Canazole 200 mg

Description

Indications:

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

• Vaginal Candidiasis
• Oropharyngeal Candidiasis
• Esophageal Candidiasis
• Tinea infections (such as Tinea corporis, Tinea cruris, Tinea pedis, and other Tinea variants)
• Kerion
• Pityriasis versicolor
• Onychomycosis (fungal nail infections)
• Invasive candidal infections and cryptococcal infections (including cryptococcal meningitis)
• Prevention of cryptococcal meningitis
• Prevention of fungal infections in immunocompromised patients
• Systemic Candidiasis and Cryptococcal infection
• Superficial Candidiasis
• Fungal urinary tract infections
• Disseminated candidiasis
• Prophylaxis of fungal infections in neutropenic cancer patients
• Acute treatment of systemic fungal infections, including coccidioidomycosis and histoplasmosis.

Take the medication according to the advice of a registered healthcare professional.

Composition:

Each film-coated tablet contains:

• Calcium Carbonate BP (equivalent to 600 mg of elemental Calcium)
• Vitamin D3 BP (as Cholecalciferol) 200 IU
• Magnesium Oxide BP (equivalent to 40 mg of Magnesium)
• Manganese Sulfate Monohydrate BP (equivalent to 1.8 mg of Manganese)
• Cupric Oxide (equivalent to 1 mg of Copper)
• Boron Citrate (equivalent to 250 mcg of Boron)
• Zinc Oxide BP (equivalent to 7.5 mg of Zinc)

Each effervescent tablet contains:

• Calcium Carbonate BP (equivalent to 600 mg of elemental Calcium)
• Vitamin D3 BP (as Cholecalciferol) 400 IU
• Magnesium Oxide BP (equivalent to 40 mg of Magnesium)
• Manganese Sulfate Monohydrate BP (equivalent to 1.8 mg of Manganese)
• Cupric Oxide (equivalent to 1 mg of Copper)
• Boron Citrate (equivalent to 250 mcg of Boron)
• Zinc Oxide BP (equivalent to 7.5 mg of Zinc)

Pharmacology:

Fluconazole, the active ingredient in Canazole, is a potent triazole antifungal agent. It works by inhibiting the fungal cytochrome P-450 dependent enzymes, which are crucial for the synthesis of ergosterol, a key component of fungal cell membranes. This inhibition disrupts the integrity of the fungal membrane, making it an effective treatment against a variety of fungal infections.

Dosage and Administration:

• 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 (e.g., Tinea corporis, Tinea cruris, Tinea pedis): 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): 400 mg on the first day, then 200–400 mg daily.
  • Prevention of cryptococcal meningitis: 200 mg daily.
  • Prevention of fungal infections in immunocompromised patients: 50–400 mg daily.

• Children (Over 1 year):

  • Superficial Candidiasis: 1–2 mg/kg daily.
  • Systemic Candidiasis & Cryptococcal infections: 3–6 mg/kg daily. In severe cases, doses up to 12 mg/kg may be administered (maximum 400 mg daily).
  • Dosage for Children (1–5 years):
    • 1 year (9 kg): 1/2 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

Follow the directions of a registered healthcare provider for proper usage.

Use in Specific Populations:

• Elderly: Standard dosages should be used unless there is evidence of renal impairment.
• Renal Impairment:
  • For single-dose therapy, no adjustments are necessary.
  • For multiple-dose therapy, adjust the dosage interval based on creatinine clearance:
    • Creatinine clearance > 41 ml/min: Dosage every 24 hours.
    • Creatinine clearance 21-40 ml/min: Dosage every 48 hours.
    • Creatinine clearance 10-20 ml/min: Dosage every 72 hours.
    • For patients receiving regular dialysis, administer one dose after each dialysis session.

Drug Interactions:

• Warfarin: Fluconazole may increase prothrombin time in patients taking warfarin, requiring careful monitoring of prothrombin time.
• Sulfonylureas: Fluconazole may prolong the effects of sulfonylureas, increasing the risk of hypoglycemia in diabetic patients.
• Phenytoin and Rifampicin: Fluconazole may increase the plasma concentration of phenytoin, while rifampicin may reduce the levels of fluconazole.
• Theophylline: Fluconazole may reduce the clearance of theophylline, so patients should be monitored for signs of toxicity.
• Other interactions: Fluconazole may interact with various other medications. Always consult your doctor for potential interactions with other treatments.

Contraindications:

• Known hypersensitivity to fluconazole or other triazole compounds.
• Use in patients with severe liver disease or renal impairment without adjustments.

Side Effects:

• Common side effects: Gastrointestinal symptoms, such as nausea, abdominal discomfort, diarrhea, and flatulence.
• Rare side effects: Skin rash, and in rare cases, severe allergic reactions like anaphylaxis.
• Long-term use: Possible liver enzyme abnormalities, exfoliative skin reactions, and, very rarely, hepatic necrosis.

Pregnancy and Lactation:

• Pregnancy: Fluconazole should not be used during pregnancy unless clearly necessary. It is advised not to use Canazole during pregnancy or while planning to become pregnant without proper medical advice.
• Lactation: Fluconazole is excreted into breast milk, and its use during breastfeeding is not recommended.

Precautions and Warnings:

• Regular monitoring of liver function is recommended, especially for patients with underlying conditions like AIDS or cancer.
• In patients with systemic fungal infections who develop skin rashes, Canazole should be discontinued.
• Use in lactation: Fluconazole is found in human breast milk and should be avoided during breastfeeding unless absolutely necessary.

Overdose Effects:

In case of overdose, symptomatic treatment and supportive measures should be initiated. Hemodialysis may help to lower plasma levels of fluconazole.

Therapeutic Class:

Drugs for systemic and subcutaneous mycoses.

Storage Conditions:

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

This product should be used as prescribed by a registered healthcare professional.