DRUGS & SUPPLEMENTS

Anusol Duo

Name: Anusol Duo drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Description:
Clinical pharmacology:
Indications and usage:
Contraindications:
Precautions:
Adverse reactions:
Overdosage:
Dosage and administration:
How supplied:
Anusol Duo reviews

DESCRIPTION:

Anusol Duo ^® Ointment is a topical preparation containing Anusol Duo 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in an emollient ointment base containing sorbitan sesquioleate, purified water, Aquaphor ^®, and white petrolatum.

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

Anusol Duo

Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11-beta)-

C ₂₃H ₃₂O ₆; mol. wt: 404.50

pramoxine hydrochloride

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

C ₁₇H ₂₇NO ₃,HCl: mol. wt: 329.87

hydrocortisoneacetate pramoxinehcl

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.

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 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.

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

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

PRECAUTIONS:

General:

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal 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 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.

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 for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressings.
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: Teratogenic Effects: 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 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 fontanels, 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.

ADVERSE REACTIONS:

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

Foliculitis

Hypertrichosis

Acneiform eruptions

Hypopigmentation

Perioral dermatitis

Allergic contact dermatitis

Maceration of the skin

Secondary infection

Skin atrophy

Striae

Miliaria

OVERDOSAGE:

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

DOSAGE AND ADMINISTRATION:

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 dressing 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.

HOW SUPPLIED:

Pramosone® Ointment 1% 1 oz tube

Pramosone® Ointment 2.5% 1 oz tube (NDC 54766-777-04)

Storage Conditions:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Rx Only.

Manufactured for Sebela Ireland Ltd.

By Ferndale Laboratories, Inc.

Ferndale, MI 48220 U.S.A.

Distributed By Sebela Pharmaceuticals Inc.

645 Hembree Parkway, Suite I

Roswell, Georgia 30076

www.sebelapharma.com

Toll free 1-844-732-3521

PI777040215

Rev. Feb. 2015

Aquaphor® is a registered trademark of Beiersdorf AG.

Pramosone® is a registered trademark of Sebela International Ltd.

#6989I

Anusol Duo pharmaceutical active ingredients containing related brand and generic drugs:

Anusol Duo available forms, composition, doses:

Anusol Duo destination | category:

Human:
Anti-inflammatory agents
Antipruritics and local anesthetics

Anusol Duo Anatomical Therapeutic Chemical codes:

C05AA01 - Hydrocortisone
D07XA01 - Hydrocortisone

Anusol Duo pharmaceutical companies:

Elea Laboratorio

References

Dailymed."IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."SALLY HANSEN ZERO BUMP BIKINI (PRAMOXINE HYDROCHLORIDE) SPRAY [COTY US LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Anusol Duo?

Depending on the reaction of the Anusol Duo after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Anusol Duo not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Anusol Duo addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Anusol Duo, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Anusol Duo consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.