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Proctocream HC

Generic Name: hydrocortisone
Dosage Form: cream

proctocream® HC 2.5%
(hydrocortisone cream, USP 2.5%)
Rx only topical 6-141-30-01-0510
Rev 05/10

DESCRIPTION: proctocream®•HC 2.5% contains Hydrocortisone [Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β-] with the molecular formula C21H30O5 and a molecular weight of 362.47, CAS 50-23-7. Each gram for topical administration contains: 25 mg of hydrocortisone in a base of glyceryl monostearate. polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water.


CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

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 resistance dermatoses (See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handles 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 (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.
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:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. 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 HPA axis suppression: Urinary free cortisol test; ACTH stimulation test.

Carcinogenesis, Mutagenesis, 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 EffectsPregnancy 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 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 hypothalamic-pituitary-adrenal (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: 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: Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition.
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.

HOW SUPPLIED: proctocream®•HC 2.5% (hydrocortisone cream USP, 2.5%) is supplied in 30 gram tubes.
                             30 g                              NDC 68220-141-30
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured for:
ALAVEN Pharmaceutical LLC
Marietta, GA 30062, USA                                                                                                                  6 - 141 - 30 - 01 - 0510
By: Nycomed US Inc.                                                                                                                                     Rev. 05/10
Melville, New York 11747                                                                                                               I5607 ALAVEN R5/10
For Medical Inquiries, call 1-888-317-0001                                                                                                       #49

Principal Display Panel – 30 g Tube

NDC 68220-141-30
proctocream® HC 2.5%
(hydrocortisone cream, USP 2.5%)
30 grams net wt                   ALAVEN®

Pharmaceutical LLC
Rx only

KEEP OUT OF REACH OF CHILDREN            FOR EXTERNAL USE ONLY            NOT FOR OPHTHALMIC USE
SEE CRIMP OF TUBE FOR LOT NUMBER AND EXPIRATION DATE.
SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

DESCRIPTION: proctocream® HC 2.5% is a topical preparation containing 25 mg of hydrocortisone per gram in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water.
DIRECTIONS: 2 to 4 APPLICATIONS DAILY.                                                                  6 - 141 - 30 - 09 - 0810
IMPORTANT: Do not use if seal has been punctured or is not visible.                              W5607 R8/10
TO OPEN: Use cap to puncture seal.
Store at 25°C (77°F); excursions 15-30°C (59-86°F)
Manufactured for:                                            By:
ALAVEN Pharmaceutical LLC                      Nycomed US Inc.
Marietta, GA 30062, USA                              Melville, New York 11747

PROCTOCREAM  HC
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68220-141
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
POLYOXYL 40 STEARATE  
GLYCERIN  
PARAFFIN  
STEARYL ALCOHOL  
ISOPROPYL PALMITATE  
SORBITAN MONOSTEARATE  
BENZYL ALCOHOL  
POTASSIUM SORBATE  
LACTIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:68220-141-30 1 TUBE (TUBE) in 1 CARTON
1 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089414 03/18/2011
Labeler - Alaven Pharmaceutical LLC (140210829)
Revised: 03/2011
 
Alaven Pharmaceutical LLC



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