Alclometasone Dipropionate - Indication, Dosage, Precautions, Side Effects, and Pharmacological Aspects

Drug Overview:

Eczema is a skin disorder marked by inflammation, itching, and redness that is frequently treated with Alclometasone dipropionate, a topical corticosteroid. The medicine significantly lessens pain and speeds up skin healing by reducing inflammatory reactions. A thin coating is applied to the afflicted areas of the skin, allowing the active component to penetrate and relieve the symptoms.

Excessive or extended use, however, may result in unfavorable side effects such as skin thinning, discoloration, or increased sensitivity. Doctors suggest taking the drug at the lowest viable dosage for the shortest possible time to reduce these hazards. This drug, especially when used under a doctor's supervision, can help those with mild to moderate eczema conditions. Regular monitoring and contact with medical specialists are essential to obtaining the best outcomes and reducing negative effects.

Drug Group: It belongs to the drug group - Topical corticosteroids.

Available Doses and Dosage Forms: It is available as a cream and an ointment and is intended only for dermatological (related to skin) purposes.

For Patients:

What is Eczema?

Eczema is an inflammatory skin disease that produces blisters, scaly areas, rashes, dry skin, itching, and infections of the skin. The most typical eczema symptom is itchy skin. The barrier function of the skin, which aids in retaining moisture and shielding the body from the external environment, is weakened by this disease.

What is the purpose of Alclometasone Dipropionate?

Alclometasone dipropionate is used to treat a number of skin issues, including eczema, dermatitis, allergies, and rashes. Alclometasone dipropionate lessens the redness, itchiness, and swelling that might develop in these disorders. This drug contains low- to medium-potency corticosteroids.

What Are the Things to Inform the Doctor Before Taking the Drug?

• If a patient has any allergies, including those to other corticosteroids (such as Hydrocortisone or Prednisone), notify the doctor or chemist before using Alclometasone.

• If a patient is trying to conceive or is pregnant.

• If the patient is a lactating mother.

• If there are signs of a large active infection, along with extensive areas of burned and damaged skin and noticeable thinning of the skin.

• Inform the physician or pharmacist about all of the medical conditions before using this drug, including diabetes (increase in blood sugar), immune system issues, and poor blood circulation.

How Is Alclometasone Dipropionate Administered?

Only topical use of the medicine is intended; it is not to be consumed orally. Without a doctor's specific permission, one should not use it on the face, groin, underarms, or to treat diaper rash. Hands must be well-cleaned and dried before application. As well as cleaning, the afflicted region has to be dried. Following a doctor's instructions, apply a little amount of the medication—typically two to three times daily—to the area that is affected and gently massage it in. The region should not be bandaged, covered, or wrapped unless specifically instructed to do so by a doctor.

Washing the hands after using medicine is advised, with the exception of situations when the drug is being used to treat one’s hands. It is important to avoid getting the medicine in one's eyes while applying it close to them because doing so might worsen or cause glaucoma. Additionally, it is crucial to keep the drug out of the mouth, nose, and eyes. If the medication gets on these areas, it is best to thoroughly rinse it off with water. Only the ailment for which it was given should be treated with the drug. Unless authorized to do so by a medical practitioner, giving this drug to a kid for more than three weeks straight is not recommended.

What Are the Side Effects of Alclometasone Dipropionate?

• Initial Side Effects:

  • Upon initial application, there may be burning, stinging, irritation, itching, redness of the skin, or drying.

  • As the body becomes used to the drug, these side effects should pass in a few days.

  • It is advisable to contact the doctor or pharmacist as soon as possible if these side effects intensify or persist.

• Late Side Effects:

  • Patients should contact their doctor right away if any severe adverse effects occur. Stretch marks, acne, thinning or discolored skin, and excessive or undesired hair growth are a few of them.

  • It is important to report folliculitis, which is characterized by little red pimples on the skin.

• Aggravation of Skin Infections:

  • The drug could make existing skin infections worse.

  • People should call the doctor right away if redness, swelling, or irritation do not go away.

• Absorption into the Bloodstream:

  • There is a small chance that the medicine will enter the bloodstream. It can result in unwanted corticosteroid effects.

  • Children and people who use the medicine often or for extended periods of time have a higher risk.

  • If one experiences unusual or excessive weariness, weight loss, a headache, swollen ankles or feet, increased thirst or urination, or eyesight issues, they should seek medical help immediately.

Missed Dose: If a dosage is forgotten, the person should take it as soon as they remember. It is advised to forgo the missed dosage and resume the regular dosing schedule if the following dose is almost due. To make up for a missed dosage, it is not recommended to double the dose, therefore, avoid doing so. The success and safety of the medicine depend on consistent adherence to the recommended dose schedule.

