Hydrocortisone 1% in Absorbase

×

Overview

What is Hydrocortisone 1% in Absorbase?

Hydrocortisone 1% in Absorbase® contains 10 mg/g of micronized hydrocortisone USP in a special absorption ointment base. Absorbase® is a water-in-oil emulsion composed of cholesterolized petrolatum and purified water USP. The product will absorb water into the internal emulsion phase, yet form a hydrophobic film on the skin. Hydrocortisone USP is C21H30O5; Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11 beta)-, Cortisol, and has the structural formula:

Action

Topical corticosteroids are primarily effective as anti-inflammatory, anti-pruritic and vasoconstrictive agents.

What does Hydrocortisone 1% in Absorbase look like?

What are the available doses of Hydrocortisone 1% in Absorbase?

Sorry No records found.

What should I talk to my health care provider before I take Hydrocortisone 1% in Absorbase?

Sorry No records found

How should I use Hydrocortisone 1% in Absorbase?

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

What interacts with Hydrocortisone 1% in Absorbase?

Sorry No Records found

What are the warnings of Hydrocortisone 1% in Absorbase?

Sorry No Records found

What are the precautions of Hydrocortisone 1% in Absorbase?

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.Patients should report any signs of local adverse reactions, especially under occlusive dressing.Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test

ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

What are the side effects of Hydrocortisone 1% in Absorbase?

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence:

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

What should I look out for while using Hydrocortisone 1% in Absorbase?

What might happen if I take too much Hydrocortisone 1% in Absorbase?

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

How should I store and handle Hydrocortisone 1% in Absorbase?

Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] . Sterile, Nonpyrogenic, Preservative-free, Lyophilized.The container closure is not made with natural rubber latex.Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] . Sterile, Nonpyrogenic, Preservative-free, Lyophilized.The container closure is not made with natural rubber latex.Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] . Sterile, Nonpyrogenic, Preservative-free, Lyophilized.The container closure is not made with natural rubber latex.Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447Each gram of Hydrocortisone 1% in Absorbase contains 10 mg of micronized Hydrocortisone USP. Supplied in a 4 oz. jar (110 g) (NDC 69499-322-10).CautionFederal law prohibits dispensing without prescription. For external use only.PharmacistWater may bleed from this product due to the nature of the water-in-oil emulsion. This separation does not affect the stability of hydrocortisone. The Absorbase base should be remixed if necessary before dispensing. Store at controlled room temperature 15°-30° C (59°-86° F). Dispense in well-closed containers.SolubiomixMadisonville, LA 70447

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

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 from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for the treatment of resistant dermatoses.

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.

Non-Clinical Toxicology

Healthy subjects who received rifampin 600 mg once daily concomitantly with saquinavir 1000 mg/ritonavir 100 mg twice daily (ritonavir-boosted saquinavir) developed severe hepatocellular toxicity. Therefore, concomitant use of these medications is contraindicated (see ).

Enzyme Induction: Rifampin is known to induce certain cytochrome P-450 enzymes. Administration of rifampin with drugs that undergo biotransformation through these metabolic pathways may accelerate elimination of coadministered drugs. To maintain optimum therapeutic blood levels, dosages of drugs metabolized by these enzymes may require adjustment when starting or stopping concomitantly administered rifampin.

Rifampin has been reported to substantially decrease the plasma concentrations of the following antiviral drugs: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. These antiviral drugs must not be co-administered with rifampin (see ).

Rifampin has been reported to accelerate the metabolism of the following drugs: anticonvulsants (e.g., phenytoin), digitoxin, antiarrhythmics (e.g., disopyramide, mexiletine, quinidine, tocainide), oral anticoagulants, antifungals (e.g., fluconazole, itraconazole, ketoconazole), barbiturates, beta-blockers, calcium channel blockers (e.g., diltiazem, nifedipine, verapamil), chloramphenicol, clarithromycin, corticosteroids, cyclosporine, cardiac glycoside preparations, clofibrate, oral or other systemic hormonal contraceptives, dapsone, diazepam, doxycycline, fluoroquinolones (e.g., ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, progestins, quinine, tacrolimus, theophylline, tricyclic antidepressants (e.g., amitriptyline, nortriptyline) and zidovudine. It may be necessary to adjust the dosages of these drugs if they are given concurrently with rifampin.

Patients using oral or other systemic hormonal contraceptives should be advised to change to nonhormonal methods of birth control during rifampin therapy.

Rifampin has been observed to increase the requirements for anticoagulant drugs of the coumarin type. In patients receiving anticoagulants and rifampin concurrently, it is recommended that the prothrombin time be performed daily or as frequently as necessary to establish and maintain the required dose of anticoagulant.

Other Interactions: When the two drugs were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampin were observed.

Concurrent use of ketoconazole and rifampin has resulted in decreased serum concentrations of both drugs. Concurrent use of rifampin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient’s clinical condition.

Concomitant antacid administration may reduce the absorption of rifampin. Daily doses of rifampin should be given at least 1 hour before the ingestion of antacids.

Probenecid and cotrimoxazole have been reported to increase the blood level of rifampin.

When rifampin is given concomitantly with either halothane or isoniazid, the potential for hepatotoxicity is increased. The concomitant use of rifampin and halothane should be avoided. Patients receiving both rifampin and isoniazid should be monitored close for hepatotoxicity.

Plasma concentrations of sulfapyridine may be reduced following the concomitant administration of sulfasalazine and rifampin. This finding may be the result of alteration in the colonic bacteria responsible for the reduction of sulfasalazine to sulfapyridine and mesalamine.

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.Patients should report any signs of local adverse reactions, especially under occlusive dressing.Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test

ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence:

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

×

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.

×

Review

×

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

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: