Drugs Details

Drugs Info of Ziana
Drugs Details
  • Drugs Type  : FDA
  • Date : 16th Jan 2015 07:42 am
  • Brand Name : Ziana
  • Generic Name : clindamycin and tretinoin (topical) (Pronunciation: klin da MYE sin TRET i noyn)
Descriptions

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:

 

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:

 

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

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:

  • mild itching, stinging, or dryness of treated...

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 »

This monograph has been modified to include the generic and brand name in many instances.

Indications

ZIANA Gel (clindamycin phosphate, tretinoin) is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Dosage Administration

At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. ZIANA Gel (clindamycin phosphate, tretinoin) should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. ZIANA Gel (clindamycin phosphate, tretinoin) is not for oral, ophthalmic, or intravaginal use.

DOSAGE FORMS AND STRENGTHS

ZIANA Gel (clindamycin phosphate, tretinoin) , a combination of a lincosamide antibiotic and a retinoid, contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a topical gel. Each gram of ZIANA Gel (clindamycin phosphate, tretinoin) contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous based gel.

ZIANA Gel (clindamycin phosphate, tretinoin) is available in 2 gram, 30 gram, and 60 gram tubes.

How Supplied

HOW SUPPLIED/STORAGE AND HANDLING

ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is supplied as follows:

2 gram tube NDC 99207-300-02
30 gram tube NDC 99207-300-30
60 gram tube NDC 99207-300-60
Storage and Handling
  • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
  • Protect from light.
  • Protect from freezing.
  • Keep out of the reach of children.
  • Keep away from heat.
  • Keep tube tightly closed.

PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling.

Instructions for Use
  • At bedtime, the face should be gently washed with a mild soap and warm water. After patting the skin dry, apply ZIANA Gel (clindamycin phosphate, tretinoin) as a thin layer over the entire face (excluding the eyes and lips).
  • Patients should be advised not to use more than the recommended pea sized amount and not to apply more often than once daily (at bedtime) as this will not make for faster results and may increase irritation.
  • A sunscreen should be applied every morning and reapplied over the course of the day as needed. Patients should be advised to avoid exposure to sunlight, sunlamp, ultraviolet light, and other medicines that may increase sensitivity to sunlight.
Skin Irritation

ZIANA Gel (clindamycin phosphate, tretinoin) may cause irritation such as erythema, scaling, itching, burning, or stinging.

Colitis

In the event a patient treated with ZIANA Gel (clindamycin phosphate, tretinoin) experiences severe diarrhea or gastrointestinal discomfort, ZIANA Gel (clindamycin phosphate, tretinoin) should be discontinued and a physician should be contacted.

Manufactured for: Medicis, The Dermatology Company®
Scottsdale, AZ 85258
By: Contract Pharmaceuticals Limited Niagara
Buffalo, NY 14213
U.S. Patent 5,721,275
U.S. Patent 6,387,383
FDA rev date: 11/7/2006

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Studies Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use for approximating rates.

The safety data presented in Table 1 (below) reflects exposure to ZIANA Gel (clindamycin phosphate, tretinoin) in 1,853 patients with acne vulgaris. Patients were 12 years and older and were treated once daily for 12 weeks. Adverse reactions that were reported in ≥1% of patients treated with ZIANA Gel (clindamycin phosphate, tretinoin) were compared to adverse reactions in patients treated with clindamycin phosphate 1.2% in vehicle gel, tretinoin 0.025% in vehicle gel, and the vehicle gel alone:

Table 1: Adverse Reactions Reported in at Least 1% of Patients
Treated with ZIANA Gel (clindamycin phosphate, tretinoin) : 12-Week Studies
  ZIANA
Gel
N=1853
N (%)
Clindamycin
N=1428
N (%)
Tretinoin
N=846
N (%)
Vehicle
N=423
N (%)
PATIENTS WITH AT LEAST ONE AR 497 (27) 342 (24) 225 (27) 91 (22)
Nasopharyngitis 65 (4) 64 (5) 16 (2) 5 (1)
Pharyngolaryngeal pain 29 (2) 18 (1) 5 (1) 7 (2)
Dry skin 23 (1) 7 (1) 3 (<1) 0 (0)
Cough 19 (1) 21 (2) 9 (1) 2 (1)
Sinusitis 19 (1) 19 (1) 15 (2) 4 (1)
Note: Formulations used in all treatment arms were in the ZIANA vehicle gel.