Overdose: If consumed, this medication can be dangerous. Call emergency services if someone has overdosed and displays dangerous symptoms like fainting or difficulty breathing.

Storage and Disposal: In accordance with the detailed instructions supplied, the person must guarantee correct pharmaceutical storage, selecting either refrigeration or room temperature. All prescription drugs must be kept out of the reach of children and animals. Unless otherwise directed, medication disposal should not be done down the sink or toilet. The product should be properly disposed of once its expiration date has passed if it is no longer needed. A chemist or nearby waste management agency should be consulted for disposal advice.

For Doctors:

Indication: Alclometasone dipropionate cream and ointment are categorized as low to medium-potency corticosteroids, specifically intended to alleviate inflammatory and itchy symptoms associated with corticosteroid-responsive dermatoses. These products are suitable for use in pediatric patients aged one year and older; however, it is important to note that there is insufficient evidence to determine the safety and effectiveness of using the medication for periods longer than three weeks. It is not advised to employ Alclometasone dipropionate cream and ointment in pediatric patients below the age of one year, as there is a lack of established safety and efficacy data for this age group.

Dose and Administration:

• A thin layer of Alclometasone dipropionate cream or ointment should be applied to the troubled skin areas two or three times daily. The patient should then gently massage the area until the drug is completely absorbed.

• It is not advised to use Alclometasone dipropionate cream or ointment in combination with occlusive dressings unless expressly told to do so by a medical practitioner.

• After control is attained, treatment should be stopped. Reassessing the diagnosis could be required if there is no improvement after two weeks.

• Pediatric Patients - Pediatric patients one year of age and older can use Alclometasone dipropionate cream and ointment, according to the manufacturer. The effectiveness and safety of using Alclometasone dipropionate cream or ointment in pediatric patients for longer than three weeks have not yet been established. Pediatric patients under the age of one year should not use Alclometasone dipropionate cream or ointment.

• Geriatric Patients - The safety of Alclometasone dipropionate cream or ointment in elderly patients (65 years of age or older) did not differ from that in younger patients; hence, no dose change is advised.

What Are the Pharmacological Aspects of Alclometasone Dipropionate?

• Physical Properties of the Drug:

  • Drug Group - Corticosteroids.

  • Appearance - White powder.

  • Empirical Formula - C28H37CIO7.

  • Molecular Weight - 521.

  • Solubility - Does not dissolve (insoluble) in water, however, it does dissolve in propylene glycol (slightly soluble) and hexylene glycol (moderately soluble) to varying degrees.

  • Components of the Drug -

    • For Cream:

    1. Active Ingredient: Each gram of the cream contains 0.5 mg of Alclometasone dipropionate.
    2. Cream Base Ingredients: Propylene glycol, Ceteth-20, white petrolatum, Cetearyl Alcohol, PEG 100 stearate, glyceryl stearate, chlorocresol, phosphoric acid, monobasic sodium phosphate, and purified water.
    3. Together, these ingredients make up the hydrophilic, emollient cream composition for Alclometasone dipropionate.
    • For Ointment: Each gram of ointment comprises 0.5 milligrams of Alclometasone dipropionate in an ointment base comprising propylene glycol stearate, hexylene glycol, white petrolatum, and white wax.

• Mechanism of Action: Alclometasone dipropionate possesses anti-inflammatory, anti-pruritic, and vasoconstrictive qualities like other topical corticosteroids. The overall mechanism behind the anti- inflammatory effect of topical steroids is unknown. However, it is hypothesized that corticosteroids generate lipocortins, which are proteins that block phospholipase A2. These proteins are thought to regulate the manufacture of powerful inflammatory mediators like prostaglandins and leukotrienes by preventing the release of their precursor, arachidonic acid. Phospholipase A2 causes the release of arachidonic acid from membrane phospholipids.

• Pharmacokinetics: The composition of the medication and the condition of the skin's protective barrier are two elements that have an impact on how much topical corticosteroids are absorbed through the skin. Occlusion over a 96-hour period greatly improves penetration, however, the use of occlusive dressings with hydrocortisone for up to 24 hours has not demonstrated a noticeably increased rise in penetration. It is crucial to remember that topical corticosteroids can still enter the body through healthy skin. This can further increase the rate of percutaneous absorption when the skin is inflamed or has other pathological conditions. Research using a radiolabeled ointment formulation was done to evaluate the systemic absorption and excretion of Alclometasone dipropionate. According to the study, when the steroid came into contact with the undamaged skin of the healthy participants, about three percent of it was absorbed over the course of eight hours.

What Are the Contraindications of Alclometasone Dipropionate?

• Patients having a history of hypersensitivity to any of the ingredients present in Alclometasone dipropionate should avoid using it.

