Clobeedrem Advance

AZ-05A:

INFORMATION FOR THE USER

Clobetasol propionate 0.05% + Neomycin sulphate 0.5% + Miconazole nitrate 2.0%

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:
Clobetasol propionate – 0.05% w/w
Neomycin sulphate – 0.5% w/w
Miconazole nitrate – 2.0% w/w

For external use only.

DESCRIPTION:
Clobetasol is a topical anti-inflammatory agent and helps to relieve pain, itching and burning sensation on the skin.
Neomycin is an anti-bacterial and helps to kill bacteria. It belongs to a class of anti-bacterial known as aminoglycosides.
Miconazole is an anti-fungal and belongs to a class of drugs known as imidazoles.

PHARMACOLOGICAL ACTION:
Clobetasol acts as an anti-inflammatory agent via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis & activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells & eosinophils, & inhibiting the metabolism of arachidonic acid.

Neomycin sulphate interferes with bacterial protein synthesis by binding to 30S ribosomal subunits. Neomycin sulphate has a bactericidal action against many Gram-negative bacteria but it lacks activity against Pseudomonas aeruginosa. It has partial activity against Gram- positive bacteria. It is used topically in the treatment of infections of the skin, ear, and eye due to susceptible staphylococci and other organisms.

Miconazole is an imidazole antifungal agent & acts by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum & has some antibacterial activity.

CLINICAL PHARMACOKINETICS:
Clobetasol can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption is determined by many factors, including the vehicle & the integrity of the epidermal barrier. Occlusion, inflammation &/or other disease processes in the skin may also increase percutaneous absorption. Mean peak plasma conc. of 0.63 ng/ml occurred 8 hrs. after the 2nd application (13 hrs after an initial application) of 30g to normal individuals with healthy skin. Following the application of 2nd dose of 30g mean peak plasma conc. were slightly higher & occurred 10 hrs after application. Use of pharmacodynamic endpoints for assessing the systemic exposure is necessary due to the fact that circulating levels are well below the level of detection. Once absorbed through the skin, it is handled through pharmacokinetic pathways similar to systemically administered clobetasol. It is metabolised, primarily in the liver. It is excreted by the kidneys. Some clobetasol & its metabolites are also excreted in the bile.
The absorption of neomycin from the is poor: Only 3% of a dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults is approximately 2-3 hours. Doses of 3g produce peak plasma concentrations of up to 4 μg/ml.
There is little absorption through skin or mucous membranes when miconazole is applied topically. Absorbed miconazole is bound to plasma proteins (88.2%) & red blood cells (10.6%). The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug & metabolites.

INDICATIONS:
Clobetasol, neomycin and miconazole cream is indicated for:
Resistant dermatoses where secondary bacterial infection &/or fungal infection is present, suspected, or likely to occur.
Psoriasis (excluding widespread plaque psoriasis)
Recalcitrant eczemas

CONTRAINDICATIONS:
Clobetasol, neomycin and miconazole cream is contraindicated in the following cases:
Hypersensitivity to any of the ingredients of the preparation
Rosacea
Acne vulgaris
Perioral dermatitis
Pruritus without inflammation
Perianal & genital pruritus
Primary cutaneous viral infections (e.g. chickenpox)
Primary infected skin lesions caused by infection with fungi, bacteria or yeast
Secondary infections due to Pseudomonas/Proteus species
Otitis externa where the eardrum is perforated because of the risk of ototoxicity
WARNINGS AND PRECAUTIONS:
May cause local skin reactions (e.g. contact dermatitis).
Avoid if sensitive skin type, especially to any of the ingredients.
Avoid applying on the skin surface that is cut, scraped, sunburned or eczema-affected.
Meant for topical application only. Not for oral, ophthalmic or intravaginal use.
In case of eye contact, make sure to thoroughly rinse eyes & contact the doctor if the irritation develops.
Talk to your doctor about your medical conditions, if any, before using this product. Make sure to inform him/her if your skin conditions do not improve or get worsened.
Manifestations of hypercortisolism (Cushing’s syndrome) & reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids.
May be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis & development of local/systemic toxicity due to impaired barrier function of the skin.
ADVERSE EFFECTS:
Common side effects include:
Eryhtema
Stinging
Blistering
Peeling of skin
Edema
Pruritis
Urticaria
Burning sensation
Skin irritation
DRUG INTERACTIONS:
Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

DOSAGE: Apply 1-2 times a day on the affected area or as prescribed by the physician. The maximum weekly dose should not exceed 50 g/week.

ADMINISTRATION:
To be applied to the skin only. Before applying this product, the affected area must be cleaned & dried. A thin layer of this cream should be applied to the affected area. Wash hands after application with soap & dry properly.

PRESENTATION: Laminated tube of 15g.
STORAGE:
Store below 25°C in a cool & dry pace. Protect from direct sunlight. Keep away from the reach of children.

MANUFACTURED BY:
MARKETED BY:

This information was last revised on February 2021.