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Ala-Scalp
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- Active ingredient
- Hydrocortisone 20 mg/1 mL
- Other brand names
- Alacort (by Crown Laboratories)
- Alkindi (by Eton Pharmaceuticals, Inc.)
- Anusol (by Salix Pharmaceuticals, Inc)
- Cortef (by Pharmacia & Upjohn Company Llc)
- Cortenema (by Ani Pharmaceuticals, Inc.)
- Home Papkit (by International Brand Management, Llc)
- Hydrocortisone (by Actavis Pharma, Inc.)
- Hydrocortisone (by Actavis Pharma, Inc.)
- Hydrocortisone (by Aidarex Pharmaceuticals Llc)
- Hydrocortisone (by Aidarex Pharmaceuticals Llc)
- Hydrocortisone (by Allegis Holdings Llc)
- Hydrocortisone (by Amneal Pharmaceuticals of New York Llc)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Aurobindo Pharma Limited)
- Hydrocortisone (by Avpak)
- Hydrocortisone (by Chartwell Rx, Llc)
- Hydrocortisone (by Chartwell Rx, Llc.)
- Hydrocortisone (by Crown Laboratories)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by Eywa Pharma Inc)
- Hydrocortisone (by Heritage Pharmaceuticals Inc. D/B/a Avet Pharmaceuticals Inc)
- Hydrocortisone (by Major Pharmaceuticals)
- Hydrocortisone (by Mylan Pharmaceuticals Inc.)
- Hydrocortisone (by Padagis Israel Pharmaceuticals Ltd)
- Hydrocortisone (by Padagis Israel Pharmaceuticals Ltd)
- Hydrocortisone (by Remedyrepack Inc.)
- Hydrocortisone (by Sportpharm, Inc. Dba Sportpharm)
- Hydrocortisone (by Sportpharm, Inc. Dba Sportpharm)
- Hydrocortisone (by Strides Pharma Inc.)
- Hydrocortisone (by Strides Pharma Science Limited)
- Hydrocortisone (by Sun Pharmaceutical Industries, Inc.)
- Hydrocortisone (by Teligent Pharma, Inc.)
- Hydrocortisone (by Teligent Pharma, Inc.)
- Hydrocortisone (by Trifluent Pharma Llc)
- Hydrocortisone Rectal Suspension (retention) (by Chartwell Rx Llc)
- Khindivi (by Eton Pharmaceuticals, Inc.)
- Procto-Med Hc (by Leading Pharma, Llc)
- Procto-Med Hc (by Leading Pharma, Llc)
- Proctocort (by Salix Pharmaceuticals, Inc)
- Proctosol-Hc (by Sun Pharmaceutical Industries, Inc.)
- Proctozone-Hc (by Rising Pharma Holdings, Inc.)
- Texacort (by Mission Pharmacal Company)
- View full label-group details →
- Drug class
- Corticosteroid
- Dosage form
- Lotion
- Route
- Topical
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- January 8, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Hydrocortisone 20 mg/1 mL
- Other brand names
- Alacort (by Crown Laboratories)
- Alkindi (by Eton Pharmaceuticals, Inc.)
- Anusol (by Salix Pharmaceuticals, Inc)
- Cortef (by Pharmacia & Upjohn Company Llc)
- Cortenema (by Ani Pharmaceuticals, Inc.)
- Home Papkit (by International Brand Management, Llc)
- Hydrocortisone (by Actavis Pharma, Inc.)
- Hydrocortisone (by Actavis Pharma, Inc.)
- Hydrocortisone (by Aidarex Pharmaceuticals Llc)
- Hydrocortisone (by Aidarex Pharmaceuticals Llc)
- Hydrocortisone (by Allegis Holdings Llc)
- Hydrocortisone (by Amneal Pharmaceuticals of New York Llc)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Ani Pharmaceuticals, Inc.)
- Hydrocortisone (by Aurobindo Pharma Limited)
- Hydrocortisone (by Avpak)
- Hydrocortisone (by Chartwell Rx, Llc)
- Hydrocortisone (by Chartwell Rx, Llc.)
