Federal government websites often end in .gov or .mil. It is used to treat infections due to susceptible bacteria. Clindamycin phosphate foam should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin component. Schlessinger J, Menter A, Gold M, Leonardi C, Eichenfield L, Plott RT, Leyden J, Wortzman M; ZIANA Study Group. J. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clindamycin Phosphate Foam, 1% can cause serious side effects including: The most common side effects of Clindamycin Phosphate Foam, 1% include: Tell your doctor if you have any side effect that bothers you or that does not go away. (2018). 2017 Apr;309(3):159-167. doi: 10.1007/s00403-017-1718-3. What should I tell my doctor before using clindamycin phosphate foam? For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from clindamycin phosphate foam, 1% based on a mg/m2 comparison. Thus the foam formulation of clindamycin is a safe and effective acne treatment; the unique foam delivery vehicle may offer cosmetic benefits to the patient and thus increase compliance. [See Microbiology (12.4)]. Clindagel, Cleocin T, Clindesse, Cleocin Vaginal, +9 more. 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. Many containers can be opened by children. This Patient Information has been approved by the U.S. Food and Drug Administration. 5 WARNINGS AND PRECAUTIONS 5.1 Colitis - Systemic absorption of clindamycin has been demonstrated following topical use of this product. [online] Available at: Toxnet.nlm.nih.gov. Patients should wash their hands after applying Clindamycin Phosphate Foam, 1%. In vitro studies have shown antagonism between these two antimicrobials. However, your physician may prescribe other drugs together with clindamycin which may cause a slight interaction, and in this case precautions are necessary. To apply this medicine: The contents of Clindamycin Phosphate Foam, 1% are flammable; avoid fire, flame and/or smoking during and immediately following application. Animal reproduction studies have not been conducted with clindamycin phosphate foam. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. Proper Use. In other countries, it may also be available as a topical foam, vaginal cream and oral suspension. Clindamycin (topical route). Keep all drugs out of the reach of children and pets. Check with your The clinical study with clindamycin phosphate foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. what signs you had. Important: For skin use only. The contents of clindamycin phosphate foam are flammable; avoid fire, flame and/or smoking during and immediately following application. See FDA-Approved patient labeling (Patient Information). Benefits of the Dermocosmetic Mineral 89 Probiotic Fractions Adjunct to Topical Retinoids for Anti-Aging Benefits. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. CLINDAMYCIN PHOSPHATE- clindamycin phosphateaerosol, foam Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride. If you stop using clindamycin too soon, acne may return. eCollection 2023. Alireza M, Gerlach B, Horvath A, Forsea D, Briantais P, Guyomar M. Eur J Dermatol. Inform your physician about the skin care products you intend to use. Augmed-375(Amoxycillin & Potassium Clavulanate tablets), Pregline(One step HCG urine pregnancy card). No evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (MRHD) of clindamycin phosphate foam based on body surface area (BSA) comparisons and assuming 100% absorption [see Data]. Information can also be found online at https://www.poisonhelp.org/help. It works to treat bacterial infections when penicillin is not an option. If irritation or dermatitis occurs, clindamycin should be discontinued. It works by killing or preventing the growth of bacteria on your skin. The white to off-white thermolabile foam is available as follows: Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. This medicine may cause harm if swallowed. Our website services, content, and products are for informational purposes only. Know the medicines you take. The contents of the foam canister are flammable. of children. Your physician will specify how much of the medication you need to apply and how often. Adverse experiences in the active treatment groups were mild or moderate and transient in nature. You must wash your hands before and after using it. You will need to talk about the benefits and risks It is therefore also important to not miss a dose. The structural formula for clindamycin phosphate is represented below: Clindamycin Phosphate Foam, 1% contains clindamycin (1%) as clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Resistance to clindamycin is often associated with resistance to erythromycin. sharing sensitive information, make sure youre on a federal Clindamycin is a lincosamide antibiotic. Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate. Resistance to clindamycin is often associated with resistance to erythromycin. Set id: 2e6f96d0-d928-4775-a7db-3e998fce675b, To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or, Staphylococcus aureus, Streptococcus pyogenes, See FDA-Approved patient labeling (Patient Information). Systemic absorption of clindamycin has been demonstrated following topical use of this product. If irritation or dermatitis occurs, clindamycin should be discontinued. