PREDNICARBATE

Main information

  • Trade name:
  • PREDNICARBATE- prednicarbate ointment
  • Composition:
  • PREDNICARBATE 1.0 mg in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PREDNICARBATE- prednicarbate ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Prednicarbate ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Prednicarbate ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.
  • Product summary:
  • Prednicarbate Ointment 0.1% is supplied in Store at 20° to 25°C (68° to 77°F). [See Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2410D R10/15 #136

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0168-0410-15, 0168-0410-60
  • Last update:
  • 15-06-2019

Summary of Product characteristics: dosage, interactions, side effects

PREDNICARBATE- prednicarbate ointment

Fougera Pharmaceuticals Inc.

----------

PREDNICARBATE OINTMENT 0.1%

FOR DERMATOLOGIC USE ONLY.

Rx only

NOT FOR USE IN EYES.

DESCRIPTION:

Prednicarbate ointment 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The

topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-

inflammatory and antipruritic agents.

Each gram of prednicarbate ointment 0.1% contains 1.0 mg of prednicarbate in a base consisting of

white petrolatum, glyceryl monooleate, octyldodecanol NF, and propylene glycol.

Prednicarbate has the empirical formula C

H O and a molecular weight of 488.58.

The CAS Registry Number is 73771-04-7.

The chemical structure is:

CLINICAL PHARMACOLOGY:

Like other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and

vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in

general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A

inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the

biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting

the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane

phospholipids by phospholipase A .

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by

many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with

hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however,

occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can

be absorbed from normal intact skin while inflammation and/or other disease processes in the skin

increase percutaneous absorption. Studies performed with prednicarbate ointment 0.1% indicate that it is

in the medium range of potency as compared with other topical corticosteroids.

INDICATIONS AND USAGE:

Prednicarbate ointment 0.1% is a medium potency corticosteroid indicated for the relief of the

inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:

Prednicarbate ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any

of the components in the preparations.

PRECAUTIONS:

Information for Patients: Patients using topical corticosteroids should receive the following

information and instructions:

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-

pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency

after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and

glucosuria can also be produced in some patients by systemic absorption of topical

corticosteroids while on treatment. Patients receiving a large dose of a higher potency topical

steroid applied to a large surface area or under occlusion should be evaluated periodically for

evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, A.M.

plasma cortisol, and urinary free cortisol tests. Prednicarbate ointment 0.1% did not produce

significant HPA-axis suppression when used at a dose of 60 grams per day for a week in patients

with extensive psoriasis or atopic dermatitis. However, 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 corticosteroid. Recovery of HPA-axis function is generally prompt and

complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of

glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their

larger skin surface area to body mass ratios (See PRECAUTIONS - Pediatric Use .) If irritation

develops, prednicarbate ointment 0.1% should be discontinued and appropriate therapy instituted.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to

heal rather than noting a clinical exacerbation, as with most topical products not containing

corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch

testing. If concomitant skin infections are present or develop, an appropriate antifungal or

antibacterial agent should be used. If a favorable response does not occur promptly, use of

prednicarbate ointment 0.1% should be discontinued until the infection has been adequately

controlled.

This medication is to be used as directed by the physician. It is for external use only. Avoid

contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped so as to be

occlusive, unless directed by the physician.

Patients should report to their physician any signs of local adverse reactions.

This medication should not be used on the face, underarms, or groin areas.

Contact between Prednicarbate Ointment 0.1% and latex containing products (eg. condoms,

diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and

reduce the effectiveness of any latex containing products. If latex products come into contact with

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study of the effect of prednicarbate on

fertility, pregnancy and postnatal development in rats, no effect was noted on the fertility or pregnancy

of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg

of prednicarbate subcutaneously. Prednicarbate has been evaluated in the Salmonella reversion test

(Ames test) over a wide range of concentrations in the presence and absence of an S-9 liver microsomal

fraction and did not demonstrate mutagenic activity. Similarly, prednicarbate did not produce any

significant changes in the numbers of micronuclei seen in erythrocytes when mice were given doses

ranging from 1 to 160 mg/kg of the drug.

Pregnancy: Teratogenic effects: Pregnancy Category C: Corticosteroids have been shown to be

teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some

corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats and Himalayan rabbits

when given subcutaneously during gestation at doses 1900 times and 45 times, respectively, the

recommended topical human dose, assuming a percutaneous absorption of approximately 3%. In the rats,

slightly retarded fetal development and an incidence of thickened and wavy ribs which were higher than

the spontaneous rates were noted.

In rabbits, there was noted increased liver weights and slight increase in the fetal intrauterine death rate.

The fetuses delivered exhibited reduced placental weight, increased frequency of cleft palate,

ossification disorders in the sternum, omphalocele, and anomalous posture of forelimbs. There are no

adequate and well-controlled studies in pregnant women on teratogenic effects of prednicarbate.

Therefore, prednicarbate ointment 0.1% should be used during pregnancy only if the potential benefit

justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress

growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not

known whether topical administration of corticosteroids could result in sufficient systemic absorption

to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution

should be exercised when prednicarbate ointment 0.1% is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of prednicarbate ointment 0.1% in pediatric patients below the

age of 10 years have not been established. Because of a higher ratio of skin surface area to body mass,

pediatric patients are at a greater risk than adults of HPA-axis suppression when they are treated with

topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency

after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects, including

striae, have been reported with inappropriate use of topical corticosteroids in pediatric patients. (See

PRECAUTIONS.) 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.

ADVERSE REACTIONS:

In controlled clinical studies, the incidence of adverse reactions associated with the use of

prednicarbate ointment 0.1% was approximately 1.5%. Reported reactions including burning, pruritus,

drying, scaling, cracking and pain and irritant dermatitis. The following additional local adverse

reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the

Prednicarbate Ointment 0.1%, patients should be advised to discard the latex products. Patients

should be advised that this medication is to be used externally only, not intravaginally.

use of occlusive dressings and especially with higher potency corticosteroids. These reactions are

listed in approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneform eruptions,

hypopigmentation, perioral dermatitis, allergic contact dermatitis, 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 a thin film of prednicarbate ointment 0.1% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED:

Prednicarbate Ointment 0.1% is supplied in

Store at 20° to 25°C (68° to 77°F). [See Controlled Room Temperature].

E. FOUGERA & CO.

A division of

Fougera

PHARMACEUTICALS INC.

Melville, New York 11747

I2410D

R10/15

#136

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

FOUGERA

Rx only

NET WT 15 grams

15 gram tube NDC 0168-0410-15

60 gram tube NDC 0168-0410-60

NDC 0168-0410-15

PREDNICARBATE

OINTMENT 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR USE IN EYES.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

FOUGERA

Rx Only

PREDNICARBATE

OINTMENT 0.1%

NET WT 15 grams

NDC 0168-0410-15

FOR DERMATOLOGIC USE ONLY.

NOT FOR USE IN EYES.

PREDNICARBATE

prednicarbate ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 16 8 -0 410

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PREDNICARBATE (UNII: V9 0 1LV1K7D) (PREDNICARBATE - UNII:V9 0 1LV1K7D)

PREDNICARBATE

1.0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

GLYCERYL O LEATE (UNII: 4PC0 54V79 P)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 16 8 -0 410 -15

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 9 /20 0 7

Fougera Pharmaceuticals Inc.

2

NDC:0 16 8 -0 410 -6 0

6 0 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 9 /20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77236

0 3/0 9 /20 0 7

Labeler -

Fougera Pharmaceuticals Inc. (043838424)

Revised: 4/2018