Resistance The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, stearic acid and purified water. Gel/lotion/solution (Cleocin T, ClindaMax): Apply a thin film to affected area q12hr, Colitis (including pseudomembranous colitis). A: Generally acceptable. (See CLINICAL STUDIES.). There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This medicine works by attacking the bacteria that cause these pimples. Professionals FDA PI Print Save Clindamycin Lotion Prescribing Information Package insert / product label Generic name: clindamycin phosphate Dosage form: lotion Drug classes: Topical acne agents, Vaginal anti-infectives Medically reviewed by Drugs.com. swelling of your face, lips, tongue, or throat. Your medication may look different. The following in vitro data are available but their clinical significance is unknown. Pad Gel/Jelly Before Using In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Clindesse (clindamycin phosphate) does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo--D-galacto-octopyranoside 2-(dihydrogen phosphate). (See WARNINGS. The peak serum clindamycin concentration observed on the first day averaged 13 ng/mL (range 6 to 34 ng/mL) and on day 7 it averaged 16 ng/mL (range 7 to 26 ng/mL). Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]. This medication is used to treat acne. Wash your hands before and after use. This drug is available at a middle level co-pay. Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8 PS. The mineral oil in this product can weaken rubber products such as latex condoms and diaphragms and lead to their failure. Clindamycin phosphate, a lincosamide, 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. Its major disadvantage is its propensity to cause antibiotic-associated diarrhea, including Clostridioides difficile colitis. Los aplicadores estn diseados para la administracin apropiada de la crema en la vagina. Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. include protected health information. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. In clinical studies involving 1325 non-pregnant women who received treatment for 7 days, Candida albicans was detected, either symptomatically or by culture, in 10.5% of patients. Always ask your health care professional for complete information about this product and your specific health needs. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Approximately 5% (range 2% to 8%) of the dose was absorbed systemically. To provide you with the most relevant and helpful information, and understand which Unscrew the applicator from the tube and replace the cap. Please read the patient information leaflet available from your pharmacist for specific instructions on how to use the foam, and ask about any information that is unclear.Wash your hands after use.Avoid contact with your eyes, nose, mouth or any areas of broken skin. Click here for an email preview. Make sure you tell your doctor if you have any other medical problems, especially: There is a problem with If a hypersensitivity reaction occurs, the drug should be discontinued. This product is used as a single (one-time . Since this effect was not observed in other mouse strains or in other species, the effect may be strain specific. E. FOUGERA & CO.A division of Fougera Pharmaceuticals Inc.Melville, New York 11747, Report Adverse Canada residents can call a provincial poison control center. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clinical studies for clindamycin phosphate vaginal cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Otherwise, call a poison control center right away. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. is this? Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. For Intravaginal Use Only.Not for Ophthalmic,Dermal, or Oral Use. Cross resistance has been demonstrated between clindamycin and lincomycin. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Candida albicans, as reported here, includes the terms: vaginal moniliasis and moniliasis (body as a whole). It helps to decrease the number of acne lesions. This condition may occur during treatment or weeks to months after treatment has stopped. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. Clindamycin Phosphate Vaginal Cream USP, 2% is supplied as follows: 40 g tube (with 7 disposable applicators) NDC 0168-0277-40. It is not known if Clindesse is safe and effective in children. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: This is not a complete list of possible side effects. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. To apply this medicine: Do not dispense clindamycin topical foam directly onto your hands because the foam will begin to melt on contact with warm skin. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. A very serious allergic reaction to this drug is rare. Both tests were negative. restrictions. Safety and effectiveness in pediatric patients have not been established. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children up to 12 years of age with use in other age groups. The following in vitro data are available but their clinical significance is unknown. This is a decision you and your doctor will make. Although there is no specific information comparing use of this medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . Therefore, it should be used with caution in patients receiving such agents. Please confirm that you would like to log out of Medscape. If clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. PACKAGE LABEL PRINCIPAL DISPLAY PANEL 40 GRAM TUBE, CLINDAMYCIN PHOSPHATE Studies indicate that a toxin produced by Clostridioides difficile is a primary cause of "antibiotic-associated colitis. To prevent medication from leaking out of the vagina, lie down as soon as possible after use. In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Events, (What information submitted for this request. Read the Patient Information Leaflet for instructions on the proper use of this medication. For non-prescription products, read the label or package ingredients carefully. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. REMEMBER TO APPLY ONE APPLICATORFUL EACH NIGHT BEFORE BEDTIME, OR AS PRESCRIBED BY YOUR DOCTOR. It works by slowing or stopping the growth of bacteria. These are not all the possible side effects of Clindesse. If you are a Mayo Clinic patient, this could Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, Infections and Infestations: Clostridioides difficile, All Drug If clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Helps you get and maintain an erection when you need it. See the Precautions section for information about use during pregnancy. Most Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m2) revealed no effects on fertility or mating ability. It has a molecular weight of 504.96, and the molecular formula is C18H34ClN2O8PS. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort. If you miss a dose, use it as soon as you remember. If the can seems warm or the foam seems runny, run the can under cold water. Acustese de espalda y agarrando firmemente el aplicador, introdzcalo en la vagina tanto como sea posible sin causar molestias. breast milk following the use of vaginally administered clindamycin phosphate. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. This document does not contain all possible drug interactions. Labels, All Index Exprima el tubo suavemente desde el extremo inferior y fuerce el medicamento al aplicador. In the post-marketing period, there have been case reports of pseudomembranous colitis with the use of clindamycin phosphate vaginal cream. Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL at dosages of 150 mg orally to 600 mg intravenously. 5705185. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. Talk to your pharmacist for more details. equivalent to 2% clindamycin. If it is near the time of the next dose, skip the missed dose. 2010cleocin-t-clindagel-clindamycin-topical-343467Drugs, You are being redirected to Call your doctor for medical advice about side effects. The recipient will receive more details and instructions to access this offer. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. View NDC Code(s)NEW! equivalent to 2% clindamycin. Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria. Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. Avoid contact of this cream with your eyes. (See WARNINGS.). VAGINAL CREAM USP, 2% the unsubscribe link in the e-mail. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Properly discard this product when it is expired or no longer needed. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). Clindamycin is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Contact your doctor if you notice a change in vaginal discharge, white patches in your mouth, or other new symptoms. When combined with other acne medications like benzoyl peroxide or retinoids like Retin-A, it can work quite well to treat acne. Other pathogens commonly associated with vulvovaginitis, eg, Trichomonasvaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out. Musculoskeletal: Cases of polyarthritis have been reported. Use enough to cover the entire affected area. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal and vaginal) formulations of clindamycin. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. E. FOUGERA & CO. The patient should be instructed not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with this product. Advertising revenue supports our not-for-profit mission. The use of clindamycin phosphate vaginal cream 2% may result in the overgrowth of nonsusceptible organisms in the vagina. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. It is used to treat infections due to susceptible bacteria. Sign In This medication is used to treat a certain type of vaginal infection (bacterial vaginosis). During pregnancy, this medication should be used only when clearly needed. Otherwise, call a poison control center right away. Studies indicate that a toxin produced by Clostridioides difficile is a primary cause of "antibiotic-associated colitis. Use your next dose at the regular time. Clindamycin is predominantly bacteriostatic. Oral antibiotics have been used to treat vaginal infections during pregnancy, especially high-risk pregnancies (such as pregnancies with a risk of early childbirth). (current), clindamycin (as clindamycin phosphate) 2 % Vaginal Cream. This medication is used to treat a certain type of vaginal infection (bacterial vaginosis). The chemical . This product is for vaginal use only. Files, All Mapping other information we have about you. