CAPITROL is an antibacterial shampoo containing 2% (w/w) chloroxine
(each gram contains 20 mg chloroxine) suspended in a base of sodium octoxynol-2
ethane sulfonate, water, PEG-6 lauramide, dextrin, sodium lauryl sulfoacetate,
sodium dioctyl sulfosuccinate, 1% benzyl alcohol, PEG-14M, magnesium aluminum
silicate, fragrance, EDTA, and color. May contain citric acid to adjust pH.
Chloroxine is a synthetic antibacterial compound that is effective
in the treatment of dandruff and seborrheic dermatitis when incorporated in
The chemical name of chloroxine is 5,7-dichloro-8-hydroxyquinoline.
The chemical structure of chloroxine is:
Well controlled studies demonstrate Capitrol effectively reduces
the excess scaling in patients with dandruff or seborrheic dermatitis. Though
the cause of dandruff is not known, it is thought to be the result of accelerated
mitotic activity in the epidermis. The presumed mechanism of action to reduce
scaling would be to slow down the mitotic activity.
The role of microbes in seborrheic dermatitis is not known; however, Staphylococcus
aureus and Pityrosporon species are often present
in increased numbers during the course of the disease. Chloroxine is antibacterial,
inhibiting the growth of Gram-positive as well as some Gram-negative organisms.
Antifungal activity against some dermatophytes and yeasts also has been shown.
The absorption, metabolism and pharmacokinetics of Capitrol in
humans have not been studied.
INDICATIONS AND USAGE
Capitrol is indicated in the treatment of dandruff and mild to
- moderately severe seborrheic dermatitis of the scalp. Clinical studies indicate
that improvement may be observed after 14 days of therapy.
Capitrol is contraindicated in those patients with a history of
hypersensitivity to any of the listed ingredients.
Capitrol should not be used on acutely inflamed (exudative) lesions
of the scalp.
Information for Patients
Exercise care to prevent Capitrol from entering the eyes. If contact
occurs, the patient should flush eyes with cool water. Discoloration of light-colored
hair (e.g. blond, gray or bleached) may follow use of this preparation.
Irritation and a burning sensation on the scalp and adjacent areas
have been reported.
Drug/Laboratory Test Interactions
There is no known interference of Capitrol with laboratory tests.
No long term studies in animals have been performed to evaluate
the carcinogenic potential of Capitrol.
Results of the in vitro Ames Salmonella/Microsome
Plate test show that Capitrol does not demonstrate genetic activity and is
Pregnancy Category C
Animal reproduction studies have not been conducted with Capitrol.
It is also not known whether Capitrol can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Capitrol should be
given to a pregnant woman only if clearly needed.
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 Capitrol
is administered to a nursing woman.
Specific studies to demonstrate the safety and effectiveness for
use of Capitrol in children have not been conducted.
One patient out of 225 in clinical studies was reported to have
The acute oral LD50 in mice was found tobe 200 mg/kg and in rats 450 mg/kg. On the basis of these animal studies,
Capitrol may be considered practically non-toxic.
DOSAGE AND ADMINISTRATION
Shake well. Capitrol should be massaged thoroughly onto the wet
scalp, avoiding contact with the eyes. Lather should remain on the scalp for
approximately three minutes, then rinsed. The application should be repeated
and the scalp rinsed thoroughly. Two treatments per week are usually sufficient.
Capitrol shampoo contains 2% (w/w) chloroxine (20 mg chloroxine
per gram) and is supplied in 110 g plastic bottles (NDC 0072-6850-04).