Arobate S

Arobate S 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.

A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed) Sodium lactate is the sodium salt of lactic acid, and has a mild saline taste. It is produced by fermentation of a sugar source, such as corn or beets, and then, by neutralizing the resulting lactic acid to create a compound having the formula NaC3H5O3.

Lactic acid was one of active ingredients in Phexxi, a non-hormonal contraceptive agent that was approved by the FDA on May 2020.

Lactic acid produces a metabolic alkalinizing effect.

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.

Urea is an osmotic diuretic similar to mannitol but more irritant. It induces diuresis by increasing osmotic pressure of the glomerular filtrate and increasing excretion of sodium, potassium and chloride ions. Its osmotic effect also draws water from cells e.g. brain, CSF and anterior chamber of the eye, thereby decreasing intracranial or intraocular pressure. Unlike mannitol, urea penetrates the eye and causes a rebound increase in intraocular pressure if the plasma concentration of the drug is less than that in the vitreous humour. Applied topically, urea promotes hydration of keratin and mild keratolysis in dry skin. It increases water uptake by the stratum corneum and has an antipruritic effect.

As a humectant, urea draws water into the striatum corneum.

Trade Name Arobate S
Generic Urea + Salicylic Acid + Lactic Acid + Clobetasol Propionate
Weight 10%, 0.05%
Type Ointment, Cream
Therapeutic Class
Manufacturer Aryan
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Arobate S
Arobate S

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.

Lactic acid is an emollient and keratolytic used agent in various cosmetic products and used as an additive in various pharmaceutical products for its antibacterial properties.

For use as an alkalinizing agent.

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).

Urea 25% cream is used for the treatment of dry, cracked skin and hyperkeratosis on the soles of the feet including the heels. Suitable for general and diabetic foot care.

Arobate S 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 PsoriasisCorns, Dehydration, Fluid Loss, Hyperkeratosis, Lichenification, Shock, Hypovolemic, Vasoplegic Shock, Warts, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Moderate Metabolic acidosis, Chemical contraception, Electrolyte replacement, Fluid replacement therapy, Parenteral Nutrition, Peritoneal dialysis therapy, Urine alkalinization therapyAcne, 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, KeratolysisDermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dry Eyes, Dry Skin, Dry Skin; Eczema, Eczema, Dyshidrotic, Eye pruritus, Helicobacter Pylori Infection, Insect Bites, Lichen Planus (LP), Neurodermatitis, Nummular Dermatitis, Psoriasis, Seborrheic Dermatitis, Sunburn, Allergic skin manifestations, Anal eczema, Calluses, Moisturizing

How Arobate S 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.

Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

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

Arobate S 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.

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.

Apply a small amount twice daily to the skin after washing or bathing.

In extreme cases, before bed you may choose to cover the feet with plastic wrap and then put socks over the plastic wrap to increase the hydration rate.

Recommended for use on adults and children over 12 years.

After use, wear sandals or slippers to avoid staining carpets.

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.

An allergic reaction (shortness of breath, closing of the throat, swelling of the lips, face or tongue or hives) or severe skin irritation.

May irritate inflamed skin or exudative lesions. Transient stinging may occur in deep cracks. Discontinue use if local irritation or rash occurs during use.

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]

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.

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.

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.

About 10% is excreted unchanged in the urine.

Pregnancy & Breastfeeding use

The safe use of Clobetasol Propionate during pregnancy & lactation has not been established.

Pregnancy Category C. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.

Urea cream can be used during pregnancy and lactation.

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

It should not be used in any patient known to be sensitive to Salicylic Acid or any other listed ingredients.

For use only on the soles of the feet and heels unless otherwise directed by the prescriber. Pregnant women should consult their Healthcare Professional before use. For External Use Only. Avoid contact with eyes. Keep out of reach of children. Always replace cap after use. Do not use if tube seal is broken or appears tampered with.

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.

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 at a temperature below 25° C.

Store between 10° – 30° C in a dry place. Keep lid tightly closed.

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