Ketoconazole 200mg Tablet comprises ketoconazole, an imidazole-dioxolane derivative classified as a broad-spectrum antifungal agent. It exhibits systemic efficacy following oral administration and is indicated for the treatment of various fungal infections, including those caused by dermatophytes, yeasts, and other pathogenic fungi.

The antifungal mechanism of ketoconazole involves the inhibition of ergosterol biosynthesis- a critical component of fungal cell membranes. By disrupting ergosterol production, ketoconazole compromises membrane integrity, leading to impaired cellular function and eventual fungal cell death.

Ketoconazole 200mg Tablet is administered orally and should be taken with food to enhance absorption. The dosage regimen, including treatment duration and potential cycling of therapy, is determined based on the type and severity of the fungal infection. Compliance with the prescribed schedule is essential to achieve optimal therapeutic outcomes and to prevent the development of resistance. Patients are advised not to discontinue treatment prematurely, even if symptomatic relief is achieved, and to avoid antacid use within one hour before or two hours after dosing, as this may interfere with drug absorption. Persistent or worsening infections should be promptly reported to a healthcare provider.

Key Features of Ketoconazole 200mg Tablet:

• Active Ingredient: Contains ketoconazole, a synthetic imidazole-dioxolane antifungal compound with broad-spectrum activity.
• Mechanism of Action: Inhibits the biosynthesis of ergosterol, an essential component of fungal cell membranes, leading to structural and functional disruption of fungal cells.
• Broad-Spectrum Efficacy: Demonstrates in vitro and in vivo activity against dermatophytes, yeasts (including Candida spp.), and various systemic and superficial fungal pathogens.
• Oral Bioavailability: Effective when administered orally, particularly when taken with food to enhance gastrointestinal absorption.
• Therapeutic Uses: Indicated for the treatment of fungal infections affecting the mouth, throat, vagina, skin, fingernails, toenails, and other internal and external body sites.
• Dosing and Administration: Taken once or twice daily as directed by a physician. Treatment duration may vary depending on infection type and severity, and may involve intermittent (cyclic) administration.
• Resistance Prevention: Continuous administration for the full prescribed course helps prevent relapse and the emergence of resistant fungal strains.
• Drug Interactions: Absorption may be reduced by antacid treatments; thus, such agents should be avoided within 1 hour before or 2 hours after taking the tablet.
• Safety and Monitoring: Patients should be monitored for therapeutic response and potential side effects. Clinical evaluation is recommended if symptoms persist or worsen.

Indications for Ketoconazole 200mg Table:

• Treatment of dermatophytosis and Malassezia (previously called Pityrosporum) folliculitis that cannot be treated topically because of the site, extent of the lesion or deep infection of the skin, in patients resistant to, or intolerant of, fluconazole, terbinafine and itraconazole.
• Treatment of chronic mucocutaneous candidosis, cutaneous candidosis, and oropharyngeal candidosis that cannot be treated topically because of the site, extent of the lesion or deep infection of the skin, in patients resistant to or intolerant of both fluconazole and itraconazole.

CONTRA-INDICATION

In patients with a known hypersensitivity to ketoconazole, to any of the other excipients, or to any other imidazole antifungal.

Dosage & Administration:

There is no known antidote to ketoconazole.

In the event of accidental overdose, treatment consists of supportive measures. Within the first hour after ingestion gastric lavage may be performed. Activated charcoal may be given if considered appropriate.

Precautions:

Liver function must be monitored in all patients receiving treatment with Ketoral 200 mg tablets.

Monitor liver function prior to treatment to rule out acute or chronic liver disease

Pregnancy : Not Recommended.

Lactation: Ketoconazole is excreted in the milk, mothers who are under treatment should not breast-feed whilst being treated with Ketoral 200 mg tablets.

WARNINGS

Because of the risk for serious hepatic toxicity, Ketoral 200 mg tablets should be used only when the potential benefits are considered to outweigh the potential risks, taking into consideration the availability of other effective antifungal therapy.

Keep medicines out of reach of children.

Side Effects:

• Headache
• Dizziness
• Somnolence
• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Pruritus
• Rash 

Storage:

Keep in a cool, dry & dark place at a temperature not exceeding 30°C.

Why Choose Ketoconazole 200mg Tablet From Regen Global Pharma?

• Pharmaceutical-Grade Quality: Regen Global Pharma adheres to stringent Good Manufacturing Practices (GMP), ensuring each Ketoconazole 200mg Tablet meets international standards for quality, safety, and consistency.
• Clinically Proven Efficacy: Formulated with high-purity ketoconazole, our tablets deliver reliable antifungal activity across a broad spectrum of fungal pathogens, including dermatophytes and Candida species.
• Enhanced Bioavailability: Optimized formulation ensures improved oral absorption when taken with food, maximizing systemic exposure and therapeutic effect.
• Trusted for Versatility: Suitable for treating a wide range of fungal infections, including those affecting the skin, nails, mucosal surfaces, and internal systems—providing comprehensive fungal control.
• Patient-Centric Formulation: Designed for ease of administration with convenient oral dosing and minimal dosing frequency, supporting improved patient compliance.
• Resistance Management: Proper use of Regen’s Ketoconazole formulation aids in preventing resistance development, a growing concern in antifungal therapy.
• Global Distribution & Support: Regen Global Pharma provides robust international logistics and regulatory support, ensuring timely delivery and compliance with country-specific regulatory requirements.
• Competitive Advantage: Offers a cost-effective, high-quality alternative to branded formulations without compromising on therapeutic outcomes.

Disclaimer: The information provided on this website is for informational purposes and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it. 

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As one of India’s leading exporters and pharmaceutical manufacturing company in Gujarat, ReGen Global Pharma Pvt. Ltd is committed to global distribution of crucial molecules that advance healthcare solutions worldwide. We have our presence in Togo, Mali, Cameroon, Gambia, Sierra Leone, Burkina Faso, Burundi, Benin Republic, Nigeria, Ghana, Niger, Chad, as well as the Caribbean Island of Guyana, Turkmenistan, and Uzbekistan in Central Asia. 

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