Cutaneous safety and tolerance evaluations were conducted at each study visit in all of the clinical trials by assessment of erythema, scaling, itching, burning, and stinging:

Table 2: ZIANA Gel (clindamycin phosphate, tretinoin) -Treated Patients with Local Skin Reactions

 

Local Reaction Baseline
N=1835
N (%)
End of Treatment
N=1614
N (%)
Erythema 636 (35) 416 (26)
Scaling 237 (13) 280 (17)
Itching 189 (10) 70 (4)
Burning 38 (2) 56 (4)
Stinging 33 (2) 27 (2)

At each study visit, application site reactions on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe), and the mean scores were calculated for each of the local skin reactions. In Studies 1 and 2, 1277 subjects enrolled with moderate to severe acne, 854 subjects treated with ZIANA Gel (clindamycin phosphate, tretinoin) and 423 treated with vehicle. Analysis over the twelve week period demonstrated that cutaneous irritation scores for erythema, scaling, itching, burning, and stinging peaked at two weeks of therapy, and were slightly higher for the ZIANA-treated group, decreasing thereafter.

One open-label 12-month safety study for ZIANA Gel (clindamycin phosphate, tretinoin) showed a similar adverse reaction profile as seen in the 12-week studies. Eighteen out of 442 subjects (4%) reported gastrointestinal symptoms.

Read the Ziana Gel (clindamycin phosphate, tretinoin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Concomitant Topical Medication

Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution. When used with ZIANA Gel (clindamycin phosphate, tretinoin) , there may be increased skin irritation.

Erythromycin

ZIANA Gel (clindamycin phosphate, tretinoin) should not be used in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ZIANA Gel (clindamycin phosphate, tretinoin) should be used with caution in patients receiving such agents.

Read the Ziana Gel Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided. Please see PRECAUTIONS below and SIDE EFFECTS & DRUG INTERACTIONS.

Precautions

Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. When significant diarrhea occurs, ZIANA Gel (clindamycin phosphate, tretinoin) should be discontinued.

Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Ultraviolet Light and Environmental Exposure

Exposure to sunlight, including sunlamps, should be avoided during the use of ZIANA Gel (clindamycin phosphate, tretinoin) , and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with ZIANA Gel (clindamycin phosphate, tretinoin) .

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. There are no well-controlled trials in pregnant women treated with ZIANA Gel (clindamycin phosphate, tretinoin) . ZIANA Gel (clindamycin phosphate, tretinoin) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ZIANA Gel (clindamycin phosphate, tretinoin) was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. ZIANA Gel (clindamycin phosphate, tretinoin) at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of ZIANA Gel (clindamycin phosphate, tretinoin) for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. For purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of ZIANA Gel (clindamycin phosphate, tretinoin) applied daily to a 60 kg person.

Clindamycin

Teratology (Segment II) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity.

Tretinoin

In oral Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison).

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of ZIANA Gel (clindamycin phosphate, tretinoin) . However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ZIANA Gel (clindamycin phosphate, tretinoin) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ZIANA Gel (clindamycin phosphate, tretinoin) in pediatric patients under the age of 12 have not been established.

Clinical trials of ZIANA Gel included patients 12-17 years of age. [See Clinical Studies]

Geriatric Use

Clinical studies of ZIANA Gel (clindamycin phosphate, tretinoin) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

ZIANA Gel (clindamycin phosphate, tretinoin) is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanisms of Action

Clindamycin

[see Microbiology ].

Tretinoin

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Pharmacokinetics

In an open-label, multiple-dose study treating 12 subjects with moderate to severe acne, the percutaneous absorption of tretinoin following 14 consecutive daily applications of approximately 4 g of ZIANA Gel (clindamycin phosphate, tretinoin) was minimal. Quantifiable tretinoin plasma concentrations ranged from 1.0 to 1.6 ng/mL, with unquantifiable plasma concentrations in 50% to 92% of subjects at any given timepoint following administration. The plasma concentrations of the key tretinoin metabolites, 13- cis -retinoic acid and 4-oxo-13-cis-retinoic acid, ranged from 1.0 to 1.4 ng/mL and from 1.6 to 6.5 ng/mL, respectively. Plasma concentrations for clindamycin generally did not exceed 3.5 ng/mL, with the exception of one subject whose plasma concentration reached 13.1 ng/mL.

