Ketoconazole Tablets Usp 200mg Tablet

What is Ketoconazole Tablets Usp 200mg Tablet?

Ketoconazole Tablets USP 200 mg contain ketoconazole 200 mg in oral tablet form. Ketoconazole is an antifungal medicine that interferes with fungal growth and is used orally only for specific serious fungal infections when appropriate alternatives are unavailable or unsuitable, according to approved product information and professional medical guidance.

Uses / Indications

Oral ketoconazole may be indicated for certain serious systemic fungal infections when other effective antifungal treatments are unavailable or not tolerated.

Its use is generally restricted because of the risk of serious liver injury and other potentially significant adverse effects.

Benefits

• Provides systemic antifungal activity against susceptible fungi.
• Available as a 200 mg oral tablet.
• May be used for specific serious fungal infections when clinically appropriate.
• Suitable for pharmaceutical sourcing requirements subject to the approved product specification.

Side Effects

Common Side Effects

Possible side effects may include:

• Nausea
• Vomiting
• Abdominal discomfort
• Diarrhea
• Headache
• Dizziness

Less Common or Serious Side Effects

Ketoconazole tablets can cause serious adverse effects, including severe liver injury, adrenal insufficiency, QT prolongation, and potentially serious drug interactions.

Symptoms such as unusual fatigue, loss of appetite, persistent nausea, dark urine, yellowing of the skin or eyes, severe abdominal pain, fainting, or abnormal heart rhythm require immediate medical attention.

How Does It Work?

Ketoconazole inhibits fungal cytochrome P450-dependent enzymes involved in the production of ergosterol, an essential component of fungal cell membranes. This disrupts fungal cell membrane formation and can inhibit the growth of susceptible fungi.

Ketoconazole also affects human steroid-producing pathways, which contributes to some of its clinically important adverse effects and drug interactions.

Dosage Guidelines

• Ketoconazole Tablets USP 200 mg should be used only according to approved product information and specialist healthcare professional guidance.
• Oral ketoconazole is reserved for specific situations where appropriate alternative antifungal treatments are unavailable, unsuitable, or not tolerated.
• The treatment dose and duration depend on the type and severity of infection and individual clinical factors.
• Tablets should be taken exactly as directed.
• Do not alter, crush, or split the tablet unless permitted by the approved product information.
• Liver function may require monitoring before and during treatment.
• If a dose is missed, follow the approved product instructions or healthcare professional’s advice. Do not double the dose.
• The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.
• If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

When Not to Use

Ketoconazole tablets may not be appropriate for individuals with:

• Acute or chronic liver disease.
• Known hypersensitivity to ketoconazole or relevant ingredients.
• Concomitant use with medicines that can cause serious or potentially life-threatening interactions with ketoconazole.
• Conditions or medicines associated with significant QT prolongation where contraindicated.
• Concomitant use of certain medicines that are strongly affected by CYP3A4 inhibition.

Oral ketoconazole should not be used for superficial fungal infections when effective topical or alternative systemic treatments are available and appropriate.

The approved product information should be reviewed for complete contraindications.

Drug / Product Interactions

Ketoconazole has significant potential for drug interactions because it strongly inhibits CYP3A4.

Important interactions may occur with:

• Certain medicines affecting heart rhythm
• Some cholesterol-lowering medicines
• Certain sedatives and hypnotics
• Some anticoagulants
• Certain immunosuppressants
• Some medicines for blood pressure or cardiovascular conditions
• Other medicines extensively metabolized by CYP3A4
• Medicines that reduce stomach acidity may affect ketoconazole absorption

A complete medication review is essential before treatment.

Safety Advice

• Liver function should be assessed before treatment and monitored as clinically appropriate.
• Stop treatment and seek urgent medical advice if symptoms of liver injury develop, including persistent nausea, severe fatigue, dark urine, or yellowing of the skin or eyes.
• Inform the healthcare professional about all prescription medicines, over-the-counter medicines, and supplements.
• Patients with adrenal disorders should receive appropriate medical assessment.
• Ketoconazole may interact with many medicines, including some medicines affecting cardiac rhythm.
• Pregnancy and breastfeeding use should be discussed with a qualified healthcare professional.
• Children should only receive oral ketoconazole when specifically indicated and professionally supervised.
• Avoid self-medication with oral ketoconazole.

