Usage
This combination cream is prescribed for various bacterial and fungal skin infections, along with inflammatory skin conditions such as eczema and dermatitis complicated by secondary infections. It is also effective against dermatophyte infections like tinea corporis, tinea cruris, and tinea pedis.
Its pharmacological classifications include:
- Corticosteroid: Clobetasol propionate
- Antibiotic: Ofloxacin and Tinidazole
- Antifungal: Terbinafine
- Provitamin: D-Panthenol (a provitamin of B5)
Mechanism of Action: This cream combines multiple actions to combat skin infections and inflammation. Clobetasol, a potent corticosteroid, reduces inflammation by suppressing the release of inflammatory mediators. Ofloxacin, a fluoroquinolone antibiotic, hinders bacterial DNA replication, thereby preventing bacterial growth. Tinidazole, another antibiotic, targets bacterial and protozoal DNA, inhibiting their growth. Terbinafine, an antifungal, disrupts fungal cell membrane formation, preventing fungal growth. D-Panthenol promotes skin hydration and healing.
Alternate Names
No internationally recognized non-proprietary name exists for this specific combination. It is often referred to by its constituent drugs. Brand names vary depending on the manufacturer and region. Some examples include Terbinik Plus, Clone Plus, and Actoskin Cream.
How It Works
Pharmacodynamics: Clobetasol binds to glucocorticoid receptors, leading to reduced inflammatory responses. Ofloxacin inhibits bacterial DNA gyrase. Terbinafine inhibits fungal squalene epoxidase. Tinidazole damages microbial DNA. Dexpanthenol converts to pantothenic acid, which supports skin integrity.
Pharmacokinetics: Topical application limits systemic absorption. However, some absorption can occur, especially with prolonged use, application to large areas, or damaged skin. The components are metabolized primarily in the liver (except D-Panthenol, which is converted to pantothenic acid in the skin) and excreted through the kidneys. More specific information on each individual component can be found in relevant medical databases.
Mode of Action: See Mechanism of Action under Usage. Specific receptor interactions, enzyme inhibitions, and neurotransmitter modulation information should be referenced in the relevant drug information resources for each component.
Elimination Pathways: Each component of this combination product exhibits its own elimination pathways: renal or hepatic excretion, and metabolism by CYP enzymes (especially concerning Ofloxacin and Tinidazole) can occur. Consult individual drug profiles for details.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected area twice daily, usually for no longer than 2-4 weeks.
Children: Use in children under 12 is generally not recommended due to potential for increased systemic absorption. If deemed necessary, a physician should closely monitor for adverse reactions.
Special Cases:
- Elderly Patients: Use with caution as skin thinning is more common.
- Patients with Renal Impairment: Use cautiously. Monitor for systemic effects.
- Patients with Hepatic Dysfunction: Use cautiously. Monitor for systemic effects.
- Patients with Comorbid Conditions: Monitor closely for patients with diabetes, Cushing’s syndrome, glaucoma, as topical corticosteroids can exacerbate these.
Clinical Use Cases
This medication is for topical dermatological use only and is not intended for systemic administration. Thus, it is not indicated for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Adjustments may be necessary based on patient-specific factors. Physicians should assess the patient and adjust accordingly.
Side Effects
Common Side Effects:
- Burning, stinging, itching, redness at the application site
- Dryness or peeling of the skin
- Skin thinning (with prolonged use)
- Changes in skin color
Rare but Serious Side Effects:
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- Signs of Cushing’s syndrome (weight gain, moon face, increased thirst/urination, easy bruising)
- Worsening of infection
- Skin atrophy
- Telangiectasia (spider veins)
Long-Term Effects:
- Skin atrophy
- Stretch marks
- Hyperpigmentation or hypopigmentation
Adverse Drug Reactions (ADR):
- Severe allergic reactions (anaphylaxis)
- Worsening of existing skin infections
Contraindications
- Hypersensitivity to any component
- Viral skin infections (e.g., herpes simplex, varicella zoster)
- Untreated parasitic infections
- Rosacea
- Acne
- Perioral dermatitis
Drug Interactions
Limited interaction data is available. Potential interactions are possible with systemic drugs metabolized by CYP450 enzymes. Consult a doctor before concurrent use with other medications.
Pregnancy and Breastfeeding
Safety during pregnancy and breastfeeding has not been established. Use with caution only if benefits outweigh risks. Consult a doctor before use. Topical application minimizes systemic exposure but some absorption can occur. Consider alternative therapies if possible.
Drug Profile Summary (See relevant sections above for details)
Popular Combinations
The specific five-drug combination is itself considered a fixed-dose combination and not typically combined with other drugs. However, depending on the diagnosis, a physician might prescribe additional medications for systemic effects or to address other related symptoms.
Precautions (See relevant sections for more details)
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + D-Panthenol + Ofloxacin + Terbinafine + Tinidazole?
A: Apply a thin layer to the affected area twice daily, typically for no longer than 2-4 weeks. Consult a doctor for individualized guidance.
Q2: Can this cream be used on the face?
A: Use with extreme caution on the face and avoid prolonged application due to the risk of skin thinning and other adverse effects.
Q3: What should I do if I miss a dose?
A: Apply the missed dose as soon as you remember. If it is near the time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra cream to make up for a missed dose.
Q4: How long should I use this cream before seeing improvements?
A: Many patients see improvement within the first few weeks, but individual responses vary. If your condition does not improve within 2-4 weeks, consult your physician.
Q5: Can I use this cream on open wounds?
A: This cream is generally not recommended for use on open wounds or broken skin. Consult your doctor for guidance.
Q6: Are there any specific storage instructions for this medication?
A: Store at room temperature, away from heat and moisture. Keep the tube tightly closed when not in use. Consult the package insert or contact the pharmacist for specific storage instructions.
Q7: What should I do if my condition worsens while using this cream?
A: Discontinue use immediately and contact your doctor. Worsening of the infection or other adverse reactions need prompt medical assessment.
Q8: Can I use other topical medications simultaneously with this cream?
A: Avoid concurrent use of other topical medications on the treated area unless specifically directed by your doctor. Concomitant use may increase the risk of adverse effects or drug interactions.
Q9: Can this cream be used to treat acne?
A: No, this cream is not designed to treat acne and may even worsen the condition. Consult a dermatologist for appropriate acne treatment.