Clinical Information
Gen. Code and Des.
34347 hydrocortisone/pramoxine RECTAL CREAM/APPL 2.5 %-1 %
GCN and Des.
84133 hydrocortisone/pramoxine RECTAL CREAM/APPL 2.5 %-1 %
Strength
2.5%
Dose Form
CREAM WITH APPLICATOR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
Active Ingredients
1359 pramoxine HCl 637581
2148 hydrocortisone acetate 50033
Inactive Ingredients
2468 propylene glycol 57556
DESCRIPTION
DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic ...
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic - and vasoconstrictive actions. The mechanism of anti-inflammatory activity ...
PHARMACOKINETICS
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 ...
INDICATIONS & USAGE
INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses ...
CONTRAINDICATIONS
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome ...
INFORMATION FOR PATIENTS
Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as ...
LABORATORY TESTS
Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free Cortisol test - ACTH stimulation ...
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
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 ...
TERATOGENIC EFFECTS
Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more ...
NURSING MOTHERS
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk ...
PEDIATRIC USE
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 ...
ADVERSE REACTIONS
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 ...
OVERDOSAGE
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
DOSAGE & ADMINISTRATION
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 ...
HOW SUPPLIED
HOW SUPPLIED: Analpram HC - ® Cream 2.5% 1 oz tube(NDC 54766-799-04) 12 x 4 gram tubes(NDC ...
STORAGE AND HANDLING
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 ...
PRINCIPAL DISPLAY PANEL - NDC 54766-799-04 Analpram HC ® Cream 2.5% 1 oz Carton
AnalpramHC1oz
PRINCIPAL DISPLAY PANEL - NDC 54766-799-65 Analpram HC ® Cream 2.5% 12 x 4g Carton
AnalpramHC12x4g
PRINCIPAL DISPLAY PANEL - NDC 54766-799-64 Analpram HC ® Cream 2.5% 30 x 4g Carton
AnalpramHC30x4g
INGREDIENTS AND APPEARANCE
