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NDC 54766-0729-04 Pramosone 10; 10 mg/mL; mg/mL Details
Pramosone 10; 10 mg/mL; mg/mL
Pramosone is a TOPICAL LOTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 54766-0729-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
Related Packages: 54766-0729-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 54766-0729 |
|---|---|
| Product ID | 54766-729_7d51ca9c-cb17-fbf6-e053-2a91aa0a0348 |
| Associated GPIs | 90559802404120 |
| GCN Sequence Number | 007417 |
| GCN Sequence Number Description | hydrocortisone/pramoxine LOTION 1 %-1 % TOPICAL |
| HIC3 | T0F |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROID-LOCAL ANESTHETIC |
| GCN | 84643 |
| HICL Sequence Number | 015163 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE/PRAMOXINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Pramosone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydrocortisone acetate and pramoxine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 10; 10 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Sebela Pharmaceuticals Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA085980 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54766-0729-04 (54766072904)
| NDC Package Code | 54766-729-04 |
|---|---|
| Billing NDC | 54766072904 |
| Package | 118 mL in 1 BOTTLE (54766-729-04) |
| Marketing Start Date | 2015-07-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f207bdff-2f41-4eee-818e-198b6462863e Details
SPL UNCLASSIFIED SECTION
DESCRIPTION: Pramosone ® Lotion is a topical preparation containing hydrocortisone acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone, potassium sorbate, sorbic acid, and purified water.
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.
hydrocortisone acetate
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
SPL UNCLASSIFIED SECTION
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. (See DOSAGE AND ADMINISTRATION.)
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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 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: 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.
SPL UNCLASSIFIED SECTION
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 | Hypertrichosis | Maceration of the skin |
| Itching | Acneiform eruptions | Secondary infection |
| Irritation | Hypopigmentation | Skin atrophy |
| Dryness | Perioral dermatitis | Striae |
| Folliculitis | Allergic contact dermatitis | Miliaria |
SPL UNCLASSIFIED SECTION
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
SPL UNCLASSIFIED SECTION
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. Lotion should be shaken well before use. 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.
SPL UNCLASSIFIED SECTION
| HOW SUPPLIED: | Pramosone® Lotion 1% | 2 fl oz (NDC 54766-729-06) |
| 4 fl oz (NDC 54766-729-04) | ||
| 8 fl oz (NDC 54766-729-03) | ||
| Pramosone® Lotion 2.5% | 2 fl oz (NDC 54766-726-06) | |
| 4 fl oz (NDC 54766-726-04) |
Storage Conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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
Pramosone® is a registered trademark of Sebela International Ltd.
#6985I
©2015 Reproduction prohibited
INGREDIENTS AND APPEARANCE
| PRAMOSONE
hydrocortisone acetate and pramoxine hydrochloride lotion |
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| Labeler - Sebela Pharmaceuticals Inc. (079104574) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ferndale Laboratories, Inc. | 005320536 | analysis(54766-729) , label(54766-729) , manufacture(54766-729) | |