Flakeoff P
Flakeoff P Uses, Dosage, Side Effects, Food Interaction and all others data.
Clobetasol Propionate Cream is a multiple combination cream which exhibits anti-bacterial, anti-protozoal, anti-fungal and steroid properties to control inflammation. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive and gram-negative bacteria. Ornidazole belongs
to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is a topical antifungal and antiparasitic drug. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.
Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Clobetasol propionate is generally applied twice daily so the duration of action is long. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
Coal tar has antipruritic, keratoplastic and keratolytic properties. It slows down excessive epidermal cell turnover and is often used topically either alone or in combination with other drugs (e.g. salicyclic acid, sulfur) in conditions such as dandruff, seborrheic dermatitis or psoriasis.
Decrease bacterial growth.
Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
Salicylic acid treats acne by causing skin cells to slough off more readily, preventing pores from clogging up. This effect on skin cells also makes salicylic acid an active ingredient in several shampoos meant to treat dandruff. Use of straight salicylic solution may cause hyperpigmentation on unpretreated skin for those with darker skin types (Fitzpatrick phototypes IV, V, VI), as well as with the lack of use of a broad spectrum sunblock. Subsalicylate in combination with bismuth form the popular stomach relief aid known commonly as Pepto-Bismol. When combined the two key ingredients help control diarrhea, nausea, heartburn, and even gas. It is also very mildly anti-biotic.
Trade Name | Flakeoff P |
Generic | Clobetasol Propionate + Coal Tar + Salicylic Acid |
Weight | 0.05%w/v |
Type | Lotion |
Therapeutic Class | |
Manufacturer | Transcend Therapeutics Pvt Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Clobetasol Propionate is used for:
- Initial control of all forms of hyperacute eczema in all age groups
- Chronic hyperkeratotic eczema of the hands and feet and patches of chronic lichen simplex
- Chronic hyperkeratotic psoriasis of any area of the body
- Severe acute photosensitivity
- Hypertrophic lichen planus
- Localized bullous disorders
- Keloid scarring
- Pretibial myxoedema
- Vitiligo
- Suppression of reaction after cryotherapy
- Scalp Solution is used for the topical therapy of recalcitrant corticosteroid-responsive dermatoses of the scalp, including recalcitrant cases of psoriasis and seborrheic dermatitis.
Coal Tar Cream is used for psoriasis. Soritar Cream has a keratoplastic and antipruritic effect in psoriasis.
6% Salicylic Acid: This topical preparations treat the following common scaly conditions:
- Chronic atopic dermatitis
- Lichen simplex
- Psoriasis
- Seborrhoeic dermatitis
- Ichthiosis
12% Salicylic Acid: This topical preparations treat the following common scaly conditions:
- Warts (small excessive growths of skin caused by a type of virus. Warts often occur on the fingers or on the back of the hands).
- Verruca (occurs only on the sole of the feet and can be painful. It often looks like a small white ring of skin with a black dot in the centre).
- Corns and Calluses (are hard, thick pads of skin caused by pressure and friction. They usually occur on the feet due to poorly fitting shoes and can occur on the hands).
Flakeoff P 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 PsoriasisDandruff, Psoriasis, Seborrheic Dermatitis, Seborrhoeic Dermatitis of the ScalpAcne, Actinic Keratosis (AK), Alopecia Areata (AA), Atopic Dermatitis (AD), Blackheads, Chronic Eczema, Chronic cutaneous lupus erythematosus, Corns, Dandruff, Dermatitis, Contact, Dermatitis, Eczematous, Dermatitis, Eczematous of the scalp, Discoid Lupus Erythematosus (DLE), Foot Callus, Fungal skin infection, Furuncle, Hand Eczema, Hyperkeratosis, Hyperkeratosis follicularis et parafollicularis, Infections, Fungal, Infections, Fungal of the Skin Folds, Infections, Fungal of the face, Infections, Fungal of the feet, Infections, Fungal of the hand, Keratosis Palmaris et Plantaris, Lichen, Lichen Plano-Pilaris, Lichen Planus (LP), Lichen simplex chronicus, Molluscum Contagiosum, Musculoskeletal Pain, Neurodermatitis, Palmo-Plantar Pustulosis, Plantar Warts, Pruritus, Psoriasis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriasis of the scalp, Rash, Ringworm of the Skin, Ringworm of the scalp, Seborrheic Dermatitis, Seborrhoeic Dermatitis of the Scalp, Skin Infections, Bacterial, Verrucous Psoriasis, Warts, Calluses, Corticosteroid-responsive dermatoses, Keratinization disorders, Scaling, Scaling of skin, Scalp seborrhea, Superficial Fungal skin infection, Keratolysis
How Flakeoff P 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.
