U.S. BRAND NAMES — Differin®
PHARMACOLOGIC CATEGORY
Acne Products
Topical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g) [alcohol free]; 0.3% (45 g) [alcohol free]
DOSAGE FORMS: CONCISE
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g); 0.3% (45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT
>10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging, sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
Disease-related concerns: Eczema: Use with caution in patients with eczema.
Special populations: Pediatrics: Safety and efficacy have not been established in children <12 years of age.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
DRUG INTERACTIONS
Vitamin A: May enhance the adverse/toxic effect of Retinoid-like Compounds. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)
Cream (Differin)
0.1% (45): $189.50
Gel (Differin)
0.1% (45): $185.59
0.3% (45): $177.06
CANADIAN BRAND NAMES — Differin®; Differin® XP
INTERNATIONAL BRAND NAMES — Aclene (KP); Acure (TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Beautyface (TW); Butipalen (KP); Deriva (MY); Differin (AR, AU, BR, CL, CN, EE, FI, HK, HN, KP, MY, NO, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differine (CZ, ES, FR); Elibel (KP); Evalen (ID); Klenzit (PH); Panalene (AR); Pindome (TW); Redap (DK); Rozac (IN)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS
Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
Showing posts with label Adapalene. Show all posts
Showing posts with label Adapalene. Show all posts
Monday, May 24, 2010
Adapalene
U.S. BRAND NAMES — Differin®
PHARMACOLOGIC CATEGORY
Acne Products
Topical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g) [alcohol free]; 0.3% (45 g) [alcohol free]
DOSAGE FORMS: CONCISE
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g); 0.3% (45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT
>10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging, sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
Disease-related concerns: Eczema: Use with caution in patients with eczema.
Special populations: Pediatrics: Safety and efficacy have not been established in children <12 years of age.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
DRUG INTERACTIONS
Vitamin A: May enhance the adverse/toxic effect of Retinoid-like Compounds. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)
Cream (Differin)
0.1% (45): $189.50
Gel (Differin)
0.1% (45): $185.59
0.3% (45): $177.06
CANADIAN BRAND NAMES — Differin®; Differin® XP
INTERNATIONAL BRAND NAMES — Aclene (KP); Acure (TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Beautyface (TW); Butipalen (KP); Deriva (MY); Differin (AR, AU, BR, CL, CN, EE, FI, HK, HN, KP, MY, NO, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differine (CZ, ES, FR); Elibel (KP); Evalen (ID); Klenzit (PH); Panalene (AR); Pindome (TW); Redap (DK); Rozac (IN)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS
Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
PHARMACOLOGIC CATEGORY
Acne Products
Topical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g) [alcohol free]; 0.3% (45 g) [alcohol free]
DOSAGE FORMS: CONCISE
Cream, topical:
Differin®: 0.1% (15 g, 45 g)
Gel, topical:
Differin®: 0.1% (15 g, 45 g); 0.3% (45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT
>10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging, sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
Disease-related concerns: Eczema: Use with caution in patients with eczema.
Special populations: Pediatrics: Safety and efficacy have not been established in children <12 years of age.
Other warnings/precautions: Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
DRUG INTERACTIONS
Vitamin A: May enhance the adverse/toxic effect of Retinoid-like Compounds. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)
Cream (Differin)
0.1% (45): $189.50
Gel (Differin)
0.1% (45): $185.59
0.3% (45): $177.06
CANADIAN BRAND NAMES — Differin®; Differin® XP
INTERNATIONAL BRAND NAMES — Aclene (KP); Acure (TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Beautyface (TW); Butipalen (KP); Deriva (MY); Differin (AR, AU, BR, CL, CN, EE, FI, HK, HN, KP, MY, NO, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differine (CZ, ES, FR); Elibel (KP); Evalen (ID); Klenzit (PH); Panalene (AR); Pindome (TW); Redap (DK); Rozac (IN)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS
Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
Thursday, January 31, 2008
Adapalene
U.S. BRAND NAMES — Differin®
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
Adapalene
U.S. BRAND NAMES — Differin®
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.
Sunday, January 20, 2008
Adapalene
U.S. BRAND NAMES — Differin®
PHARMACOLOGIC CATEGORY Acne ProductsTopical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
DOSAGE FORMS: CONCISE Cream, topical: Differin®: 0.1% (15 g, 45 g)
Gel, topical: Differin®: 0.1% (15 g, 45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT >10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS — Use with caution in patients with eczema. Avoid excessive exposure to sunlight and sunlamps. Avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)Cream (Differin) 0.1% (45): $132.93
Gel (Differin) 0.1% (45): $117.28
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Toxic signs of an overdose commonly respond to drug discontinuation, and generally return to normal spontaneously within a few days to weeks. When confronted with signs of increased intracranial pressure, treatment with mannitol (0.25 g/kg I.V. up to 1 g/kg/dose repeated every 5 minutes as needed), dexamethasone (1.5 mg/kg I.V. load followed with 0.375 mg/kg every 6 hours for 5 days), and/or hyperventilation should be employed.
