April 23, 2008

BenzaClin

BenzaClin® Topical Gel contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). 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.\
Chemically, clindamycin phosphate is (C18 H34 ClN2 O8 PS). The structural formula for clindamycin is represented below:
Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate).
BenzaClin Topical Gel also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14 H10 O4). It has the following structural formula:
Benzoyl peroxide has a molecular weight of 242.23.
Each gram of BenzaClin Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as BenzaClin phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.
CLINICAL PHARMACOLOGY
An in vitro percutaneous penetration study comparing BenzaClin Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin Topical Gel is suggested to be less than 1%.
Benzoyl peroxide has been shown to be absorbed by the skin BenzaClin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.
MICROBIOLOGY:
The clindamycin and benzoyl peroxide components individually have 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 this product.
CLINICAL STUDIES
In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks, 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:
Most important fact about BenzaClin
Although BenzaClin is applied only to the skin, some of this medication could be absorbed into the bloodstream. Once in the system, it has been known to cause severe colitis. Symptoms include severe or bloody diarrhea and abdominal cramps.
How should you use BenzaClin?
Before applying BenzaClin, gently wash the affected skin and rinse with warm water. Pat the skin dry. Apply the medication to the entire area, not just the pimples. Do not use BenzaClin more often than recommended by your doctor. Excessive use can make your skin dry or irritated.
–If you miss a dose…
Apply it as soon as you remember. If it is almost time for your next application, skip the one you missed and go back to your regular schedule.
–Storage instructions…
Store BenzaClin in the refrigerator in a tightly closed container. Do not freeze. Discard any unused medication after two months.


What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue using BenzaClin.
*       More common side effects may include:
Dry skin, skin irritation

Why should BenzaClin not be prescribed?
Do not use BenzaClin if you are allergic to either of its ingredients, or to the antibiotic lincomycin. Also avoid BenzaClin if you have a history of colitis.

Special warnings about BenzaClin
BenzaClin gel is for external use only. Avoid contact with your eyes, nose, mouth, and all mucous membranes.
BenzaClin can cause skin irritation, especially if it is used with other skin treatments that are abrasive or cause peeling. Do not combine BenzaClin with other treatments unless directed by your doctor. If your skin becomes severely irritated, stop using BenzaClin and call your doctor.

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