Coal tar ointment is a keratolytic. It works by slowing bacterial growth and loosening and softening scales and crust.
Salicylic acid directly irreversibly inhibits COX-1 and COX-2 to decrease conversion of arachidonic acid to precursors of prostaglandins and thromboxanes. Salicylate's use in rheumatic diseases is due to it's analgesic and anti-inflammatory activity. Salicylic acid is a key ingredient in many skin-care products for the treatment of acne, psoriasis, calluses, corns, keratosis pilaris, and warts. Salicylic acid allows cells of the epidermis to more readily slough off. Because of its effect on skin cells, salicylic acid is used in several shampoos used to treat dandruff. Salicylic acid is also used as an active ingredient in gels which remove verrucas (plantar warts). Salicylic acid competitively inhibits oxidation of uridine-5-diphosphoglucose (UDPG) with nicotinamide adenosine dinucleotide (NAD) and noncompetitively with UDPG. It also competitively inhibits the transferring of the glucuronyl group of uridine-5-phosphoglucuronic acid (UDPGA) to a phenolic acceptor. Inhibition of mucopoly saccharide synthesis is likely responsible for the slowing of wound healing with salicylates.
Dosage
Flakeoff P dosage
Nyclobate Cream & Ointment
Adults and children over 1 year:
• Apply sparingly to cover the affected area, and gently rub into the skin. Frequency of application is 2 to 3 times daily according to the severity of the condition. The total dose applied should not exceed 50 g weekly.
• 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 Clobetasol may be used to control exacerbations
Children below 1 year: Under 1 year this preparation is not recommended
Nyclobate Scalp Application
• It should be applied to the affected scalp areas twice daily, once in morning and once at night.
• Total dosage should not exceed 50 ml per week.
• As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved
Children: Under 1 year this preparation is not recommended.
Nyclobate Shampoo
• It should be applied to the dry (not wet) scalp once a day to the affected areas only.
• It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing.
• Treatment should be limited to 4 consecutive weeks.
• Total dosage of shampoo should not exceed 50 g per week.
• Under 18 years this preparation is not recommended.
Adults and children over 12 years of age: Ensure that the lesions are clean. Apply a thin layer of Coal Tar Cream two or three times a day on to the affected areas massage in gently and leave to dry.
For young children under 12 years of age and the elderly: The emulsion may be diluted by mixing it with a few drops of cooled freshly boiled in the palm of the hand.
Topical/Cutaneous (Adult)-
Hyperkeratotic and scaling skin conditions: As 1.8-3% preparation: Apply to affected area of the skin and/or scalp 1-4 times daily.
Acne: As 0.5-2% preparation: Apply thinly to affected area 1-3 times daily, reduce to once daily or every other day if dryness or peeling occur.
Warts and calluses:
- As 12-40% plaster: Fit over the wart/callus for 48 hr, repeat process 48 hrly as needed until wart/callus is removed (up to 12 wk for warts or up to 14 days for calluses).
- As 5-17% preparation in collodion-like vehicle: Apply a small amount to sufficiently cover wart/callus and allow to dry. Repeat 1-2 times daily until wart/callus is removed (up to 12 wk for warts or up to 14 days for calluses).
- As 15% preparation in karaya gum-glycol plaster vehicle: Smoothen warts with emery board and place a drop of warm water prior to application. Apply the plaster in the evening and leave in place for at least 8 hr to be removed in the morning. Repeat process 24 hrly, if necessary up to 12 wk.