Warnings and Precautions:

• General - When topical corticosteroids are absorbed systemically, the hypothalamic-pituitary-adrenal (HPA) axis may be temporarily suppressed, which might result in glucocorticosteroid insufficiency. While still receiving therapy, some patients may exhibit signs of Cushing syndrome, hyperglycemia, and glucosuria as a result of the topical corticosteroids' systemic absorption. People who often apply topical steroids to large areas of the skin or to occluded skin areas should be periodically assessed for any indications of HPA axis suppression. If HPA axis suppression is seen, an effort should be made to stop using the medication, cut back on how often it is applied, or switch to a less strong corticosteroid. Following the cessation of topical corticosteroids, the HPA axis function usually returns quickly. Rarely, glucocorticosteroid insufficiency signs and symptoms may appear, necessitating additional systemic corticosteroids.

• Pediatric Patients - Given the greater skin surface area to body mass ratios, pediatric patients may be more vulnerable to systemic toxicity at equal dosages.

• If irritation occurs, stop using Alclometasone dipropionate and start the proper treatment. Instead of seeing a clinical aggravation, like with most topical treatments that do not include corticosteroids, allergic contact dermatitis with corticosteroids is often diagnosed by watching a failure to recover. Such a finding has to be supported by proper diagnostic patch testing. Use the proper antifungal or antibacterial agent if concurrent skin infections are already present or are developing.

What Are the Adverse Reactions of Alclometasone Dipropionate?

• About two percent of patients have experienced the local side effects of itching and burning, erythema, dryness, irritation, and papular rashes when using Alclometasone dipropionate cream.

• Itching, burning, and erythema are some of the local adverse effects to Alclometasone dipropionate ointment application that have been seen in about one1 percent of patients. Moreover, although uncommon, the following additional local adverse responses may appear more frequently when topical corticosteroids are used with occlusive dressings. Folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria are the responses that are listed in roughly descending order of frequency.

Specific Considerations:

• Pregnancy - It comes under pregnancy category C. Studies have shown that corticosteroids, even at modest doses, when given systemically to laboratory animals, can cause birth abnormalities. Additionally, when administered to the skin of laboratory animals, several corticosteroids have been proven to cause teratogenic effects. However, thorough and well-planned studies with expectant women are scarce. Only when the benefits outweigh the potential hazards to the developing fetus is it advised to use Alclometasone dipropionate cream or ointment during pregnancy.

• Lactation - Corticosteroids administered through systemic means can be found in human breast milk, potentially leading to growth suppression, disruption of natural corticosteroid production, or other adverse effects. Uncertainty surrounds the possibility of systemic absorption of topically administered corticosteroids and their appearance in human milk. When assessing whether nursing moms should use Alclometasone dipropionate cream or ointment, it is advised to proceed with caution because many drugs are secreted in breast milk.

• Pediatric Population -

  • When children use topical corticosteroids, HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have all been documented. Low plasma cortisol levels and no response to ACTH stimulation are two signs of adrenal suppression in pediatric patients. Bilateral papilledema, headaches, and swollen fontanelles are signs of intracranial hypertension.

  • Pediatric patients who are at least one year old should be carefully assessed for treatment with Alclometasone dipropionate cream and ointment. It is crucial to remember that the usefulness and safety of using the medicine for more than three weeks have not yet been proven. Results from rigorous and well-controlled trials involving kids with skin diseases that respond to corticosteroids provide support for the use of Alclometasone dipropionate cream and ointment in pediatric patients.

  • It is not advised to use Alclometasone dipropionate cream and ointment on pediatric patients under the age of one since its safety and effectiveness are yet unknown in this population. Children are more susceptible to potential side effects, such as suppression of the hypothalamic-pituitary-adrenal (HPA) axis and the onset of Cushing syndrome, when treated with topical corticosteroids, because they have a relatively larger skin surface area to body mass ratio than adult patients. As a result, children are more likely to develop adrenal insufficiency during or after treatment cessation. Inappropriate topical corticosteroid usage in babies and children has been linked to adverse consequences, including striae.

  • Diaper dermatitis cannot be treated with Alclometasone dipropionate.

• Geriatric Population - During clinical studies carried out in the United States, a small group of people aged 65 and above were given treatment with Alclometasone dipropionate cream and ointment. This older patient group's sample size was too small to enable a separate examination of both effectiveness and safety measures. Notably, geriatric individuals utilizing Alclometasone dipropionate ointment reported no adverse reactions. Furthermore, just one negative reaction to Alclometasone dipropionate cream was noted among this group, and it was similar to the reactions noted by younger patients. There is no reason to change the dosage of Alclometasone dipropionate cream and ointment for elderly patients, according to the currently available dataset.