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ERFA HYDROQUINONE is a brand name for Hydroquinone, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ERFA HYDROQUINONE is indicated for: the short-term treatment of hyperpigmented skin conditions such as chloasma, melasma, ‘liver spots’, ‘age spots’, freckles, senile/solar lentigines, and post- inflammatory hyperpigmentation. • UV protection (sunscreen, and/ or protective clothing) should be used. See Warnings and…
Verbatim from this product's HC label. Tap a section to expand.
1 Recommended Dose and Dosage Adjustment Test for skin sensitivity before use: Apply a small amount of gel on unbroken skin, and check for irritations within 24 hours. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation, or vesicle formation occurs.
Dosing:
ERFA HYDROQUINONE should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment (within 3 weeks for melasma), ERFA HYDROQUINONE should be discontinued, and the skin reassessed for potentially more serious conditions.
Hydroquinone gel should not be used for maintenance therapy beyond 2 or 3 months. UV protection 4 (sunscreen SPF > 30 (UVA and UVB), and/ or protective clothing) should be used. See Warnings and Precautions. The use of hydroquinone products in paranasal and infraorbital areas increases the risk of irritation.
Discontinue use if mild irritation persists or if severe irritation or rash occurs. Health Canada has not authorized an indication for pediatric use. 2 Administration For topical use only. Not for oral, ophthalmic or intravaginal use.
1 Adverse Reaction Overview In published clinical trials of varying duration (most were of 12-week duration), the adverse effects 7 reported in 559 patients treated with various formulations of hydroquinone cream (2% or 4%) mainly for melasma were local irritation, erythema, itchy eruptions, stinging, tingling, burning, pruritus at the application site.
Most events were mild in intensity. Contact dermatitis was reported in three patients, one patient had a positive patch test for sensitization. Spontaneous adverse event reports in Canada for hydroquinone topical skin products include the following events: contact dermatitis, burning sensation, skin discolouration/ hyperpigmentation, rash, serious rash, chemical burn, scarring, drug ineffective, serious erythema, and benign neoplasm of the skin.
Long term treatment with hydroquinone may result in ochronosis or leukoderma (see Warnings and Precautions).
Sulfite Sensitivity Reactions:
Sulfite may cause allergic-type reactions (including anaphylaxis and life- threatening reactions and asthmatic episodes) in certain susceptible individuals. See Warnings and Precautions. This product contains glycolic acid and citric acid, which are alpha-hydroxy acids (AHAs) which may increase the skin's sensitivity to the sun and particularly the possibility of sunburn.
This product can cause skin irritation as it contains propylene glycol. This product can cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes as it contains butylhydroxytoluene. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Hydroquinone may produce exogenous ochronosis with continuous use (progressive asymptomatic hyperpigmentation of gray-blue or blue-black darkening of the skin, erythema, and papules on the sun exposed treated areas of the skin). In severe cases, ochronosis may cause disfiguring effects.
If hyperpigmentation develops, treatment should immediately be discontinued. g. antimalarial drugs, resorcinol, phenol or injections of quinine). Hydroquinone may produce leukoderma if used for a relatively long period of time. Leukoderma is mostly irreversible as melanocytes are destroyed leaving white patches on the skin.
It may possibly mask Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical Hydroquinone gel 4% w/w Ammonium hydroxide, butylhydroxytoluene , citric acid anhydrous, disodium edetate, ethanol 96%, glycolic acid, propylene glycol, polyquaternium-10, sodium metabisulfite , sodium sulfite anhydrous, and purified water.
5 other skin lesions, including malignant lesions. General Hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects. Use only as directed. The physician should be familiar with conditions of use of hydroquinone for skin application before prescribing.
The skin lesions should be assessed by the physician before prescribing the drug in order to exclude malignant skin lesions. UV protection (sunscreen, and/or protective clothing) should be used to avoid re-pigmentation. Hyperpigmentation or depigmentation during treatment should prompt discontinuation of therapy.
