Ziana

• Medicis Pharmaceutical Corp.

• Valeant Pharmaceuticals North America LLC

Ziana is part of the drug classes:

• OTHER ANTINEOPLASTIC AGENTS

• Retinoids for topical use in acne

• Gynecological Antibiotics

• Antiinfectives for treatment of acne

• Lincosamides

In the U.S.

• Veltin
• Ziana

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Antiacne

Chemical Class: Clindamycin

This section provides information on the proper use of a number of products that contain clindamycin and tretinoin. It may not be specific to Ziana. Please read with care.

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

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

To use:

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash your face with warm water and a mild soap, rinse well, and pat dry.
• Apply just enough medicine to lightly cover the affected areas, and rub it in gently but well. A pea-sized amount is enough to cover the whole face.
• You should not wash your face too often, 2 or 3 times a day is enough. Washing your face too often may dry your skin and make the acne worse.

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 (gel):
  • For acne:
    • Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
    • Children younger than 12 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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not put on sunburned skin.
• Do not put on cuts, scrapes, or damaged skin.
• Skin may look worse before it looks better.
• It may take several weeks to see the full effects.
• Use other pimple (acne) drugs with care. More skin irritation may happen.
• Talk with your doctor before you use other drugs or products on your skin.
• Practice good skin care and avoid the sun.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Some weather conditions may irritate the skin. Talk with the doctor.
• Diarrhea, bloody diarrhea, and a certain bowel problem (colitis) have happened with Ziana. Very bad colitis may lead to death. Call your doctor right away if you have stomach pain or cramps, very bad or watery diarrhea, or bloody diarrhea. Do not try to treat diarrhea without first checking with your doctor.
• It is common to have skin irritation with this medicine. These reactions may include burning, dry skin, itching, peeling, redness, and scaling. Call your doctor if you have skin irritation that is very bad, bothers you, or does not go away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ziana while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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

• Do not take Ziana by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Put on at bedtime.
• 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.
• To gain the most benefit, do not miss doses.

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.

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.

Ziana Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

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.