Indicaties

Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

Contra-indicaties

Adapalene Gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ] . Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3%. ( 4 )

Waarschuwingen en voorzorgen

Allergic/Hypersensitivity Reactions: Allergy/ hypersensitivity reactions include anaphylaxis, angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue Adapalene Gel, 0.3% in the event of an allergic/hypersensitivity reaction. ( 5.1 ) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided ( 5.2 ). Local Cutaneous Reactions: Erythema, scaling, dryness, and stinging/burning were reported with use of Adapalene Gel, 0.3%.

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) should be approached with caution. ( 5.3 ).

5.1Allergic/ Hypersensitivity Reactions

Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using Adapalene Gel, 0.3% and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment.

Waarschuwingen en voorzorgen

5.1Allergic/ Hypersensitivity Reactions

Bijwerkingen

The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene Gel, 0.3% once daily for 12 weeks.

Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with Adapalene Gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel, 0.3% Incidence of Local Cutaneous Irritation with Adapalene Gel, 0.3% (N = 253 Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. ) Maximum Severity Scores Higher Than Baseline Mild Moderate Severe Erythema 66 (26.1%) 33 (13%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel, 0.3% Adapalene Gel, 0.3% Vehicle Gel N=258 N=134 Related Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adverse Reactions 57 (22.1%) 6 (4.5%) Dry Skin 36 (14%) 2 (1.5%) Skin Discomfort 15 (5.8%) 0 (0%) Desquamation 4 (1.6%) 0 (0%) The following adverse reactions occurred in less than 1% of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.

6.2Post-Marketing Experience

The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Verpakking	Code	Status
ADAPALENE 0.1%	ANDA090962-001	Over-the-counter
ADAPALENE 0.3%	ANDA208322-001	Prescription
ADAPALENE 0.1%	ANDA215940-001	Over-the-counter
ADAPALENE 0.3%	ANDA213508-001	Prescription
ADAPALENE 0.1%	ANDA091314-001	Over-the-counter
ADAPALENE 0.1%	ANDA091314-002	Over-the-counter
ADAPALENE 0.3%	ANDA201000-001	Prescription
ADAPALENE 0.3%	ANDA200298-001	Prescription

Adapalene

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

5.1Allergic/ Hypersensitivity Reactions

Twee geneesmiddelen in één vraag?

Adapalene

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

5.1Allergic/ Hypersensitivity Reactions

Twee geneesmiddelen in één vraag?

5.2Ultraviolet Light and Environmental Exposure Exposure

5.3Local Cutaneous Reactions

Zwangerschap en borstvoeding

8.1Pregnancy Risk Summary

Bijwerkingen

6.1Clinical Trials Experience

6.2Post-Marketing Experience

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Verpakkingen

Documenten

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