Hydroquinone should only be applied to small areas of the body, and should not be applied on broken skin or mucous membranes. Avoid contact with eyes; in case of contact, the patient must rinse thoroughly with water. If no improvement is seen after 2 or 3 months of treatment (within 3 weeks for melasma), ERFA HYDROQUINONE should be discontinued, and the skin reassessed for potentially more serious conditions.
ERFA HYDROQUINONE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
The safety of topical hydroquinone use during pregnancy or for children has not been studied.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In a study to demonstrate the efficacy and safety of a novel pharmaceutical formulation of hydroquinone 4%, in the gel form (HQ*-4% (02-0268)) there were no severe adverse reactions detected.
3% were related to the product. 7% experienced 4 adverse reactions. 25% of patients in the placebo group. 25% of patients in the placebo group. 25% of the placebo group participants. 3 Clinical Trial Adverse Reactions (Pediatrics) ERFA HYDROQUINONE was not studied in pediatric populations.
000), very rare (<1/10,000) and unknown frequency (cannot be estimated from the data available). Skin and subcutaneous tissue disorders Uncommon: erythema and itching. Rare: cutaneous sensitivity. In long-term treatment it can cause a cutaneous hyperpigmentation reaction.
The treatment should be discontinued if these disorders do not disappear after one week. Very rare: leukoderma has been observed in isolated cases. Ochronosis has been observed in long-term treatments (more than 6 months), mainly in black people.
No systemic adverse effects have been described. TREATMENT SHOULD BE STOPPED IF ADVERSE REACTIONS ARE OBSERVED.
ERFA HYDROQUINONE contains glycolic acid and citric acid, which are alpha-hydroxy acids (AHAs) which may increase the skin's sensitivity to the sun and particularly the possibility of sunburn. It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen.
Contact of the product with the skin must be of limited frequency or duration. See Warnings and Precautions – Immune. ERFA HYDROQUINONE contains sodium metabisulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or asthmatic episodes.
Sulfite sensitivity is more frequently reported among asthmatic subjects. This medicinal product can cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes as it contains butylhydroxytoluene.
See Warnings and Precautions – Immune. Carcinogenesis and Mutagenesis Long term exposure to hydroquinone in animal carcinogenicity studies has shown some evidence of carcinogenicity. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen.
See NON-CLINICAL TOXICOLOGY. Dermal application of hydroquinone was associated with cutaneous malignancy (spindle cell squamous cell carcinoma) in some cases reported in the literature. It is unknown whether hydroquinone was a pro- carcinogen or malignancy was due to suppression of natural photo-protection effect of melanin.
Caution should be exercised in patients who have a history of, or are at risk of developing cancer when using hydroquinone-containing products. Close monitoring should be considered. Immune Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 6 Allergic contact dermatitis may occur. If contact dermatitis is reported or suspected, ERFA HYDROQUINONE should be discontinued immediately.
) Sexual Health Reproduction and Fertility Oral administration of hydroquinone did not produce embryotoxic, fetotoxic, or teratogenic effects in rats, nor did it produce significant adverse reproductive effects in a two-generation study.
However in rabbits, various teratogenic/reproductive treatment-related effects were observed at high doses. (See NON- CLINICAL TOXICOLOGY). Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Topical hydroquinone should be given to a pregnant woman only if clearly needed. Skin This product contains glycolic acid and citric acid, which are alpha-hydroxy acids (AHAs) which may increase the skin's sensitivity to the sun and particularly the possibility of sunburn.
It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen. Contact of the product with the skin must be of limited frequency or duration. This medicinal product can cause skin irritation as it contains propylene glycol.
This medicinal product can cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes as it contains butylhydroxytoluene. 1 Pregnant Women The safety of topical hydroquinone use during pregnancy has not been studied.
Topical hydroquinone should be given to a pregnant woman only if the treatment benefit outweighs the perceived risks. 2 Breast-feeding The safety of topical hydroquinone use during breast-feeding has not been studied. It is unknown if the drug is excreted in human […]