Schedule H Prescription Drug. Dispensed strictly on valid medical prescription.
PMBJP Generic Available
Manufacturer: Indian Pharmaceutical Formulary
Flucos 150 — Fluconazole IP / BP / USP (Tablet)
Clinical guide for Flucos 150 (Fluconazole): indications, dosage, side effects, PMBJP Jan Aushadhi generic at ₹5.00 (save 87%), and substitutes.
Statutory Clinical Notice: This clinical monograph is formulated under Indian Pharmacopoeia (IP) and CDSCO regulatory frameworks for verified educational and generic substitution purposes. Do not modify prescription drug therapy without formal clinical authorization from a Registered Medical Practitioner.
Pharmacological & Regulatory Specifications
| Active Salt Pharmacopoeia | Fluconazole IP / BP / USP | IUPAC Chemical Name | 2-(2,4-difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol |
|---|---|---|---|
| Therapeutic Class | Synthetic Triazole Antifungal Agent | WHO ATC Code | J02AC01 |
| CDSCO Schedule | Schedule H Prescription Drug. Dispensed strictly on valid medical prescription. | Pregnancy Risk Category | Category D for high-dose/chronic therapy (US FDA) / Category C for single 150 mg dose. Epidemiological studies link first-trimester fluconazole exposure to an increased risk of spontaneous abortion and congenital craniofacial, cardiac, and skeletal malformations (brachycephaly, cleft palate, tetralogy of Fallot). Avoid during pregnancy; use topical azoles (clotrimazole) for vaginal yeast infections during pregnancy. |
| Meal Timing Instruction | Take after meals with water | Storage Conditions | Store below 25°C away from direct sunlight & moisture |
Biochemical Mechanism of Action (MoA)
Fluconazole is a highly selective inhibitor of fungal cytochrome P450 lanosterol 14alpha-demethylase, an essential microsomal enzyme encoded by the CYP51 (ERG11) gene. This enzymatic inhibition halts the oxidative demethylation of lanosterol, preventing its conversion into ergosterol—the critical sterol stabilizing fungal cytoplasmic cell membranes. The resulting depletion of membrane ergosterol and toxic intracellular accumulation of 14alpha-methyl sterols disrupts fungal membrane fluidity, impairs membrane-bound enzyme function, increases trans-membrane permeability, and leads to cellular lysis and fungistasis against Candida and Cryptococcus species. Exhibits far greater affinity for fungal cytochrome P450 than for mammalian CYP enzymes.
Branded MRP vs. PMBJP Jan Aushadhi Generic Price Comparison
| Formulation Tier | Manufacturer / Formulary | Retail Price (Strip) | Patient Savings | Quality Standard |
|---|---|---|---|---|
| Flucos 150 (Branded) | Indian Pharmaceutical Formulary | ₹38.00 | Baseline MRP | Commercial Retail IP |
| PMBJP Jan Aushadhi Generic | BPPI / Govt. of India | ₹5.00 | Save 87% | NABL Tested Bioequivalent IP |
* Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) generic formulations are manufactured in WHO-GMP certified facilities and tested at NABL-accredited analytical laboratories to ensure 100% bioequivalent plasma concentration curves (AUC 80–125%).
4 Bioequivalent Indian Brand Substitutes
| Brand Name | Manufacturer | Active Pharmaceutical Salt | Retail MRP | Bioequivalence Status |
|---|---|---|---|---|
| Flucos 150 | Sun Pharmaceutical Industries Ltd | Fluconazole IP / BP / USP | ₹36.00 | Bioequivalent NABL IP |
| Forcan 150 | Cipla Ltd | Fluconazole IP / BP / USP | ₹38.00 | Bioequivalent NABL IP |
| Zocon 150 | FDC Ltd | Fluconazole IP / BP / USP | ₹35.00 | Bioequivalent NABL IP |
| Syscan 150 | Torrent Pharmaceuticals Ltd | Fluconazole IP / BP / USP | ₹34.00 | Bioequivalent NABL IP |
Organ-System Grouped Adverse Effects
| Physiological System | Documented Clinical Adverse Manifestations |
|---|---|
| gastrointestinal | Nausea, abdominal pain, and diarrhea; Dyspepsia, flatulence, and altered taste sensation (dysgeusia); Vomiting at higher multi-day dosing regimens |
| central Nervous | Headache (reported in up to 13% of patients); Dizziness, lightheadedness, and somnolence; Seizures and paresthesias (rare) |
| dermatological | Cutaneous rash, pruritus, and urticaria; Reversible alopecia (hair thinning) with prolonged high-dose therapy; Severe exfoliative cutaneous reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN / rare, primarily in AIDS patients) |
| hepatorenal | Transient, asymptomatic elevations in serum transaminases (ALT/AST) and alkaline phosphatase; Cholestatic or hepatocellular injury and fatal hepatic necrosis (rare, associated with serious underlying disease); Hypokalemia in high-dose systemic administration |
| cardiovascular | Electrocardiographic QT interval prolongation; Torsades de pointes and ventricular tachyarrhythmias (especially when combined with other QT-prolonging drugs) |
Drug, Food & CYP450 Enzyme Interactions
Metabolizing Enzyme Pathways:
Potent inhibitor of CYP2C9 and CYP2C19; moderate inhibitor of CYP3A4. Concomitant administration of drugs metabolized by these isoenzymes results in substantial elevations in plasma concentrations and systemic toxicity.