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. Before using clindamycin, let your physician or pharmacist know if you are allergic to clindamycin, lincomycin (Lincocin) or to any of the other ingredients in the gel, foam, lotion, suspension or pads or to any other medication. Both tests were negative. Staphylococcus aureus, Streptococcus pyogenes. These highlights do not include all the information needed to use Clindamycin Phosphate Foam, 1% safely and effectively. Clindamycin ( oral and injection) is a prescription medication used to treat bacterial infections of the skin, airways, blood, joints, bones, female reproductive organs, and internal organs. In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used clindamycin phosphate foam, 1% or the vehicle Foam once daily for twelve weeks. Do not puncture or incinerate. No microbiology studies were conducted in the clinical trials with this product. Batch CBD Full-Spectrum Gummies. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. If you get clindamycin phosphate foam in your eyes, mouth, on lips or broken skin, rinse well with water. Wash your hands after applying clindamycin phosphate foam. See full prescribing information for Clindamycin Phosphate Foam, 1%. The most common side effects of clindamycin phosphate foam include, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, 50 g in 1 CAN; Type 0: Not a Combination Product, 100 g in 1 CAN; Type 0: Not a Combination Product. Your physician may want to monitor closely for side-effects or to adjust doses of your medications. If clindamycin foam is swallowed, call a doctor or poison control center right away. Throw away any of the unused medicine that you dispensed out of the can. Who should not use clindamycin phosphate foam? Contents under pressure. How should I use clindamycin phosphate foam? On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for clindamycin phosphate foam, 1% than for the clindamycin gel, 1%. all medications Both tests were negative. (2018). Clindamycin is available as a prescription topical treatment. Dosage form: aerosol, foam Do not use it more than the recommended dose. If immediate assistance is necessary because the victim has collapsed, had a seizure, has trouble breathing, or cant be awakened, call 911. Table 1: Adverse Reactions Occurring in 1% of Subjects, Application site reaction, not otherwise specified. Do not store clindamycin phosphate foam at temperatures above 120F (49C). Know the medicines you take. It is not known if Clindamycin Phosphate Foam, 1% is safe and effective in children under 12 years of age. Clindamycin can be prescribed alone or in combination with other topical or oral acne treatments. Do not get clindamycin in your eyes, nose, or mouth. Combination products of clindamycin are also available, such as clindamycin + tretinoin. Store the medication at room temperature. Make sure to dry well. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Mechanism of action of clindamycin in acne vulgaris is unknown [see Microbiology (12.4)]. Clindamycin ( topical, vaginal, oral, and injection) belongs to a group of drugs called lincosamide antibiotics, which slow or stop the growth of bacteria. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The clinical significance of this in vitro antagonism is not known. Furthermore, when your physician also prescribes other topical treatments along with clindamycin, it is preferable to apply medications at different times to avoid skin irritation. These are not all the possible side effects of clindamycin phosphate foam. For more information, ask your doctor or pharmacist. Keep the medication away from excessive heat and moisture do not store in the bathroom. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally. Safety and effectiveness of clindamycin phosphate foam in children under the age of 12 have not been studied. Keep out of reach of children. Medically reviewed by Drugs.com. See FDA-Approved patient labeling (Patient Information). Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. MeSH See full prescribing information for CLINDAMYCIN PHOSPHATE FOAM. . Before using clindamycin, inform your physician if you ever have ever suffered from inflammatory bowel disease (a condition in which all or a part of the intestine is swollen or irritated), stomach or intestinal disease or severe diarrhea. Pharmacodynamics of clindamycin phosphate foam is unknown. If you are using clindamycin and are breastfeeding, talk to your physician about using clindamycin during this period. For better efficacy of the medicine, the course of the treatment should be completed even if you feel better. Do not puncture or incinerate. 1998 Nov;11(3):227-33. Use enough to cover the entire affected area. Apply Clindamycin Phosphate Foam, 1% once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. The carcinogenicity of a 1.2% clindamycin phosphate gel similar to Clindamycin Phosphate Foam, 1% was evaluated by daily application to mice for two years. Do not expose to heat or store at temperature above 120F (49C). Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility. [online] Available at: Epocrates.com. CLINDAMYCIN (KLIN da MYE sin) treats acne. The can is pressurized with a hydrocarbon (propane/butane) propellant. Following multiple applications of clindamycin phosphate foam, 1%, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5. P. acnes resistance to clindamycin has been documented. Both tests were negative. Severe colitis may result in death. Patients should use enough clindamycin phosphate foam to cover the face and to apply once daily. Foam: The can of clindamycin foam should not be stored at temperatures above 49 degrees Celcius (120 degrees Fahrenheit). We comply with the HONcode standard for trustworthy health information. Un programa que dej de tener gracia cuando se. 10. Clindamycin phosphate is the most widely used topical antibacterial agent for acne treatment. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally. Inactive ingredients: cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol. Available for Android and iOS devices. What are possible side effects with clindamycin phosphate foam? You may have to use clindamycin for months or longer, as prescribed by your physician. Children of 12 years and older, adolescents, and adults. Use enough clindamycin to lightly cover the acne-affected areas. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love Do not use clindamycin for a skin condition that it was not prescribed for, without consulting your physician first. have had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use, have or have had bowel problems (such as Crohn's disease, ulcerative colitis, colitis), have or have had eczema or other skin problems. The preferred propellant for use in the clindamycin phosphate foam compositions of the present invention comprises a propane and butane mixture. Clindamcyin. Reproduction studies in rats using oral doses of clindamycin hydrochloride or clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility. Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. 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. The carcinogenicity of a 1.2% clindamycin phosphate gel similar to clindamycin phosphate foam was evaluated by daily topical administration to mice for two years. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. Clinrich -CT Vaginal Soft Gelatin Capsule is to be used as per the label instructions or as suggested by your doctor. (4), The most common adverse reactions (>1%) are headache and application site reactions including burning, pruritus, and dryness. Clindamycin Phosphate Foam, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is white to off-white in color and thermolabile. The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Keep Clindamycin Phosphate Foam, 1% and all medicines out of the reach of children. White to off-white thermolabile foam. by: Taro Pharmaceutical Industries Ltd. COMMON BRAND NAME (S): Evoclin Be ready to tell or show what was Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Clindamycin Phosphate Foam, 1% should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin component. Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane . Results of a randomised, multicentre study comparing a new water-based gel of clindamycin 1% versus clindamycin 1% topical solution in the treatment of acne vulgaris. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes (P. acnes), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with clindamycin phosphate foam. J. Med . Drug classes: Topical acne agents, Vaginal anti-infectives. Reproduction studies have been conducted in rats and mice using subcutaneous or oral doses of clindamycin phosphate, clindamycin hydrochloride or clindamycin palmitate hydrochloride administered daily during organogenesis at doses up to the equivalent of 432 mg/kg/day clindamycin phosphate. There are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Contact your pharmacist to learn about the availability of a medicine take-back program in your neighborhood, or get in touch with your local garbage/recycling department to ensure safe disposal. These CBD candies offer a simple and flexible . The carcinogenicity of a 1.2% clindamycin phosphate gel similar to clindamycin phosphate foam was evaluated by daily topical administration to mice for two years. Do not use clindamycin phosphate foam in your eyes, mouth or vagina. Napumpujte ho antioxidantmi a vitamnmi! The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Uses Before taking Warnings Side effects Overdose Dosage Uses of Clindamycin Foam: [online] Available at. Keep your regular appointments with your physician to track your response to clindamycin. The topical doses used in this study were approximately 3 and 15 times higher than the MRHD of clindamycin phosphate from clindamycin phosphate foam, based on BSA comparison and assuming 100% absorption. Clindamycin Phosphate Foam, 1% is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older. 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.. If used during lactation and clindamycin phosphate foam is applied to the chest, care should be taken to avoid accidental ingestion by the infant. Flammable. If clindamycin gets into a cut or scrape, rinse it off with water. Side effects and warnings. No significant increase in tumors was noted in the treated animals. to make sure that it is safe for you to take clindamycin foam with all of your drugs and health problems. Do not expose to heat or store at temperature above 120F (49C). Patwardhan SV, Richter C, Vogt A, Blume-Peytavi U, Canfield D, Kottner J. Arch Dermatol Res. 2023 Angel Pharmaceutical | Theme by Theme Farmer, Be the first to review Clinrich -CT (Clindamycin, Clotrimazole & Tinidazole Vaginal Soft Gelatin Capsule). What should I avoid while using Clindamycin Phosphate Foam, 1%? Clindamycin should only be applied to intact skin. A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with clindamycin phosphate foam. Clindamycin phosphate foam may cause irritation such as erythema, scaling, itching, burning, or stinging. 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