Locoid Lipocream (Hydrocortisone Butyrate)
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Locoid Lipocream (Hydrocortisone Butyrate)

Locoid Lipocream
(hydrocortisone butyrate) Cream, 0.1%

For topical use only

DRUG DESCRIPTION

Locoid Lipocream contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] for topical dermatologic use.

Chemically, hydrocortisone butyrate is C25H36O6. It has the following structural formula:

Locoid Lipocream (hydrocortisone butyrate)  Structural Formula Illustration

Hydrocortisone butyrate is a white to practically white powder with a molecular weight of 432.56. 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 Locoid Lipocream (hydrocortisone butyrate) contains 1 mg hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) and water.

What are the possible side effects of hydrocortisone topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • feeling tired.

Less serious side effects may include:

  • skin redness, burning, itching, or peeling;
  • thinning...

Read All Potential Side Effects and See Pictures of Locoid Lipocream »

What are the precautions when taking hydrocortisone butyrate (Locoid Lipocream)?

Before using hydrocortisone butyrate, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone, triamcinolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.

Do not use if there is an infection or sore in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency...

Read All Potential Precautions of Locoid Lipocream »

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Locoid Lipocream (hydrocortisone butyrate) ® is a topical corticosteroid indicated for:

Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults.

The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age.

DOSAGE AND ADMINISTRATION

Locoid Lipocream (hydrocortisone butyrate) is not for oral, ophthalmic, or intravaginal use.

Therapy should be discontinued 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, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Locoid Lipocream has not been established beyond 4 weeks of use.

Corticosteroid-Responsive Dermatoses in Adults

Apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition. Rub in gently.

Atopic Dermatitis in Patients From 3 Month to 18 Years

Apply a thin film to the affected skin areas two times daily. Rub in gently.

Locoid Lipocream (hydrocortisone butyrate) should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

HOW SUPPLIED

Dosage Forms And Strengths

Cream, 0.1% (1 mg/g), supplied in tubes of 15g, 45g and 60g.

Storage And Handling

Locoid Lipocream (hydrocortisone butyrate) Cream, 0.1% is supplied in tubes of 15g (NDC 14290-313-15), 45g (NDC 14290-313-45) and 60g (NDC 14290-313-60).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of the reach of children.

Manufactured for: Triax Pharmaceuticals, LLC, Cranford NJ 07016. By: Ferndale Laboratories, Inc., Ferndale MI 48220.

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience: Adults

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 an approximate decreasing order of occurrence: burning, itching, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Clinical Trials Experience: Pediatrics

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 Locoid Lipocream (hydrocortisone butyrate) clinical trials reflect exposure to Locoid Lipocream twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis.

Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream (hydrocortisone butyrate) .

Table 1 : Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis

  Locoid Lipocream
(N=131)
Vehicle
(N=133 )
Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema 1.5% 1.5%
Acne 0.8% 0.0%
Telangiectasia 0.0% 0.8%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Locoid Lipocream (hydrocortisone butyrate) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin: Erythema, Rash and Application site irritation.

Read the Locoid Lipocream (hydrocortisone butyrate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

There are no known drug interactions with Locoid Lipocream (hydrocortisone butyrate) .

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypothalamic-pituitary-adrenal (HPA) Axis Suppression

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Locoid Lipocream (hydrocortisone butyrate) . Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lipocream (hydrocortisone butyrate) due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations].

Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered 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, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Concomitant Skin Infections

If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Locoid Lipocream (hydrocortisone butyrate) should be discontinued until the infection has been adequately controlled.

Skin Irritation

Locoid Lipocream (hydrocortisone butyrate) may cause local skin adverse reactions [see ADVERSE REACTIONS].

If irritation develops, Locoid Lipocream (hydrocortisone butyrate) should be discontinued and appropriate therapy instituted. 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies were conducted to determine the photoco-carcinogenic or dermal carcinogenic potential of Locoid Lipocream.

Hydrocortisone butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and L5178Y/TK+ mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay).

No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and including 1.8 mg/kg/day (0.7X MTHD). Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥ 0.6 mg/kg/day (0.2X MTHD).

Use In Specific Populations

Pregnancy

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Locoid Lipocream (hydrocortisone butyrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.

Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m²/day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate cream (25 g).

Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 – 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day (2X MTHD) included an increased incidence of ossification variations and unossified sternebra. No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses of 5.4 mg/kg/day and 1.8 mg/kg/day, respectively (2X MTHD and 0.7X MTHD, respectively).

Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 – 20. An increased incidence of abortion was noted at 0.3 mg/kg/day (0.2X MTHD). In the absence of maternal toxicity, a dose dependent decrease in fetal body weight was noted at doses ≥ 0.1 mg/kg/day (0.1X MTHD). Additional indicators of embyrofetal toxicity (reduction in litter size, decreased number of viable fetuses, increased post-implantation loss) were noted at doses ≥ 0.2 mg/kg/day (0.2X MTHD). Additional fetal effects noted in this study included delayed ossification noted at doses ≥ 0.1 mg/kg/day and an increased incidence of fetal malformations (primarily skeletal malformations) noted at doses ≥ 0.2 mg/kg/day. A dose at which no treatment related effects on embryofetal toxicity or teratogenicity were observed was not established in this study.

Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 – 15. In the presence of maternal toxicity, an increase in fetal deaths and fetal resorptions and an increase in the number of ossifications in caudal vertebrae were noted at a dose of 9 mg/kg/day (3X MTHD). No treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.1 mg/kg/day (0.1X MTHD).

Subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 – 13. In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at a dose of 1 mg/kg/day (0.2X MTHD). No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses of 1 and 0.2 mg/kg/day, respectively (0.2X MTHD and 0.1X MTHD, respectively).

No topical embryofetal development studies were conducted with hydrocortisone butyrate cream. However, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. Topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. A dose-dependent increase in fetal resorptions was noted in rabbits (0.2 – 2X MTHD) and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose (80X MTHD). No treatment related effects on embyrofetal toxicity were noted at the 1% hydrocortisone butyrate ointment dose in rats (8 MTHD). A dose at which no treatment related effects on embryofetal toxicity were observed in rabbits after topical administration of hydrocortisone butyrate ointment was not established in this study. No treatment related effects on teratogenicity were noted at a dose of 10% hydrocortisone butyrate ointment in rats or rabbits (80X MTHD and 2X MTHD, respectively).

A peri- and post-natal development study was conducted in rats. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats from gestation day 6 – lactation day 20. In the presence of maternal toxicity, a dose dependent decrease in fetal weight was noted at doses ≥ 1.8 mg/kg/day (0.7X MTHD). No treatment related effects on fetal toxicity were noted at 0.6 mg/kg/day (0.2X MTHD). A delay in sexual maturation was noted at 5.4 mg/kg/day (2X MTHD). No treatment related effects on sexual maturation were noted at 1.8 mg/kg/day. No treatment related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day.

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 Locoid Lipocream (hydrocortisone butyrate) is administered to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients below 3 months of age have not been established.

Because of higher skin surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment.

Eighty-six (86) pediatric subjects (between 5 months and 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Locoid Lipocream (hydrocortisone butyrate) three times daily for up to 4 weeks were assessed for HPA axis suppression in two separate studies. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in these HPA axis studies were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (two times daily) for which Locoid Lipocream (hydrocortisone butyrate) is indicated in this population. Five of the 82 evaluable subjects (6.1%) demonstrated evidence of suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter after cosyntropin stimulation. Suppressed subjects ranged in age from 5 months to 16 years and, at the time of enrollment, had 25% to 95% BSA involvement. These subjects did not demonstrate any clinical signs or symptoms despite evidence of HPA axis suppression. At the first follow up visit, approximately one month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by 65 days post-treatment.

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

Geriatric Use

Clinical studies of Locoid Lipocream (hydrocortisone butyrate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

None.

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the antiinflammatory activity of the topical corticosteroids 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, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin, occlusive dressings, or widespread application may increase percutaneous absorption and increase the risk of HPA Axis suppression.

The vasoconstrictor assay showed that Locoid Lipocream (hydrocortisone butyrate) had a more pronounced skin blanching effect than Locoid Cream, suggesting greater percutaneous absorption from the former.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees.

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Clinical Studies

Pediatric Atopic Dermatitis

In a multicenter, randomized, vehicle-controlled trial of 264 pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis, Locoid Lipocream (hydrocortisone butyrate) or vehicle was applied twice daily for up to four weeks. Treatment success was assessed at day 29 (after 28 days of treatment) and was defined as the proportion of patients who achieved both “clear” or “almost clear” and at least a two grade improvement from baseline on a 5-point Physician's Global Assessment (PGA) scale.

Study results are shown in Table 3.

