Procto-Med HC

Name: Procto-Med HC

Procto-Med HC - 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 to 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 resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical cortico steroids 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.

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 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.

To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Overdosage

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

Procto-Med HC Dosage and Administration

Topical corticosteroids are generally applied to the affected area as a thin film from 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 is Procto-Med HC Supplied

Hydrocortisone Cream USP, 2.5% is available as follows:

30 g (1.1 oz) tube (NDC 69315-302-30) Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.

Manufactured by:
G &W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Leading Pharma, LLC
Fairfield, NJ 07004

Revised – January 2016

365I600-0613 GW 7067

Procto-Med HC 
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69315-302
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
CETYL ALCOHOL  
CITRIC ACID MONOHYDRATE  
GLYCERYL MONOSTEARATE  
ISOPROPYL MYRISTATE  
METHYLPARABEN  
POLYOXYL 40 STEARATE  
POLYSORBATE 60  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM CITRATE, UNSPECIFIED FORM  
SORBIC ACID  
SORBITAN MONOSTEARATE  
STEARYL ALCOHOL  
WHITE WAX  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:69315-302-30 1 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 ANDA089682 05/09/2016
Labeler - Leading Pharma, LLC (079575060)
Registrant - Leading Pharma, LLC (079575060)
Establishment
Name Address ID/FEI Operations
G&W NC Laboratories, LLC 079419931 MANUFACTURE(69315-302)
Revised: 05/2016   Leading Pharma, LLC

For the Consumer

Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

Other dosage forms:

  • topical application cream, topical application lotion, topical application ointment, topical application solution
  • topical application cream
  • topical application cream, topical application ointment

Along with its needed effects, hydrocortisone topical (the active ingredient contained in Procto-Med HC) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrocortisone topical:

Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • irritation
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • redness and scaling around the mouth
  • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
  • thinning, weakness, or wasting away of the skin

Some side effects of hydrocortisone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Acne or pimples
  • burning and itching of the skin with pinhead-sized red blisters
  • burning, itching, and pain in hairy areas, or pus at the root of the hair
  • increased hair growth on the forehead, back, arms, and legs
  • lightening of normal skin color
  • lightening of treated areas of dark skin
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • softening of the skin

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