Perrigo Pharmaceuticals has voluntarily recalled their clindamycin/benzoyl peroxide (1.2%/5%) gel, due to the presence of a small amount of mold on the caps of the tubes. A plan by Ionis Pharmaceuticals to open a development and manufacturing center with 200 new, permanent full-time jobs in Oceanside's El Corazon Park could clear another hurdle this week. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% passes into your breast milk. Durham, NC 27713 USA, PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Severe colitis may result in death. Clindamycin Phosphate. 800-438-2568 Claim This Listing. 20 mm. Read this Patient Information before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and each time you get a refill. What are the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. See the end of this leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Minimize sun exposure including use of tanning beds or sun lamps following drug application. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Clindamycin Phosphate and, Benzoyl Peroxide Gel, 1.2%/5% Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Clindamycin Phosphate Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following size: 75 mL bottle - NDC 68682-462-75 - Store at controlled . Inactive ingredients: carbomer homopolymer (type C), dimethicone, edetate disodium, glycerin, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide. You can also ask your pharmacist or healthcare provider for information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% that is written for health professionals. General information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. A 1% clindamycin phosphate gel similar to Clindamycin Phosphate Topical Gel caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use. 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. Percent reductions in inflammatory lesion counts after treatment for 11 weeks in these 5 trials are shown in Table 2. Plot No. 68682-0462. 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. Both tests were negative. During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 mL of Clindamycin Phosphate Topical Gel, assuming complete absorption and based on a body surface area comparison. In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. DV Medical Supply, Inc. 2000 W 135th Street Gardena, CA. Clindamycin Phosphate and Benzoyl Peroxide Gel is not for oral, ophthalmic, or intravaginal use. Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Oceanside Pharmaceuticals. Severe colitis may result in death. FDA testing has found this lot to contain undeclared methanol. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin, Oceanside Pharmaceuticals product information by RSS, Additional medications in the Prescription Medications section by. Call your doctor for medical advice about side effects. CLINDAMYCIN PHOSPHATE- clindamycin phosphate gelOceanside Pharmaceuticals. Table 1. Clindamycin Phosphate and Benzoyl Peroxide Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. When significant diarrhea occurs, Clindamycin Phosphate and Benzoyl Peroxide Gel should be discontinued. Through its subsidiaries, Intas markets its products in 80 countries. Privacy Policy | Copyright 2022. D10602 Clindamycin phosphate and benzoyl peroxide <JP/US>. Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately. 2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Safely throw away expired 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. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to slightly yellow, opaque, aqueous gel formulation. UNCLAIMED. These are not all of the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Urticaria, application site reactions, including discoloration have been reported. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening before retiring. data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAKAAAAB4CAYAAAB1ovlvAAADOUlEQVR4Xu3XQUpjYRCF0V9RcOIW3I8bEHSgBtyJ28kmsh5x4iQEB6/BWQ . Clindamycin Phosphate and Benzoyl Peroxide Gel is a, Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e. seizure clusters, acute repetitive seizures) that are, Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release, Sun, 06 Nov 2022. Last updated on May 1, 2021. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. 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)]. This Patient Information has been approved by the U.S. Food and Drug Administration. This Patient Information has been approved by the U.S. Food and Drug Administration. How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel? Pharmacokinetics: In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of Clindamycin Phosphate Topical Gel for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL. 400 Somerset Corp Boulevard Bridgewater, NJ 08807 (908) 927-1400. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Important: For use on the skin only (topical use). This action was taken voluntarily with the. How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada It is not known whether Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is excreted into human milk after topical application. Do not freeze. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1. Subjects were evaluated and acne lesions counted at each clinical visit at Weeks 2, 5, 8, 11. More Info Omeprazole And Sodium B. If significant diarrhea occurs, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should be discontinued. Table 1: Percent of Subjects with Local Skin Reactions. No microbiology studies were conducted in the clinical trials with this product. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% for a condition for which it was not prescribed. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2,000 mg per kg per day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. Table 2. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. 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 in vitro activity is not known. C-1, Madkaim Industrial Estate, Madkaim, Clindamycin is an antibiotic which works by stopping the growth of bacteria. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause skin and facial hair to temporarily change color (yellow or orange) when used with topical products that contain sulfones. Advise the patient to read the FDA-approved patient labeling (Patient Information). Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. It is supplied as follows: Advise the patient to read the FDA-approved patient labeling (Patient Information). The expiration date of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is 60 days from the date when you fill your prescription. Clindamycin Phosphate Topical Gel is indicated for topical application in the treatment of acne vulgaris. Clindamycin Phosphate/ Benzoyl Peroxide. Acne and Rosacea Agents. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. It may harm them. What are the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS). Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2C and 8C (36F and 46F). Use of Clindamycin Phosphate and Benzoyl Peroxide Gel beyond 12 weeks has not been evaluated. To minimize exposure to sunlight, a hat or other clothing should be worn. Clindamycin Phosphate and Benzoyl Peroxide Gel can cause serious side effects including: The most common side effects of Clindamycin Phosphate and Benzoyl Peroxide Gel include application site pain, application site irritation including redness, itching, burning, and stinging. This site complies with the HONcode standard for trustworthy health information: verify here. The group treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% showed greater overall improvement in the investigator's global assessment than the benzoyl peroxide, clindamycin, and vehicle groups in three of the five trials (Trials 1, 2, and 5). 2634 Antibiotics for external use. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. More Info Urolet Mb More Info Prednicarbate More Info Metronidazole Gel More Info Erythromycin And Benzoy. 68682-0300. D01073 Clindamycin phosphate (JP18/USP) Drug groups [BR: br08330] Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in your mouth, eyes, nose, vagina, or on your lips. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Each gram of 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. This site complies with the HONcode standard for trustworthy health information: verify here. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing. https://medlibrary.org/lib/rx/meds/clindamycin-phosphate-22/. Use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% exactly as your healthcare provider tells you to use it. Microbiology: Although clindamycin phosphate is inactive invitro, rapid invitro hydrolysis converts this compound to clindamycin, which has antibacterial activity. Clindamycin phosphate is C 18H 34ClN 2O 8PS. had inflammation of the colon (colitis) with past antibiotic use. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or, Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Sunscreen may also be used. 263 Suppurative dermatosis agents. 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. 611 Acting mainly on gram-positive bacteria. 1. What should I avoid while using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? Avoid using tanning beds or sun lamps. Dosage form: gel Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel. Do not give Clindamycin Phosphate and Benzoyl PeroxideGel, 1.2%/5% to other people, even if they have the same symptoms you have. 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. Clindamycin Phosphate List of the 142 NDC products with the active ingredient Clindamycin Phosphate. 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