General Instructions

• Use only under qualified healthcare professional supervision.
• Follow the prescribed treatment schedule.
• Do not discontinue treatment without professional advice unless serious adverse effects require urgent medical attention.
• Do not use for conditions for which oral ketoconazole is not approved.
• Keep the product out of reach of children.
• Do not use after the expiry date.
• Read the approved package insert before use.

Special Dietary / Lifestyle Tips

• Follow dietary guidance provided for the underlying fungal infection and overall health.
• Avoid excessive alcohol consumption because of the potential for liver toxicity.
• Inform the healthcare professional about any herbal products or supplements being used.
• Do not independently use antacids or acid-reducing medicines without checking for potential effects on ketoconazole absorption.

Comparison with Other Treatments

Oral ketoconazole is an antifungal treatment with systemic activity, but its use is restricted because of potentially serious liver toxicity and drug interactions. Other systemic antifungals, such as fluconazole, itraconazole, or other agents, may be preferred depending on the fungal infection and susceptibility.

Treatment selection depends on the identified fungus, infection site, severity, patient-specific factors, potential interactions, and professional clinical assessment.

Precautions & Warnings

• Oral ketoconazole carries a risk of serious hepatotoxicity.
• Liver function should be assessed and monitored according to approved guidance.
• Ketoconazole can significantly affect the metabolism of numerous medicines.
• Some drug combinations may result in serious or life-threatening cardiovascular or other adverse effects.
• Use caution in patients with adrenal insufficiency or conditions affecting steroid hormone production.
• Patients should report symptoms suggestive of liver injury immediately.
• Oral ketoconazole should not be used casually for routine fungal infections when suitable alternatives are available.

Can I Use It With Other Medicines?

Generally Compatible With

Because ketoconazole has substantial interaction potential, concurrent medicines should be reviewed individually by a qualified healthcare professional. Some medicines may be used together only with appropriate monitoring.

Use With Caution / Avoid

Particular caution or avoidance may be required with:

• Strong CYP3A4 substrates
• Certain medicines that prolong the QT interval
• Certain statins
• Some anticoagulants
• Certain sedatives
• Some cardiovascular medicines
• Certain immunosuppressants
• Medicines that significantly reduce gastric acidity

Potential interactions should always be checked against the approved product information before use.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep the tablets in their original packaging.
• Protect the product from unsuitable environmental conditions as specified on the approved label.
• Keep out of reach and sight of children.
• Do not use after the stated expiry date.

Frequently Asked Questions

1. What is Ketoconazole Tablets USP 200 mg used for?

Oral ketoconazole is used for certain serious systemic fungal infections when appropriate alternative antifungal treatments are unavailable, unsuitable, or not tolerated.

2. What is the active ingredient in this product?

The active ingredient is ketoconazole at a strength of 200 mg per tablet.

3. Is oral ketoconazole suitable for routine fungal infections?

Oral ketoconazole is generally restricted because of the risk of serious liver injury and significant drug interactions. It should only be used when clinically appropriate according to approved product information.

4. Can ketoconazole affect the liver?

Yes. Oral ketoconazole can cause serious liver injury. Liver function assessment and monitoring are important when treatment is prescribed.

5. Does ketoconazole interact with other medicines?

Yes. Ketoconazole strongly inhibits CYP3A4 and can interact with numerous medicines. A complete medication review is important before treatment.

6. Can Ketoconazole 200 mg be used during pregnancy?

Pregnancy use should be discussed with a qualified healthcare professional, who can assess the specific clinical circumstances and approved product information.

7. What symptoms may indicate a serious reaction to ketoconazole?

Persistent nausea, severe fatigue, abdominal pain, dark urine, yellowing of the skin or eyes, fainting, or abnormal heart rhythm should receive prompt medical attention.

8. Is a pack insert available for this product?

Yes. The pack insert or leaflet is available upon request.