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Capex
Overview
What is Capex?
Capex Shampoo 0.01% is supplied as a shampoo formulation with a 12 mg fluocinolone acetonide capsule which is emptied into the shampoo base by the pharmacist at the time of dispensing. After mixing, Capex Shampoo contains fluocinolone acetonide(6α,9-Difluoro-11β,16α, 17,21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone), a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agents.
Chemically, Capex Shampoo mixture is CHFO. It has the following structural formula:
Fluocinolone acetonide in Capex Shampoo has the molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light and melts at 270°F with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each fluocinolone capsule contains 12 mg of fluocinolone acetonide, 548 mg of dibasic calcium phosphate dihydrate USP, and 240 mg of talc USP. The shampoo base contains aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, and fragrances, with D&C Yellow #10 and FD&C Blue #1 as coloring.
What does Capex look like?
What are the available doses of Capex?
Sorry No records found.
What should I talk to my health care provider before I take Capex?
Sorry No records found
How should I use Capex?
Capex Shampoo is a low to medium potency corticosteroid indicated for the treatment of seborrheic dermatitis of the scalp. This product has not been proven to be effective in other corticosteroid-responsive dermatoses.
The pharmacist must empty the contents of the enclosed capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately one (1) 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 approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.
What interacts with Capex?
Sorry No Records found
What are the warnings of Capex?
Sorry No Records found
What are the precautions of Capex?
Sorry No Records found
What are the side effects of Capex?
The following local adverse reactions have been reported infrequently with topical corticosteroids. 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, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation and hypopigmentation.
What should I look out for while using Capex?
Capex Shampoo is 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 Capex?
Topically applied Capex Shampoo can be absorbed in sufficient amounts to produce systemic effects (See ).
How should I store and handle Capex?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015Capex Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex Shampoo is dispensed to the patient in a 6 ounce bottle.Shake well before using.Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAMade in Canada.P52306-3Galderma is a registered trademark.Revised: December 2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
Pharmacokinetics:
Capex Shampoo is in the low to medium range of potency as compared with other topical corticosteroids.
Non-Clinical Toxicology
Capex Shampoo is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.No drugs are known to interfere with the conversion of fosphenytoin to phenytoin. Conversion could be affected by alterations in the level of phosphatase activity, but given the abundance and wide distribution of phosphatases in the body it is unlikely that drugs would affect this activity enough to affect conversion of fosphenytoin to phenytoin. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in clinically significant effects, caution is advised when administering fosphenytoin with other drugs that significantly bind to serum albumin.
The pharmacokinetics and protein binding of fosphenytoin, phenytoin, and diazepam were not altered when diazepam and fosphenytoin were concurrently administered in single submaximal doses.
The most significant drug interactions following administration of fosphenytoin are expected to occur with drugs that interact with phenytoin. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes.
The most commonly occurring drug interactions are listed below:
Note: The list is not intended to be inclusive or comprehensive. Individual drug package inserts should be consulted.
Drugs that affect phenytoin concentrations:
Drugs affected by phenytoin:
Monitoring of plasma phenytoin concentrations may be helpful when possible drug interactions are suspected (see ).
General:
Patients applying a topical steroid to a large surface area or to areas 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 2 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. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See ).
If irritation develops, Capex Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by a rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
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 Capex Shampoo should be discontinued until the infection has been adequately controlled.
The following local adverse reactions have been reported infrequently with topical corticosteroids. 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, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation and hypopigmentation.
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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