Amcinonide

Amcinonide uses

• Indications and usage:
• Contraindications:
• Precautions:
• Adverse reactions:
• Overdosage:
• Dosage and administration:
• How supplied:
• Amcinonide reviews

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 (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

Conditions that 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 with 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.

Pediatric patients 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 products are not for ophthalmic use.

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 those that occur 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, since 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 of topical corticosteroids or the effect on fertility.

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 quantitiesnot likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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.

ADVERSE REACTIONS:

In the clinical trials with Amcinonide Lotion, the investigators reported a 4.7% incidence of side effects. In a weekly acceptability evaluation, approximately 20% of the patients treated with Amcinonide Lotion or placebo reported itching, stinging, soreness, or burning at one or more of the visits. 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 and miliaria.

OVERDOSAGE:

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

DOSAGE AND ADMINISTRATION:

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

The lotion may be applied topically to the specified lesions, particularly to those in hairy areas, two times per day. The lotion should be rubbed into the affected area completely, and the area should be protected from washing, clothing, rubbing, etc. until the lotion is dried.

Occlusive dressings may be a valuable therapeutic adjunct 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.

HOW SUPPLIED:

Amcinonide Lotion, 0.1% is supplied as follows:

NDC 0168-0280-60 60 mL bottle

Store at controlled room temperature 15° - 30°C (59° - 86°F)

DO NOT FREEZE.

E. FOUGERA & CO.

A division of

Fougera

PHARMACEUTICALS INC.

Melville, New York 11747

I2280C

R07/12

#84

NDC 0168-0280-60

FOUGERA^®

Amcinonide

LOTION, 0.1%

60 mL (58.8 g)

NOT FOR OPHTHALMIC USE.

FOR DERMATOLOGIC USE ONLY.

Rx only

NDC 0168-0280-60

FOUGERA^®

Amcinonide

LOTION, 0.1%

60 mL (58.8 g)

NOT FOR OPHTHALMIC USE.

FOR DERMATOLOGIC USE ONLY.

Rx only

Amcinonide pharmaceutical active ingredients containing related brand and generic drugs:

• Amcinonide

Amcinonide available forms, composition, doses:

Amcinonide destination | category:

• Human:
• Anti-inflammatory agents

Amcinonide Anatomical Therapeutic Chemical codes:

• D07AC11 - Amcinonide

Amcinonide pharmaceutical companies:

• Altana Pharma
• Astellas Pharma
• Central Poly Trading
• Continental Pharma
• Crosara Laboratorio Farmaco Biologico
• ERFA
• GlaxoSmithKline
• Hermal Kurt Herrmann
• Pharma Developpement
• Ratiopharm
• Stiefel Laboratories
• Taro Pharmaceutical Industries
• Wyeth

References

1. Dailymed."AMCINONIDE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."AMCINONIDE: 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).
3. "amcinonide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Amcinonide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Amcinonide 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.

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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology