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BENZACLIN is a brand name for Clindamycin, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General For external (dermatological) use only. Not for ophthalmic use. Concomitant topical acne therapy is not recommended because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.
Exposure to sunlight or unnecessary UV light should be minimized. Gastrointestinal Orally and parenterally administered clindamycin have been associated with severe colitis, which may result in patient death. Use of the topical formulation of clindamycin can result in absorption of the antibiotic from the skin surface.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Studies indicate that a toxin produced by clostridia is a 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. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for Clostridium difficile toxin may be helpful diagnostically.
When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
Ophthalmologic/Mucosal/Skin Avoid contact with eyes and mucous membranes. In the event of accidental contact with such sensitive surfaces (mucous membranes, eyes, abraded skin), rinse with large amounts of tepid tap water. Special Populations Pregnant Women There are no well-controlled trials in pregnant women treated with BENZACLIN (clindamycin, as phosphate, 1% and benzoyl peroxide 5%).
It is not known whether BENZACLIN can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BENZACLIN should not be given to a pregnant woman unless the benefits to the mother clearly outweigh the possible risks to the fetus.
Nursing Women It is not known whether BENZACLIN is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast PrBENZACLIN ® Product Monograph Page 5 of 20 milk.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clindamycin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. Pediatrics (<12 years of age) The safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
Geriatrics (>65 years of age) The safety and effectiveness of this product in geriatric patients above the age of 65 years have not been established. Susceptibility/Resistance Development of Drug-Resistant Bacteria Prescribing BENZACLIN in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth Prolonged use of BENZACLIN may result in overgrowth of non-susceptible organisms including fungi. If this should occur, therapy with BENZACLIN should be discontinued and appropriate measures taken.
P. acnes resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin. If this should occur, therapy with BENZACLIN should be discontinued and alternative therapy should be initiated.
ADVERSE REACTIONS Adverse Drug Reaction Overview The most frequent adverse reactions that may occur with BENZACLIN (clindamycin, as phosphate, 1% and benzoyl peroxide 5%) are mild to moderate adverse reactions of the skin; most commonly, dry skin.
Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 1 below presents a pooled summary of the most frequent (≥ 1%) adverse reactions reported during four randomized, double-blind, vehicle-controlled, multicentre trials conducted with BENZACLIN in patients with moderate acne vulgaris.
A total of 420 male and female patients with PrBENZACLIN ® Product Monograph Page 6 of 20 an average age of 19 years received BENZACLIN in these studies; 168 patients received vehicle. The average duration of treatment with BENZACLIN was 69 days.
Table 1 - Most Frequent Adverse Events (≥ 1%) Reported in the BENZACLIN or Vehicle Groups Considered to be Possibly, Probably or Definitely Related to Product Administration Body System: Skin and Appendages BENZACLIN n= 420 Vehicle n= 168 Very Common Adverse Reaction: Dry Skin 12% 6% Common Adverse Reactions: Application site reaction 3% <1% Peeling 2% - Pruritus 2% <1% Erythema 1% <1% Sunburn was observed in 1% of the BENZACLIN group but considered related to the drug in less than 1% (2 patients).
The use of a moisturizer in the studies may have reduced the incidence of dry skin. Less Common Clinical Trial Adverse Drug Reactions (<1%) Body as a Whole: Face edema, headache Nervous System: Dizziness Skin and Appendages: Rash, skin burning Post-Market Adverse Drug Reactions The most frequently reported post-market adverse events are related to the application site and are consistent with the type of events recorded in the controlled clinical trials.
Typically, these application site reactions have included dry skin, erythema, burning sensation, rash, peeling and pruritis. Application site hypersensitivity (allergic reaction), colitis and diarrhea have also been reported. DRUG INTERACTIONS […]