CLASSES
Topical Dermatological Antifungals
Topical Scalp Antifungals
DESCRIPTION
Topical preparation used to treat skin infections and eczema.
COMMON BRAND NAMES
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
No adequate and well-controlled studies have been conducted in pregnant individuals and its ability to cause fetal harm or affect reproductive capacity is unknown. Animal reproductive studies have not been conducted with topical iodoquinol; aloe. 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
No adequate and well-controlled studies have been conducted in pregnant individuals and its ability to cause fetal harm or affect reproductive capacity is unknown. Animal reproductive studies have not been conducted with topical iodoquinol; aloe. 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.