FDA Label for Alcortin

Alcortin 2.0 G Ucarton.Jpg

Alcortin 2 G Packet.Jpg

Insert

Prescribing Information
ALCORTINgel
DESCRIPTION
Each gram of Alcortin contains 2.0% (20 mg)
Hydrocortisone and 1.0% (10 mg) lodoquinol.
Also contains 1.0% (10 mg) Aloe polysaccharide
and 5.0% (50 mg) Biopeptide combination
of Palmitoyloligopeptide, Polyglycerylmethacrylate
and Propylene glycol. Other
ingredients: Aminomethyl propanol, Benzyl
alcohol, Blue 1, Carbomer, Fragrance, Glycerin,
Magnesium aluminum silicate, PPG-20 methyl
glucose ether, Propylene glycol, Purified water,
SO alcohol 40-B and Yellow 10.
lodoquinol
lodoquinol is an antifungal and antibacterial
agent. Chemically, lodoquinol is [5,7-diiodo-8-
quinolinol] with the molecular formula
(C9HsI2NO)
Hydrocortisone
Hydrocortisone is an anti-inflammatory and
antipruritic agent. Chemically, hydrocortisone is
[Pregn-4-ene-3, 20-dione, 11, 17, 21- trihydroxy-,
(11 B)-] with the molecular formula
(C21H300s)
CLINICAL PHARMACOLOGY
Hydrocortisone has anti-inflammatory, antipruritic
and vasoconstrictive properties. While the
mechanism of anti-inflammatory activity is
unclear, there is evidence to suggest that a recognizable
correlation exists between vasoconstrictor
potency and therapeutic efficacy in
humans. lodoquinol has both antifungal and
antibacterial properties.
Pharmacokinetics
The extent of percutaneous absorption of topical
steroids is determined by many factors
including the vehicle, the integrity of the epidermal
barrier and the use of occlusive dressings.
Hydrocortisone can be absorbed from normal
intact skin. Inflammation and/or other inflammatory
disease processes in the skin increase
percutaneous absorption. Occlusive dressings
substantially increase the percutaneous
absorption of topical corticosteroids. Once
absorbed throuah the skin. hvdrocortisone is
tetrahydrocortisone and tetrahydrocortisol.
These are excreted in the urine, mainly conjugated
as glucuronides, together with a very
small proportion of unchanged hydrocortisone.
There are no data available regarding the percutaneous
absorption of iodoquinol; however,
following oral administration, 3-5% of the dose
was recovered in the urine as a glucuronide.
INDICATIONS AND USAGE
Based on a review of a related drug by the
National Research Council and subsequent
FDA classification for that drug, the indications
are as follows: "Possibly" Effective: Contact or
atopiC dermatitis; impetiginized eczema; nummular
eczema; endogenous chronic infectious
dermatitis; stasis dermatitis; pyoderma; nuchal
eczema and chronic eczematoid otitis externa;
acne urticata; localized or disseminated neurodermatitis;
lichen simplex chronicus; anogenital
pruritus (vulvae, scroti, ani); folliculitis; bacterial
dermatoses; mycotic dermatoses such as tinea
(capitis, cruris, corporis, pedis); monliasis; intertrigo.
Final classification of the less-than-effective
indications requires further investigation.
CONTRAINDICATIONS
Alcortin is contraindicated in those patients with
a history of hypersensitivity to hydrocortisone,
iodoquinol, aloe vera, glycine, histidine, lysine,
palmitic acid or any other components of the
preparation.
WARNINGS AND PRECAUTIONS
For external use only. Keep away from eyes. If
irritation develops, the use of Alcortin should be
discontinued and appropriate therapy instituted.
Staining of the skin, hair and fabrics may occur.
Not intended for use on infants or under diapers
or occlusive dressings. If extensive areas are
treated or if the occlusive dressing technique is
used, the possibility exists of increased systemic
absorption of the corticosteroid, and suitable
precautions should be taken. Children may
absorb proportionally larger amounts of topical
corticosteroids and thus be more susceptible to
systemic toxicity. 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. lodoquinol may be
absorbed through the skin and interfere with
thyroid function tests. If such tests are contemplated,
wait at least one month after discontinuance
of therapy to perform these tests. The ferric
chloride test for phenylketonuria (PKU) can
yield a false positive res!Jlt if iodoquinol is present
in the diaper or urine. Prolonged use may
result in overgrowth of non-susceptible organisms
requiring appropriate therapy. Keep out of
reach of children. Burning, itching, irritation and
dryness have been reported infrequently following
the use of topical corticosteroids.
Carcinogenesis, Mutagenisis and Impairment of
Fertility: Long term animal studies have not
been performed to evaluate the carcinogenic
potential of the effect on fertility of hydrocortinegative
results. Mutagenicity studies have not
been performed with iodoquinol.
Pregnancy Category C: Animal reproductive
studies have not been conducted with Alcortin.
It is not known whether Alcortin can cause fetal
harm when administered to pregnant women or
can affect reproductive capacity. Alcortin
should be given to pregnant women only if
clearly needed.
Nursing Mothers: It is not known whether this
drug is excreted in human milk. Because many
drugs are excreted in human milk, caution
should be exercised when Alcortin is administered
to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric
patients under the age of 12 have not been
established.
ADVERSE REACTIONS
The following local adverse reactions are
reported infrequently with topical corticosteroids.
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 infections,
skin atrophy, striae and miliaria.
DOSAGE AND ADMINISTRATION
Apply to affected area 3-4 times daily in accordance
with physician's directions or as directed
otherwise by a physician.
HOW SUPPLIED
FORM NDC # 68040-702-13 .
48.0 gram carton of 24-count of 2.0 gram gel individual packs
FORM NDC # 68040-702-02
2.0 gram gel individual pack
FORM NDC # 68040-702-08
10 count carton of 2.0 gram gel sample packs - not for resale
Each 2.0 gram gel pack contains multiple doses
depending on the surface area treated.
STORAGE
Store at room temperature 15°-30°C (59°-86°F).
Keep tightly closed.
Rx only www.alcortin.com
U.S. Patents
#6,436,679; #6,271 ,214; #6,133,440;
#5,708,038; patent pending
Manufactured for:
Primus Pharmaceuticals, Inc.
Scottsdale, AZ 85254
www.primusrx.com