Hydrocortisone Acetate Pramoxine Hcl

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Overview

What is Hydrocortisone Acetate Pramoxine Hcl?

Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream

Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below.

hydrocortisone acetate

Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,

17-dihydroxy-, (11-beta)-

CHO; mol. wt: 404.50

pramoxine hydrchloride

4-(3-(butoxyphenoxy)propyl)morpholine hydrochloride

CHNO.HCl; mol. wt: 329.87

What does Hydrocortisone Acetate Pramoxine Hcl look like?

What are the available doses of Hydrocortisone Acetate Pramoxine Hcl?

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What should I talk to my health care provider before I take Hydrocortisone Acetate Pramoxine Hcl?

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How should I use Hydrocortisone Acetate Pramoxine Hcl?

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 three 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 Hydrocortisone Acetate Pramoxine Hcl?

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 Hydrocortisone Acetate Pramoxine Hcl?

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What are the precautions of Hydrocortisone Acetate Pramoxine Hcl?

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 potent topical steroid applied to a large surface area and 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. (See PRECAUTIONS-Pediatric Use.)

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

Urinary free cortisol test

ACTH stimulation test

Carcinogenesis, Mutagenesis, 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

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts 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 Acetate Pramoxine Hcl?

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:

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 Acetate Pramoxine Hcl?

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 Hydrocortisone Acetate Pramoxine Hcl?

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

How should I store and handle Hydrocortisone Acetate Pramoxine Hcl?

Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used.Injection vials are single-dose only. After opening, any unused product should be discarded.Store under refrigeration at 2°C to 8°C (36°F to 46°F). The product should not be stored at room temperature for more than 48 hours. Vials that develop particulate matter should not be used.Injection vials are single-dose only. After opening, any unused product should be discarded.Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows:1 oz tube (NDC 45802--64)Carton of 12 4-gram tubes (NDC 45802--53)Carton of 30 4-gram tubes (NDC 45802--65)Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows:1 oz tube (NDC 45802--64)Carton of 12 4-gram tubes (NDC 45802--53)Carton of 30 4-gram tubes (NDC 45802--65)Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows:1 oz tube (NDC 45802--64)Carton of 12 4-gram tubes (NDC 45802--53)Carton of 30 4-gram tubes (NDC 45802--65)Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows:1 oz tube (NDC 45802--64)Carton of 12 4-gram tubes (NDC 45802--53)Carton of 30 4-gram tubes (NDC 45802--65)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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

The mechanism of anti-inflammatory activity of 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.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Non-Clinical Toxicology

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Furosemide tablets may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.

Furosemide tablets should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Furosemide tablets, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.

There is a risk of ototoxic effects if cisplatin and Furosemide tablets are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Furosemide tablets are not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.

Furosemide tablets have a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.

Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.

Furosemide tablets combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of Furosemide tablets, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.

Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Furosemide tablets may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.

Simultaneous administration of sucralfate and Furosemide tablets may reduce the natriuretic and antihypertensive effects of Furosemide tablets. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved. The intake of Furosemide tablets and sucralfate should be separated by at least two hours.

In isolated cases, intravenous administration of Furosemide tablets within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of Furosemide tablets concomitantly with chloral hydrate is, therefore, not recommended.

Phenytoin interferes directly with renal action of Furosemide tablets. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of Furosemide tablets, and consequently to lower peak serum furosemide concentrations.

Methotrexate and other drugs that, like Furosemide tablets, undergo significant renal tubular secretion may reduce the effect of Furosemide tablets. Conversely, Furosemide tablets may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Furosemide tablets and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Furosemide tablets.

Furosemide tablets can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.

Concomitant use of cyclosporine and Furosemide tablets is associated with increased risk of gouty arthritis secondary to Furosemide tablets-induced hyperurecemia and cyclosporine impairment of renal urate excretion.

One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.

Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Furosemide tablets (furesomide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Furosemide tablets should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furosemide tablets is achieved.

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 potent topical steroid applied to a large surface area and 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. (See PRECAUTIONS-Pediatric Use.)

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:

Burning

Itching

Irritation

Dryness

Folliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

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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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