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TRIMOVATE is a brand name for Nystatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clobetasone 17-butyrate is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. Nystatin is a polyene antifungal. Oxytetracycline is a broad spectrum antibiotic. Topical…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults, Elderly, Children and Infants For topical use only. Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day for up to seven days.
If the infection worsens, treatment and diagnosis should be re-evaluated as soon as possible. If the condition does not improve within seven days, treatment and diagnosis should be re-evaluated. Treatment should not be continued for more than seven days without medical supervision.
Allow adequate time for absorption after each application before applying an emollient. Patients should be advised to wash their hands after applying clobetasone with nystatin and oxytetracycline, unless it is the hands that are being treated.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations. If further treatment is required to achieve control of the pre-existing dermatoses, it may be necessary to continue therapy with another corticosteroid preparation not containing nystatin and oxytetracycline Children Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults (see Warnings and Precautions).
Care should be taken when using clobetasone with nystatin and oxytetracycline to ensure the amount applied is the minimum that provides therapeutic benefit. Elderly Clinical studies have not identified differences in responses between the elderly and younger patients.
The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal / Hepatic Impairment In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data), including isolated reports.
Post-marketing data Infections and Infestations Not known:
Opportunistic infection Immune System Disorders Not known: Hypersensitivity Endocrine Disorders Not known: Hypothalamic-pituitary adrenal (HPA) axis suppression: (see also Skin and Subcutaneous Tissue Disorders). g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels Skin and Subcutaneous Tissue Disorders Common or very common: Telangiectasia Not known (cannot be estimated from available data): Allergic contact dermatitis/dermatitis, urticaria, skin atrophy*/skin thinning, pigmentation changes*, exacerbation of underlying symptoms, local skin burning/skin pain, hypertrichosis, rash (including erythematous and macropapular), pruritus, erythema, photosensitivity reaction Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin, peeling, oozing pustules.
4) *Skin features related to hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions Not known:
Application site pain/reaction Eye disorders Not known: Vision, blurred Vascular disorders Not known: Vasodilation Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Instruct patients not to smoke or go near naked flames - risk of severe burns. ) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Pseudomembranous colitis Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use.
Although this is less likely to occur with topically applied oxytetracycline, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids.
If either of the above are observed, withdraw the drug gradually by reducing the frequency of application or by substituting a less potent corticosteroid. 8). g. on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing).
- Increasing hydration of the stratum corneum - Use on thin skin areas such as the face - Use on broken skin or other conditions where the skin barrier may be impaired. Paediatric population In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.
This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
The following should not be treated with clobetasone with nystatin and oxytetracycline: - Patients with known history of hypersensitivity to clobetasone butyrate, nystatin, oxytetracycline or any components of the formulation - Primary cutaneous viral infections - Primary infected skin lesions caused by infection with fungi, bacteria or yeasts - Cutaneous infections caused by Acinetobacter species, methicillin resistant Staphylococcus aureus (MRSA), Pseudomonas species, Proteus species Serratia species or Streptococcus B.
- Rosacea - Acne vulgaris - Pruritus without inflammation. - Perioral dermatitis
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Infection risk with occlusion Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Infection Extension of infection may occur due to the masking effect of the steroid. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy. Application to the face Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Chronic leg ulcers Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
8). If signs of hypersensitivity appear, application should be stopped immediately. Contact sensitisation Extended or recurrent application of clobetasone with nystatin and oxytetracycline may increase the risk of contact sensitisation.
Staining Clobetasone with nystatin and oxytetracycline may cause slight staining of hair, skin or fabric, but this can be removed by washing. The application may be covered with a non-occlusive dressing to protect clothing. Dilution Products which contain antimicrobial agents should not be diluted.
Photosensitivity reactions Photosensitivity reactions may occur in hypersensitive persons and such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
g. contact dermatitis). Chlorocresol may cause allergic reactions. Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).
A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
The label will state moderate steroid.