Microbiology

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis Clindamycin has been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with ZIANA Gel (clindamycin phosphate, tretinoin) . P acnes resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and impairment of fertility testing of ZIANA Gel (clindamycin phosphate, tretinoin) have not been performed in any species.

Clindamycin

The carcinogenicity of a 1% clindamycin phosphate gel similar to ZIANA Gel (clindamycin phosphate, tretinoin) was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 13 and 72 times higher than the human dose of clindamycin phosphate from ZIANA Gel (clindamycin phosphate, tretinoin) , assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals. For purposes of comparisons of the animal exposure to human exposure, the recommended human topical clinical dose is defined as 1 g of ZIANA Gel (clindamycin phosphate, tretinoin) applied daily to a 60 kg person.

Fertility (Segment 1) studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 290 times the amount of clindamycin delivered from the recommended clinical dose for ZIANA Gel (clindamycin phosphate, tretinoin) , based on a body surface area comparison) revealed no effects on fertility or mating ability.

Tretinoin

In two independent studies with long-term topical application of tretinoin in mice, carcinogenicity was not observed. In both studies, tretinoin was administered topically (0.025% or 0.1%) three times per week for up to two years. No carcinogenicity was observed with maximum effects of dermal amyloidosis in the basal layer of the skin.

Tretinoin has been shown to enhance photoco-carcinogenicity in properly performed specific studies, employing concurrent or intercurrent exposure to the drug and UV radiation. The contribution of clindamycin to that effect is unknown. Although the significance of these studies to humans is not clear, patients should minimize exposure to sun.

The genotoxic potential of tretinoin was evaluated in an in vitro Ames Salmonella reversion test and an in vitro chromosomal aberration assay in Chinese hamster ovary cells. Both tests were negative.

In oral Segment 1 studies in rats treated with tretinoin, the no-observed-effect-level was 2 mg/kg/day (~78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison).

CLINICAL STUDIES

The safety and efficacy of once daily use of ZIANA Gel (clindamycin phosphate, tretinoin) for treatment of acne vulgaris were assessed in three 12-week prospective, multi-center, randomized, blinded studies in patients 12 years and older. Studies 1 and 2 were of identical design, and compared ZIANA Gel (clindamycin phosphate, tretinoin) to clindamycin in the vehicle gel, tretinoin in the vehicle gel, and the vehicle gel alone. Patients with mild, moderate, or severe acne were enrolled in the studies. The co-primary efficacy variables were:

(1) Mean percent change from baseline at Week 12 in

  • inflammatory lesion counts,
  • non-inflammatory lesion counts, and
  • total lesion counts

(2) Percent of subjects who cleared or almost cleared at Week 12 as judged by an Evaluator's Global Severity (EGS) score.

The EGS scoring scale used in all of the clinical trials for ZIANA Gel (clindamycin phosphate, tretinoin) is as follows:


Grade Description
Clear Normal, clear skin with no evidence of acne vulgaris
Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
Mild Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions)
Moderate Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulo-cystic lesion
Severe Inflammatory lesions are more apparent many comedones and papules/pustules, there may or may not be a few nodulocystic lesions
Very Severe Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions

In Study 1, a total of 1,252 patients were enrolled, and in Study 2, a total of 1,288 patients were enrolled. The combined results are presented in Table 3.

Table 3: Efficacy Results at Week 12 in Studies 1 and 2.

  ZIANA
Gel
N=845
Clindamycin
N=426
Tretinoin
N=846
Vehicle
N=423
Evaluator's Global Severity: N (%)
Patients 180 70 122 34
achieving success* (21%) (16%) (14%) (8%)
Inflammatory Lesion Count (% reduction from baseline)
Mean 48% 42% 39% 26%
Non-inflammatory Lesion Count (%reduction from baseline)
Mean 36% 27% 31% 16%
Total Lesion Count (% reduction from baseline)
Mean 41% 34% 34% 20%

* Success was defined as cleared or almost cleared at Week 12

In Study 3, ZIANA Gel (clindamycin phosphate, tretinoin) was compared to clindamycin gel in a total of 2,010 patients with moderate or severe acne vulgaris (see Table 3). As with Studies 1 and 2, the co-primary endpoints were mean percent reduction in lesion counts (inflammatory, non-inflammatory and total) and the Evaluator's Global Severity score. In Study 3, success on the EGS score was assessed by the percentage of subjects who had at least 2 grades of improvement from Baseline to Week 12.

