Pronunciation:

TRET-i-noin, BEN-zoe-il per-OX-ide

Brand Names:

• Twyneo

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antiacne

Chemical—

Retinoid

Uses of This Medicine:

Tretinoin and benzoyl peroxide combination is used to treat acne vulgaris.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tretinoin and benzoyl peroxide combination in children 9 years of age and older. However, safety and efficacy have not been established in children younger than 9 years of age.

Older adults—

Appropriate studies on the relationship of age to the effects of tretinoin and benzoyl peroxide combination have not been performed in the geriatric population.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eczema (skin problem) or
• Sunburn—May cause skin irritation in patients with these conditions.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to be irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, corners of your nose, lips, mouth, or vagina. Do not use on skin areas that have cuts, scrapes, or sunburn. If it does get on these areas, rinse it off right away.

To use the cream:

• Wash your hands with soap and water before and after you use this medicine.
• Apply this medicine on a clean and dry skin.
• Apply a thin layer to the affected areas, and gently rub it in.

Do not apply this medicine in your hair or on colored fabric. It may bleach your hair or colored fabric.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For acne:
    • Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused medicine 12 weeks after the date you receive it or 30 days after first opening, whichever is sooner.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or unusual tiredness or weakness.

Serious skin reactions including pain, irritation, itching, burning, redness, peeling, dryness, scaling, or stinging of the skin can occur during treatment with this medicine. Your doctor may tell you to use a moisturizer to treat skin irritation.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen and wear loose-fitting clothes when you are outdoors. Avoid sunlamps and tanning beds.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Pain, burning, changes in color, dryness, itching, peeling, redness, scaling, stinging, or swelling of the skin where the medicine is applied

Incidence not known

Chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

increased sensitivity of the skin to sunlight

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

redness or other discoloration of the skin

severe sunburn

trouble breathing

unusual tiredness or weakness