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Clobetasol Cream Cream or Ointment – Clobetasol Propionate Cream USP 0.05%

Clobetasol propionate cream or ointment contains the active compound clobetasol propionate 0.05%, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β) – 21 – chloro – 9 – fluoro – 11 – hydroxy – 16 – methyl – 17 – (1 – oxopropoxy) – pregna – 1,4 – diene – 3,20 – dione  and it has the following structural formula:

Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol propionate cream contains clobetasol propionate 0.5 mg|g in an emollient base of cetomacrogol 1000, cetostearyl alcohol, citric acid, dimethicone 350, imidurea, isopropyl myristate, propylene glycol, purified water, and sodium citrate.

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Clobetasol Cream – Clinical Pharmacology

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and|or other disease processes in the skin may increase percutaneous absorption. Studies performed with clobetasol propionate cream (emollient) indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Clobetasol propionate cream (emollient) is a super-high potencycorticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g|week because of the potential for the drug  to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

In the treatment of moderate to severe plaque-type psoriasis, clobetasol propionate cream (emollient) applied to 5 % to 10 % of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g|week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of.

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Clobetasol Cream is used for:

  • itching
  • redness
  • swelling associated with countless skin conditions.

Clobetasol Cream or Ointment is a topical corticosteroid. It works by decreasing specific immune responses, which lowers redness and itching of skin.

Contraindications

Clobetasol propionate cream (emollient) is contraindicated in those  patients with a history of hypersensitivity to any of the components of  the preparation.

Do NOT utilize Clobetasol Ointment or Cream if you are allergic to any ingredient in Clobetasol Cream. Contact your doctor or health care supplier immediately if any of these apply to you.

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Before using Clobetasol Cream:

Some medical conditions might interact with Clobetasol Cream. Inform your doctor or pharmacist if you need any sort of medical conditions, particularly if any of the following apply to you:

  • if you are pregnant, organizing to become pregnant, or are breast-feeding
  • if you are taking any sort of prescribed or nonprescription medicine, herbal preparation, or nutritional supplement
  • if you need allergies to medicines, foods, or additional materials
  • if you need measles, tuberculosis (TB), chickenpox, shingles, or have needed a current vaccination
  • if you have a skin infection or thinning of the skin (atrophy)

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Some MEDICINES COULD INTERACT by having Clobetasol Cream. Nevertheless, no particular interactions by having Clobetasol Cream are recognized at this time.

Ask your health care supplier if Clobetasol Cream might interact by having further medicines that you take. Consult your health care provider before you start, stop, or alter the dose of any sort of medicine.

How to Use Clobetasol Cream:

  • Apply a small amount of medicine to the afflicted area. Softly rub the medicine in till it is evenly circulated. Wash your hands right away after applying Clobetasol Cream, unless your hands are part of the treated area. Do not bandage or wrap the affected area unless directed normally by your specialist.
  • Treatment should be limited to 2 consecutive weeks.
  • If you miss out on a dosage of Clobetasol Cream, use it as quickly as feasible. If it is practically time for your next dose, skip the missed out on serving and go back to your routine dosing timetable. Do not make use of 2 doses at once.

Ask your health care carrier any questions you might have about how to use Clobetasol Cream.

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Necessary protection details:

  • Do not use greater than 50 grams per week.
  • Avoid contact with the eyes.
  • Do not make use of Clobetasol Cream for further skin conditions at a later time.
  • Do not make use of Clobetasol Cream for diaper eruption.
  • Clobetasol Cream has a corticosteroid in it. Before you start any brand-new medicine, check the label to watch if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Corticosteroids may influence growth rate in KIDS and teens in some situations. They might require routine development checks while they make use of Clobetasol Cream.
  • Clobetasol Cream must be made use of by having exceptional caution in LITTLE ONES; safety and usefulness in little ones have not been affirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, check with your specialist. You will definitely should discuss the advantages and hazards of using Clobetasol Cream while you are pregnant. It is not known if Clobetasol Cream is discovered in breast milk after topical usage. If you are or will definitely be breast-feeding while you use Clobetasol Cream, check with your doctor. Talk about any possible hazards to your baby.

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Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g|day. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a dose to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppression.

In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, clobetasol propionate cream (emollient) applied to 5 % to 10 % of body surface area resulted in additional benefits in the treatment of patients for 4 consecutive weeks. In thistrial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction. Therefore, the additional benefits of extending treatment beyond 2 weeks should be weighed against the potential for HPA suppression.

Therapy should be discontinued when control has been achieved. Treatment beyond 4 consecutive weeks is not recommended. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids.

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Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. The use of clobetasol propionate cream (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.

If irritation develops, clobetasol propionate cream (emollient) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of clobetasol propionate cream (emollient) should be discontinued until the infection has been adequately controlled.

Clobetasol propionate cream (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

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Information for Patients

Patients using topical corticosteroids should receive the following  information and instructions:

  • This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • This medication should not be used for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
  • Patients should report any signs of local adverse reactions to the physician.
  • Patients should inform their physicians that they are using clobetasol propionate cream (emollient) if surgery is contemplated.
  • This medication should not be used on the face, underarms, or groin areas.
  • As with other corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, contact the physician.

