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DRUGS & SUPPLEMENTS
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Mykoproct Sine
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Mykoproct Sine uses
- Indications and usage:
- Contraindications:
- Precautions:
- Adverse reactions:
- Overdosage:
- Dosage and administration:
- How supplied:
INDICATIONS AND USAGE:
Mykoproct Sine cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the Mykoproct Sine component alone during the first few days of treatment.
CONTRAINDICATIONS:
This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.
PRECAUTIONS:
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use ).
If irritation or hypersensitivity develops with the combination Mykoproct Sine, treatment should be discontinued and appropriate therapy instituted.
Information for the Patient: Patients using this medicine should receive the following information and instructions.
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ).
- Patients should report any signs of local adverse reactions.
- When using this medication in the inguinal area, patients should be advised to apply cream sparingly and to wear loose fitting clothing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
- Patients should be advised on preventative measures to avoid reinfection.
Laboratory Tests: If there is a lack of therapeutic response, appropriate microbiological studies (e.g. KOH smears and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens, before instituting another course of therapy.
A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroid.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term animal studies have not been performed to evaluate the carcinogenic or mutagenic potential or possible impairment of fertility in males or females.
Pregnancy: Teratogenic effects - Pregnancy Category C: There are no teratogenic studies with combined Mykoproct Sine.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during use of this preparation by a nursing woman.
Pediatric Use: In clinical studies of a limited number of pediatric patients ranging in age from 2 months through twelve years, Mykoproct Sine cream cleared or significantly ameliorated the disease state in most patients.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
ADVERSE REACTIONS:
A single case (approximately one percent of patients studied) of acneiform eruption occured with the use of combined Mykoproct Sine in clinical studies.
Mykoproct Sine is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.
The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in the approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.
OVERDOSAGE:
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General ). However, acute overdosage and serious adverse effects with dermatologic use are unlikely.
DOSAGE AND ADMINISTRATION:
Mykoproct Sine cream is usually applied to the affected areas twice daily in the morning and the evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ).
Mykoproct Sine cream should not be used with occlusive dressings.
HOW SUPPLIED:
Mykoproct Sine cream USP, a yellow to tan cream supplied in:
15 gram tube NDC 0168-0081-15
30 gram tube NDC 0168-0081-30
60 gram tube NDC 0168-0081-60
Store at 20°-25°C (68°-77°F).. Avoid freezing.
E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747
I28115I
R09/13
#176
NDC 0168-0081-15
Fougera®
Mykoproct Sine and
TRIAMCINOLONE
ACETONIDE CREAM USP
Rx only
NET WT 15 grams
15g tube
NDC 0168-0081-15
Fougera Rx only
Mykoproct Sine and TRIAMCINOLONE
ACETONIDE CREAM USP
WARNING: Keep out of
reach of children.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
NET WT 15 grams
15g carton
Mykoproct Sine pharmaceutical active ingredients containing related brand and generic drugs:
Mykoproct Sine available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.