- Hydrocortisone (by Crown Laboratories)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by E. Fougera & Co. a Division of Fougera Pharmaceuticals Inc.)
- Hydrocortisone (by Eywa Pharma Inc)
- Hydrocortisone (by Heritage Pharmaceuticals Inc. D/B/a Avet Pharmaceuticals Inc)
- Hydrocortisone (by Major Pharmaceuticals)
- Hydrocortisone (by Mylan Pharmaceuticals Inc.)
- Hydrocortisone (by Padagis Israel Pharmaceuticals Ltd)
- Hydrocortisone (by Padagis Israel Pharmaceuticals Ltd)
- Hydrocortisone (by Remedyrepack Inc.)
- Hydrocortisone (by Sportpharm, Inc. Dba Sportpharm)
- Hydrocortisone (by Sportpharm, Inc. Dba Sportpharm)
- Hydrocortisone (by Strides Pharma Inc.)
- Hydrocortisone (by Strides Pharma Science Limited)
- Hydrocortisone (by Sun Pharmaceutical Industries, Inc.)
- Hydrocortisone (by Teligent Pharma, Inc.)
- Hydrocortisone (by Teligent Pharma, Inc.)
- Hydrocortisone (by Trifluent Pharma Llc)
- Hydrocortisone Rectal Suspension (retention) (by Chartwell Rx Llc)
- Khindivi (by Eton Pharmaceuticals, Inc.)
- Procto-Med Hc (by Leading Pharma, Llc)
- Procto-Med Hc (by Leading Pharma, Llc)
- Proctocort (by Salix Pharmaceuticals, Inc)
- Proctosol-Hc (by Sun Pharmaceutical Industries, Inc.)
- Proctozone-Hc (by Rising Pharma Holdings, Inc.)
- Texacort (by Mission Pharmacal Company)
- View full label-group details →
- Drug class
- Corticosteroid
- Dosage form
- Lotion
- Route
- Topical
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- January 8, 2025
- Manufacturer
- Derm Ventures LLC
- Registration number
- ANDA083231
- NDC root
- 77052-010
- FDA Insert
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Hydrocortisone is a topical corticosteroid, which is a type of synthetic steroid used to reduce inflammation and relieve itching. It is commonly found in products like hydrocortisone lotion, which contains 20 mg of hydrocortisone per mL. This medication is specifically indicated for treating inflammatory and itchy skin conditions that respond to corticosteroids.
When applied to the skin, hydrocortisone works by being absorbed through the skin barrier, where it helps to alleviate symptoms associated with various skin disorders. Its effectiveness can be enhanced when used with occlusive dressings, which help to increase absorption and improve treatment outcomes for stubborn skin issues.
Uses
Hydrocortisone Lotion is used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. If you’re experiencing discomfort from these skin issues, this lotion can provide some relief.
It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.
Dosage and Administration
When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. Depending on how severe your condition is, you may need to do this two to four times a day. It's important to follow this schedule to help manage your symptoms effectively.
If you're dealing with psoriasis or other stubborn skin conditions, you might consider using occlusive dressings, which are coverings that help keep the medication in contact with your skin. However, if you notice any signs of infection, such as increased redness or pus, you should stop using the dressings immediately and consult your healthcare provider for appropriate treatment.
What to Avoid
You should avoid using Hydrocortisone Lotion if you have a history of hypersensitivity (allergic reactions) to any of its ingredients. If you experience irritation while using the lotion, stop using it immediately and seek appropriate treatment. Additionally, if you have a skin infection, it's important to treat that infection with the right antifungal or antibacterial medication before using the lotion. If you do not see improvement in your infection quickly, discontinue the use of the corticosteroid until the infection is properly managed.
Side Effects
You may experience some local side effects when using topical corticosteroids, including burning, itching, irritation, and dryness of the skin. Other possible reactions are folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acne-like eruptions, and changes in skin color. In some cases, you might also notice perioral dermatitis (a rash around the mouth), allergic contact dermatitis, or skin thinning. If you develop irritation, it's important to stop using the product and seek appropriate treatment.