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Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis  suppression:

  • ACTH stimulation test
  • A.M. plasma cortisol test
  • Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg|kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

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Pregnancy

Teratogenic Effects – Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals  when administered systemically at relatively low dosage levels. Some  corticosteroids have been shown to be teratogenic after dermal  application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the  rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in  fetotoxicity at the highest dose tested (1 mg|kg) and teratogenicity at  all dose levels tested down to 0.03 mg|kg. These doses are approximately  1.4 and 0.04 times, respectively, the human topical dose of clobetasol  propionate cream (emollient). Abnormalities seen included cleft palate  and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10  mcg|kg. These doses are approximately 0.02 and 0.05% times, respectively,  the human topical dose of clobetasol propionate cream (emollient).  Abnormalities seen included cleft palate, cranioschisis, and other  skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic  potential of clobetasol propionate in pregnant women. Clobetasol  propionate cream (emollient) should be used during pregnancy only if the  potential benefit justifies the potential risk to the fetus.

Nursing Mothers 

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate cream (emollient) is administered to nursing woman.

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Pediatric Use

Safety and effectiveness of clobetasol propionate cream (emollient) in  pediatric patients have not been established. Use in pediatric patients  under 12 years of age is not recommended. For continued use beyond 2  consecutive weeks, the safety of clobetasol propionate cream (emollient)  has not been studied. Because of a higher ratio of skin surface area to  body mass, pediatric patients are at a greater risk than adults of HPA  axis suppression and Cushing’s syndrome when they are treated with  topical corticosteroids. They are therefore also at greater risk of  adrenal insufficiency during or after withdrawal of treatment. Adverse  effects including striae have been reported with inappropriate use of  topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation,  delayed weight gain, and intracranial hypertension have been reported in  children receiving topical corticosteroids. Manifestations of adrenal  suppression in children include low plasma cortisol levels and absence  of response to ACTH stimulation. Manifestations of intracranial  hypertension include bulging fontanelles, headaches, and bilateral  papilledema.

Clinical studies of clobetasol propionate emollient cream, 0.05%  in US  clinical trials did not include sufficient numbers of subjects aged 65  and over to determine whether they respond differently from younger  subjects. Other reported clinical experience has not identified  differences in responses between the elderly and younger patients. In  general, dose selection for an elderly patient should be cautious.

Adverse Effects in Using Clobetasol Ointment or Cream

In controlled trials by having all clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritus, irritation, erythema, folliculitis, cracking and fissuring of the skin, tingling of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia.

The occurrence of neighborhood unfavorable reactions reported in the trials with clobetasol propionate cream was 2 % of patients treated with the exception of burning/stinging, which took place in 5 % of treated sufferers. Cushing’s disorder has been reported in infants and adults as a result of extended usage of other topical clobetasol propionate formulations. The following added local unfavorable reactions are reported infrequently with topical corticosteroids, however could transpire more frequently by having super-high effectiveness corticosteroids such as clobetasol propionate cream.

These reactions are detailed in an approximately decreasing order of incident: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, hypersensitive contact dermatitis, secondary infection, striae, and miliaria. Overdosage Topically applied clobetasol propionate cream  can be absorbed in enough amounts to produce systemic effects. Clobetasol Cream Dosage and Administration Apply a thin layer of clobetasol propionate cream to the affected skin areas twice day-to-day and rub in gently and entirely. Clobetasol propionate cream (emollient) is a super-high potency topical corticosteroid; for that reason, therapy really should be limited to 2 consecutive weeks and amounts greater than 50 g/week must not be utilized.

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In moderate to serious plaque-type psoriasis, clobetasol propionate cream applied to 5 % to 10 % of body surface area can be depleted to 4 weeks. The total amount ought to not extend past 50 g/week. When dosing for beyond 2 weeks, any sort of additional benefits of extending treatment really should be weighed against the risk of HPA suppression. As with additional highly active corticosteroids, treatment must be ceased when control has been accomplished. If no improvement is viewed within 2 weeks, reassessment of diagnosis might be required. Therapy further than 4 consecutive weeks is not suggested. Use in pediatric patients under 16 years of age has not been studied. Clobetasol propionate cream (emollient) ought to not be utilized with occlusive dressings.

Possible side effects of Clobetasol Cream:

All medicines may create side effects, yet many people have no, or minor, side effects. Consult your specialist if any of these most TYPICAL side effects persist or turn into bothersome irritation and stinging.

Seek medical attention without delay if any of these SERIOUS side effects happen:

  • Severe allergic reactions (eruption; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eliminating; itching; redness; skin thinning or splotch; swelling.

This is not a complete listing of all side effects that may arise. If you need questions about side effects, contact your health care company. Call your specialist for medical guidance about side effects. To describe side effects to the proper agency, please review the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your neighborhood poison control center, or emergency room instantly. Clobetasol Cream could be damaging if ingested.

Appropriate storage of Clobetasol Cream:

Outlet Clobetasol Cream at room climate, between 68 and 77 degrees F (20 and 25 qualifications C), in a firmly closed container. Shop away from heat, moisture, and light. Do not make use of near an open flame. Keep Clobetasol Cream out of the reach of youngsters and beyond pets.

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General data:

If you have any sort of questions about Clobetasol Cream, please talk by having your physician, pharmacist, or other health care carrier.

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Clobetasol Cream is to be made use of just by the person for whom it is prescribed. Do not share it with further individuals.

If your signs do not enhance or if they become worse, check with your specialist.

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