Adapalene

Yes

The most common side effects of adapalene are:

• irritation,
• redness,
• dryness, and
• itching
• flares of acne.

Most of these side effects lessen with continued use; however, if they are bothersome, decreasing the frequency with which adapalene is applied may reduce these side effects.

Adapalene may increase the sensitivity of the skin to sun and lead to sunburn. Excessive sun exposure should be avoided, and sunscreens should be used over the treated areas if exposure to the sun cannot be avoided. Adapalene should not be applied to sunburned skin, cuts, eyes, nose, or lips.

Gel, 0.1%

Store at room temperature, 20 C - 25 C (68 F - 77 F)

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take adapalene by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get this medicine in any of these areas, rinse well with water.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Do not put on sunburned skin.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where adapalene is used.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about adapalene, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about adapalene. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using adapalene.

Review Date: October 4, 2017

Adapalene Gel is indicated for the topical treatment of acne vulgaris.

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

Absorption

Topical: Minimal; only trace amounts have been measured in serum after chronic application

Excretion

Bile

Acne vulgaris: Topical: Apply once daily; use cream and gel in the evening before bedtime

Rosacea (off-label use): Topical: 0.1% Gel: Apply to affected area once daily in the evening for up to 12 weeks (Altinyazar 2005)

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.

Pregnancy category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Usual dose: Apply a thin layer to the affected area once a day at bedtime

Comments:
-The affected area should be thoroughly washed and dried before application.
-Patients may experience a transient warming sensation after application of the cream formulation.
-An apparent exacerbation of acne may occur during the first weeks of treatment, and should not be a reason to discontinue treatment.

Use: Topical treatment of acne vulgaris

Caution is recommended; use considered a low risk to the nursing infant. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -This drug should be used in areas away from the chest to prevent accidental contact with the infant's skin. -Ointments should not be applied to the breast prior to breastfeeding; if necessary, water-miscible cream or gel products may be used, but the products should not be applied to the nipple area.

Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.

Substance Name

Adapalene

CAS Registry Number

106685-40-9

Drug Class

Dermatologic Agents

Anti-Inflammatory Agents, Non-Steroidal