Ziana is a gel containing a combination of clindamycin and tretinoin. Clindamycin is an antibiotic. It fights bacteria in the body.

Tretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Ziana is used to treat severe nodular acne in adults and children who are at least 12 years old.

Ziana may also be used for purposes other than those listed in this medication guide.

Avoid getting Ziana in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply Ziana to sunburned, windburned, dry, chapped, irritated, or broken skin.

You should not use this medication if you have ulcerative colitis, Crohn's disease, inflammation of your intestines (also called enteritis), or if you have ever had severe diarrhea caused by antibiotic medicine.

You should not use Ziana if you are also taking another antibiotic called erythromycin, or using other skin medications that contain erythromycin.

Although Ziana is applied to the skin, your body may absorb enough clindamycin to cause serious side effects.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ziana can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Use Ziana exactly as your doctor has prescribed it for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Wash your hands before and after applying this medication.

Wash your face with a mild soap or cleanser and pat the skin dry with a clean towel.

Use only a pea-sized amount of Ziana. Apply to your entire face every night at bedtime.

Do not wash your face more than 3 times daily while using this medication. Washing more often or scrubbing your face when you wash it can make your acne worse.

Avoid getting Ziana in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply this medicine to sunburned, windburned, dry, chapped, irritated, or broken skin.

Use Ziana for the full prescribed length of time, even if you think it is not working. Call your doctor if skin irritation becomes severe or if your acne does not improve after several weeks of using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using Ziana.

Store at room temperature away from moisture, heat, and light. Do not freeze.

Although Ziana is applied to the skin, your body may absorb enough clindamycin to affect certain medical conditions you may have.

You should not use this medication if you are allergic to clindamycin or tretinoin, or if you have:

• inflammation of your intestines (also called enteritis);

• Crohn's disease, ulcerative colitis; or

• if you have ever had severe diarrhea caused by antibiotic medicine.

You should not use Ziana if you are also taking another antibiotic called erythromycin, or using other skin medications that contain erythromycin.

To make sure Ziana is safe for you, tell your doctor if you have:

• any allergies; or

• a history of stomach or intestinal disorders.

FDA pregnancy category C. It is not known whether Ziana will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether clindamycin and tretinoin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

This medicine should not be used on a child younger than 12 years old.

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid washing treated skin or applying other skin products for at least 1 hour after applying this medicine.

Avoid using other medications on the areas you treat with Ziana unless your doctor tells you to. Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using this medicine and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ziana can make you sunburn more easily. Apply sunscreen (SPF 30 or higher) every morning and throughout the day as needed. Avoid exposure to sunlight or tanning beds.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Get emergency medical help if you have any of these signs of an allergic reaction to Ziana: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe redness, burning, stinging, or scaling of treated skin areas; or

• diarrhea that is watery or bloody.

Common Ziana side effects may include:

• mild skin irritation, dryness or peeling;

• mild skin redness; or

• itching of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied clindamycin and tretinoin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.