DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Alclometasone dipropionate cream USP and Alclometasone dipropionate ointment USP are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream USP and Alclometasone dipropionate ointment USP may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since the safety and efficacy of Alclometasone dipropionate cream USP and Alclometasone dipropionate ointment USP have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Alclometasone dipropionate cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid 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.
The effects of Alclometasone dipropionate cream and ointment on the HPA axis have been evaluated. In one study, Alclometasone dipropionate cream and ointment were applied to 30% of the body twice daily for 7 days, and occlusive dressings were used in selected patients either 12 hours or 24 hours daily. In another study, Alclometasone dipropionate cream was applied to 80% of the body surface of normal subjects twice daily for 21 days with daily 12-hour periods of whole body occlusion. Average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids were decreased (about 10%), suggesting suppression of the HPA axis under these conditions. Plasma cortisol levels have also been demonstrated to decrease in pediatric patients treated twice daily for 3 weeks without occlusion.
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, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface area to body mass ratios.
If irritation develops, Alclometasone dipropionate cream or ointment 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 Alclometasone dipropionate cream or ointment should be discontinued until the infection has been adequately controlled.
In a transgenic mouse study, chronic use of Alclometasone dipropionate cream led to an increased number of animals with benign neoplasms of the skin at the treatment site. The clinical relevance of the findings in animal studies to humans is not clear.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
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
Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of Alclometasone dipropionate. The effects of Alclometasone dipropionate on mutagenesis or fertility have not been evaluated.
In a 26-week dermal carcinogenicity study conducted in transgenic mice, topical application once daily of both the vehicle cream and the 0.05% Alclometasone dipropionate cream significantly increased the incidence of benign neoplasms of the skin in both sexes at the treatment site when compared to untreated controls. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.
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 in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Alclometasone dipropionate cream or ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 topical 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 Alclometasone dipropionatecream or ointment is administered to a nursing woman.
Alclometasone dipropionate cream and ointment may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Use of Alclometasone dipropionate cream and ointment is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since the safety and efficacy of Alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, its use in this age-group is not recommended. 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 syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying Alclometasone dipropionate cream or ointment to >20% of the body surface area are at higher risk for HPA axis suppression.
HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Alclometasone dipropionate cream or ointment should not be used in the treatment of diaper dermatitis.
A limited number of patients at or above 65 years of age have been treated with Alclometasone dipropionate cream and ointment in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with Alclometasone dipropionate ointment in geriatric patients, and the single adverse reaction reported with Alclometasone dipropionate cream in this population was similar to those reactions reported by younger patients. Based on available data, no adjustment of dosage of Alclometasone dipropionate cream and ointment in geriatric patients is warranted.
The following local adverse reactions have been reported with Alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes.
The following local adverse reactions have been reported with Alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Topically applied Alclometasone dipropionate cream and ointment can be absorbed in sufficient amounts to produce systemic effects.
DOSAGE AND ADMINISTRATION
Apply a thin film of Alclometasone dipropionate cream USP or Alclometasone dipropionate ointment USP to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.
Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of Alclometasone dipropionate cream or ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with Alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Alclometasone dipropionate cream USP, 0.05% is supplied in:
15-g tubes (NDC 68462-300-17)
45-g tubes (NDC 68462-300-47)
60-g tubes (NDC 68462-300-65)
Alclometasone dipropionate ointment USP, 0.05% is supplied in:
15-g tubes (NDC 68462-299-17)
45-g tubes (NDC 68462-299-47)
60-g tubes (NDC 68462-299-65)
Store between 2° and 30°C (36° and 86°F).
Glenmark Pharmaceuticals Ltd.
Village Kishanpura, Baddi Nalagarh Road
District: Solan, Himachal Pradesh - 174101, India
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
Alclometasone pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Alclometasone available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Alclometasone destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Alclometasone Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Alclometasone pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Alclometasone?
Depending on the reaction of the Alclometasone after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alclometasone not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Alclometasone addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Alclometasone, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Alclometasone consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology