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| Pharmaceuticals \ Glyquin® |
Glyquin Package Insert
| RX ONLY
FOR EXTERNAL USE ONLY
I. DESCRIPTION
Each gram of Glyquin contains 40 mg hydroquinone USP, 80 mg padimate USP, 40 mg oxybenzone USP, and 40 mg octyl methoxycinnamate in a vanishing cream of purified water, glycolic acid, poloxamer, propylene glycol, glycerol monostearate, triethanolamine, polyoxyl 4 lauryl ether, lemon extract, propyl gallate, ascorbyl palmitate,
vitamin E, methylparaben, and benzalkonium chloride.
II. CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa)(Denton, C et al., 1952)1 and suppression of other melanocyte metabolic processes. (Jimbow, K. et al., 1974)2
III. INDICATIONS AND USAGE
Glyquin is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
IV. CONTRAINDICATIONS
Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
V. WARNINGS
A. CAUTION: Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
B. Test for skin sensitivity before using Glyquinâ by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided.
If no bleaching or lightening effect is noted after 2 months of treatment use, Glyquin should be discontinued. Glyquin is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. The sunscreens in Glyquin provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent or protective clothing to prevent repigmentation.
D. Keep this and all medications out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
VI. PRECAUTIONS (SEE WARNINGS)
A. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.
B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.
C. Pediatric usage. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
VII. ADVERSE REACTIONS
No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.
VIII. OVERDOSAGE
There have been no systemic reactions from the use of topical hydroquinone in Glyquin. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.
IX. DRUG DOSAGE AND ADMINISTRATION
Glyquin should be applied to the affected area and rubbed in well twice daily or as directed by a physician. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.
X. HOW SUPPLIED
Glyquin is available as follows:
SIZE: 1 ounce jar (28 grams) NDC 0187-0420-46
Store at 25oC (77o F); excursions permitted to 15oC-30oC (59oF-86oF).
REFERENCES:
1. Denton, C., A.B Lerner and T.B. Fitzpatrick, “Inhibition of Melanin Formation by Chemical Agents.” Journal of Investigative Dermatology, 18:119-135,1952.
2. Jimbow, K., H. Obata, M. Pathak, and T.B. Fitzpatrick, 'Mechanism of Depigmentation by Hydroquinone," Journal of Investigative Dermatology, 62:436-449,1974.
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