Tenovate

Tenovate Cream belongs to a group of medicines called steroids. It treats various skin conditions such as dermatitis, eczema, and allergies. It works by reducing swelling, redness, and itchiness of the skin and prevents further irritation

Product dosage: 15g
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Tenovate (clobetasol propionate 0.05%) is a super-high potency topical corticosteroid indicated for the short-term treatment of severe, resistant inflammatory dermatoses. It represents a first-line intervention for conditions where conventional mid-potency steroids have proven inadequate, offering rapid anti-inflammatory, antipruritic, and vasoconstrictive effects. Its optimized formulation ensures maximal epidermal penetration with minimal systemic absorption when used appropriately, making it a cornerstone in the dermatological arsenal for managing acute flare-ups. This product card provides a comprehensive, evidence-based overview for healthcare professionals to ensure safe and effective prescribing.

Features

• Active Ingredient: Clobetasol propionate USP 0.05% w/w
• Pharmacological Class: Super-high potency topical corticosteroid (Group I)
• Available Formulations: Cream, ointment, lotion, foam, and shampoo
• Vehicle Options: Optimized for different skin types and conditions (e.g., ointment for dry, lichenified areas; foam for scalp)
• Mechanism: Binds to cytoplasmic glucocorticoid receptors, inhibiting the release of pro-inflammatory cytokines
• Onset of Action: Noticeable anti-pruritic and anti-inflammatory effects often within 24-48 hours
• Prescription Status: Rx-only

Benefits

• Rapid Symptom Resolution: Provides swift and potent relief from intense itching, redness, swelling, and plaque elevation associated with severe inflammatory skin conditions.
• High Efficacy in Resistant Cases: Effective where other corticosteroids have failed, often inducing remission in stubborn dermatoses within a two-week treatment cycle.
• Targeted Action with Low Systemic Exposure: When applied correctly to limited body surface area, its potent effects are largely confined to the site of application, minimizing the risk of HPA axis suppression.
• Multiple Formulation Flexibility: Allows clinicians to select the most appropriate vehicle (cream, ointment, foam, etc.) based on the lesion type, body site, and patient preference, enhancing adherence and efficacy.
• Short Treatment Duration: Due to its high potency, a course of treatment is typically brief (often 2 weeks), which can improve patient compliance and reduce the long-term risk of local adverse effects.

Common use

Tenovate is specifically reserved for the short-term palliative treatment of moderate to severe corticosteroid-responsive dermatoses that are unresponsive to lower-potency agents. Its use is typically initiated and monitored by a dermatologist or a physician experienced in managing complex skin disorders.

Primary Indications:

• Plaque Psoriasis (especially recalcitrant plaques): For thick, scaly plaques on elbows, knees, and torso. The occlusive vehicle of the ointment formulation is particularly effective for these lesions.
• Lichen Planus: Especially hypertrophic or erosive variants, and oral lichen planus (using specifically formulated products).
• Severe Atopic Dermatitis/Eczema: For acute exacerbations and lichenified areas in patients over 12 years of age.
• Discoid Lupus Erythematosus (DLE): For managing the chronic, scarring lesions associated with this condition.
• Alopecia Areata: Used as a potent topical agent or intralesional injection (not from the topical tube) to suppress the autoimmune attack on hair follicles.
• Other Conditions: Includes chronic hand eczema, lichen simplex chronicus, and severe contact dermatitis.

It is not intended for mild conditions, rosacea, perioral dermatitis, acne, or on large body surface areas.

Dosage and direction

Application Frequency: Apply a thin film to the affected area twice daily (morning and evening), unless otherwise directed by a physician. More frequent application does not confer greater efficacy and significantly increases the risk of adverse effects.

Amount: Use the smallest amount necessary to lightly cover the affected area. The “fingertip unit” (FTU) is a useful measure: the amount of ointment or cream expressed from a tube with a 5mm diameter nozzle, from the distal skin crease to the tip of the index finger. One FTU is sufficient to treat an area of skin twice the size of the flat of an adult hand with fingers together.

Duration of Treatment:

• Adults: Treatment should be limited to 2 consecutive weeks. The total dosage should not exceed 50 g per week.
• Pediatric Patients (12 years and older): Use should be extremely limited in duration and frequency, with close supervision. Not recommended for children under 12 years.
• Occlusive Dressing: May be used for severe, localized plaques for a short period under medical supervision to enhance penetration. Occlusion increases systemic absorption and the risk of local atrophy and striae. It should not be used on large areas, for prolonged periods, or in infants.

