Mycomar

Uses

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

is used for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses including atopic dermatitis, contact dermatitis, eczematous dermatitis, neurodermatitis, seborrheic dermatitis, insect bites, lichen simplex chronicus, exfoliative dermatitis, stasis dermatitis, nummular eczema, psoriasis and pruritus ani and vulvae.

Mycomar 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 candidiasisAcne, Acne Vulgaris, Acute Gouty Arthritis, Allergic Contact Dermatitis, Allergic Rhinitis (AR), Allergy Skin, Alopecia Areata (AA), Ankylosing Spondylitis (AS), Asthma, Atopic Dermatitis (AD), Autoimmune Hemolytic Anemia, Berylliosis, Bullous dermatitis herpetiformis, Chapped skin, Chronic Eczema, Chronic Inflammatory Skin Diseases, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Crohn's Disease (CD), Dental Cavity, Dermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dermatomyositis, Diaper Rash, Discoid Lupus Erythematosus (DLE), Edema of the cerebrum, Epicondylitis, Erythroderma, Fungal infectious disorders of the Beard, Gingivitis, Hemangiomas, Hemorrhoids, Hypercalcemia, Infected Wound, Infections, Fungal, Inflammation of Mouth, Intertrigo, Itching of the Anus, Itching of the External Genitalia, Itching of the Foot, Itching of the genitals, Itching of the hand, Juvenile Idiopathic Arthritis (JIA), Keloid Scars, Leukemias, Lichen Planus (LP), Lichen simplex chronicus, Malignant Lymphomas, Mycosis Fungoides (MF), Mycotic Eczema, Necrobiosis lipoidica diabeticorum, Neurodermatitis, Nummular Dermatitis, Ocular Inflammation, Ophthalmia, Sympathetic, Oral Erosive Lichen Planus, Oral Infection, Otitis Externa, Pemphigus, Pericarditis, Polymyositis, Post-Herpetic Neuralgia (PHN), Primary adrenocortical insufficiency, Proteinuria, Psoriasis Vulgaris (Plaque Psoriasis), Psoriatic Arthritis, Psoriatic plaque, Pure Red Cell Aplasia, Purulent Wounds, Pyoderma caused by susceptible bacteria, Regional Enteritis, Rheumatoid Arthritis, Ringworm Folliculitis, Seborrheic Dermatitis, Seborrheic Dermatitis, Eczematous, Secondary Impetiginization, Secondary adrenocortical insufficiency, Secondary thrombocytopenia, Serum Sickness, Skin Mycoses, Stomatitis, Aphthous, Stomatitis, Denture, Synovitis, Systemic Lupus Erythematosus (SLE), Temporal Arteritis, Tinea Corporis, Transfusion Reactions, Trichinosis, Tuberculosis (TB), Ulcerative Colitis, Urticaria, Uveitis, Acute Bursitis, Acute Multiple sclerosis, Acute Rheumatic heart disease, unspecified, Acute Tenosynovitis, Corticosteroid-responsive dermatoses, Cutaneous candidiasis, Cystic tumour of the ganglia, Exfoliative erythroderma, Granuloma annulare lesions, Idiopathic eosinophilic pneumonias, Non-suppurative Thyroiditis, Oral infections, Oral lesions, Severe Erythema multiforme, Subacute Dermatitis, Eczematous, Symptomatic Sarcoidosis, Ulceration of the mouth, Ulcerative stomatitis

How Mycomar 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.

Corticosteroids like triamcinolone inhibit phospholipase A2 on cell membranes, preventing the breakdown of lysosomal membranes of leukocytes, which in turn prevent the formation of arachidonic acid, which decrease expression of cyclooxygenase and lipoxygenase, inhibiting synthesis of prostaglandins and leukotrienes. Anti-inflammatory activity occurs via reversal of vascular dilation and reducing permeability, which prevents macrophage and leukocyte migration. Triamcinolone also inhibits nuclear factor kappa-B, which decreases the production of pro-inflammatory signals such as interleukin-6, interleukin-8, and monocyte chemoattractant protein-1.

Dosage

Mycomar dosage

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.

A small amount of Triamcinolone is gently rub to the affected area 1-2 times daily. Some cases of eczematised psoriasis may be treated more effectively by the application of Triamcinolone under an occlusive dressing.