There are also general precautions to consider. Using topical corticosteroids can lead to systemic absorption, which may cause issues like adrenal suppression (a decrease in hormone production), Cushing's syndrome (a condition caused by excess cortisol), and elevated blood sugar levels. In children, these medications can result in growth delays and other serious effects, such as increased pressure in the brain. If you notice any concerning symptoms, consult your healthcare provider for guidance.
Warnings and Precautions
This medication is for external use only and should not be applied to the eyes. It is important to use it as directed by your healthcare provider, as it is available by prescription only.
Be aware that using topical corticosteroids can sometimes lead to serious side effects, such as hormonal imbalances (HPA axis suppression), which may cause symptoms like Cushing's syndrome (a condition caused by excess cortisol), high blood sugar, and glucose in the urine. If you are using a strong steroid over a large area of skin or under a bandage, your doctor may recommend tests like the urinary free cortisol test or ACTH stimulation test to monitor your hormone levels. If you notice any irritation, stop using the medication and consult your doctor for further guidance. Additionally, if you have a skin infection, make sure to treat it with the appropriate antifungal or antibacterial medication before continuing with the corticosteroid.
If you experience any irritation or if your skin infection does not improve quickly, discontinue use and contact your healthcare provider for advice.
Overdose
When using topical corticosteroids (medications applied to the skin to reduce inflammation), it's important to be aware that they can sometimes be absorbed into your body in amounts that may lead to systemic effects (effects that impact the entire body). This means that even though you are applying the medication to your skin, it can still affect other parts of your body.
If you suspect an overdose, look for signs such as unusual changes in mood, weight gain, or increased thirst. If you notice any of these symptoms or feel unwell, it’s crucial to seek medical help immediately. Always consult your healthcare provider if you have concerns about the use of topical corticosteroids or if you experience any unexpected side effects.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to be cautious with corticosteroids, which are a type of medication often used to reduce inflammation. These medications are classified as Pregnancy Category C, meaning that while they may be necessary for some conditions, their safety during pregnancy has not been fully established. Laboratory studies have shown that corticosteroids can cause birth defects (teratogenic effects) in animals, especially when used in high doses or for long periods.
Because there are no well-controlled studies in pregnant women regarding the use of topical corticosteroids (those applied to the skin), you should only use them if your healthcare provider believes the benefits outweigh the potential risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for prolonged periods during your pregnancy. Always consult with your healthcare provider before starting or continuing any medication while pregnant.
Lactation Use
When using corticosteroids while breastfeeding, it's important to be aware of how they may affect you and your baby. While it is unclear if applying corticosteroids to the skin can lead to enough absorption into your bloodstream to appear in breast milk, systemic (taken into the body) corticosteroids are known to be present in breast milk in amounts that are unlikely to harm your infant.
However, it's wise to be cautious when using topical corticosteroids (those applied directly to the skin) while nursing. Always consult with your healthcare provider to ensure the safety of both you and your baby.
Pediatric Use
When using topical corticosteroids (medications applied to the skin) for children, it's important to be aware that they may be more sensitive to side effects than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious issues like adrenal suppression (a condition where the body doesn't produce enough hormones) and Cushing's syndrome (a hormonal disorder caused by high levels of cortisol). Signs of these conditions can include slowed growth, delayed weight gain, low cortisol levels, and in some cases, increased pressure in the brain, which may show up as headaches or bulging fontanelles (the soft spots on a baby's head).
To minimize risks, you should use the smallest effective amount of topical corticosteroids for your child and avoid long-term use whenever possible, as prolonged treatment can affect their growth and development. Always consult with your child's healthcare provider for guidance on the appropriate use of these medications.
Geriatric Use
When it comes to using ALA-SCALP (hydrocortisone lotion) for older adults, there is no specific information available regarding age-related considerations, dosage adjustments, or safety precautions. This means that the drug insert does not provide guidance on how the medication may affect elderly patients differently compared to younger individuals.
