presentation sakshi bande

RBT-D College of
Pharmacy
Topic:ADR(Ketoconazole)
Presented by
Sakshi Bande( Assistant Professor)
ADR(Adverse Drug Reaction)
 Anadverse drug reaction (ADR) is an

unwanted, harmful effect experienced after
the administration of a medication, under
normal conditions of use. ADRs can range
from mild side effects, such as a headache
or upset stomach, to severe outcomes like
organ damage, anaphylaxis, or death.
ADRs are typically classified into different types:
 TypeA (Augmented): Dose-dependent and
predictable based on the drug's known
pharmacological properties (e.g., drowsiness
with sedatives).
 TypeB (Bizarre):* Not dose-dependent and
unpredictable, often related to individual
hypersensitivity (e.g., allergic reactions).
 3. Type C (Chronic): Occur as a result of long-
term use of a drug (e.g., kidney damage from
long-term NSAID use).
 4. Type D (Delayed): Occur after a prolonged
time following drug exposure (e.g., cancer
developing years after chemotherapy).
 5. Type E (End-of-use): Associated with drug
withdrawal (e.g., withdrawal symptoms after
discontinuing antidepressants).
 Factors influencing ADRs:-
-Age (e.g., elderly or very young)
-Genetics (pharmacogenetics)
-Pre-existing health conditions
-Drug interactions- Dosage and duration of
treatment
It's important to distinguish ADRs from side
effects, which may not necessarily be harmful,
and from drug toxicity, which is specifically related
to excessive dosing. Monitoring and reporting
ADRs help improve drug safety and guide
healthcare providers in managing treatment
effectively. While some ADRs are unpredictable –
such as anaphylaxis in a patient after one
previous uneventful exposure to a penicillin-
containing antibiotic – many are preventable with
adequate foresight and monitoring.
There are two basic steps that can be followed
to prevent an ADR occurring:
 Identify the subgroup of patients who are
likely to be susceptible to the adverse effect
and modify the treatment choice
accordingly.
 Ensure the treatment plan mitigates any
possible adverse effects.
Ketoconazole
 Ketoconazole is an antifungal medication

that treats infections caused by fungi. It
works by preventing the growth of fungus by
interfering with the production of the fungal
cell membrane. It belongs to the
“azole”class of antifungal drugs and is
available in different forms, including:
INTRODUCTION
Ketoconazole is an azole antifungal that was first

approved in the 1980s. It works by inhibiting the
synthesis of ergosterol, an essential component of
fungal cell membranes, leading to fungal cell
death. Ketoconazole was originally developed as a
systemic antifungal, but due to its significant side
effects, especially liver toxicity, its use has
declined for systemic infections. However, it is still
widely used topically for various skin and scalp
conditions.
Forms and Uses
Topical (cream, gel, foam, shampoo): -
Cream/Gel/Foam: Used to treat fungal infections
of the skin such as
-Tinea corporis (ringworm)
-Tinea cruris (jock itch)
-Tinea pedis (athlete’s foot)
-Seborrheic dermatitis: A condition causing
scaly patches, redness, and dandruff on the
scalp and other parts of the body.
-Cutaneous candidiasis: Skin infections caused
by yeast.
 Shampoo: Ketoconazole shampoo is often
prescribed for:
-Dandruff (Pityriasis capitis): Helps reduce the
formation of flakes.
-Tinea versicolor: A yeast infection that causes
lighter or darker patches of skin.
-Seborrheic dermatitis: of the scalp.
Oral tablets (systemic use)
Used for serious fungal infections such as:
Blastomycosis
Histoplasmosis
Coccidioidomycosis
Chronic mucocutaneous candidiasis
Mechanism of Action
Ketoconazole inhibits the enzyme 14-α-
demethylase, which is responsible for
converting lanosterol to ergosterol, a key
component of fungal cell membranes. Without
ergosterol, the fungal cell membrane becomes
compromised, leading to cell death.
Pharmacokinetics
Absorption: Oral ketoconazole is best
absorbed in an acidic environment, so it should
be taken with food or acidic beverages (e.g.,
cola). Absorption is reduced in individuals
taking antacids or proton pump inhibitors (PPIs).
Distribution: Ketoconazole is widely
distributed in tissues but has poor penetration
into the central nervous system (CNS)
Metabolism: It is primarily metabolized in the
liver.
Excretion: Mostly excreted through the bile
and to a lesser extent in urine.
Adverse Effect
1.Topical Application:
- Skin irritation (burning, redness, or itching)
-Dry or oily hair (with shampoo use)
-Allergic contact dermatitis (rare)
Contraindications
1. Liver disease: Due to its potential for
hepatotoxicity, ketoconazole is contraindicated in
individuals with liver disease or elevated liver
enzymes.
2. Pregnancy and breastfeeding: Oral
ketoconazole is not recommended during
pregnancy unless the potential benefits outweigh
the risks. The topical forms may be used cautiously.
3. Coadministration with certain medications:
Due to its inhibition of CYP3A4, ketoconazole should
not be taken with drugs like dofetilide, quinidine, or
cisapride, as it may cause dangerous heart
rhythms.
Special Considerations
4.Monitoring: Liver function tests (LFTs) are

recommended before and during the use of
oral ketoconazole.
Adrenal function may need to be monitored,
especially if the patient develops symptoms of
adrenal insufficiency (fatigue, nausea,
hypotension).
2. Drug Interactions: Because it inhibits CYP3A4,
ketoconazole has the potential to interact with a
wide range of medications. It is important to
review all concomitant medications when starting
ketoconazole to avoid harmful interactions.
3. Current Status: Oral ketoconazole is now rarely
used for systemic fungal infections in many
countries due to its risk profile, and its use is
largely restricted to topical formulations. In 2013,
the U.S. Food and Drug Administration (FDA)
issued a warning advising against the use of oral
ketoconazole for fungal infections due to its risks
unless no alternative treatments are available.
Conclusion
Ketoconazole remains an important antifungal
agent, particularly in its topical forms for
treating skin and scalp fungal infections.
However, its systemic use has been largely
replaced by safer alternatives due to
significant risks of hepatotoxicity, adrenal
suppression, and drug interactions. Close
monitoring and caution are required when
using ketoconazole, especially the oral form.
THANK YOU

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presentation sakshi bande

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RBT-D College of

 Anadverse drug reaction (ADR) is an

 Ketoconazole is an antifungal medication

Ketoconazole is an azole antifungal that was first

4.Monitoring: Liver function tests (LFTs) are

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