Ziana

Generic name: clindamycin and tretinoin (topical)
Brand names: Veltin, Ziana
Drug class: Topical acne agents

Medically reviewed by A Ras MD.

What is Ziana?

Ziana Gel is a prescription medicine that is used as an antibiotic and retinoid combination medicine used for the skin treatment of acne in patients 12 years and older. Not for mouth, eye, or vaginal use.

Description

ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo–α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate:
Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97

The chemical name for tretinoin is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8 nonatetraenoic acid (all-trans form). The structural formula for tretinoin is represented below:

Tretinoin:

Molecular Formula: C20H28O2
Molecular Weight: 300.44

ZIANA Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.

What is the most important information I should know about Ziana?

Ziana Gel is not for mouth, eye, or vaginal use.

Who should not use Ziana Gel?

Do not use Ziana Gel if you:

have Crohn’s Disease
have Ulcerative Colitis
have developed colitis with past antibiotic use

What should I tell my healthcare provider before using Ziana?

Tell your doctor:

if you are pregnant or planning to become pregnant. It is not known if Ziana Gel may harm your unborn baby.
if you are breastfeeding. Ziana Gel may pass through your milk and may harm your baby.
about all the medicines and skin products you use:
- Ziana Gel should not be used with erythromycin-containing products.
- Avoid medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and skin products that contain alcohol, astringents, spices or lime. These products may cause increased skin irritation if used with Ziana Gel.

How should I use Ziana?

Use Ziana Gel exactly as prescribed. It may take some time for you to see improvement of your acne with Ziana Gel. Your doctor will tell you how long to use Ziana Gel.

At bedtime:

Wash your face gently with a mild soap and warm water.
Pat the skin dry.
Apply a pea-size amount of Ziana Gel to your fingertip and spread it over your face. Gently, smooth it into your skin. Do not get Ziana Gel in your eyes or mouth, on your lips, on the corners of your nose, or on open wounds.

In the morning:

Apply a sunscreen and reapply during the day as needed.
Do not apply Ziana Gel more than once a day.
Do not use too much Ziana Gel. Too much Ziana Gel may irritate your skin.
Do not wash your face more than 2 to 3 times a day. Washing your face too often or scrubbing it may make your acne worse.

What should I avoid while taking Ziana?

excessive exposure to the sun, cold, and wind. Weather extremes can dry and burn the skin. Always use a sunscreen on Ziana Gel treated skin, even on cloudy days. Use other protective clothing such as a hat when you are in the sun.
the use of sunlamps and tanning booths.

If your face becomes sunburned, stop Ziana Gel until your skin has healed.

What are the possible side effects of Ziana?

Skin irritation. Ziana Gel may cause skin irritation such as dryness, redness, peeling, burning, or stinging. Stop Ziana Gel and call your doctor if your skin becomes very red, swollen, blistered, or crusted.
Change in skin color. Ziana Gel may cause a temporary skin color change (lighter or darker).
Colitis. This occurs rarely. Stop Ziana Gel and call your doctor if you develop severe watery diarrhea, or bloody diarrhea.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Ziana Gel. Ask your doctor or pharmacist for more information.

General information about the safe and effective use of Ziana

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use Ziana Gel for a condition for which it was not prescribed. Do not give ZIANA Gel to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Ziana Gel. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about ZIANA Gel that is written for healthcare professionals.

If you have questions about Ziana Gel you can also call: 1-800-321-4576 (this is a toll-free number) between 10:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday.

How should I store Ziana?

Store Ziana Gel at room temperature, 59° to 86°F (15° to 30°C). Do not freeze.
Keep Ziana Gel away from heat and light.
Keep the tube tightly closed.
Keep Ziana Gel and all medicines out of reach of children.

What are the ingredients in Ziana?

Active Ingredients: clindamycin phosphate 1.2% and tretinoin 0.025%

Inactive Ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.

Label

PRINCIPAL DISPLAY PANEL – 30 g Carton

NDC 99207-300-30
ZIANA®
(clindamycin phosphate 1.2%
and tretinoin 0.025%) Gel
Rx only

Net Wt. 30 g
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL,
OR INTRAVAGINAL USE

SRC: NLM .

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