Composition: NC-315
Composition: Beclomethasone Di Propionate IP 0.025%
w/w Clotrimazole IP 1.0% w/w
Cream Base qs
Dosage Form: Cream Base Tube
INFORMATION FOR THE USER
Salicylic acid 3% w/w and Beclomethasone 0.25% w/w Ointment
Read all of this information carefully before you start taking this medicine because it contains important information for you.
- Keep this information. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
- COMPOSITION:
Each tube contains:
Salicylic acid – 3% w/w
Beclomethasone – 0.25% w/w
For external use only.
2. DESCRIPTION:
Salicylic acid is a topical keratolytic that helps remove dry and flaky skin to increase absorption of the steroid component. Beclomethasone is a topical steroid that helps to relieve pain and inflammation on the skin.
3. PHARMACOLOGICAL ACTION:
Contain becomethasone which exhibits the general properties of corticosteroids & salicylic acid which has keratolytic properties. Salicylic acid is applied topically in the treatment of hyperkeratotic & scaling conditions where its keratolytic action facilitates penetration of the corticosteroid. Corticosteroids are used primarily for their anti-inflammatory and/or immune suppressive effects. Beclomethasone is effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic & vasoconstrictive actions.
4. CLINICAL PHARMACOKINETICS:
Salicylic acid exerts only local action after topical application. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier & the use of occlusive dressings. Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolised primarily in the liver & excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted in the bile.
5. INDICATIONS:
Salicylic acid and beclomethasone ointment is indicated for the treatment of hyperkeratotic & dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid.
6. CONTRAINDICATIONS:
Salicylic acid and beclomethasone ointment is contraindicated in:
- Systemic Rosacea
- Acne
- Perioral dermatitis
- Perianal & genital pruritus
- Hypersensitivity to any of the ingredients
- Tuberculous & most viral lesions of the skin, particularly herpes simplex, vacinia, varicella
Should not be used in napkin eruptions, fungal/bacterial skin infections without suitable concomitant anti-infective therapy.
7. WARNINGS AND PRECAUTIONS:
Occlusion must not be used since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid. Local & systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion.
May be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis & local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
It is dangerous if it comes into contact with the eyes. Avoid contact with the eyes & mucous membranes.
The systemic absorption may be increased if extensive body surface areas/skin folds are treated for prolonged periods/with excessive amounts of steroids. If irritation or sensitisation develops treatment should be discontinued. Side effects including adrenal suppression may also occur especially in infants and children.
If excessive dryness/ increased skin irritation develops, discontinue use of this preparation.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituary-adrenal axis suppression & to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
8. ADVERSE EFFECTS:
Local symptoms such as:
- Hypersensitivity
- Contact dermatitis
- Eczema
- Pruritis
- Dry skin
- Erythema
- Urticaria
- Rash
- Pain at the application site
9. DRUG INTERACTIONS:
No drug interactions have been identified.
10. DOSAGE:
A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.
11. ADMINISTRATION:
A thin layer of cream should be applied to the affected area with a piece of clean cotton wool/gauze swab.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
13. MANUFACTURED BY:
14. MARKETED BY:
Last revised on May 2019.