Trimovate

Trimovate Uses, Dosage, Side Effects, Food Interaction and all others data.

Nystatin has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.

Nystatin is an antifungal that is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It exerts its antifungal effects via disruption of the fungal cell membrane. Resistance to nystatin is minimal in Candida albicans, but tends to develop in other species of Candida. Nystatin carries no significant activity against bacteria, protozoa, or viruses. It carries significant systemic toxicity and is currently unavailable in a formula appropriate for systemic use - its efficacy is currently restricted, therefore, to topical, oral, and gastrointestinal infections.

Trimovate
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Trimovate
Generic	clobetasone butyrate + Nystatin + oxytetracycline calcium
Type
Therapeutic Class
Manufacturer	Ennogen Healthcare Ltd
Available Country	United Kingdom
Last Updated:	September 19, 2023 at 7:00 am

Uses

Clobetasone Butyrate preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone Butyrate may be used as a maintenance therapy between courses of one of the more active topical steroids.

Nystatin Cream is used for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not used for systemic, oral, intravaginal or ophthalmic use.

Nystatin tablet is an antifungal antibiotic active against a wide range of yeasts and yeast like fungi including Candida albicans. It is used for the prevention and treatment of Candida infections of oral cavity, esophagus and intestinal tract. It provides effective prophylaxis against oral candidiasis in those born of mothers with vaginal candidiasis. It is used for the prophylaxis of Candida overgrowth during courses of broadspectrum antibiotics

Trimovate is also used to associated treatment for these conditions: Anal candidiasis, Candidiasis, Invasive, Intestinal Candidiasis, Mixed Vaginal Infections caused by Trichomonas Vaginalis, candida albicans, Oral Candidiasis, Pruritus Ani, Pruritus Vulvae, Skin candida, Trichomonas Vaginitis, Vaginal Candidiasis, Vulvovaginal Candidiasis, Corticosteroid-responsive dermatoses, Cutaneous candidiasis

How Trimovate works

Nystatin is a channel-forming ionophore, meaning it exerts its therapeutic effect via formation of a membrane-spanning pore in the fungal plasma membrane. The formation of this pore results in a change in membrane permeability that allows for leakage of intracellular contents and the subsequent disruption of electrochemical gradients necessary for proper cell function. Selectivity for fungal cells over mammalian cells is due to nystatin’s greater binding affinity for ergosterol, a key sterol found in fungal cell walls, as opposed to its mammalian counterpart, cholesterol.

Dosage

Trimovate dosage

Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

Children:

In intestinal and oral candidiasis (thrush): 1,00,000 units (1 ml) should be dropped into the mouth four times daily.The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
For prophylaxis in the newborn:The suggested dose is 1,00,000 units (1 ml) once daily or as prescribed by the physician.

Adult:

For the treatment of intestinal or esophageal candidiasis: 5,00,000 units (5 ml) by mouth 3 or 4 times daily. The dose may be doubled, if required.
For prophylaxis of intestinal candidiasis in adults: 10,00,000 units (10 ml) daily.
For prophylaxis to suppress the over growth of Candida albicans in patients receiving broad spectrum antibiotic therapy: 10,00,000 units (10 ml) daily.
For the treatment of dental sores and oral infection: 1,00,000 units (1 ml) suspension should be dropped into the mouth four times daily.

Elderly: Older people with intestinal candidiasis who are unable to swallow tablets should be given 5,00,000 units (5 ml) suspension four times daily.

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.

Pediatric Use: Safety and effectiveness have been established in the pediatric population from birth to 16 years.

Geriatric Use: Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Side Effects

In the unlikely event of signs of hypersensitivity appearing, application should stop immediately. When large areas of the body are being treated with Clobetasone Butyrate, it is possible that some patients will absorb sufficient steroid to cause transient adrenal suppression despite the low degree of systemic activity associated with Clobetasone Butyrate.Local atopic changes could possibly occur in situations where moisture increases absorption of Clobetasone Butyrate, but only after prolonged use.There are reports of pigmentation changes and hypertrichosis with topical steroids.Exacerbation of symptoms may occur.

Nystatin cream: The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.

Nystatin tablet: Nausea, vomiting and diarrhoea have occasionally been reported with high doses of Nystatin. No systemic effects or allergic reactions have been associated with its oral dose.

Toxicity

The oral LD₅₀ in rats is 10 g/kg. There have been no reports of serious toxic effects following overdosage of nystatin - doses in excess of five million units daily have resulted in nausea and gastrointestinal upset with no other associated effects.

Precaution

May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.

Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Absorption from the gastrointestinal tract is negligible, therefore no special precaution is required to apply in pregnancy and lactation

Interaction

Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.

Volume of Distribution

Nystatin is not absorbed into the systemic circulation and thus does not undergo distribution.

Elimination Route

Systemic absorption of nystatin is minimal following oral administration, and no detectable plasma concentrations are attained following topical or vaginal administration.

Elimination Route

The majority of orally administered nystatin is eliminated unchanged in the feces.

Pregnancy & Breastfeeding use

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.

Pregnancy Category C. Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers: It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Mouth/Throat/PO/Topical: Pregnancy catagory C

Vaginal: Pregnancy catagory A

Contraindication

Skin lesions caused by infection with viruses (e.g. herpes simplex, chicken pox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo), hypersensitivity to the preparations.Although generally regarded as safe, even for long-term administration in adults, there is a potential for overdosage, and in infants and children this may result in adrenal suppression. Extreme caution is required indermatoses in such patients including napkin eruption (as the napkin may act as an occlusive dressing and increase absorption) and treatment should not normally exceed seven days.Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.As with all corticosteroids, prolonged application to the face is undesirable. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, and risk of generalized toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is important.If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma might result.

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

There is no known contraindication to the use of Nystatin oral.

Acute Overdose

Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.