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  • CLASSES

    Topical Dermatological Antifungals
    Topical Scalp Antifungals

    DEA CLASS

    Rx

    DESCRIPTION

    Topical preparation used to treat skin infections and eczema.

    COMMON BRAND NAMES

    Aloquin, QUINJA

    HOW SUPPLIED

    QUINJA Topical Gel: 1.25-1%

    DOSAGE & INDICATIONS

    For the treatment of contact dermatitis, atopic dermatitis, impetiginized eczema/ impetigo, nummular eczema, endogenous chronic infectious dermatitis, stasis dermatitis, pyoderma, nuchal eczema, chronic eczematoid otitis externa, acne urticata, localized or disseminated neurodermatitis, lichen simplex chronicus, anogenital pruritus (vulvus, scrotum, anus), folliculitis, bacterial dermatoses, mycotic dermatoses (tinea capitis, tinea cruris, tinea corporis, tinea pedis), monliasis, and intertrigo.
    NOTE: Indications are based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug; the indications are listed as "possibly” effective.]
    Topical dosage
    Adults, Adolescents, and Children >= 12 years

    Apply to affected area(s) 3 to 4 times daily or as directed by a physician.

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information is not available.

    Elderly

    Maximum dosage information is not available.

    Adolescents

    Maximum dosage information is not available.

    Children

    >= 12 years: Maximum dosage information is not available.
    < 12 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available. Oral iodoquinol is contraindicated in patients with hepatic insufficiency; however, use of the topical preparation would not be expected to yield significant systemic concentrations. Use with caution.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration
    Other Topical Formulations

    Apply a thin film sparingly to the affected area.
    Do not cover with an occlusive dressing.
    Do not apply topical gel to eyes.

    STORAGE

    Aloquin:
    - Brief exposure up to 104 degrees F does not adversely affect product
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    QUINJA:
    - Store at 77 degrees F; brief exposure up to 104 degrees F does not adversely affect product
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Iodine hypersensitivity, iodoquinol hypersensitivity

    Aloe polysaccharide; iodoquinol is contraindicated in patients with known iodine hypersensitivity or iodoquinol hypersensitivity or a history of hypersensitivity reactions to any product components.

    Goiter, Graves' disease, hyperthyroidism, hypothyroidism, thyroid disease

    Aloe polysaccharide; iodoquinol should be used with caution in patients with thyroid disease (e.g., goiter, Graves' disease, hyperthyroidism or hypothyroidism). Iodoquinol contains 64% organically bound iodine. Significant systemic concentrations of iodine-containing drugs like iodoquinol may result in overt thyroid disease (e.g., iodine-induced hypothyroidism with associated goiter, or hyperthyroidism). It is unknown if topical iodoquinol preparations could result in thyroid disease; however, according to the manufacturer, iodoquinol may be absorbed through the skin and interfere with thyroid function tests.

    Children, infants, neonates, phenylketonuria

    Aloe polysaccharide; iodoquinol may produce a false positive ferric chloride test for phenylketonuria (PKU) if iodoquinol is present in the diaper or urine. Aloe polysaccharide; iodoquinol is not recommended for use in neonates, infants, or children < 12 years old and should not be used under a diaper or occlusive dressings.

    Pregnancy

    Aloe polysaccharide; iodoquinol is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and its' ability to cause fetal harm or affect reproductive capacity is unknown. There have been limited case reports of oral iodoquinol used during pregnancy without apparent harm to the fetus. Iodoquinol contains 64% organically bound iodine, and the fetus is potentially susceptible to iodine-induced thyroid disorders or other potential iodoquinol side effects. It is unknown if topical use of iodoquinol could result in significant maternal or fetal concentrations. Administer during pregnancy only when clearly needed.

    Breast-feeding

    Data are limited regarding use of aloe polysaccharide; iodoquinol during breast-feeding and its' excretion in human breast milk is unknown. Elevated iodine concentrations in the breast-fed infant are theoretically possible, and neonates are among those persons susceptible to iodine-induced thyroid disorders. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Mild

    pruritus / Rapid / Incidence not known
    skin discoloration / Delayed / Incidence not known
    urticaria / Rapid / Incidence not known
    hair discoloration / Delayed / Incidence not known
    diarrhea / Early / Incidence not known
    abdominal pain / Early / Incidence not known
    vomiting / Early / Incidence not known
    nausea / Early / Incidence not known
    headache / Early / Incidence not known
    fever / Early / Incidence not known
    vertigo / Early / Incidence not known
    chills / Rapid / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Aloe Polysaccharide; Iodoquinol products.

    PREGNANCY AND LACTATION

    Pregnancy

    Aloe polysaccharide; iodoquinol is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and its' ability to cause fetal harm or affect reproductive capacity is unknown. There have been limited case reports of oral iodoquinol used during pregnancy without apparent harm to the fetus. Iodoquinol contains 64% organically bound iodine, and the fetus is potentially susceptible to iodine-induced thyroid disorders or other potential iodoquinol side effects. It is unknown if topical use of iodoquinol could result in significant maternal or fetal concentrations. Administer during pregnancy only when clearly needed.

    Data are limited regarding use of aloe polysaccharide; iodoquinol during breast-feeding and its' excretion in human breast milk is unknown. Elevated iodine concentrations in the breast-fed infant are theoretically possible, and neonates are among those persons susceptible to iodine-induced thyroid disorders. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: The mechanism of activity of aloe polysaccharide; iodoquinol is unknown. Iodoquinol has antifungal and antibacterial activity.

    PHARMACOKINETICS

    Aloe polysaccharide; iodoquinol is administered topically. Pharmacokinetic data are not available.