General Instructions: Gently cleanse and dry the area before application. Wash hands thoroughly after application, unless hands are the treatment site.

Precautions

• Systemic Absorption: Percutaneous absorption of topical corticosteroids can result in reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. This risk is higher with potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
• Local Skin Reactions: Prolonged use can lead to irreversible skin atrophy, striae, telangiectasia, hypopigmentation, and contact dermatitis. The face, groin, and axillae are more susceptible to these effects.
• Use on Specific Sites: Avoid application on the face, groin, and axillae unless absolutely necessary and for a minimal duration due to higher absorption rates and sensitivity.
• Use in Specific Populations:
  • Pregnancy: Category C. Use only if the potential benefit justifies the potential risk to the fetus. Not recommended for extensive use, in large amounts, or for prolonged periods.
  • Lactation: Do not apply to breasts prior to nursing.
  • Pediatrics: Children are more susceptible to systemic toxicity due to a larger skin surface area to body mass ratio. Use is generally contraindicated in infants and not recommended in young children.
• Infection: Do not use in the presence of cutaneous infections (bacterial, fungal, viral). Corticosteroids may mask signs of infection or facilitate the spread of an existing infection.

Contraindications

Tenovate is contraindicated in patients with:

• A history of hypersensitivity to clobetasol propionate, other corticosteroids, or any component of the formulation.
• Viral skin diseases (e.g., varicella, vaccinia, herpes simplex).
• Bacterial or fungal skin infections at the site of application.
• Rosacea and perioral dermatitis.
• Acne vulgaris.
• Use on the eyes or mucous membranes.
• Children under 12 years of age.

Possible side effect

Patients should be monitored for the following potential adverse reactions:

• Very Common (>10%): Burning, itching, irritation, and dryness at the application site, especially during initial use.
• Common (1-10%): Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, skin atrophy.
• Uncommon (<1%): Allergic contact dermatitis, striae, miliaria, telangiectasia.
• Rare (Systemic Effects): With prolonged use or inappropriate application: HPA axis suppression (manifesting as fatigue, weakness, nausea, hypotension), Cushing’s syndrome, hyperglycemia, glaucoma (if applied near eyes).

Drug interaction

Formal drug interaction studies have not been conducted with topical clobetasol propionate. However, caution is advised when using other corticosteroid-containing products concurrently, as this may increase the potential for systemic effects. There are no known interactions with systemic medications, but systemic absorption could theoretically interact with other drugs that affect cortisol levels or metabolism.

Missed dose

If a dose is missed, apply it as soon as it is remembered. However, if it is almost time for the next scheduled dose, skip the missed dose and resume the usual dosing schedule. Do not apply a double dose to make up for a missed one.

Overdose

• Topical Overdose: Applying excessively large amounts or using for prolonged periods can lead to severe systemic corticosteroid effects as described above (e.g., Cushing’s syndrome, HPA axis suppression). Treatment involves discontinuation of the product, with symptomatic and supportive care. Recovery of HPA axis function is typically prompt and complete.
• Acute Ingestion: Oral ingestion is unlikely to cause acute toxic effects due to the low bioavailability of the topical formulation. However, medical attention should be sought if a large quantity is ingested.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Keep the tube tightly closed and in its original carton to protect from light and moisture.
• Do not freeze.
• Keep out of reach of children and pets.

Disclaimer

This information is intended for healthcare professionals and is a summary of product characteristics. It is not exhaustive. The prescriber should refer to the full prescribing information for complete details. The practitioner must rely on their own professional knowledge and judgment in diagnosing, treating, and advising patients. The use of Tenovate must be based on a thorough assessment of the individual patient’s condition and a careful risk-benefit evaluation.

Reviews

• “As a dermatologist, Tenovate is my go-to for breaking the cycle of severe, lichenified plaque psoriasis. The rapid response it elicits is unparalleled. The key is strict patient education on the limited duration of use to avoid side effects.” – Dr. E. Lawson, MD, Dermatology.
• “For our patients with severe, refractory scalp psoriasis, the foam formulation has been a game-changer. Efficacy is high, and patient compliance is much better compared to messy lotions or oils.” – Clinical Nurse Specialist, Psoriasis Clinic.
• “While incredibly effective, this is not a benign medication. I reserve it for the most severe cases and always schedule a close follow-up at the two-week mark to reassess and ensure we are not seeing early signs of atrophy.” – Physician Assistant, Dermatology.
• “Used appropriately, it can provide life-changing relief from the intense itch of a severe eczema flare. The two-week-on, two-week-off approach has worked well for some of my most challenging adult patients.” – Consultant Dermatologist.