If you are caring for an older adult who may need this treatment, it’s important to consult with a healthcare professional. They can help determine the best approach and ensure that any potential risks are managed appropriately. Always prioritize open communication with your healthcare provider about any concerns or questions you may have regarding medication use in older adults.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
Drug Interactions
It's important to be aware that using strong topical corticosteroids (medications applied to the skin) can sometimes lead to serious side effects, such as affecting your body's hormone levels. This can happen if the medication is used over large areas of skin, for a long time, or if covered with a bandage. These effects may include symptoms like Cushing's syndrome, high blood sugar, and changes in hormone production.
If you are using a potent topical steroid, your healthcare provider may recommend regular check-ups to monitor your hormone levels. Tests like the urinary free cortisol test and the ACTH stimulation test can help assess how your body is responding. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.
Storage and Handling
To ensure the best performance and safety of your product, store it at a temperature between 20º to 25º C (68º to 77º F). This range is considered a controlled room temperature according to the United States Pharmacopeia (USP).
When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.
Additional Information
If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. The urinary free cortisol test measures the level of cortisol in your urine, while the ACTH (adrenocorticotropic hormone) stimulation test assesses how well your adrenal glands respond to ACTH. These tests can provide valuable insights into your adrenal health. If you have any questions or concerns about these tests, it's best to discuss them with your healthcare provider.
FAQ
What is Hydrocortisone?
Hydrocortisone is a topical corticosteroid used as an anti-inflammatory and antipruritic agent, primarily for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
How should I apply Hydrocortisone Lotion?
Apply a thin film of Hydrocortisone Lotion to the affected area two to four times daily, depending on the severity of your condition.
What should I do if I experience irritation while using Hydrocortisone?
If irritation develops, discontinue use of the topical corticosteroid and consult your healthcare provider for appropriate therapy.
Are there any contraindications for using Hydrocortisone Lotion?
Yes, Hydrocortisone Lotion is contraindicated in patients with a history of hypersensitivity to any of its components.
What are the potential local adverse reactions of Hydrocortisone?
Local adverse reactions may include burning, itching, irritation, dryness, and other skin conditions such as folliculitis and acneiform eruptions.
Can I use Hydrocortisone Lotion during pregnancy?
Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies on teratogenic effects in pregnant women.
Is Hydrocortisone safe for pediatric use?
Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids, so use should be limited to the least amount necessary for effective treatment.
What should I do if I have a dermatological infection while using Hydrocortisone?
If a dermatological infection develops, discontinue Hydrocortisone and initiate appropriate antifungal or antibacterial therapy until the infection is adequately controlled.
How should I store Hydrocortisone Lotion?
Store Hydrocortisone Lotion at 20º to 25º C (68º to 77º F) to maintain its effectiveness.
Packaging Info
The table below lists all NDC Code configurations of Ala-Scalp (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Lotion | 20 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Lotion | 20 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Ala-Scalp, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Topical corticosteroids are a class of primarily synthetic steroids utilized for their anti-inflammatory and antipruritic properties. Hydrocortisone, a member of this class, is chemically designated as pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11β)-. The structural formula of hydrocortisone is provided in the accompanying documentation. Each milliliter of ALA-SCALP (Hydrocortisone Lotion USP), 2%, contains 20 mg of hydrocortisone USP, formulated in a vehicle consisting of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride.
Uses and Indications
Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
This formulation is suitable for use in patients requiring symptomatic relief from conditions that respond to corticosteroid treatment. There are no teratogenic or nonteratogenic effects associated with this medication, indicating its safety profile in these aspects.
Dosage and Administration
Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of two to four times daily, depending on the severity of the condition being treated.
For the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment. However, if an infection occurs, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should be initiated to address the infection.
Contraindications
Hydrocortisone Lotion is contraindicated in patients with a history of hypersensitivity to any of its components.