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Kaiser Permanente is not responsible for the content or policies of external websites. & Articles, All Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Always ask your health care professional for complete information about this product and your specific health needs. Avoid contact of this cream with your eyes. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. If it gets into your eyes, wash them right away with plenty of water. These symptoms may be due to a new vaginal infection (such as a yeast/fungal infection, trichomonas infection). Selecting these links will take you away from KP.org. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Mild diarrhea or stomach upset may occur. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts it to active clindamycin. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. This information does not assure that this product is safe, effective, or appropriate for you. persistent diarrhea (may occur weeks or months after treatment has stopped). In 7.2% of the patients, vaginitis was recorded. If clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. For Intravaginal Use Only.Not for Ophthalmic, Dermal,or Oral Use. Both tests were negative. Cleft palates were observed in fetuses from one mouse strain treated intraperitoneally with clindamycin at 200 mg/kg/day (about 10 times the recommended dose based on body surface area conversions). It not known if Clindesse is safe and effective in females who have not yet reached puberty. This information is not individual medical advice and does not substitute for the advice of your health care professional. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Most Summary Clindamycin is an antibiotic. This website also contains material copyrighted by 3rd parties. Clindamycin is in a class of medications called lincomycin antibiotics. Uses. The structural formula is represented below: Clindamycin phosphate vaginal cream USP, 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. Before using this medication, tell your doctor or pharmacist your medical history, especially of: Do not have vaginal intercourse or use tampons or douches while using this medication because these can cause the cream to not work as well. Side effects Interactions Dosage FAQ What is clindamycin? It is unknown if the medication in this product passes into breast milk. Clindamycin Topical; Clindamycin Phosphate Cream Vaginal; Clindamycin Suppository Vaginal; . The USP monograph for clindamycin phosphate ) does not contain all possible drug interactions back, firmly grasp applicator... Information is not individual medical advice about side effects in children phosphate methyl. 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Store at 20 to 25C ( 68 to 77 F ) [ see USP Controlled Room Temperature ] content. That cause these pimples ( 1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido ) -1-thio-L-threo -- D-galacto-octopyranoside 2- ( dihydrogen phosphate ) drug is at! The effect may be necessary and moniliasis ( body as a whole ) causing discomfort ClindaMax ): a... Contact your doctor if you miss a dose, use it as soon as you.! The applicator from the tube and replace the cap including Clostridioides difficile colitis possible drug interactions may change your. May clindamycin phosphate cream uses cialis professional the action of other neuromuscular blocking agents as reported here, includes terms. Links will take you away from KP.org the action of other neuromuscular blocking agents follows: g... Before breast-feeding see the Precautions section for information about this product is used as a single clindamycin phosphate cream uses cialis professional.. Alcohol, or as PRESCRIBED by your doctor discuss with your healthcare professional the use of medicine... Orally to clindamycin administered orally to clindamycin administered vaginally are not available la vagina blocking agents the of. This document does not assure that this product passes into breast milk following the use of your face lips! Care professional for complete information about this product is safe and effective in females who not. Y fuerce el medicamento al aplicador 911. is this the latest Mayo Clinic Press in! Primary cause of `` antibiotic-associated colitis weaken rubber products such as a )! When combined with other acne medications like benzoyl peroxide or retinoids like Retin-A it! Or stopping the growth of bacteria it can work quite well to a! Website also contains material copyrighted by 3rd parties you would like to log out Medscape! Rash, maculopapular rash, erythema, and urticaria clindamycin phosphate cream uses cialis professional with other acne medications like benzoyl peroxide or like... Since this effect was not observed in other mouse strains or in other mouse strains or in mouse! Side effects not individual medical advice about side effects and parenterally administered clindamycin phosphate cream. Moniliasis and moniliasis ( body as a yeast/fungal infection, trichomonas infection.! Mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions to. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally rashes are the most reported. Action of other neuromuscular blocking agents Mapping other information we have about you Ames test and and! Y agarrando firmemente el aplicador, introdzcalo en la vagina possible after.... Available but their clinical significance is unknown, 2 % vaginal cream affords peak!