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Generic Ketoconazole Information
Introduction
Ketoconazole is an antifungal medication approved for systemic and topical use in the United Kingdom. The active compound, Ketoconazole, belongs to the azole class of antifungals and works by disrupting fungal cell membranes. It is prescribed for a range of fungal infections, most commonly dermatophyte infections of the skin and nails, as well as certain systemic mycoses. While originally developed by Janssen‑Cilag, Ketoconazole is now available from many generic manufacturers, offering a cost‑effective alternative to brand‑name preparations.
What is Ketoconazole?
Ketoconazole is the generic version of the original brand Nizoral, containing the same active compound Ketoconazole. Our online pharmacy provides this generic alternative as a cost‑effective treatment option. Classified as an imidazole antifungal, it was first synthesised in the 197s and received regulatory approval in the UK in the early 198s. The medication is supplied in oral tablet form (typically 200 mg) and as a topical cream or shampoo for dermatological indications. Generic manufacturers must meet the Medicines and Healthcare products Regulatory Agency (MHRA) standards for quality, safety and efficacy before the product can be dispensed in the UK.
How Ketoconazole Works
Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a cytochrome P450‑dependent protein essential for converting lanosterol to ergosterol. Ergosterol is a critical component of the fungal cell membrane; without it, the membrane becomes permeable and unable to maintain cellular homeostasis. The resulting disruption leads to leakage of intracellular contents and ultimately fungal cell death. Systemic absorption after oral dosing allows the drug to reach deep‑tissue sites, while topical formulations act locally on the skin and scalp. Peak plasma concentrations are usually achieved within 1‑2 hours after ingestion, and the drug has a terminal half‑life of approximately 8 hours in healthy adults, allowing for once‑ or twice‑daily dosing schedules.
Conditions Treated with Ketoconazole
- Dermatophytosis (ringworm) – Infections caused by Trichophyton, Microsporum and Epidermophyton species affecting skin, hair and nails.
- Seborrhoeic dermatitis – Chronic scalp condition characterized by flaking and erythema; ketoconazole shampoo reduces Malassezia yeast colonisation.
- Candidiasis (systemic) – Invasive Candida infections such as candidemia when alternative agents are unsuitable.
- Cryptococcal meningitis (adjunct) – Used in combination therapy for certain resistant strains, although newer agents are preferred.
In the UK, dermatophyte infections affect roughly 10 % of the population each year, making an effective oral antifungal essential for patients with extensive or resistant disease. Ketoconazole’s broad spectrum and oral bioavailability make it a valuable option when topical therapy fails or when rapid systemic eradication is required.
Who is Ketoconazole For?
- Adults with confirmed fungal infections where a systemic azole is indicated, particularly when the pathogen is known or highly suspected to be susceptible to ketoconazole.
- Patients with extensive tinea corporis, tinea capitis or onychomycosis who have not responded to topical agents alone.
- Individuals with chronic seborrhoeic dermatitis who benefit from periodic ketoconazole shampoo treatment.
- Patients with contraindications to newer azoles (e.g., fluconazole‑resistant Candida) and who have normal liver function.
Ketoconazole is not recommended for:
- Pregnant or breastfeeding women (category X for systemic use).
- Individuals with moderate to severe hepatic impairment, as the drug is metabolised hepatically and can exacerbate liver injury.
- Patients taking potent CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) without close monitoring, because of the risk of toxic plasma levels.
Risks, Side Effects, and Interactions
Common
- Gastrointestinal upset – nausea, abdominal pain, diarrhoea.
- Headache – mild to moderate intensity, typically transient.
- Elevated liver enzymes – reversible increases in ALT/AST in up to 5 % of treated adults.
Rare
- Hypersensitivity reactions – rash, pruritus, urticaria; may progress to Stevens‑Johnson syndrome (extremely uncommon).
- Hormonal disturbances – inhibition of steroid synthesis can cause gynecomastia or menstrual irregularities in rare cases.
Serious
- Hepatotoxicity – clinically significant hepatitis, cholestasis or liver failure; reported in <.1 % of patients but warrants immediate discontinuation and medical review.
- Adrenal insufficiency – prolonged high‑dose therapy may suppress adrenal cortex function, potentially leading to adrenal crisis.
Drug–Drug Interactions
- CYP3A4 substrates (e.g., simvastatin, tacrolimus, midazolam) – ketoconazole can increase plasma concentrations, raising the risk of toxicity.
- CYP3A4 inhibitors (e.g., erythromycin, grapefruit juice) – may elevate ketoconazole levels, increasing hepatotoxic risk.
- Oral anticoagulants (warfarin) – enhanced anticoagulant effect has been observed; INR monitoring is advisable.
Patients should provide a full medication list to their healthcare provider before initiating therapy.
Practical Use: Dosing, Missed Dose, Overdose
- Standard oral dose – 200 mg taken once daily for mild to moderate infections; for severe or deep‑tissue infections, 200 mg twice daily is common. Treatment duration varies from 2 weeks (cutaneous infections) to 6‑12 weeks (onychomycosis).
- Topical formulations – ketoconazole 2 % shampoo applied to the scalp for 5 minutes, twice weekly for 4 weeks; cream applied once or twice daily to affected skin.
