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Differin
Overview
What is Differin?
DIFFERIN(adapalene) Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine.
The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is CHO and molecular weight is 412.53. Adapalene is represented by the following structural formula.
What does Differin look like?
What are the available doses of Differin?
Sorry No records found.
What should I talk to my health care provider before I take Differin?
Sorry No records found
How should I use Differin?
DIFFERIN Cream is indicated for the topical treatment of acne vulgaris.
DIFFERIN Cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of DIFFERIN Cream.
What interacts with Differin?
DIFFERIN Cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.
What are the warnings of Differin?
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What are the precautions of Differin?
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General
Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of DIFFERIN Cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene.
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- This medication is to be used only as directed by the physician.
- It is for external use only.
- Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
- Cleanse area with a mild or soapless cleanser before applying this medication.
- Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
- Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.
- This medication should not be applied to cuts, abrasions, eczematous or sunburned skin.
- Wax epilation should not be performed on treated skin due to the potential for skin erosions.
- During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects.
Information for Patients
Patients using DIFFERIN Cream should receive the following information and instructions:
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Drug Interactions
As DIFFERIN Cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Cream. If these preparations have been used, it is advisable not to start therapy with DIFFERIN Cream until the effects of such preparations in the skin have subsided.
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Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m/day the maximum potential exposure at the recommended topical human dose (MRHD), assumed to be 2.5 grams DIFFERIN Cream, which is approximately 1.5 mg/m adapalene. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.
No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.
Adapalene did not exhibit mutagenic or genotoxic effects (mouse micronucleous test) and (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) studies.
Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m comparisons). No effects of adapalene were found on the reproductive performance or fertility of the F males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F generation.
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Pregnancy
Teratogenic effects. Pregnancy Category C.
2
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Nursing Mothers
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 DIFFERIN Cream is administered to a nursing woman.
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Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
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Geriatric Use
Clinical studies of DIFFERIN Cream were conducted in patients 12 to 30 years of age with acne vulgaris and therefore did not include subjects 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
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What are the side effects of Differin?
In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used DIFFERIN Cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with DIFFERIN Cream from the controlled clinical studies is provided in the following table:
Other reported local cutaneous adverse events in patients who used DIFFERIN Cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with DIFFERIN Cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
| Incidence of Local Cutaneous Irritation with DIFFERIN® Cream from Controlled Clinical Studies (N=285) | ||||||||
| None | Mild | Moderate | Severe | |||||
| Erythema | 52% (148) | 38% (108) | 10% (28) | < 1% (1) | ||||
| Scaling | 58% (166) | 35% (100) | 6% (18) | <1% (1) | ||||
| Dryness | 48% (136) | 42% (121) | 9% (26) | <1% (2) | ||||
| Pruritus (persistent) | 74% (211) | 21% (61) | 4% (12) | <1% (1) | ||||
| Burning/Stinging (persistent) | 71% (202) | 24% (69) | 4% (12) | <1% (2) |
What should I look out for while using Differin?
DIFFERIN Cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.
What might happen if I take too much Differin?
DIFFERIN Cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of DIFFERIN Cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
How should I store and handle Differin?
DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011DIFFERIN (adapalene) Cream, 0.1% is supplied in the following size:45 g tube – 0299-5915-45Storage: Marketed by:GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USAManufactured by:G Production Inc.Baie d'Urfé, QCH9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.www.differin.comP50448-1Revised: November 2011
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.
Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Non-Clinical Toxicology
DIFFERIN Cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of DIFFERIN Cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene.
In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used DIFFERIN Cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with DIFFERIN Cream from the controlled clinical studies is provided in the following table:
Other reported local cutaneous adverse events in patients who used DIFFERIN Cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with DIFFERIN Cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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