Prescription Drug Information: Neuac

NEUAC- clindamycin phosphate and benzoyl peroxide gel
Medimetriks Pharmaceuticals

1 INDICATIONS AND USAGE

1.1 Indication

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.

1.2 Limitations of Use

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

2 DOSAGE AND ADMINISTRATION

Apply a thin layer of Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% to the face once daily, in the evening or as directed by the physician. The skin should be gently washed, rinsed with warm water, and patted dry before applying Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Gel, 1.2%/5%

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a white, opaque gel. Each gram of Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% [see Adverse Reactions (6.2) ].

4.2 Colitis/Enteritis

Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ].

5 WARNINGS AND PRECAUTIONS

5.1 Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% should be discontinued.

Severe colitis has occurred following oral and 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.

5.2 Ultraviolet Light and Environmental Exposure

Benzoyl peroxide, a component of Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%, may cause increased sensitivity to sunlight. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. [See Nonclinical Toxicology (13.1) ] 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.

6 ADVERSE REACTIONS

The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical trials, 397 subjects used clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris. All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1.

Table 1. Local Skin Reactions With Use Of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% Combined Results From Five Trials (n=397)
% of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with Symptom Present
Before Treatment (Baseline) During Treatment
Symptom Mild Moderate Severe Mild Moderate Severe
Erythema 28% 3% 0 26% 5% 0
Peeling 6% <1% 0 17% 2% 0
Burning 3% <1% 0 5% <1% 0
Dryness 6% <1% 0 15% 1% 0

(Percentages derived by number of subjects receiving clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% with symptom score/number of enrolled subjects receiving clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%.

Urticaria, application site reactions, including discoloration have been reported.

7 DRUG INTERACTIONS

7.1 Erythromycin

Avoid using Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

7.2 Concomitant Topical Medications

Concomitant topical acne therapies should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

7.3 Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% should be used with caution in patients receiving such agents.

7.4 Topical Sulfone Products

Use of topical benzoyl-peroxide-containing preparations with topical sulfone products may cause skin and facial hair to temporarily change color (yellow/orange).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) revealed no evidence of teratogenicity.

8.3 Nursing Mothers

It is not known whether Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is excreted into human milk after topical application.

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. Because many drugs are excreted in human milk, caution should be exercised when Neuac® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% in pediatric patients below the age of 12 have not been established.

8.5 Geriatric Use

Clinical studies of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

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