Title : Locoid Cream online meds RX without-full index Locoid Cream - quality health products internet store.
Short descriptions : Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor skin irritations, itching, and rashes caused by eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and jewelry; (2) itchy anal and rectal areas; and (3) itching and irritation of the scalp. It is also used to relieve the discomfort of mouth sores.Hydrocortisone may be prescribed by your doct F-Hydrocortisone
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Locoid Cream - the popular prescribed quality products- usage online guide
Brand : Locoid Cream (Lipocream)
[Ferndale Laboratories] For Dermatological Use Only
DESCRIPTION
Locoid Lipocream® Cream contains the topical corticosteroid hydrocortisone
butyrate, a hydrocortisone ester.
It has the chemical name: (11ß)-11,21-dihydroxy-17-[(1-oxobutyl)oxy]-pregn-4-ene-3,20-dione;
the molecular formula: C25H36O6; the molecular weight: 432.54; and the
CAS registry number: 13609-67-1.
Image from Drug Label Content
Each gram of Locoid Lipocream® Cream contains 1 mg of hydrocortisone
butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20,
mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben
and butylparaben (preservatives) and purified water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive
actions.
The mechanism of anti-inflammatory activity of topical corticosteroids
is unclear. Various laboratory methods, including vasoconstrictor assays,
are used to compare and predict potencies and/or clinical efficacies
of 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 or widespread application may increase the possibility
of hypothalamic-pituitary-adrenal (HPA) axis suppression.
The vasoconstrictor assay showed that Locoid Lipocream® Cream had
a more pronounced skin blanching effect than Locoid® Cream, suggesting
greater percutaneous absorption from the former. At the present time,
no adequate HPA axis suppresion studies have been conducted for Locoid
Lipocream® Cream.
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 Locoid Cream (Lipocream)
Locoid Lipocream® (hydrocortisone butyrate 0.1%) Cream is indicated
for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are 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
HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia,
and glucosuria in some patients. Conditions which increase the risk of
systemic toxicity include the application of more potent steroids, use
over large surface areas, prolonged use, and the addition of occlusive
dressings. 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.
4. Patients should report any signs of local adverse reactions.
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
Carcinogenesis, 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 in Salmonella ryphimurium strains TA98, TA100,
and TA92 with prednisolone and hydrocortisone have revealed negative
results.
Pregnancy
Teratogenic Effects
Pregnancy Category C Locoid Cream (Lipocream) :
Corticosteroids are generally 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.
In teratogenicity studies, topical administration of 1% or 10% hydrocortisone
butyrate in an ointment to pregnant Wistar rats (gestational days 6-15)
or New Zealand white rabbits (gestational days 6-18) resulted in no teratogenic
findings. However, a dose-dependant increase in fetal resorptions was
reported in rabbits, and fetal resorptions were observed in rats treated
with 10% hydrocortisone butyrate.
The doses given to rats are approximately 8 to 80 times the human topical
dose based on a body surface area comparison (assuming 100% absorption).
For rabbits, the doses given were approximately 0.2 and 2 times the
human topical dose. Increased resorptions were also noted in Wistar rats
given subcutaneous administrations of hydrocortisone butyrate (9mg/kg/day;
3 times the human topical dose) on gestational days 9 through 15. In
CS mice given subcutaneous administrations of 1mg/kg/day (0.2 times the
human topical dose), an increased number of cervical ribs and one fetus
with clubbed legs was reported.
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.
Locoid Lipocream® (hydrocortisone butyrate 0.1%) Cream should not
be used extensively on pregnant patients, in large amounts, or for longer
than two weeks.
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
Safety and effectiveness in pediatric patients have not been established.
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.
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.
Chronic corticosteroid therapy may interfere with the growth and development
of children.
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, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, 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
Locoid Lipocream® (hydrocortisone butyrate 0.1%) Cream should be
applied to the affected areas as a thin film two or three times daily
(depending on the severity of the condition) and for no longer than two
weeks. If an infection develops, appropriate antimicrobial therapy should
be instituted.
HOW SUPPLIED
Locoid Lipocream® (hydrocortisone butyrate 0.1%) Cream is supplied
in tubes containing:
15 g NDC 0496-0821-15 ; 45 g NDC 0496-0821-45 ; 60 g NDC 0496-0821-25
STORAGE
Store at controlled temperature between 59º - 77ºF (15º -
25ºC).
How to buy Locoid Cream
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