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hydrocortisone
Overview
What is Anusol?
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Anusol-HC 2.5% (Hydrocortisone Cream, USP) is a topical corticosteroid with hydrocortisone 2.5% (active ingredient) in a water-washable cream containing the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer 934, sodium lauryl sulfate, edetate disodium, sodium hydroxide to adjust the pH, and purified water.
Hydrocortisone has the chemical name Pregn-4-ene-3,20-dione, 11,17, 21, trihydroxy-,(11ß) - and the following chemical structure:
What does Anusol look like?
What are the available doses of Anusol?
Sorry No records found.
What should I talk to my health care provider before I take Anusol?
Sorry No records found
How should I use Anusol?
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Anusol-HC 2.5% (Hydrocortisone Cream, USP) should be applied to the affected area 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 dressings should be discontinued and appropriate antimicrobial therapy instituted.
What interacts with Anusol?
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What are the warnings of Anusol?
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What are the precautions of Anusol?
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.
If HPA axis suppression is noted (by using the urinary free cortisol and ACTH stimulation tests) an attempt should be made to withdraw the drug or to reduce the frequency of application.
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.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see ).
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
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Patients using topical corticosteroids should receive the following information and instructions:
Laboratory Tests
The urinary free cortisol test and the ACTH stimulation test may be helpful in evaluating the HPA axis suppression.
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 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
What are the side effects of Anusol?
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 an approximate decreasing order of occurrence:
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Anusol?
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What might happen if I take too much Anusol?
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (
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How should I store and handle Anusol?
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayInspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayInspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayAnusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied in 30 gram tubes (NDC 65649-401-30). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING.Manufactured for: Rev. 04/2016952100022013207C800 9L J1
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Topical corticosteroids share anti-inflammatory, antipruritic 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.
Non-Clinical Toxicology
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.Since colestipol hydrochloride is an anion exchange resin, it may have a strong affinity for anions other than the bile acids. studies have indicated that colestipol hydrochloride binds a number of drugs. Therefore, colestipol hydrochloride granules resin may delay or reduce the absorption of concomitant oral medication. The interval between the administration of colestipol hydrochloride granules and any other medication should be as long as possible. Patients should take other drugs at least one hour before or four hours after colestipol hydrochloride granules to avoid impeding their absorption.
Repeated doses of colestipol hydrochloride given prior to a single dose of propranolol in human trials have been reported to decrease propranolol absorption. However, in a follow-up study in normal subjects, single dose administration of colestipol hydrochloride and propranolol and twice-a-day administration for 5 days of both agents did not effect the extent of propranolol absorption, but had a small yet statistically significant effect on its rate of absorption; the time to reach maximum concentration was delayed 30 minutes. Effects on the absorption of other beta-blockers have not been determined. Therefore, patients on propranolol should be observed when colestipol hydrochloride granules is either added or deleted from a therapeutic regimen.
Studies in humans show that the absorption of chlorothiazide as reflected in urinary excretion is markedly decreased even when administered one hour before colestipol hydrochloride. The absorption of tetracycline, furosemide, penicillin G, hydrochlorothiazide, and gemfibrozil was significantly decreased when given simultaneously with colestipol hydrochloride; these drugs were not tested to determine the effect of administration one hour before colestipol hydrochloride.
No depressant effect on blood levels in humans was noted when colestipol hydrochloride was administered with any of the following drugs: aspirin, clindamycin, clofibrate, methyldopa, nicotinic acid (niacin), tolbutamide, phenytoin or warfarin. Particular caution should be observed with digitalis preparations since there are conflicting results for the effect of colestipol hydrochloride on the availability of digoxin and digitoxin. The potential for binding of these drugs if given concomitantly is present. Discontinuing colestipol hydrochloride could pose a hazard to health if a potentially toxic drug that is significantly bound to the resin has been titrated to a maintenance level while the patient was taking colestipol hydrochloride.
Bile acid binding resins may also interfere with the absorption of oral phosphate supplements and hydrocortisone.
A study has shown that cholestyramine binds bile acids and reduces mycophenolic acid exposure. As colestipol also binds bile acids, colestipol may reduce mycophenolic acid exposure and potentially reduce efficacy of mycophenolate mofetil.
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.
If HPA axis suppression is noted (by using the urinary free cortisol and ACTH stimulation tests) an attempt should be made to withdraw the drug or to reduce the frequency of application.
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.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see ).
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.
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 an approximate decreasing order of occurrence:
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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. 315.72Tips
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