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Cloderm
Overview
What is Cloderm?
Cloderm Cream 0.1% contains the medium potency topical corticosteroid,
clocortolone pivalate, in a specially formulated water-washable emollient cream
base consisting of purified water, white petrolatum, mineral oil, stearyl
alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium
hydroxide, with methylparaben and propylparaben as preservatives.
What does Cloderm look like?
What are the available doses of Cloderm?
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What should I talk to my health care provider before I take Cloderm?
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How should I use Cloderm?
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.
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 anti-microbial therapy instituted.
What interacts with Cloderm?
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What are the warnings of Cloderm?
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What are the precautions of Cloderm?
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What are the side effects of Cloderm?
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:
What should I look out for while using Cloderm?
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What might happen if I take too much Cloderm?
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see ).
How should I store and handle Cloderm?
Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes.
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine sodium tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
Drug-Food Interactions - Consumption of certain foods may affect levothyroxine absorption thereby necessitating adjustments in dosing. Soybean flour (infant formula), cotton seed meal, walnuts, and dietary fiber may bind and decrease the absorption of levothyroxine sodium from the GI tract.
Drug-Laboratory Test Interactions - Changes in TBG concentration must be considered when interpreting T and T values, which necessitates measurement and evaluation of unbound (free) hormone and/or determination of the free-T index (FTI). Pregnancy, infectious hepatitis, estrogens, estrogen-containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Decreases in TBG concentrations are observed in nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, and after androgen or corticosteroid therapy (see also ). Familial hyper- or hypo-thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.
Carcinogenesis, Mutagenesis, and Impairment of Fertility - Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine. The synthetic T in Levothyroxine sodium tablets, USP is identical to that produced naturally by the human thyroid gland. Although there has been a reported association between prolonged thyroid hormone therapy and breast cancer, this has not been confirmed. Patients receiving Levothyroxine sodium tablets, USP for appropriate clinical indications should be titrated to the lowest effective replacement dose.
Pregnancy - – Studies in women taking levothyroxine sodium during pregnancy have not shown an increased risk of congenital abnormalities. Therefore, the possibility of fetal harm appears remote. Levothyroxine sodium tablets, USP should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated.
Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal and childhood growth and development. During pregnancy, serum T levels may decrease and serum TSH levels increase to values outside the normal range. Since elevations in serum TSH may occur as early as 4 weeks gestation, pregnant women taking Levothyroxine sodium tablets, USP should have their TSH measured during each trimester. An elevated serum TSH level should be corrected by an increase in the dose of Levothyroxine sodium tablets, USP. Since postpartum TSH levels are similar to preconception values, the Levothyroxine sodium tablets, USP dosage should return to the pre-pregnancy dose immediately after delivery. A serum TSH level should be obtained 6-8 weeks postpartum.
Thyroid hormones cross the placental barrier to some extent as evidenced by levels in cord blood of athyreotic fetuses being approximately one-third maternal levels. Transfer of thyroid hormone from the mother to the fetus, however, may not be adequate to prevent hypothyroidism.
Nursing Mothers - Although thyroid hormones are excreted only minimally in human milk, caution should be exercised when Levothyroxine sodium tablets, USP are administered to a nursing woman. However, adequate replacement doses of levothyroxine are generally needed to maintain normal lactation.
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 ).
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.
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:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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