ALACORT
-
hydrocortisone acetate cream
Crown Laboratories
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Ala Cort, 1% Hydrocortisone CreamAla Cort 1oz Label - P650201.jpg
P650201.jpg
NDC 0316-0126-01
Ala-Cort Hydrocortisone Cream USP, 1%
Each g contains 10mg Hydrocortisone USP in a cream base consisting of Purified Water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, sorbic acid
1ounce (28.4g)
Distributed by Del-Ray Dermatologicals
Manufactured by Crown Laboratories, Inc
Johnson City, TN 37604
Usual dosage: Apply as a thin film to the affected areas 2 to 4 time daily. See insert.
See crimp of tube for Expiration Date and Batch Number
Caution: Federal law prohibits dispensing without prescription
For External Use Only.
Not for Ophthalmic Use.
Keep Out Of Reach Of Children
P6500001.jpg
NDC 0316-0126-03
Ala-Cort Hydrocortisone Cream USP, 1%
Each g contains 10mg Hydrocortisone USP in a cream base consisting of Purified Water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, sorbic acid
3ounce (85.2g)
Distributed by Del-Ray Dermatologicals
Manufactured by Crown Laboratories, Inc
Johnson City, TN 37604
Usual dosage: Apply as a thin film to the affected areas 2 to 4 time daily. See insert.
See crimp of tube for Expiration Date and Batch Number
Caution: Federal law prohibits dispensing without prescription
For External Use Only.
Not for Ophthalmic Use.
Keep Out Of Reach Of Children
Ala Cort Patient Package Insert
Ala Cort Product Package Insert
Ala Cort Prescribing Information
DESCRIPTION:
The topical corticosteroids constitute a class of primarily synthetic steroids used as anit-inflammitory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (IIβ). Its structural formula is:
Each gram of ALA CORT (Hydrocortisone Cream USP) 1% contains 10 mg
hydrocortisone USP in a creambase consisting of purified water, cetyl alcohol,
glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, and sorbic acid
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 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.
Once absorbed through the skin, topical corticosteroids 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.
INDICATIONS AND USAGE
Hydrocortisone cream is indicated for the
relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Hydrocortisone cream is 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 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
the HPA axis suppression:
∙ Urinary free cortisol test
∙ ACTH stimulation
test
Carinogensis, 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 corticosteroids.
Studies to
determine mutagenicity with prednisolone and hydrocortisone have revealed
negative results.
Pregnancy 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 HPA axis suppression and
Cushing’s syndrome than mature patients because of a larger skin surface area to
body weight ratio.
Hypothalamic-pituitary-adrenaI (HPA) axis suppression, Cushing’s syndrome,
and intracranial hypertension have been reported in children receiving topical
corticosteroids. Manifestations of adrenal suppression in children 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
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
∙Foliculities
∙Hypertrichosis
∙Acneiform
eruptions
∙Hypopigmentation
∙Perioral
dermatitis
∙Allergic
contact dermatitis
∙Maceration of the
skin
∙Secondary
infection
∙Skin
Atrophy
∙Striae
∙Miliaria
OVERDOSAGE
Topically applied corticosteroids can be absorbed in
sufficient amounts to produce systems effects (See PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally
applied to the affected area as a thin film from two to four 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:
Ala Cort (Hydrocortisone Cream USP) 1% is supplied in 3 ounce (85.2g) and 1 ounce (28.4g) tubes
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT
PRESCRIPTION.
Manufactured by:
CROWN LABORATORIES, INC.
For DEL-RAY DERMATOLOGICALS
349 Lafe Cox Drive
Johnson City,
Tennessee 37604
PRINTED IN USA
REVISED 07/03
| ALACORT
hydrocortisone acetonide cream |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA080706 | 03/09/1973 | |
| Labeler - Crown Laboratories (079035945) |
| Registrant - Crown Laboratories (079035945) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Crown Laboratories | 079035945 | manufacture | |