Occlusive dressing technique: Gently rub a small amount of Triamcinolone on the lesion until it disappears. Then reapply, leaving a thin coating and cover with a pliable non porous film. For convenience apply Triamcinolone intermittently (12 hour occlusion during the night) followed by reapplication without occlusion, during the day.

Pediatric use: Triamcinoloneshould not be used in children under 8 years. 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. As children are more likely to get side effects, they should not normally be treated for longer than 5 days.

Side Effects

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.

The following local side effects have been reported with topical corticosteroids, either with or without occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

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.

The subcutaneous LD₅₀ of triamcinolone acetonide in rats is 13,100µg/kg and in mice is 132mg/kg. The oral LD₅₀ in rats is 1451mg/kg and in mice is 2168mg/kg.[LD₅₀] The intraperitoneal LD₅₀ in mice is 105mg/kg.[LD₅₀]

Patients experiencing an overdose may develop Cushing's syndrome. This overdose may be treated with supportive therapy and mifepristone for its antiglucocorticoid activity.

Precaution

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

If reactions or idiosyncrasies are encountered, Triamcinolone Acetonide should be discontinued. The use of topical steroids on infected areas should be attended with caution and careful observation, bearing in mind the potential spreading of infections by anti-inflammatory steroids and the possible advisability of discontinuing steroid therapy and/or initiating antibacterial measures.

Triamcinolone Acetonide should not be used on healthy skin or over large areas of skin and not to be used in the eye as there is potential risk of glaucoma and cataract. When steroids are applied for long periods of time (more than 4 weeks) the occurrence of atrophic striae is likely. Prolonged use on flexures and intertriginous areas is undesirable. Children may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. In infants, long term continuous topical steroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

Volume of Distribution

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

The apparent volume of distribution of triamcinolone is 115.2±10L. The mean apparent volume of distribution of triamcinolone acetonide is 1.96L/kg. The apparent volume of distribution of triamcinolone diacetate is 119.7±33.14L.

Elimination Route

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

A 16mg oral dose of triamcinolone reaches a C_max of 5.23±0.84ng/mL with a T_max of 2.24±0.78h and an AUC of 36.0±6.2ng*h/mL.

A 2mg intravenous dose of triamcinolone acetonide has an AUC of 57.7ng*h/mL. The bioavailability of 800µg of inhaled triamcinolone acetonide is 25%, with 10.4% coming from pulmonary absorption and the rest being accounted for by deposition on the oral mucosa and other underlying factors. An inhaled dose of triamcinolone acetonide reaches a C_max of 0.92ng/mL with a T_max of 1.74h and an AUC of 5.12ng*h/mL. The fraction of an inhaled dose that is actually absorbed via the pulmonary route reaches a C_max of 0.55ng/mL with a T_max of 0.66h and an AUC of 2.15ng*h/mL.

A 16mg oral dose of triamcinolone diacetate reaches a C_max of 5.33±1.55ng/mL with a T_max of 1.86±0.47h and an AUC of 32.7±9.9ng*h/mL.

Half Life

The half life of triamcinolone is 2.7h. The mean terminal elimination half life following an inhaled dose of triamcinolone acetonide is 2.4h. The half life of triamcinolone diacetate is 2.8h.

Clearance

The clearance of triamcinolone is 28.6±5.6L/h. The mean total body clearance of triamcinolone acetonide is 0.57L/h. The clearance of triamcinolone diacetate is 34.4±10.6L/h.

Elimination Route

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

Approximately 20% of a dose of triamcinolone is recovered in the urine as the unchanged drug, 25% is recovered as 6-beta-hydroxy-triamcinolone, and 5% is recovered as unidentified metabolites.

Pregnancy & Breastfeeding use

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

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroid could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Contraindication

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.

Triamcinolone Acetonide is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in tuberculosis of the skin, fungus infections and viral diseases of the skin (Herpes simplex, chickenpox and vaccinia), perioral dermatitis, rosacea and ulcerative conditions.

Acute Overdose

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects e.g., mild, reversible suppression of adrenal function, ecchymoses of the skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness

Storage Condition

Store at 20° to 25°C. Avoid freezing.

Store in a cool & dry place. Protect from light.

Innovators Monograph

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