Side Effects
Generally Clobetasol Propionate is well tolerated. However, few side effects after prolonged and intensive treatment may cause local atrophic changes in the skin such as Burning, itching, irritation, dry skin eczema.
Skin and subcutaneous tissue disorders: Skin irritation, photosensitivity of the skin, Coal Tar Cream may cause acne-like eruptions of the skin. There is an increased risk of skin cancer in psoriatic patients treated with a combination of Coal Tar Cream and UVB radiation has been reported. However epidemiological studies of patients treated with Coal Tar Cream on its own are inconclusive. The risk of toxicity should be taken into account when considering the prescribing this product for the patient.
An allergic reaction (shortness of breath, closing of the throat, swelling of the lips, face or tongue or hives) or severe skin irritation.
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]
LD50: Not available.
Oral rat LD50: 891 mg/kg. Inhalation rat LC50: > 900 mg/m3/1hr. Irritation: skin rabbit: 500 mg/24H mild. Eye rabbit: 100 mg severe. Investigated a mutagen and reproductive effector.
Precaution
Do not swallow. For external use only.
For external use only. Avoid contact with eyes and other mucous membranes.
Interaction
No hazardous interactions have been reported with use of Clobetasol Propionate.
Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.
Volume of Distribution
Data regarding the volume of distribution of clobetasole propionate are not readily available.
Intended for local use only, no systemic absorption.
The volume of distribution is about 170 mL/kg of body weight.
Elimination Route
Twice daily application of clobetasol foam leads to a Cmax of 59±36pg/mL with a Tmax of 5 hours. Clobetasol cream showed an increase in clobetasol concentrations from 50.7±96.0pg/mL to 56.3±104.7pg/mL.
Intended for local use only, no systemic absorption.
Half Life
Data regarding the half life of clobetasol propionate are not readily available.
Intended for local use only, no systemic absorption.
Clearance
Data regarding the clearance of clobetasol propionate are not readily available.
Intended for local use only, no systemic absorption.
Elimination Route
Corticosteroids are eliminated predominantly in the urine.
Intended for local use only, no systemic absorption.
About 10% is excreted unchanged in the urine.
Pregnancy & Breastfeeding use
The safe use of Clobetasol Propionate during pregnancy & lactation has not been established.
There is no direct evidence of the safety in pregnant and lactating mother. Coal tar preparations have been in use for many years without apparent ill-consequence. No harmful effects on the health of the child is anticipated with the proper use of coal tar. However it is recommended that the use of coal tar in pregnancy and lactation is restricted to intermittent use in low concentrations on a small percentage of body’s surface, use during the first trimester be avoided.
Pregnancy Category C. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.
Contraindication
Contraindicated in Cutaneous infections such as impetigo, tinea corporis and herpes simplex, Infestations such as scabies, Acne vulgaris, Hypersensitivity, Rosacea, Gravitational ulceration, Perioral dermatitis, Children under 1 year
Coal Tar should not be used when a patient has known sensitivity to Coal Tar or any of the other ingredients. If you have folliculitis and acne vulgaris. Coal Tar Cream should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight. Coal Tar Cream should not be applied to inflamed or broken skin. Warnings and precautions: For topical administration only. Coal Tar Cream may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued. Coal Tar enhances photosensitivity of the skin after applying Coal Tar Cream exposure to direct sunlight should be avoided. Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the eye, flush with normal saline solution or water. Do not apply to genital and rectal areas. Apply with caution to the face do not get in the eyes. Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be cause a delayed reaction.
It should not be used in any patient known to be sensitive to Salicylic Acid or any other listed ingredients.
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.
Salicylic Acid is used in children over 2 years.
Acute Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdose or misuse the features of hypercortisolism may appear.
There is no evidence that an overdose of topical Coal Tar Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Coal Tar Cream may require gastric lavage depending on the quantity taken and should be treated symptomatically.
An overdose of Salicylic Acid topical is unlikely to occur. If you do suspect an overdose or if the medication has been ingested, call a poison control center or emergency room for advice.
Storage Condition
Do not store above 30 0 C. Keep away from light and out of the reach of children. Do not freeze.
Store in a cool and dry place, protected from light.
Store at a temperature below 25° C.
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