MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Clindagel, Xaciato, Cleocin Phosphate, Clindamycin Hydrochloride, CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)
FDA boxed warning
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because CLEOCIN PHOSPHATE therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. …
CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions CLINDAGEL QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.05 Noninflammatory 25% 12% Total 38% 27% There was a trend in the investigator’s global assessment of the results, which favored CLINDAGEL QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to CLINDAGEL. There was no signal for contact sensitization in the clinical trials under normal use conditions.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Vaginal Intercourse and Use with Vaginal Products Instruct the patients not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with XACIATO and for 3 days after using XACIATO. Use with Polyurethane Condoms Advise the patient that XACIATO may weaken polyurethane condoms. Therefore, use of polyurethane condoms concurrently or for 7 days following treatment with XACIATO is not recommended. During this time period polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used. Vaginal Candida Infections Inform the patient that vaginal yeast infections can occur following use of XACIATO and may require treatment with an antifungal drug. Distributed by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA For patent information: www.organon.com/our-solutions/patent/ © 2025 Organon group of companies. All rights reserved. uspi-og9423-gl-2512r001
In the one well-controlled clinical study comparing CLINDAGEL and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table: Number (%) of Patients Body System/Adverse Event CLINDAGEL QD N=168 Vehicle Gel QD N=84 Skin and Appendages Disorders Dermatitis 0 1 Dermatitis contact 0 1 Dermatitis fungal 0 1 Folliculitis 0 1 Photosensitivity reaction 0 1 Pruritus 1 1 Rash erythematous 0 0 Skin dry 0 0 Peeling 1 0 Orally and parente…
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Ask a doctor — $19.99CLINDAGEL is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Apply a thin film of CLINDAGEL once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — antiinfectives for treatment of acne
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.