Table 4: Efficacy Results at Week 12 in Study 3

  ZIANA Gel
N = 1008
Clindamycin
N = 1002
Evaluator's Global Severity: N (%)
Patients achieving success* 415 (41%) 345 (34%)
Inflammatory Lesion Count (% reduction from baseline)
Mean 61% 55%
Non-inflammatory Lesion Count (% reduction from baseline)
Mean 50% 41%
Total Lesion Count (% reduction from baseline)
Mean 54% 47%

* Success was defined as at least a 2-grade improvement at Week 12 from baseline.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

PATIENT INFORMATION ZIANA (ZEE-AH-NA)
(clindamycin phosphate 1.2% and tretinoin 0.025%) Gel

IMPORTANT: Not for mouth, eye, or vaginal use.

Read the Patient Information that comes with ZIANA Gel (clindamycin phosphate, tretinoin) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your acne or treatment.

What is ZIANA Gel (clindamycin phosphate, tretinoin) ?

ZIANA Gel (clindamycin phosphate, tretinoin) is an antibiotic and retinoid combination medicine used for the skin treatment of acne in patients 12 years and older.

Who should not use ZIANA Gel (clindamycin phosphate, tretinoin) ? Do not use ZIANA Gel (clindamycin phosphate, tretinoin) if you:
  • have Crohn's Disease
  • have Ulcerative Colitis
  • have developed colitis with past antibiotic use
Tell your doctor:
  • if you are pregnant or planning to become pregnant. It is not known if ZIANA Gel (clindamycin phosphate, tretinoin) may harm your unborn baby.
  • if you are breastfeeding. ZIANA Gel (clindamycin phosphate, tretinoin) may pass through your milk and may harm your baby.
  • about all the medicines and skin products you use:
    • ZIANA Gel (clindamycin phosphate, tretinoin) 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 (clindamycin phosphate, tretinoin) .

How should I use ZIANA Gel (clindamycin phosphate, tretinoin) ?

Use ZIANA Gel (clindamycin phosphate, tretinoin) exactly as prescribed. It may take some time for you to see improvement of your acne with ZIANA Gel (clindamycin phosphate, tretinoin) . Your doctor will tell you how long to use ZIANA Gel (clindamycin phosphate, tretinoin) .

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 (clindamycin phosphate, tretinoin) to your fingertip and spread it over your face. Gently, smooth it into your skin. Do not get ZIANA Gel (clindamycin phosphate, tretinoin) 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 (clindamycin phosphate, tretinoin) more than once a day
  • Do not use too much ZIANA Gel (clindamycin phosphate, tretinoin) . Too much ZIANA Gel (clindamycin phosphate, tretinoin) 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.
Avoid:
  • excessive exposure to the sun, cold, and wind. Weather extremes can dry and burn the skin. Always use a sunscreen on ZIANA Gel (clindamycin phosphate, tretinoin) 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 (clindamycin phosphate, tretinoin) until your skin has healed.

What are possible side effects with ZIANA Gel (clindamycin phosphate, tretinoin) ?

  • Skin irritation. ZIANA Gel (clindamycin phosphate, tretinoin) may cause skin irritation such as dryness, redness, peeling, burning, or stinging. Stop ZIANA Gel (clindamycin phosphate, tretinoin) and call your doctor if your skin becomes very red, swollen, blistered, or crusted.
  • Change in skin color. ZIANA Gel (clindamycin phosphate, tretinoin) may cause a temporary skin color change (lighter or darker).
  • Colitis. This occurs rarely. Stop ZIANA Gel (clindamycin phosphate, tretinoin) 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 (clindamycin phosphate, tretinoin) . Ask your doctor or pharmacist for more information.

How should I store ZIANA Gel (clindamycin phosphate, tretinoin) ?

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

General information about ZIANA Gel (clindamycin phosphate, tretinoin)

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use ZIANA Gel (clindamycin phosphate, tretinoin) for a condition for which it was not prescribed. Do not give ZIANA Gel (clindamycin phosphate, tretinoin) 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 (clindamycin phosphate, tretinoin) . If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about ZIANA Gel (clindamycin phosphate, tretinoin) that is written for healthcare professionals.

If you have questions about ZIANA Gel (clindamycin phosphate, tretinoin) you can also call: 1-800-900-6389 (this is a toll-free number) between 10:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday.

