Antif-DS
Generic Name
Fluconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| antif ds 250 mg suspension | ৳ 65.20 | N/A |
Description
Overview of the medicine
Fluconazole is an antifungal medication used to treat a variety of fungal infections, including vaginal, oral, and systemic candidiasis, as well as cryptococcal meningitis. It belongs to the azole class of antifungals. The 250 mg/5 ml suspension is formulated for oral administration, particularly useful for pediatric patients or those who have difficulty swallowing tablets.
Uses & Indications
Dosage
Adults
Dosage varies depending on the indication. For oropharyngeal candidiasis, 50-100 mg once daily for 7-14 days. For esophageal candidiasis, 100-200 mg once daily for 14-30 days. For vaginal candidiasis, a single 150 mg oral dose. For systemic candidiasis and cryptococcal meningitis, initial loading dose of 400 mg followed by 200-400 mg daily.
Elderly
No specific dosage adjustment needed solely based on age; however, dosage should be adjusted based on renal function if impaired.
Renal_impairment
For patients with creatinine clearance < 50 mL/min, the dosage should be reduced by 50% after the initial loading dose (if applicable). For patients on regular hemodialysis, a single dose should be administered after each dialysis session.
How to Take
Antif-DS 250 mg Suspension is for oral administration. Shake the bottle well before each use. It can be taken with or without food. Use the provided measuring device for accurate dosing, especially for children.
Mechanism of Action
Fluconazole works by inhibiting the fungal cytochrome P450 enzyme 14α-demethylase. This enzyme is crucial for the biosynthesis of ergosterol, a vital component of the fungal cell membrane. Inhibition of ergosterol synthesis leads to increased cell membrane permeability, leakage of cellular contents, and ultimately, fungal cell death. Fluconazole is primarily fungistatic, but can be fungicidal at higher concentrations against certain susceptible organisms.
Pharmacokinetics
Onset
Peak plasma concentrations are generally achieved within 1 to 2 hours after oral dosing. Clinical effects can be observed within a few days, depending on the infection.
Excretion
The primary route of excretion is renal, with approximately 80% of the administered dose excreted unchanged in the urine. Renal clearance is directly proportional to creatinine clearance.
Half life
The plasma elimination half-life is approximately 30 hours, which supports once-daily dosing.
Absorption
Fluconazole is well absorbed following oral administration, with bioavailability typically exceeding 90%. Oral absorption is not significantly affected by food.
Metabolism
Fluconazole undergoes minimal hepatic metabolism; approximately 11% of the dose is metabolized in the liver to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole derivatives, or any component of the formulation.
- Concomitant administration with drugs that are known to prolong the QT interval and are metabolized by the cytochrome P450 enzyme CYP3A4 (e.g., terfenadine, astemizole, cisapride, pimozide, quinidine, erythromycin).
Drug Interactions
Warfarin
Increased prothrombin time, increased risk of bleeding.
Phenytoin
Increased phenytoin serum concentrations.
Rifampicin
Decreased fluconazole plasma concentrations.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased blood glucose lowering effect, risk of hypoglycemia.
Statins (e.g., Atorvastatin, Simvastatin)
Increased risk of myopathy and rhabdomyolysis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children. Discard any unused suspension 14 days after opening.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. In case of overdose, symptomatic and supportive measures should be initiated as necessary. Gastric lavage may be considered. Fluconazole is largely excreted in urine, and a 3-hour hemodialysis session reduces plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy: Category C. Avoid during pregnancy unless the potential benefit justifies the potential risk to the fetus. High doses (400-800 mg/day) for prolonged periods have been associated with congenital anomalies in infants whose mothers were treated for coccidioidomycosis. Single dose for vaginal candidiasis is generally considered low risk. Lactation: Fluconazole is excreted into breast milk. Caution should be exercised when Antif-DS is administered to a nursing woman.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole derivatives, or any component of the formulation.
- Concomitant administration with drugs that are known to prolong the QT interval and are metabolized by the cytochrome P450 enzyme CYP3A4 (e.g., terfenadine, astemizole, cisapride, pimozide, quinidine, erythromycin).
Drug Interactions
Warfarin
Increased prothrombin time, increased risk of bleeding.
Phenytoin
Increased phenytoin serum concentrations.
Rifampicin
Decreased fluconazole plasma concentrations.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased blood glucose lowering effect, risk of hypoglycemia.
Statins (e.g., Atorvastatin, Simvastatin)
Increased risk of myopathy and rhabdomyolysis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children. Discard any unused suspension 14 days after opening.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. In case of overdose, symptomatic and supportive measures should be initiated as necessary. Gastric lavage may be considered. Fluconazole is largely excreted in urine, and a 3-hour hemodialysis session reduces plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy: Category C. Avoid during pregnancy unless the potential benefit justifies the potential risk to the fetus. High doses (400-800 mg/day) for prolonged periods have been associated with congenital anomalies in infants whose mothers were treated for coccidioidomycosis. Single dose for vaginal candidiasis is generally considered low risk. Lactation: Fluconazole is excreted into breast milk. Caution should be exercised when Antif-DS is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various fungal infections across diverse patient populations. Studies have established its role in the treatment and prophylaxis of candidiasis and cryptococcosis.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) should be monitored, especially in patients with pre-existing hepatic impairment or those on prolonged therapy.
- Renal function (serum creatinine, BUN) should be monitored, particularly in patients with renal impairment.
- Electrolytes (potassium, magnesium) may need monitoring, especially in patients at risk for QT prolongation.
- ECG monitoring is recommended for patients with risk factors for QT prolongation.
Doctor Notes
- Crucially advise patients to complete the entire prescribed course of Antif-DS to prevent relapse and development of resistance.
- Monitor liver function tests (LFTs) periodically, especially in patients on prolonged therapy or with underlying hepatic conditions.
- Be aware of significant drug-drug interactions, particularly with medications that prolong the QT interval or are substrates of CYP3A4 and CYP2C9.
Patient Guidelines
- Take Antif-DS Suspension exactly as prescribed by your doctor. Do not stop taking it even if your symptoms improve, unless instructed by your doctor.
- Shake the bottle vigorously before each use to ensure proper mixing of the suspension.
- Use the provided measuring spoon or cup for accurate dosing. Do not use household spoons.
- Report any new or worsening side effects, especially severe rash, yellowing of the skin or eyes, dark urine, or unusual bruising/bleeding, to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Antif-DS may cause dizziness or seizures in some patients. Patients should be advised to exercise caution when driving or operating machinery until they are aware of how fluconazole affects them.
Lifestyle Advice
- Maintain good hygiene practices to prevent recurrence of fungal infections.
- For skin fungal infections, keep the affected area clean and dry. Wear loose-fitting, breathable clothing.
- Avoid sharing personal items like towels, combs, or clothing to prevent spreading infections.
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