of hepatic necrosis have been reported, often in patients with multiple comorbidities or hepatotoxic medications.
• Severe skin reactions (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis) are possible.
• If skin reactions occur, treatment should be discontinued.
• Caution is advised in patients with systemic fungal infections and rashes.

Overdose Management

• Supportive care and symptomatic treatment are recommended.
• Gastric lavage may be performed if necessary.
• Forced diuresis may enhance Fluconazole elimination.
• Hemodialysis reduces plasma Fluconazole levels by approximately 50% over three hours.

Therapeutic Class

• Antifungal agents for subcutaneous and systemic mycoses

Storage Conditions

• Store in a cool, dry place, away from light and heat.
• Keep out of reach of children.