SUMMARY
Clindamycin phosphate(7(S)-chloro-7deoxylincomycin-2-phosphate) is an ingredient in BenzaClin® Topical Gel. Clindamycin phosphate is a water-soluble ester of a semi-synthetic antibiotic that is created by substituting the parent antibiotic lincomycin's 7(R)-hydroxyl group with a 7(S) hydroxyl group. Clindamycin phosphate is (C18H34ClN2O8PS) chemically. Below is a representation of the clindamycin structural formula:
Methyl
7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) – 1-thio-L- threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate) is the chemical name for clindamycin phosphate, which has a molecular weight of 504.97%.
For topical use, BenzaClin Topical Gel furthermore includes benzoyl peroxide.
Benzoyl peroxide is (C14H10O4) chemically. The following structural formula applies to it:
The molecular weight of benzoyl peroxide is 242.23.
10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide are distributed in each gram of BenzaClin Topical Gel, with the base consisting of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and filtered water.
MEDICAL PHARMACEUTICALS
There was no statistically significant difference in the penetration of BenzaClin Topical Gel and topical 1% clindamycin gel alone, according to an in vitro percutaneous penetration investigation. It is recommended that topical clindamycin in BenzaClin Topical Gel have a mean systemic bioavailability of less than 1%.
It has been demonstrated that the skin absorbs benzoyl peroxide and transforms it into benzoic acid. Benzoic acid makes up less than 2% of the dosage that reaches the bloodstream. Benzoyl peroxide's lipophilic properties are thought to concentrate the substance inside the lipid-rich sebaceous follicle.
pharmacokinetics:
The pharmacokinetics of clindamycin from BenzaClin Topical Gel were investigated in 13 male and female patients with acne vulgaris in the urine and plasma. For four and a half (4.5) days, BenzaClin Topical Gel (~2g) was applied topically to the face and back twice a day. On Days 1 and 5, respectively, six out of thirteen participants (46.2%) and twelve out of thirteen subjects (92.3%) had quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations. The range of clindamycin's peak plasma concentrations (Cmax) was 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. On Day 1 and Day 5, respectively, the AUC (0–12h) varied from 2.74 ng. h/mL to 12.86 ng. h/mL and 11.4 ng. h/mL to 69.7 ng. h/mL.
ACTIONS TO AVOID
General: Not for use in ophthalmology; only for use in dermatology. It is advisable to take caution while using concurrent topical acne therapy, since there is a potential for cumulative irritancy, particularly when using abrasive, peeling, or desquamating agents. Antibiotic use may contribute to the proliferation of resistant organisms, such as fungi. If this happens, stop using this drug and take the necessary action.
Refrain from touching your eyes or mucous membranes.
Products containing erythromycin and clindamycin shouldn't be taken together. In vivoResearch has indicated a conflict between these two antimicrobials. It is unknown what therapeutic significance this in vitro antagonist will have.
Information for Patients: The following details and guidelines should be given to patients using BenzaClin Topical Gel:
- Use BenzaClin Topical Gel according to your doctor's instructions. It should only be used externally. This product may irritate eyes, nose, mouth, and mucous membranes, therefore avoid coming into touch with them.
- This drug should only be used to treat the condition for which it was prescribed.
- Unless their doctor instructs them otherwise, patients shouldn't use any other topical acne preparation.
- When taking BenzaClin Topical Gel, patients should limit or stay away from exposure to sunlight, whether it be from the sun, tanning beds, or UVA/B treatments. Wearing a wide-brimmed hat or other protective gear can help reduce exposure to the sun, and a
Colored clothing or hair may be bleached using BenzaClin Topical Gel.
- For three months, BenzaClin Topical Gel can be kept at room temperature up to 25°C (77°F). Avoid freezing. After three months, discard any unused product.
- Wash the afflicted regions of the skin carefully, rinse with warm water, and pat dry before using BenzaClin Topical Gel.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide is a tumor promoter and progression agent in several animal studies. The clinical significance of this is unknown. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment. In a 52-week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of BenzaClin Topical Gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).
Teratogenic Effects of Pregnancy: Pregnancy Category C
BenzaClin Topical Gel and benzoyl peroxide have not been the subject of any animal reproductive or developmental toxicity studies. No evidence of teratogenicity was found in developmental toxicity studies conducted in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively).
No well-controlled studies are using BenzaClin Topical Gel on expectant patients. Furthermore, it is unknown if giving BenzaClin Topical Gel to a pregnant woman might damage the fetus.
conclusion
The combination gel BenzaClin (clindamycin 1%/benzoyl peroxide 5%) is recommended for use twice daily, or as prescribed by a physician, for the topical treatment of acne vulgaris lesions that are both inflammatory and noninflammatory.
