Candinil 50 mg

Description

Indications
Candinil is indicated for the treatment and prevention of the following conditions:

• Vaginal Candidiasis
• Oropharyngeal Candidiasis
• Esophageal Candidiasis
• Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea infections
• Kerion
• Pityriasis versicolor
• Onychomycosis
• Invasive candidal infections 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 urinary tract infections
  • Disseminated candidiasis
  • Prophylaxis for fungal infections in neutropenic cancer patients
  • Acute treatment of systemic fungal infections like coccidioidomycosis and histoplasmosis

Note: Use only as directed by a registered medical professional.

Pharmacology
Candinil contains fluconazole, a triazole antifungal agent that inhibits fungal cytochrome P-450 dependent enzymes. This enzyme system is essential for the synthesis of ergosterol, a key component of the fungal cell membrane.

Dosage & Administration

For Adults:

• Vaginal Candidiasis: 150 mg as a single dose.
• Oropharyngeal Candidiasis: 200 mg on Day 1, followed by 100 mg daily for 14 days.
• Esophageal Candidiasis: 200 mg on Day 1, followed by 100 mg daily for 14-30 days.
• Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea: 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 12 months.
• Invasive Candidal Infections and Cryptococcal Infections (Including Meningitis): Orally or by IV infusion, 400 mg on the first day, then 200-400 mg daily.
• Prevention of Cryptococcal Meningitis: Orally or by IV infusion, 200 mg daily.
• Prevention of Fungal Infections in Immunocompromised Patients: Orally or by IV infusion, 50-400 mg daily.

For Children (over 1 year):

• Superficial Candidiasis: 1-2 mg/kg daily.
• Systemic Candidiasis & Cryptococcal Infections: 3-6 mg/kg daily.
• For serious infections, doses of up to 12 mg/kg daily may be given to children aged 5-13 years (Maximum 400 mg daily).

Use in Special Populations

• Elderly Patients: Normal dosing unless there is evidence of renal impairment.
• Renal Impairment: Dosing should be adjusted based on creatinine clearance (CrCl):
  • CrCl > 40 ml/min: Dosage interval 24 hours
  • CrCl 21-40 ml/min: Dosage interval 48 hours
  • CrCl 10-20 ml/min: Dosage interval 72 hours
  • Patients receiving dialysis: One dose after each dialysis session

Interactions

• Warfarin: Fluconazole may increase prothrombin time in patients on warfarin. Monitoring is recommended.
• Sulphonylureas: Fluconazole can increase the half-life of sulphonylureas (e.g., chlorpropamide, glibenclamide, glipizide, tolbutamide).
• Phenytoin and Rifampicin: Co-administration may affect the serum levels of phenytoin and fluconazole.
• Other interactions: Close monitoring is recommended when combined with other drugs, such as cyclosporine, oral contraceptives, theophylline, and certain diuretics.

Contraindications
Candinil should not be used in patients with known hypersensitivity to fluconazole or related triazole compounds.

Side Effects
Candinil is generally well tolerated, but common side effects include:

• Gastrointestinal issues: nausea, abdominal discomfort, diarrhea, flatulence
• Rash: Rare occurrences
• Anaphylaxis: In rare cases, particularly with azoles

Pregnancy & Lactation

• Pregnancy: Should be avoided during pregnancy or in women of childbearing potential unless adequate contraception is employed.
• Lactation: Candinil is present in breast milk and its use is not recommended during breastfeeding.

Precautions & Warnings

• Hepatic toxicity has been observed in some patients, particularly those with underlying diseases.
• Rare skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
• Liver Enzyme Monitoring: Discontinue use if significant liver enzyme elevation occurs.
• Rash: If a rash occurs, consider discontinuing therapy, especially for superficial infections.

Overdose Effects
In the event of overdose, supportive measures and gastric lavage may be employed. A three-hour session of hemodialysis can reduce plasma levels by 50%.

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