Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment

Uses

Any inflammatory skin disorders like eczema & psoriasis where secondary bacterial or fungal infection is present, suspected or likely to occur.

Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment is also used to associated treatment for these conditions: Alopecia, Severe Plaque psoriasis, Corticosteroid responsive, Inflammatory Dermatosis, Corticosteroid responsive, pruritic Dermatosis, Moderate Plaque psoriasis, Moderate Scalp Psoriasis, Severe Scalp PsoriasisAnal 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 Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment works

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.

Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.

Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

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

Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment dosage

Adults and children over 2 years:

• Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations therapy should be discontinued when control is achieved.
• In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of this preparaton can be enhanced, if necessary, by occluding the treatment area with polythene.
• Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.
• Repeated short courses of Nyclobate NN may be used to control exacerbations
• Elderly: This preparation is suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.Children: Under 2 years this preparation is not recommended.

Side Effects

Generally Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment is well tolerated. However, few side effects after prolonged and intensive treatment may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved.

Toxicity

Data regarding acute overdoses of glucocorticoids are rare. Overdoses of clobetasol propionate can lead to reversible HPA axis suppression and glucocorticoid insufficiency. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.[A188405] Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.[A188405]

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

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If used in childhood, or on the face, courses should be limited to 5 days and occlusion should not be used. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye. If used in psoriasis careful patient supervision is important. Scalp Application: Keep away from eye. Flammable. Do not use or dry the hair near a fire or flame.

Interaction

Neomycin Sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with the recommendations, systemic exposure to Neomycin Sulphate is expected to be minimal and drug interactions are unlikely to be significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin.

Volume of Distribution

Data regarding the volume of distribution of clobetasole propionate are not readily available.

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

Elimination Route

Twice daily application of clobetasol foam leads to a C_max of 59±36pg/mL with a T_max of 5 hours. Clobetasol cream showed an increase in clobetasol concentrations from 50.7±96.0pg/mL to 56.3±104.7pg/mL.

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

Half Life

Data regarding the half life of clobetasol propionate are not readily available.

Clearance

Data regarding the clearance of clobetasol propionate are not readily available.

Elimination Route

Corticosteroids are eliminated predominantly in the urine.

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

Pregnancy & Breastfeeding use

Pregnancy category C: The safe use of Aclobet-N (0.5 mg+5 mg+1 Lac IU)/gm Ointment during pregnancy & lactation has not been established.

Contraindication

This medication is contraindicated in rosacea, acne vulgaris and perioral dermatitis, primary cutaneous viral infection (eg-Herpes simplex, chicken pox) and hypersensitivity to the preparation.

Special Warning

Use in Paediatrics: The drug may be used in paediatrics patients in appropriate dosage, but large quantities for prolonged period should be avoided. It is contraindicated in children less than one year.

Acute Overdose

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. Also, consideration should be given to significant systemic absorption of Neomycin Sulphate. If this is suspected, use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored. Haemodialysis may reduce the serum level of Neomycin Sulphate.

Interaction with other Medicine

Neomycin Sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with the recommendations systemic exposure to Neomycin Sulphate is expected to be minimal and drug interactions are unlikely to be significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin.

Storage Condition

Store below 25° C temperature. Do not freeze. Keep out of reach of children.

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