Topical corticosteroids should be discontinued if irritation develops, and appropriate therapy should be initiated. In cases of dermatological infections, the use of an appropriate antifungal or antibacterial agent is necessary. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Warnings and Precautions
Rx only. This product is intended for external use only and is not suitable for ophthalmic application.
Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.
Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. Recommended laboratory tests for monitoring include the urinary free cortisol test and the ACTH stimulation test. If evidence of HPA axis suppression is detected, it is advisable to withdraw the medication, reduce the frequency of application, or switch to a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely upon discontinuation of the corticosteroid; however, in rare cases, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.
Pediatric patients are at an increased risk of systemic toxicity due to the potential for greater absorption of topical corticosteroids. In cases where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate alternative therapy should be initiated. Additionally, in the presence of dermatological infections, it is essential to implement suitable antifungal or antibacterial treatment. If there is no prompt improvement, the corticosteroid should be discontinued until the infection is adequately managed.
Side Effects
Patients may experience a range of local adverse reactions when using topical corticosteroids. Common local reactions include burning, itching, irritation, and dryness. Other local effects may include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria. If any irritation develops, it is recommended that the topical corticosteroid be discontinued and appropriate therapy initiated.
Systemic absorption of topical corticosteroids has been associated with serious adverse reactions, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids.
In pediatric patients, the use of topical corticosteroids has been linked to HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.
In cases where dermatological infections are present, it is essential to initiate treatment with an appropriate antifungal or antibacterial agent. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Drug Interactions
Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.
For patients receiving high doses of potent topical corticosteroids, particularly when applied to large areas of the body or under occlusive dressings, it is recommended that they undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. The urinary free cortisol test and ACTH stimulation test are both useful in monitoring potential HPA axis suppression in these patients.
Packaging & NDC
The table below lists all NDC Code configurations of Ala-Scalp (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Lotion | 20 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Lotion | 20 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome compared to mature patients, primarily due to a higher skin surface area to body weight ratio. Reports indicate that HPA axis suppression, Cushing's syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.
Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.
To mitigate these risks, the administration of topical corticosteroids in pediatric patients should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. Prolonged use of corticosteroids may adversely affect the growth and development of pediatric patients.
Geriatric Use
There is no specific information regarding the use of ALA-SCALP (hydrocortisone lotion) in geriatric patients, including recommended age considerations, dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of treatment risks and benefits in this population.
Pregnancy
Corticosteroids are classified as Pregnancy Category C, indicating that risk cannot be ruled out. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenic effects following dermal application in laboratory animals. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.
Given the potential risks, topical corticosteroids should be used during pregnancy only if the anticipated benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.
Caution should be exercised when topical corticosteroids are administered to lactating mothers.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be aware that overdosage may occur, particularly with prolonged use or application over large surface areas.
In cases of suspected overdosage, it is essential to monitor the patient for potential symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, and other hormonal imbalances.
Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. In severe cases, particularly where systemic effects are pronounced, further medical intervention may be necessary. Healthcare providers should assess the patient's clinical status and consider appropriate measures to mitigate any adverse effects. Regular follow-up may be warranted to monitor for delayed reactions or complications arising from the overdosage.
Nonclinical Toxicology
Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.
Postmarketing Experience
Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Reports indicate that pediatric patients receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. In this population, manifestations of adrenal suppression can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.
Infrequent local adverse reactions associated with topical corticosteroids have been noted, particularly with the use of occlusive dressings. These reactions may include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Patient Counseling
Healthcare providers should advise patients that this medication is to be used strictly as directed by their physician and is intended for external use only. Patients must be cautioned to avoid contact with the eyes to prevent irritation or injury.
It is important for healthcare providers to emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. Additionally, patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.
Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for medical evaluation or adjustment of treatment.
For parents of pediatric patients, it is crucial to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. Such garments may act as occlusive dressings, potentially leading to increased risk of adverse effects.
Storage and Handling
The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20º to 25º C (68º to 77º F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.
Additional Clinical Information
The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Ala-Scalp as submitted by Derm Ventures LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.