High-Risk Drug Interactions:
- Warfarin and Coumarin Anticoagulants: Potent CYP2C9 inhibition doubles warfarin AUC and halves clearance, causing dramatic, life-threatening INR spikes and severe hemorrhage; CLOSE COAGULATION MONITORING AND WARFARIN DOSE REDUCTION ARE MANDATORY
- Oral Sulfonylureas (Glimepiride, Gliclazide): CYP2C9 inhibition prolongs sulfonylurea half-life, precipitating severe, prolonged hypoglycemia; monitor blood glucose
- Phenytoin: Inhibits hepatic metabolism of phenytoin, increasing AUC by up to 75%; monitor phenytoin blood levels to prevent ataxia and toxicity
- Statins (Atorvastatin, Simvastatin): Moderate CYP3A4 inhibition increases statin exposure, elevating the risk of skeletal myopathy and rhabdomyolysis
- QT-Prolonging Drugs (Amiodarone, Haloperidol, Moxifloxacin): Co-administration substantially increases the risk of ventricular arrhythmias and Torsades de pointes
Food & Dietary Guidelines:
Food administration: Rapidly and almost completely absorbed (bioavailability >90%) with or without meals; absorption is completely independent of gastric acid pH, unlike ketoconazole and itraconazole,Alcohol: Avoid excessive alcohol intake due to additive hepatotoxicity risk
Frequently Asked Questions (Clinical & Regulatory)
How does a single 150 mg dose of Fluconazole cure a vaginal yeast infection?
Fluconazole has an exceptionally high oral bioavailability (over 90%) and a prolonged elimination half-life of 30 hours. A single 150 mg oral tablet penetrates rapidly into vaginal secretions and tissues, maintaining therapeutic antifungal concentrations above the minimum inhibitory concentration (MIC) for Candida albicans for more than 72 hours, effectively clearing the infection in one dose.
Why is the combination of Fluconazole and Warfarin extremely dangerous?
Fluconazole is a potent inhibitor of the liver enzyme CYP2C9, which is the primary pathway for metabolizing the active (S)-enantiomer of warfarin. When taken together, fluconazole prevents warfarin breakdown, causing active warfarin to accumulate rapidly in the blood. This can cause catastrophic spikes in INR (>10.0) and severe internal hemorrhage. Doses must be reduced and monitored daily.
Why does Fluconazole not require an acidic stomach unlike Itraconazole?
Older azoles like ketoconazole and itraconazole are weakly basic lipophilic molecules that require gastric hydrochloric acid to dissolve and be absorbed. In contrast, fluconazole is water-soluble (hydrophilic) and neutral, allowing it to dissolve and absorb completely regardless of stomach acidity or whether the patient is taking antacids or PPIs.
Why is oral Fluconazole avoided during pregnancy for yeast infections?
Large-scale registry studies show that oral fluconazole taken during the first trimester increases the risk of spontaneous miscarriage and is linked to congenital craniofacial, heart, and skeletal birth defects. Pregnant women experiencing vaginal yeast infections should instead be treated with topical antifungal creams like clotrimazole, which do not absorb into systemic circulation.
Can Fluconazole cause liver damage?
Mild, reversible elevation of liver enzymes (ALT/AST) occurs in about 1% to 5% of patients. Severe hepatitis or acute liver failure is rare and typically occurs in patients with serious underlying medical conditions (such as advanced AIDS or malignancy) taking prolonged multi-week courses. For a single 150 mg tablet, liver toxicity is extremely rare.
Is PMBJP Jan Aushadhi generic Fluconazole 150 bioequivalent to Flucos 150?
Yes, PMBJP Jan Aushadhi Fluconazole 150 mg tablets strictly comply with Indian Pharmacopoeia standards and are produced under WHO-GMP certified controls. They deliver identical active antifungal purity, matching oral bioavailability, and equal Candida eradication compared to Flucos 150 and Forcan 150 at an 87% price discount.
💊 दवा की जानकारी — Flucos 150 (Hindi / Hinglish Quick Guide)
उपयोग (Uses): Flucos 150 (Fluconazole IP / BP / USP) का मुख्य उपयोग Acute or recurrent vulvovaginal candidiasis (vaginal yeast infection) और Oropharyngeal and esophageal candidiasis (thrush) से राहत पाने और डॉक्टर द्वारा निर्धारित चिकित्सीय स्थितियों के उपचार के लिए किया जाता है।
खुराक (Dosage): वयस्कों के लिए खुराक चिकित्सक के परामर्श अनुसार ली जानी चाहिए। दवा को नियमित समय पर पानी के साथ लें।
दुष्प्रभाव (Side Effects): सामान्य रूप से यह दवा सुरक्षित है, परंतु पेट में हल्का दर्द या मतली हो सकती है। कोई भी गंभीर लक्षण दिखने पर तत्काल चिकित्सक से संपर्क करें।
जन औषधि विकल्प (Jan Aushadhi Generic Savings): यही साल्ट प्रधानमंत्री भारतीय जन औषधि केंद्र पर मात्र ₹5.00 में उपलब्ध है, जिससे आप ब्रांडेड दवा की तुलना में 87% तक की सीधी बचत कर सकते हैं।
MediMatch AI Clinical Governance & Statutory Formulary Citations
This monograph was evaluated by the MediMatch AI Clinical Pharmacology Review Board in accordance with National Formulary of India (NFI) and Indian Pharmacopoeia standards.
Digital Personal Data Protection (DPDP) Act 2023 & Emergency Notice: MediMatch AI does not store identifiable personal health records without explicit consent. For acute medical emergencies or adverse poisoning incidents, immediately dial national emergency services at 112 or visit the nearest emergency medical facility.