DRUGS & SUPPLEMENTS

Prax

Name: Prax drug & pharmaceuticals. Prax available forms, doses, prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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DESCRIPTION: Prax^® (hydrocortisone acetate 1% and Prax hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and Prax hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.

Prax^® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Hydrocortisone acetate

Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL.

Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-.

Prax hydrochloride

Molecular weight: 329.86. Prax hydrochloride is freely soluble in water.

Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.

chemical structure - Hydrocortisone acetate chemical structure - Prax hydrochloride

CLINICAL

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.

Prax Hydrochloride: A surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids. 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 corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS: Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.

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 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.

In pediatric patients absorption may result in higher blood levels and thus more susceptibility 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.
Do not use this medication for any disorder other than for which it has been prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Report any signs of local adverse reactions especially under occlusive dressings.
Do not use any tight fitting diapers or plastic pants on a pediatric patient 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:

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate 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 of 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. Caution should be exercised when any topical corticosteroids are administered to a nursing woman.

Pediatric Use: PEDIATRIC PATIENTS MAY DEMONSTRATE GREATER SUSCEPTIBILTY 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 cortisone 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.

Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 approximately 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

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

DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily.

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.

Directions For Use:

Shake the container vigorously for 5-10 seconds before each use.
While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to affected areas.
NOTE: The aerosol container should never be inserted into vagina or anus.
The container and cap should be disassembled and rinsed with warm water after use.

HOW SUPPLIED:

Epifoam® is supplied in 10 g pressurized cans.

NDC 0037-6824-10 10 g

Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE.

Distributed by:

MEDA PHARMACEUTICALS^®

Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120

For Medical Inquiries, call toll-free 1-877-848-6610

Prax and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.

IN-682410-01

CIA71192B

Rev. 7/2013

NDC 0037-6824-10

STORE UPRIGHT

10 g net wt

Prax^®

(hydrocortisone acetate 1% and

Prax hydrochloride 1%)

topical aerosol

Rx Only

HOLD UPRIGHT TO DISPENSE

WARNINGS: Contents of

the container are under

pressure. Do not burn or

puncture the aerosol

container. Do not store at

temperatures above 120°F

(49°C).

MEDA

PHARMACEUTICALS

Prax pharmaceutical active ingredients containing related brand and generic drugs:

Pramoxine Hydrochloride

Prax available forms, composition, doses:

Lotion; Topical; Pramocaine Hydrochloride

Prax destination | category:

Human:
Antipruritics and local anesthetics
Topical anaesthetic, analgesic, antipruritic

Prax Anatomical Therapeutic Chemical codes:

C05AD07 - Pramocaine
D04AB07 - Pramocaine

Prax pharmaceutical companies:

Ferndale Laboratories

References

Dailymed."SALLY HANSEN ZERO BUMP BIKINI (PRAMOXINE HYDROCHLORIDE) SPRAY [COTY US LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"pramoxine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"pramoxine". http://www.drugbank.ca/drugs/DB0934... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Prax?

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