FDA Label for Prednicarbate
View Indications, Usage & Precautions
- OTHER
- DESCRIPTION:
- CLINICAL PHARMACOLOGY:
- PHARMACOKINETICS
- INDICATIONS AND USAGE:
- CONTRAINDICATIONS:
- GENERAL PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- TERATOGENIC EFFECTS
- NURSING MOTHERS
- PEDIATRIC USE
- ADVERSE REACTIONS:
- OVERDOSAGE:
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Prednicarbate Product Label
The following document was submitted to the FDA by the labeler of this product Fougera Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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 C27H36O8 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 A2 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 A2.
Pharmacokinetics
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.
General Precautions
Information For Patients
Information for Patients: 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. This medication should not be used for any disorder other than that 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 to their physician any signs of local adverse reactions.5. This medication should not be used on the face, underarms, or groin areas.6. 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 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.
Laboratory Tests
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
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.
Teratogenic Effects
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
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
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 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
60 gram tube NDC 0168-0410-60
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
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER
OINTMENT 0.1%
NOT FOR USE IN EYES.
NOT FOR USE IN EYES.
FOUGERA®
Rx only
NET WT 15 grams
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON
FOUGERA®
Rx Only
PREDNICARBATE
OINTMENT 0.1%
NET WT 15 grams
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