- Missed dose – take the dose as soon as remembered unless it is within 6 hours of the next scheduled dose; in that case, skip the missed dose and resume the regular schedule. Do not double‑dose.
- Overdose – symptoms may include severe nausea, vomiting, abdominal pain, and hepatic dysfunction. Seek urgent medical attention; supportive care and monitoring of liver function are the mainstays of management.
- Food and alcohol – ketoconazole tablets should be taken with a full glass of water, preferably after a meal to improve absorption. Alcohol consumption should be limited, as both agents can stress hepatic metabolism.
Buying Ketoconazole from Our Online Pharmacy
Ketoconazole can be purchased securely from our online pharmacy in the UK. We specialise in providing verified, high‑quality generic medications at prices close to the manufacturer’s cost, ensuring affordability without compromising safety.
- Affordable pricing – our wholesale sourcing model removes intermediate mark‑ups, delivering a lower out‑of‑pocket expense for patients.
- Verified quality – all products are sourced from MHRA‑approved licensed suppliers and undergo rigorous quality checks before dispatch.
- Guaranteed delivery – discreet packaging is used for all orders; standard delivery arrives within 7 days across the UK, with an express option available for urgent needs.
- International access – as a pharmacy broker service, we partner with overseas licensed pharmacies to source medications that may be scarce locally, while maintaining full compliance with UK import regulations.
Our service is designed for individuals who encounter limited availability through conventional pharmacies or who require a cost‑effective generic alternative for long‑term treatment.
FAQ
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Is Ketoconazole available in both brand‑name and generic forms in the UK?
Yes. The original brand name is Nizoral, produced by Janssen‑Cilag. Generic versions containing the identical active ingredient are widely distributed by multiple manufacturers and can be purchased at a lower cost. -
How should Ketoconazole tablets be stored to preserve potency?
Store tablets at room temperature (15‑25 °C) in a dry place, away from direct sunlight and moisture. Do not keep them in bathrooms or near heat sources, as humidity can degrade the active compound over time. -
What does the packaging of Ketoconazole look like when ordered online?
Packages typically contain a blister pack of 20 × 200 mg tablets sealed in a cardboard box with a label indicating the strength, batch number, and expiry date. All shipments are placed in a discreet, tamper‑evident envelope to protect privacy. -
Can I import Ketoconazole for personal use into the UK without a prescription?
Personal import of medicines for non‑commercial use is permitted under UK law provided the quantity does not exceed a three‑month supply and the product complies with UK safety standards. Importing without a prescription may still be subject to customs checks, so ordering from a reputable source is advisable. -
Are there any differences in the inactive ingredients between UK and US formulations?
Yes. While the active ingredient is identical, excipients such as lactose, magnesium stearate or sodium starch glycolate can vary between regions. These differences may affect tolerability in patients with specific allergies or intolerances. -
Does Ketoconazole interact with hormonal contraceptives?
Ketoconazole can inhibit CYP3A4, potentially increasing plasma concentrations of estrogen‑containing contraceptives. This may raise the risk of side effects but does not generally reduce contraceptive efficacy. Nevertheless, patients should discuss any concerns with a healthcare professional. -
What is the historical significance of Ketoconazole in antifungal therapy?
Ketoconazole was the first orally active azole antifungal, representing a breakthrough that shifted treatment from purely topical agents to systemic therapy. Its introduction in the 198s expanded the therapeutic options for deep‑seated fungal infections and paved the way for newer azoles like fluconazole and itraconazole. -
How does Ketoconazole compare to newer azoles in terms of resistance?
While ketoconazole remains effective against many dermatophytes, resistance rates have risen in some Candida species due to over‑use. Newer azoles generally have broader spectra and lower resistance incidence, but ketoconazole remains a viable alternative when susceptibility testing confirms effectiveness. -
Can I travel internationally with Ketoconazole tablets?
Yes, provided you carry the medication in its original labelled container, keep it in your hand luggage, and have a copy of the prescription or a letter from a clinician if required. Some countries impose additional controls on azole antifungals, so it is prudent to check destination‑specific regulations before travel. -
What are the environmental considerations for disposing of unused Ketoconazole?
Unused tablets should not be flushed down the toilet or poured into the drain. The recommended disposal method is to return them to a pharmacy take‑back program or follow local hazardous waste guidelines to minimise environmental contamination. -
Is there a risk of false‑positive drug tests due to Ketoconazole?
Ketoconazole does not typically trigger standard occupational drug screens. However, rare cross‑reactivity has been reported with certain immunoassays; confirmatory testing using mass spectrometry can rule out false positives.
Glossary
- Azole antifungal
- A class of drugs that inhibit the synthesis of ergosterol, an essential component of fungal cell membranes, leading to fungal cell death.
- Lanosterol 14α‑demethylase
- A cytochrome P450 enzyme targeted by azoles; blocking this enzyme prevents conversion of lanosterol to ergosterol.
- Hepatotoxicity
- Liver injury caused by a chemical substance, manifesting as elevated liver enzymes, jaundice, or, in severe cases, liver failure.
- CYP3A4
- A major enzyme in the liver that metabolises many drugs; inhibitors or inducers of CYP3A4 can significantly alter the plasma levels of co‑administered medications.
⚠️ Disclaimer
The information provided about Ketoconazole is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Ketoconazole for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.