CANADIAN BRAND NAMES — Differin® XP; Differin®
INTERNATIONAL BRAND NAMES — Acure (HK, TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Differin (AR, AU, BR, CA, CL, EE, FI, HK, HU, KR, MY, NZ, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differin XP (CA); Differine (ES, FR); Klenzit (PH); Panalene (AR); Redap (DK)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
PHARMACOLOGIC CATEGORY Acne ProductsTopical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
DOSAGE FORMS: CONCISE Cream, topical: Differin®: 0.1% (15 g, 45 g)
Gel, topical: Differin®: 0.1% (15 g, 45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT >10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS — Use with caution in patients with eczema. Avoid excessive exposure to sunlight and sunlamps. Avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)Cream (Differin) 0.1% (45): $132.93
Gel (Differin) 0.1% (45): $117.28
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Toxic signs of an overdose commonly respond to drug discontinuation, and generally return to normal spontaneously within a few days to weeks. When confronted with signs of increased intracranial pressure, treatment with mannitol (0.25 g/kg I.V. up to 1 g/kg/dose repeated every 5 minutes as needed), dexamethasone (1.5 mg/kg I.V. load followed with 0.375 mg/kg every 6 hours for 5 days), and/or hyperventilation should be employed.
CANADIAN BRAND NAMES — Differin® XP; Differin®
INTERNATIONAL BRAND NAMES — Acure (HK, TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Differin (AR, AU, BR, CA, CL, EE, FI, HK, HU, KR, MY, NZ, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differin XP (CA); Differine (ES, FR); Klenzit (PH); Panalene (AR); Redap (DK)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
Adapalene
U.S. BRAND NAMES — Differin®
PHARMACOLOGIC CATEGORY Acne ProductsTopical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
DOSAGE FORMS: CONCISE Cream, topical: Differin®: 0.1% (15 g, 45 g)
Gel, topical: Differin®: 0.1% (15 g, 45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT >10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS — Use with caution in patients with eczema. Avoid excessive exposure to sunlight and sunlamps. Avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)Cream (Differin) 0.1% (45): $132.93
Gel (Differin) 0.1% (45): $117.28
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Toxic signs of an overdose commonly respond to drug discontinuation, and generally return to normal spontaneously within a few days to weeks. When confronted with signs of increased intracranial pressure, treatment with mannitol (0.25 g/kg I.V. up to 1 g/kg/dose repeated every 5 minutes as needed), dexamethasone (1.5 mg/kg I.V. load followed with 0.375 mg/kg every 6 hours for 5 days), and/or hyperventilation should be employed.
CANADIAN BRAND NAMES — Differin® XP; Differin®
INTERNATIONAL BRAND NAMES — Acure (HK, TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Differin (AR, AU, BR, CA, CL, EE, FI, HK, HU, KR, MY, NZ, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differin XP (CA); Differine (ES, FR); Klenzit (PH); Panalene (AR); Redap (DK)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
PHARMACOLOGIC CATEGORY Acne ProductsTopical Skin Product, Acne
DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.
DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.
(For additional information see "Adapalene: Pediatric drug information")
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
DOSAGE FORMS: CONCISE Cream, topical: Differin®: 0.1% (15 g, 45 g)
Gel, topical: Differin®: 0.1% (15 g, 45 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of acne vulgaris
ADVERSE REACTIONS SIGNIFICANT >10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application
<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging sunburn, rash (topical cream)
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel
WARNINGS / PRECAUTIONS — Use with caution in patients with eczema. Avoid excessive exposure to sunlight and sunlamps. Avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)Cream (Differin) 0.1% (45): $132.93
Gel (Differin) 0.1% (45): $117.28
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Toxic signs of an overdose commonly respond to drug discontinuation, and generally return to normal spontaneously within a few days to weeks. When confronted with signs of increased intracranial pressure, treatment with mannitol (0.25 g/kg I.V. up to 1 g/kg/dose repeated every 5 minutes as needed), dexamethasone (1.5 mg/kg I.V. load followed with 0.375 mg/kg every 6 hours for 5 days), and/or hyperventilation should be employed.
CANADIAN BRAND NAMES — Differin® XP; Differin®
INTERNATIONAL BRAND NAMES — Acure (HK, TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Differin (AR, AU, BR, CA, CL, EE, FI, HK, HU, KR, MY, NZ, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differin XP (CA); Differine (ES, FR); Klenzit (PH); Panalene (AR); Redap (DK)
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS / KINETICS Absorption: Topical: Minimal
Excretion: Bile
PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.
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