TABLE 3 : Efficacy Results at Day 29 in Pediatric Subjects

  Locoid Lipocream
(n=131)
Vehicle
(n=133)
Number (%) successes 82 (63%) 37 (28%)

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients using Locoid Lipocream (hydrocortisone butyrate) should receive the following information and instructions:

  • Discontinue Locoid Lipocream (hydrocortisone butyrate) when control is achieved.
  • Apply a thin film to the affected skin areas two or three times daily for corticosteroid-reponsive dermatoses in adults. Consult with your physician to determine if treatment is needed beyond 2 weeks.
  • Apply a thin film to the affected skin areas two times daily for atopic dermatitis in patients 3 months of age and older. Safety of Locoid Lipocream (hydrocortisone butyrate) in pediatric patients has not been established beyond 4 weeks of use.
  • Rub in gently.
  • Avoid contact with the eyes.
  • Do not bandage, otherwise cover, or wrap the affected skin area so as to be occlusive unless directed by your physician.
  • Do not use Locoid Lipocream (hydrocortisone butyrate) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
  • Do not use Locoid Lipocream (hydrocortisone butyrate) on the face, underarms, or groin areas unless directed by your physician.
  • If no improvement is seen within 2 weeks, contact your physician.
  • Do not use other corticosteroid-containing products while using Locoid Lipocream (hydrocortisone butyrate) without first consulting your physician.

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients using Locoid Lipocream (hydrocortisone butyrate) should receive the following information and instructions:

  • Discontinue Locoid Lipocream (hydrocortisone butyrate) when control is achieved.
  • Apply a thin film to the affected skin areas two or three times daily for corticosteroid-reponsive dermatoses in adults. Consult with your physician to determine if treatment is needed beyond 2 weeks.
  • Apply a thin film to the affected skin areas two times daily for atopic dermatitis in patients 3 months of age and older. Safety of Locoid Lipocream (hydrocortisone butyrate) in pediatric patients has not been established beyond 4 weeks of use.
  • Rub in gently.
  • Avoid contact with the eyes.
  • Do not bandage, otherwise cover, or wrap the affected skin area so as to be occlusive unless directed by your physician.
  • Do not use Locoid Lipocream (hydrocortisone butyrate) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
  • Do not use Locoid Lipocream (hydrocortisone butyrate) on the face, underarms, or groin areas unless directed by your physician.
  • If no improvement is seen within 2 weeks, contact your physician.
  • Do not use other corticosteroid-containing products while using Locoid Lipocream (hydrocortisone butyrate) without first consulting your physician.

Last reviewed on RxList: 11/6/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Locoid Lipocream Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYDROCORTISONE BUTYRATE - TOPICAL

(HYE-droe-KOR-ti-sone BUE-ti-rate)

COMMON BRAND NAME(S): Locoid

USES: This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Hydrocortisone butyrate reduces the swelling, itching, and redness that can occur in these types of conditions. The topical solution is used to treat severe dandruff (seborrheic dermatitis). This medication is a medium-strength corticosteroid.

HOW TO USE: Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in. Apply the ointment, cream, or solution form of this medication usually 2-3 times daily or as directed by your doctor. Apply the lotion form of this medication usually 2 times daily or as directed. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens after 2 weeks.

Disclaimer

Locoid Lipocream Consumer (continued)

SIDE EFFECTS: Stinging, burning, itching, irritation, dryness, or redness at the application site may occur when this medication is first applied to the skin. These effects should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Skin infections can become worse when this medication is used. Notify your doctor promptly if redness, swelling, or irritation does not improve.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Locoid Lipocream (hydrocortisone butyrate) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using hydrocortisone butyrate, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., prednisone, triamcinolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.

Do not use if there is an infection or sore in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

Disclaimer

Locoid Lipocream Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription or nonprescription/herbal products you may use, especially of: corticosteroids taken by mouth (e.g., prednisone), drugs that lower the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Inform all your doctors that you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Different brands of this medication may have different storage requirements. Refer to the package labeling or ask your pharmacist for the storage requirements for the brand you are using. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

Locoid Lipocream Patient Information Including Side Effects

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

Generic Name: hydrocortisone topical (Pronunciation: hye droe KOR ti sone)

What is hydrocortisone topical (Locoid Lipocream)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

Hydrocortisone 2.5% Cr-PER

Hydrocortisone 2.5% Oin-PER

Hydrocortisone Valerate 0.2% Cr-PER

What are the possible side effects of hydrocortisone topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • feeling tired.

Less serious side effects may include:

  • skin redness, burning, itching, or peeling;
  • thinning of your skin;
  • blistering skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Locoid Lipocream (hydrocortisone butyrate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about hydrocortisone topical?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Locoid Lipocream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using hydrocortisone topical?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use hydrocortisone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit.

Store hydrocortisone topical at room temperature away from moisture and heat.

Locoid Lipocream Patient Information including If I Miss a Dose

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using hydrocortisone topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

What other drugs will affect hydrocortisone topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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