Class: Topical Preparations
Dosage Form: Cream
Description: For skin hyperpigmentation disorders
Manufacturer: Eva Pharma
Each 100 gm contains:
Hydrocortisone acetate………………1 g
Euslex oily………………………………….4 g
Tretinoin stimulates epidermal mitosis while causing a thinning and densification of the stratum corneum. Increased proliferation of the epidermal cells causes bleaching of the skin, and thinning of the stratum corneum facilitates the penetration of other active principles applied topically.
Topical application of hydroquinone causes depigmentation of hyperpigmented skin by inhibiting the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and inhibition of other metabolic processes in melanocytes.
Hydrocortisone acetate as anti-inflammatory corticosteroid can cause skin bleaching and may occasionally cause hypopigmentation and simultaneously has a clear anti-irritant effect. Prolonged application may lead to the emergence of local adverse effects such as atrophy possibly in the eyelids. The systemic effect of hydrocortisone acetate can be neglected during application on small areas.
No absorption studies have been performed with preparation. A penetrating study was conducted with hydroquinone. Till now, there are no available systemic undesirable effects after local application of tretinoin. As a substance that can cause irritation, it should not therefore be applied to wounds, skin lesions or mucous membranes. In humans, the percutaneous absorption of non-inflamed skin is 2-5% of the applied amount. Hydroquinone has properties similar to phenols. Hydrocortisone acetate, under normal conditions, only a small portion of the amount of corticosteroid applied topically is systemically available.
Tritospot is indicated in different forms of acquired melanin hyperpigmentation, such as:
- Due to scarring
- Post-traumatic hyperpigmentation due to drugs
- Post-inflammatory hyperpigmentation due to phototoxic reactions
Tritospot cream is contraindicated in:
- Acquired non-melanin pigmentations
- Vitiligo and suspicion of melanoma
- Intolerance to tretinoin or any other component of the preparation
- Acute inflammations and eczema of the skin
- Children under 12 years
- Skin infections (viral, bacterial including TBC and mycotic origin)
- Reactions to vaccinations
- Skin ulcers
- Rosacea and perioral dermatitis
- Applications to large surfaces
- Kidney disease
In rare cases, skin reactions in the form of erythema, irritation, pruritis, peeling and burns can manifest especially in early treatment.
During treatment of very long duration, adverse local effects, such as skin thinning, vasodilatation, stretch marks and acne-like events may occur in isolated cases (<1/10,000). Increased risk of secondary infections due to local reduction of immune defenses.
During a short use of Tritospot cream (1-3 months), there was no such adverse effects.
A local implementation of hydroquinone may result in very rare cases of allergic contact dermatitis.
Hydroquinone may also cause ochronosis, a gradual blue-black staining of the skin; in this case, stop the treatment. Tritospot cream should be stopped upon occurrence of bright spots around the treated area or on other parts of the body or when the skin doesn’t get clear within 3 months.
Dosage and Administration:
The following is generally recommended:
- The cream should be applied sparingly once a day on hyper-pigmented areas
- Application must be limited to areas where the skin is changed
- Avoid application on large surfaces (not to exceed 10% of total body surface)
- Treatment duration is on average 7 weeks
Only in exceptional cases may one consider applying the cream over a longer period, up to three months, taking into consideration the benefits of treatment versus risks. If no depigmentation appears after 3 months, use of the cream should be stopped.
Application and safety of Tritospot in children under 12 years of age has not yet been revised.
In overdose, symptoms mentioned under may occur more significantly.
Pregnancy and Lactation:
Reproduction studies in rats and rabbits with doses of topically applied tretinoin showed no effect on fertility or harm to the fetus. There are no controlled studies in humans. In experimental animals, topical application of corticosteroids was teratogenic. There were no controlled studies available neither in animals nor in pregnant women on the effect of hydroquinone upon topical application.
In those circumstances, the drug should be administered only when absolutely necessary. Even during breastfeeding, use of Tritospot cream should be restricted to cases where it is absolutely necessary. If necessary, avoid treatment around the breast area, so that breastfed infant is not in contact with the treated skin area.
Avoid contact with the eyes, lips and nasal mucosa. Do not expose the hyper-pigmented treated areas to intense solar radiation. The corticosteroid may mask the symptoms of a skin allergy reaction to any component of the preparation.
Patient should use Tritospot for current skin troubles only and not to pass the cream to another person to avoid further browning of the skin and prevent the appearance of skin irritations, patients should protect the treated skin from intense sunlight and UV radiation.
In special cases, it is recommended to cover the treated area with adequate sun protection.
Aluminium tube of 15 or 30 gm cream.
Store at room temperature, below 25°C.