What are the ingredients in ZIANA Gel (clindamycin phosphate, tretinoin) ?

Active Ingredients: clindamycin phosphate 1.2% and tretinoin 0.025%

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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CLINDAMYCIN/TRETINOIN GEL - TOPICAL

 

(klin-da-MYE-sin/TREt-i-noyn)

 

COMMON BRAND NAME(S): Ziana

 

USES: This combination medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells. Clindamycin is an antibiotic that stops the growth of bacteria that cause acne.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Wash your hands before applying this medication. Gently clean the affected skin with a mild/soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication (about the size of a pea) in a thin layer over the face, usually once daily at bedtime or as directed by your doctor. Be careful to avoid the eyes and lip area.

Use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin.

Avoid getting this medication in your eyes. If this occurs, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

During the first few weeks of using this product, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take several weeks to notice results from this medication.

Use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, but your risk of redness, peeling, and pain will increase.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

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.

 

Read the Ziana Gel (clindamycin phosphate, tretinoin) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

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

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: erythromycin products used on the skin, hair perming solutions, products that contain alcohol/lime/menthol (such as astringents, toners, shaving lotions), medicated or abrasive soaps and cleansers, products containing alpha hydroxy acid, products containing glycolic acid, products containing sulfur/resorcinol/salicylic acid, soaps and cosmetics with a strong drying effect, other drugs that may increase your sensitivity to sunlight (e.g., fluoroquinolones such as ciprofloxacin, tetracyclines, thiazide water pills such as hydrochlorothiazide, sulfa drugs such as sulfamethoxazole, phenothiazines such as chlorpromazine).

Benzoyl peroxide can be very irritating and may decrease the effectiveness of this medication if the two products are applied at the same time. Talk with your doctor or pharmacist about using prescription and non-prescription benzoyl peroxide products safely.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers, or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

 

MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until the next day, wait until your next dose is scheduled.

 

STORAGE: Store with the cap tightly closed at room temperature away from light and moisture. Gel preparations are flammable. Do not expose to heat or fire sources. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

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.

Read the Ziana Gel (clindamycin phosphate, tretinoin) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

Side Effects Centers
  • Ziana Gel

Patient Detailed How Take

What should I discuss with my health care provider before using clindamycin and tretinoin topical (Ziana Gel)?

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

Do not use this medication if you are allergic to clindamycin (Cleocin, Clina-Derm, Clindets), or tretinoin (Renova, Retin-A, Tretin-X), or if you have:

  • inflammation of your intestines (also called enteritis);
  • ulcerative colitis; or
  • if you have ever had severe diarrhea caused by antibiotic medicine.

Before using clindamycin and tretinoin topical, tell your doctor if you are allergic to any drugs, or if you have a history of stomach or intestinal disorders. You may not be able to use the medication, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

How should I use clindamycin and tretinoin topical (Ziana Gel)?

Use clindamycin and tretinoin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.

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 clindamycin and tretinoin topical. 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 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.

Use this medication for as many days as it has been prescribed for you 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.

Store tretinoin topical at room temperature away from moisture and heat.

Side Effects Centers
  • Ziana Gel

Patient Detailed Avoid Taking

What happens if I miss a dose (Ziana Gel)?

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.

What happens if I overdose (Ziana Gel)?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a clindamycin and tretinoin topical overdose may result if you absorb this medicine through your skin by applying too much of it. Symptoms of a clindamycin overdose may include watery or bloody diarrhea.

What should I avoid while using clindamycin and tretinoin topical (Ziana Gel)?

Do not wash the treated area for at least 1 hour after applying tretinoin topical. Avoid the use of other skin products on the treated area for at least 1 hour following application of tretinoin topical.

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.

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.

What other drugs will affect clindamycin and tretinoin topical (Ziana Gel)?

Before using clindamycin and tretinoin topical, tell your doctor if you are using any of the following drugs:

  • erythromycin topical (Akne-Mycin, Emcin Clear, Eryderm, Erygel, Erythra-Derm, Ery-Sol, and others); or
  • erythromycin taken by mouth (E.E.S., E-Mycin, Ery-Tab, E-Mycin, Robimycin, and others).

If you are using any of these drugs, you may not be able to use clindamycin and tretinoin topical, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect clindamycin and tretinoin topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about clindamycin and tretinoin topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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