Ziana Gel

DRUG 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-?-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate:

Ziana (Clindamycin phosphate 1.2% and tretinoin 0.025%) Structural Formula Illustration

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 (clindamycin phosphate, tretinoin) contains the following inactive ingredients: purified water USP, glycerin USP, carbomer 981 NF, methylparaben NF, polysorbate 80 NF, edetate disodium USP, citric acid USP, propylparaben NF, butylated hydroxytoluene NF, and tromethamine USP.

What are the possible side effects of clindamycin and tretinoin topical (Ziana)?

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

Stop using this medicine and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, stinging, or peeling of treat skin areas; or
  • diarrhea that is watery or bloody.

Continue using this medicine and talk with your doctor if you have any of these less serious side effects:

    ...

Read All Potential Side Effects and See Pictures of Ziana Gel

What are the precautions when taking clindamycin phosphate, tretinoin (Ziana Gel)?

Before using this product, tell your doctor or pharmacist if you are allergic to clindamycin or to tretinoin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal problems (e.g., regional enteritis, ulcerative colitis, colitis caused by the use of antibiotics, Clostridium difficile-associated diarrhea, Crohn's disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more...

Read All Potential Precautions of Ziana Gel


Ziana Gel Consumer (continued)

SIDE EFFECTS: Skin redness, dryness, itching, peeling, mild burning/stinging, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use the medication or stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, crusting, severe burning/swelling of the skin.

This medication may be absorbed into your bloodstream and very rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria. This condition may occur weeks after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Stop using this medication and tell your doctor immediately if any of these rare but very serious side effects occur: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to clindamycin or to tretinoin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal problems (e.g., regional enteritis, ulcerative colitis, colitis caused by the use of antibiotics, Clostridium difficile-associated diarrhea, Crohn's disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use a sunscreen daily, and wear protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using this product.

Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol, or salicylic acid, use this product with caution. Wait until the effects of such products on the skin have decreased before using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Ziana Gel Patient Information Including Side Effects

Brand Names: Ziana

Generic Name: clindamycin and tretinoin (topical) (Pronunciation: klin da MYE sin TRET i noyn )

  • What is clindamycin and tretinoin topical (Ziana Gel)?
  • What are the possible side effects of clindamycin and tretinoin topical (Ziana Gel)?
  • What is the most important information I should know about clindamycin and tretinoin topical (Ziana Gel)?
  • What should I discuss with my health care provider before using clindamycin and tretinoin topical (Ziana Gel)?
  • How should I use clindamycin and tretinoin topical (Ziana Gel)?
  • What happens if I miss a dose (Ziana Gel)?
  • What happens if I overdose (Ziana Gel)?
  • What should I avoid while using clindamycin and tretinoin topical (Ziana Gel)?
  • What other drugs will affect clindamycin and tretinoin topical (Ziana Gel)?
  • Where can I get more information?

What is clindamycin and tretinoin topical (Ziana Gel)?

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.

The combination of clindamycin and tretinoin is used to treat severe nodular acne in adults and children who are at least 12 years old.

Clindamycin and tretinoin topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of clindamycin and tretinoin topical (Ziana Gel)?

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

Stop using this medicine and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, stinging, or peeling of treat skin areas; or
  • diarrhea that is watery or bloody.

Continue using this medicine and talk with your doctor if you have any of these less serious side effects:

  • mild itching, stinging, or dryness of treated skin;
  • temporary lightening or darkening of treated skin; or
  • stuffy nose, sore throat, cough.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clindamycin and tretinoin topical (Ziana Gel)?

Avoid getting this medication 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.

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. Do not use other medicated skin products unless your doctor has told you to.

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

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Clindamycin and tretinoin topical 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.

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