Product Description

Ketoconazole Shampoo IP 2% 60 ml is a topical antifungal medication used to treat dandruff (pityriasis capitis) and seborrheic dermatitis of the scalp, which are often caused by overgrowth of Malassezia fungi or yeasts. 

It inhibits fungal growth, reducing flaking, itching, and inflammation. The shampoo is for external use only on the scalp and hair; it is not a cosmetic product and should not be used for general hair care. 

Apply to wet hair and scalp, massage into a lather, leave for 3–5 minutes, then rinse thoroughly with lukewarm water. Use as directed by a doctor or dermatologist, typically for 2–4 weeks initially. If symptoms persist, consult for alternatives like oral antifungals.

Avoid if you have hypersensitivity to azoles or excipients. Not for use on broken or infected skin beyond the scalp.

Uses

Ketoconazole 2% Shampoo IP is indicated for:

• Treatment of dandruff (scalp flaking and itching due to Malassezia)

• Management of seborrheic dermatitis (scalp inflammation with redness and scaling)

• Adjunctive therapy for pityriasis versicolor (tinea versicolor—a superficial fungal infection causing discolored patches on skin, though shampoo is used off-label for body application)

For scalp conditions primarily, short-term use (up to 4 weeks) followed by maintenance. Not for bacterial/fungal infections elsewhere without advice.

How it works

Ketoconazole 2% Shampoo IP contains ketoconazole, an imidazole antifungal that disrupts fungal cell membrane integrity. It inhibits the enzyme lanosterol 14α-demethylase, blocking ergosterol synthesis (a key sterol in fungal membranes). 

This increases membrane permeability, allowing leakage of essential cellular components (e.g., ions, proteins) and inhibiting fungal growth/reproduction. 

Against Malassezia spp., it reduces yeast colonization on the scalp by >90% after 2–4 weeks, alleviating dandruff and inflammation without significant absorption (systemic levels <1%).

Benefits

Ketoconazole 2% Shampoo effectively controls dandruff and seborrheic dermatitis by targeting the underlying fungal cause, reducing scalp itching, flaking, and redness within 1–2 weeks (improvement in 70–80% of users per clinical trials). It provides longer-lasting relief than non-medicated shampoos, with a once- or twice-weekly maintenance regimen preventing recurrence. The formulation cleanses while treating, improving scalp health and hair appearance without greasiness, making it suitable for oily or sensitive scalps.

How to use

Take a small amount of shampoo on one hand and gently rub it on wet hair and scalp, then gently massage it to work up a good lather. Leave it for 5 minutes and then rinse using lukewarm water and dry normally.

Side Effects

Most side effects are mild, local, and resolve upon discontinuation. Common side effects (affecting 1–10% of patients) include:

• Dryness or oiliness of hair/scalp

• Itching or burning sensation

• Redness or irritation at the application site

Less common but notable side effects:

• Hair texture changes (e.g., dryness, discoloration in bleached hair)

• Contact dermatitis (rash, swelling)

Safety Advice

• Alcohol: No direct interaction, as it is topical; however, avoid excessive alcohol if underlying liver issues, as ketoconazole (oral form) affects the liver—consult for systemic concerns.

• Pregnancy: Category C (animal studies show no teratogenicity; minimal topical absorption <0.1%—low fetal risk). Use only if benefits outweigh risks (e.g., severe dandruff); safer alternatives like selenium sulfide are preferred. Consult your doctor.

• Breastfeeding: Safe; negligible systemic exposure, no milk transfer. Avoid application near the breasts if irritation is possible.

• Driving/Operating Machinery: No effects, as it is topical and non-sedating.

Storage Conditions

• Store at a temperature below 30°C (86°F), in a cool, dry place away from direct sunlight, heat, and excessive moisture.

FAQs

What is Ketoconazole Anti-Dandruff Shampoo used for?

Ketoconazole shampoo primarily treats dandruff from fungal infections, effectively reducing scalp itching, flaking, and irritation.

Can Ketoconazole Shampoo cause hair fall?

Though rare, some individuals may experience slight hair thinning or shedding.

Can Ketoconazole Shampoo be used daily?

Ketoconazole shampoo is not meant for daily use, as excessive use may lead to scalp dryness. Apply it 2–3 times weekly unless your doctor advises otherwise.

Can Ketoconazole Shampoo be used on children?

Ketoconazole shampoo is typically not advised for children under 12 unless directed by a doctor.