Usage
Cetrimide + Ketoconazole is prescribed for the topical treatment of fungal skin infections, including:
- Tinea corporis (ringworm)
- Tinea cruris (jock itch)
- Tinea pedis (athlete’s foot)
- Tinea versicolor
- Cutaneous candidiasis
- Seborrheic dermatitis
- Dandruff
Pharmacological Classification: Antifungal and Antiseptic
Mechanism of Action: Ketoconazole inhibits ergosterol synthesis, a critical component of fungal cell membranes, leading to fungal cell death. Cetrimide is an antiseptic that disrupts the cell membranes of bacteria, fungi, and viruses, causing cell death. It also has anti-inflammatory properties.
Alternate Names
- Ketoconazole + Cetrimide
- KETLIMAC
- KETASO-CM
- Zilzip C
- Ketostar
- Ketodermis (brand name for soap formulation)
How It Works
Pharmacodynamics: Ketoconazole exerts its antifungal effect by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes. This disruption alters membrane permeability and leads to fungal cell death. Cetrimide’s antiseptic action stems from its ability to disrupt the cell membranes of various microorganisms. Additionally, it possesses anti-inflammatory properties, contributing to the reduction of itching and redness associated with fungal infections.
Pharmacokinetics: Topical application results in minimal systemic absorption. The drug primarily exerts its effects locally at the site of application.
Mode of Action: Ketoconazole targets the fungal cell membrane by inhibiting the enzyme lanosterol 14α-demethylase, responsible for ergosterol synthesis. This inhibition disrupts the integrity of the fungal cell membrane, resulting in cell death. Cetrimide, as a quaternary ammonium compound, directly interacts with the cell membranes of microorganisms, leading to their disruption and death.
Elimination Pathways: Due to minimal systemic absorption, elimination pathways are not clinically significant for topical application.
Dosage
Cetrimide + Ketoconazole is available as a topical cream, lotion, or soap.
Standard Dosage
Adults:
Apply a thin layer to the affected area(s) once or twice daily, or as directed by a physician. For soap formulations, use daily during bathing. Lather and leave on the skin for a few minutes before rinsing thoroughly.
Children:
Use in children should be directed by a physician. Dosage depends on the child’s age, weight, and the specific condition being treated.
Special Cases:
- Elderly Patients: No specific dose adjustments are typically required. However, close monitoring for adverse effects is recommended.
- Patients with Renal Impairment: No specific dose adjustments are generally necessary due to minimal systemic absorption.
- Patients with Hepatic Dysfunction: Systemic absorption is low; however, caution is advised, especially with prolonged use or if large areas of skin are treated.
- Patients with Comorbid Conditions: Use with caution in patients with open wounds or severely damaged skin, as increased absorption may occur.
Clinical Use Cases
Dosage in specific medical settings is generally the same as the standard dosage. There are no specific recommendations for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dose modification is rarely needed due to minimal systemic absorption following topical application. However, individual patient characteristics (e.g., the size of the affected skin areas, presence of open wounds) or specific medical conditions should be considered.
Side Effects
Common Side Effects:
- Skin irritation
- Burning sensation
- Dry skin
- Itching
- Rash
Rare but Serious Side Effects:
- Allergic reactions (e.g., contact dermatitis)
Long-Term Effects:
No specific long-term effects are typically associated with topical use.
Adverse Drug Reactions (ADR):
Contact dermatitis or other hypersensitivity reactions require immediate discontinuation of treatment.
Contraindications
- Hypersensitivity to ketoconazole, cetrimide, or any inactive ingredients.
- Open wounds or broken skin (for cream/lotion formulations).
- Application to mucous membranes.
Drug Interactions
No significant drug interactions are expected with topical application. However, inform your physician about all other topical medications used on the same area to avoid potential interactions or additive effects.
Pregnancy and Breastfeeding
Consult with a physician before using during pregnancy or breastfeeding. Limited data are available regarding the safety of topical ketoconazole and cetrimide during pregnancy and breastfeeding. While topical application results in minimal systemic absorption, it is essential to exercise caution and assess the potential risks versus benefits.
Drug Profile Summary
- Mechanism of Action: Ketoconazole: Inhibits ergosterol synthesis. Cetrimide: Antiseptic, disrupts cell membranes.
- Side Effects: Skin irritation, burning, dryness, itching, rash. Rarely, allergic reactions.
- Contraindications: Hypersensitivity, open wounds.
- Drug Interactions: Limited with topical use.
- Pregnancy & Breastfeeding: Consult physician.
- Dosage: Apply topically once or twice daily or as directed by a physician. Soap: use daily during bathing.
- Monitoring Parameters: Observe for local skin reactions and signs of infection resolution.
Popular Combinations
No specific combinations are typically recommended.
Precautions
- Avoid contact with eyes, nose, and mouth.
- Wash hands thoroughly after application.
- Discontinue use if irritation occurs.
- Pre-existing medical conditions like heart disease, diabetes, liver disease, and kidney disease don’t usually require dosage adjustments for topical application due to minimal systemic absorption. But it is important to inform the doctor about any comorbidity.
- Not recommended as a first line of treatment for systemic infections due to risk of hepatotoxicity.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cetrimide + Ketoconazole?
A: Apply topically to the affected area once or twice daily, or as directed by a physician. Use soap formulation daily during bathing.
Q2: How long should I use this medication?
A: Treatment duration varies depending on the infection and individual response. Typically, continue treatment for a few days after symptoms resolve, as directed by your physician.
Q3: Can I use this medication on my face?
A: Yes, but avoid contact with eyes, nose, and mouth. Exercise caution around sensitive areas.
Q4: What should I do if I miss a dose?
A: Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra to make up for a missed dose.
Q5: Can I use this medication if I am pregnant or breastfeeding?
A: Consult your physician before using Cetrimide + Ketoconazole during pregnancy or breastfeeding. The safety profile in these situations is not fully established.
Q6: Can I use other topical medications simultaneously on the same area?
A: Inform your physician about all other topical medications you are using, as concomitant use may lead to interactions or additive effects.
Q7: Is it safe to drive or operate machinery while using this medication?
A: Yes, topical Cetrimide + Ketoconazole should not impair your ability to drive or operate machinery.
Q8: What are the signs of an allergic reaction to this medication?
A: Signs of an allergic reaction may include severe itching, redness, swelling, or blistering at the application site. If you experience any of these symptoms, discontinue use immediately and consult your physician.
Q9: Can this medication be used on broken skin?
A: Cream and lotion formulations should not be applied to open wounds or broken skin due to the potential for increased systemic absorption. The soap is generally considered safe but may cause irritation. If the skin is damaged, use as directed by a physician.
Q10: What if my symptoms don’t improve after using this medication?
A: If your symptoms do not improve or worsen after the recommended treatment period, consult your physician. They may consider alternative treatment options or further investigations.
