CAPEX SHAMPOO DESCRIPTION
Capex Shampoo
Manufactured by Galderma Canada Inc. This medicine is a corticosteroid shampoo used on the scalp to reduce itching, redness, and swelling associated with certain skin conditions.
CAPEX SHAMPOO
Fluocinolone Acetonide Shampoo 0.01%
Synthetic corticosteroid with anti-inflammatory,
antipruritic, and vasoconstrictive properties
Where Can I order Capex From? Can I buy Capex at Canadian Prices?
Yes, if you are from the U.S. then you can buy Capex at Canadian prices. Currently we will only accept an order for Capex from U.S. and Canadian residents. Both U.S. and Canadian residents require a prescription to purchase Capex and when you order Capex it will be delivered with express shipping.
PHARMACODYNAMICS. Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, anti-pruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. Various laboratory methods, including skin blanching assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is evidence of recognizable correlation between vasoconstrictor potency and therapeutic efficacy in man. Generally, fluocinolone acetonide is considered to be in the low range of corticosteroid potency.
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.
Once absorbed through the skin, topical corticosteroids are handled through the same metabolic and elimination pathways as after systemic administration.
CAPEX INDICATIONS
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is indicated for the treatment of seborrheic dermatitis of the scalp. CapexTM Shampoo has not been proven, by clinical trials, to be effective in other corticosteroid-responsive dermatoses.
CAPEX CONTRAINDICATIONS
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Topical application to the eye is absolutely contraindicated, especially in the presence of ophthalmological infections.
CAPEX WARNINGS
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is considered an eye irritant. If the product is accidentally introduced into the eyes, liberal rinsing with water should be immediately performed.
CAPEX PRECAUTIONS
GENERAL. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients receiving a large dose of a higher potency topical steroid applied to a large surface area or under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.
Patients receiving superpotent corticosteroids should not be treated for more than two weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppression.
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 corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids.
Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
If irritation develops, Capex Shampoo (Fluocinolone Acetonide, 0.01%) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch test.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of CapexTM Shampoo should be discontinued until the infection has been adequately controlled.
PEDIATRIC USE. Safety and effectiveness in children and infants have not been established. Because of a higher ratio of skin surface area to body mass, children 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 infants and children.
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. No studies have been done on CapexTM Shampoo to show teratologic effects on animals.
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 CapexÔ Shampoo is administered to a nursing woman.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY. Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Capex™ Shampoo (0.01% Fluocinolone Acetonide).
INFORMATION FOR PATIENTS. Patients using topical corticosteroids should receive the following information and instructions:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.
This medication should not be used for any disorder other than that for which it was prescribed.
The treated area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
Patients should report to their physician any signs of local adverse reaction.
Capex Shampoo mixture is to be discarded after three (3) months.
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
DRUG INTERACTION. No studies have been done on Capex Shampoo (Fluocinolone Acetonide, 0.01%) to show any drug interaction. Generally, there are known drug interactions caused by glucocorticoids, not necessarily from topical application.
Glucocorticoids decrease the hypoglycemic activity of insulin and oral hypoglycemics, so that a change in dose of the antidiabetic drugs may be necessitated. The usual doses of mineralocorticoids and large doses of some glucocorticoids cause hypokalemia and may exaggerate the hypokalemic effects of thiazides and high-cleaning diuretics.
In combination with amphotericin-B, they also may cause hypokalemia. Glucocorticoids appear to enhance the ulcerogenic effects of non-steroidal anti-inflammatory drugs. They decrease the plasma levels of salicylates, and salicylism may occur on discontinuing steroids. Glucocorticoids may increase or decrease the effects of prothrombopenic anticoagulants. Estrogens, phenobarbital, phenytoin and rifampin increase the metabolic clearance of adrenal steroids and hence necessitate dose adjustments.
ACAPEX DVERSE REACTIONS
In controlled clinical trials, the total incidence of adverse reactions associate with the use of Capex Shampoo (Fluocinolone Acetonide, 0.01%) was less than 1%. There was no evidence of skin atrophy or increased irritation in patients treated in the controlled clinical trials.
The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: dryness, folliculitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation, and hypopigmentation.
CAPEX OVERDOSAGE
Topically applied CapexTM Shampoo (Fluocinolone Acetonide, 0.01%) can be absorbed in sufficient amounts to produce systemic effects (refer to PRECAUTIONS).
CAPEX DOSAGE AND ADMINISTRATION
The pharmacist must empty the contents of the Fluocinolone acetonide capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately 30 ml (one ounce) of the medicated shampoo should be applied to the scalp area once daily, worked into a lather and allowed to remain on the scalp for about 5 minutes. The hair and scalp should then be rinsed completely twice. It has been found, through patient responses, that the shampoo lathers better if the hair is fully wet before applying the shampoo.
CapexTM Shampoo (Fluocinolone Acetonide, 0.01%) is supplied as a two-component package: a capsule containing the active ingredient, fluocinolone acetonide; and 118 milliliters (4 fluid ounces) of the shampoo base in a 180 ml (6 oz.) bottle. The pharmacist must mix the capsule contents into the shampoo base at the time of dispensing; hence, is supplied to patients as mixed CapexTM Shampoo.
STABILITY AND STORAGE RECOMMENDATIONS
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is dispensed to the patient as the mixture form in 180 ml bottles (capsule mixed into the shampoo base by the pharmacist). It is recommended that the (mixed) dispensed dosage form be kept at room temperature, approximately 15º - 30º C (59º - 86º F) and shaken well before each use.
Storage conditions for unmixed dosage form of CapexTM Shampoo capsule is at controlled room temperature of 15º - 30º C (59º - 86º F).
CAPEX DIRECTIONS FOR MIXING
The contents of the capsule is mixed into the shampoo base prior to dispensing to the patients. The mixed form, when dispensed to the patient, should be disposed of after three (3) months.
CAPEX AVAILABILITY OF DOSAGE FORMS
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is marketed as a two-component product: capsule and shampoo base. Each capsule contains 12 mg of the active ingredient, Fluocinolone Acetonide. The shampoo base, quantity 118.28 ml, is packaged in a 180 ml bottle. The mixed dosage form Capex Shampoo has a concentration of 0.01% Fluocinolone Acetonide.
CAPEX INFORMATION FOR THE CONSUMER
Capex Shampoo (Fluocinolone Acetonide, 0.01%) is considered an eye irritant. If accidentally introduced into the eyes, the eyes should be liberally rinsed with tap water.
Capex Shampoo is to be used only as directed by the physician. It is for external use only.
Capex Shampoo should not be used for any other disorder other than that for which it is indicated (prescribed) for.
To get better lather, the hair should be totally wet before applying CapexTM Shampoo. Once applied to the scalp, this is worked into a lather and let to stand for approximately 5 minutes, after which it should be rinsed off completely. It is recommended that the hair and scalp be rinsed twice with water.
The treated scalp should not be bandaged or covered in any way, unless directed by the physician.
The contents of Capex Shampoo (mixed) is to be discarded after three (3) months.
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