locoid lipocream
Locoid Lipocream (Hydrocortisone Butyrate) is a corticosteroid used to treat Adrenal Insufficiency, Congenital Adrenal Hyperplasia, Ulcerative Colitis, Contact Dermatitis.
Hydrocortisone Butyrate · by Precision Dermat
Key facts
- Active ingredient
- Hydrocortisone Butyrate
- Drug class
- Corticosteroid
- Form
- Topical
- Strength
- Hydrocortisone Butyrate 0.1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Precision Dermat
- Half-life
- about 1.5 hours (how long it stays in your system)
- FDA application
- NDA020769
What is Locoid Lipocream?
From the FDA label:Hydrocortisone Butyrate Cream (lipid), 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula: Hydrocortisone butyrate is a white to off-white powder with a molecular weight of 432.56, and a molecular formula of C 25 H 36 O 6 . It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream (lipid), 0.1% contains 1 mg of hydrocortisone butyrate in a white to off-white hydrophilic cream base consisting of anhydrous citric acid, butylparaben, ceteth-20, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum. hydrocortisone butyrate structure
How to use
Recommended Dosage for Corticosteroid-Responsive Dermatoses For corticosteroid-responsive dermatoses in adults, apply a thin layer to the affected skin areas 2 or 3 times daily, depending on the severity of the condition, and rub in gently. Recommended Dosage for Atopic Dermatitis For atopic dermatitis in patients 3 months of age and older, apply a thin layer to the affected skin areas 2 times daily and rub in gently. Administration Instructions Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, weigh any additional benefits of extending treatment to 4 weeks against the risk of HPA-axis suppression and local adverse events [see Warnings and Precautions ( 5.1 )] . Hydrocortisone Butyrate Cream (lipid), 0.1% is not for oral, ophthalmic, or intravaginal use. Do not use Hydrocortisone Butyrate Cream (lipid), 0.1%: With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. On the face, underarms, or groin areas unless directed by a healthcare provider. Corticosteroid-Responsive Dermatoses: Apply a thin layer to the affected skin areas 2 or 3 times daily for corticosteroid-responsive dermatoses in adults. Rub in gently. ( 2 ) Atopic Dermatitis: Apply a thin…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Endocrine system adverse reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] Ophthalmic adverse reactions [see Warnings and Precautions ( 5.2 )] Skin infections [see Warnings and Precautions ( 5.3 )] Allergic contact dermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis. Table 1. Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133)…
Warnings
Important safety information
Endocrine System Adverse Reactions: Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA-axis suppression if Hydrocortisone Butyrate Cream (lipid), 0.1% is applied to large surface areas or used under occlusion. If HPA-axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid. ( 5.1 , 8.4 ) Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 , 8.4 ) Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) Skin Infections: Initiate appropriate therapy if concomitant skin infections develop. ( 5.3 ) 5.1 Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause systemic adverse reactions including HPA-axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Consider patients for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). If HPA-axis suppression is noted, reduce the frequency of application or withdraw Hydrocortisone Butyrate Cream (lipid), 0.1%, or substitute a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Studies conducted in pediatric subjects demonstrated reversible HPA-axis suppression after use of Hydrocortisone Butyrate Cream (lipid), 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Cream (lipid), 0.1% due to their larger skin-surface-to-body-mass ratios [ see Use in Specific Populations ( 8.4 ) , Clinical Pharmacology ( 12.2 ) ]. Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations for Endocrine Adverse Reactions Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Cream (lipid), 0.1% as recommended [ see Dosage and Administration ( 2 ) ]. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products [ see Adverse Reactions ( 6.2 ) ]. Avoid contact of Hydrocortisone Butyrate Cream (lipid), 0.1% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Skin Infections Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, use an appropriate antifungal, antibacterial or antiviral agent. If a favorable response does not occur promptly, discontinue use of Hydrocortisone Butyrate Cream (lipid), 0.1% until the infection has been adequately controlled. 5.4 Allergic Contact Dermatitis Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause allergic contact dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Hydrocortisone Butyrate Cream (lipid), 0.1% if the diagnosis is established. 5.1 Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause systemic adverse reactions including HPA-axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Consider patients for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). If HPA-axis suppression is noted, reduce the frequency of application or withdraw Hydrocortisone Butyrate Cream (lipid), 0.1%, or substitute a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Studies conducted in pediatric subjects demonstrated reversible HPA-axis suppression after use of Hydrocortisone Butyrate Cream (lipid), 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Cream (lipid), 0.1% due to their larger skin-surface-to-body-mass ratios [ see Use in Specific Populations ( 8.4 ) , Clinical Pharmacology ( 12.2 ) ]. Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations for Endocrine Adverse Reactions Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Cream (lipid), 0.1% as recommended [ see Dosage and Administration ( 2 ) ]. 5.3 Skin Infections Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, use an appropriate antifungal, antibacterial or antiviral agent. If a favorable response does not occur promptly, discontinue use of Hydrocortisone Butyrate Cream (lipid), 0.1% until the infection has been adequately controlled. 5.4 Allergic Contact Dermatitis Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause allergic contact dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Hydrocortisone Butyrate Cream (lipid), 0.1% if the diagnosis is established.
Who should not take Locoid Lipocream
None. None. ( 4 )
How long does Hydrocortisone Butyrate stay in your body?
The elimination half-life of hydrocortisone butyrate is about 1.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life; the FDA label states "The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets" in healthy adults, so roughly 90% of a dose clears within about 8 hours and nearly all within ~12 hours. Hydrocortisone is not a prodrug, but its half-life measures how fast the drug leaves the blood, not how long its effects last: as a short-acting glucocorticoid its biological (tissue) effect on the body persists well beyond blood clearance, and this short plasma half-life is why oral replacement is usually dosed 2-3 times a day. Because hydrocortisone is metabolized in the liver, significant liver impairment can slow clearance; the label does not give a specific half-life adjustment for age, kidney, or liver function. Half-life is not the same as a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ALKINDI SPRINKLE (hydrocortisone) oral granules — FDA prescribing information, DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- adrenal insufficiency
- congenital adrenal hyperplasia
- ulcerative colitis
- contact dermatitis
- facial dermatoses
- foot dermatoses
See how Locoid Lipocream ranks — best-rated corticosteroid for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Locoid Lipocream treat?
- Locoid Lipocream (Hydrocortisone Butyrate) may be used to treat adrenal insufficiency, congenital adrenal hyperplasia, ulcerative colitis, contact dermatitis, facial dermatoses, foot dermatoses, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Locoid Lipocream work?
- Locoid Lipocream is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- Is there a coupon or discount for Locoid Lipocream?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Locoid Lipocream. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Locoid Lipocream?
- Locoid Lipocream is marketed by Precision Dermat. You can see Precision Dermat's full profile, rating, and other products on pharmaranks.
- Is Locoid Lipocream a brand-name or generic drug?
- Locoid Lipocream is a brand-name product with the active ingredient Hydrocortisone Butyrate.
- Is Locoid Lipocream available over the counter?
- No. Locoid Lipocream is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Locoid Lipocream come in?
- Locoid Lipocream is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Locoid Lipocream?
- Locoid Lipocream is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Locoid Lipocream FDA-registered?
- Locoid Lipocream is on record with the U.S. FDA under application number NDA020769. You can verify this on its official FDA label.
- Is Locoid Lipocream safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Locoid Lipocream. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Locoid Lipocream?
- Locoid Lipocream's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in other sections of the labeling: Endocrine system adverse reactions [see Warnings and Precautions ( 5.1 ),… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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