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Hydrocortisone Butyrate

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Overview

What is Hydrocortisone Butyrate?

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate, USP is 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate.

It has the following structural formula:

Hydrocortisone butyrate, USP is a white to off white powder with a molecular weight of 432.56, and a molecular formula of CHO. 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 USP, 0.1% (Lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a white to off white hydrophilic cream base consisting of anhydrous citric acid, butylparaben (preservative), ceteth-20, cetostearyl alcohol, mineral oil, propylparaben (preservative), purified water, sodium citrate, and white petrolatum.



What does Hydrocortisone Butyrate look like?



What are the available doses of Hydrocortisone Butyrate?

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

What should I talk to my health care provider before I take Hydrocortisone Butyrate?

How should I use Hydrocortisone Butyrate?

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is indicated for:

For 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, and rub in gently.

For atopic dermatitis in patients 3 months to 18 years of age, apply a thin film to the affected skin areas two times daily, and rub in gently. Do not apply Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) in the diaper area unless directed by a physician.

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, 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 Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) has not been established beyond 4 weeks of use .

Do not use Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) with occlusive dressings unless directed by a physician.

Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is not for oral, ophthalmic, or intravaginal use.


What interacts with Hydrocortisone Butyrate?

Sorry No Records found


What are the warnings of Hydrocortisone Butyrate?

Sorry No Records found


What are the precautions of Hydrocortisone Butyrate?

Sorry No Records found


What are the side effects of Hydrocortisone Butyrate?

Sorry No records found


What should I look out for while using Hydrocortisone Butyrate?

None.


What might happen if I take too much Hydrocortisone Butyrate?

Sorry No Records found


How should I store and handle Hydrocortisone Butyrate?

StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is supplied in tubes of 15 g (NDC 0472-0490-15), 45 g (NDC 0472-0490-45), and 60 g (NDC 0472-0490-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Protect from freezing.Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is supplied in tubes of 15 g (NDC 0472-0490-15), 45 g (NDC 0472-0490-45), and 60 g (NDC 0472-0490-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Protect from freezing.Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is supplied in tubes of 15 g (NDC 0472-0490-15), 45 g (NDC 0472-0490-45), and 60 g (NDC 0472-0490-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Protect from freezing.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical corticosteroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 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 A.

Non-Clinical Toxicology
None.

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 Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic). Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) due to their larger skin surface-to-body-mass ratios .

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 (ACTH) stimulation testing (CST).

Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) as recommended .

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 .

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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