Kanada - angielski - Health Canada

generic medical partners inc - clindamycin (clindamycin hydrochloride) - capsule - 150mg - clindamycin (clindamycin hydrochloride) 150mg - lincomycins

Kanada - angielski - Health Canada

generic medical partners inc - clindamycin (clindamycin hydrochloride) - capsule - 300mg - clindamycin (clindamycin hydrochloride) 300mg - lincomycins

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

actavis pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate and tretinoin gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate and tretinoin gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of clindamycin phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 60 kg person. clindamycin teratology (segment ii) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. tretinoin in oral segment iii studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). with widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison. it is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. however, orally and parenterally administered clindamycin has been reported to appear in breast milk. 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. it is not known whether tretinoin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman. safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established. clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age. [see clinical studies (14)] clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 10 mg in 1 g - clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). risk summary there are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with clindamycin phosphate foam. 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] . in the u.s. general population, the estimat

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

versapharm incorporated - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 10 mg in 1 ml - clindamycin phosphate topical solution is indicated in the treatment of acne vulgaris. 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 .) clindamycin phosphate topical solution 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

physicians total care, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 20 mg in 1 g - 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). clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (see clinical studies.) 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. 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. other pathogens commonly associated with vulvovaginitis, e.g., trichomonas vagin

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate topical solution, clindamycin phosphate gel, and clindamycin phosphate lotion are indicated in the treatment of acne vulgaris. 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. ) clindamycin phosphate topical solution, clindamycin phosphate gel, and clindamycin phosphate lotion are 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.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

a-s medication solutions - clindamycin hydrochloride (unii: t20oq1yn1w) (clindamycin - unii:3u02el437c) - clindamycin 150 mg - clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin hydrochloride capsules are also indicated in the treatment of seri­ous infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of colitis, as described in the boxed warning , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). anaerobes: serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastroin­testinal tract); infecti

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

bryant ranch prepack - clindamycin hydrochloride (unii: t20oq1yn1w) (clindamycin - unii:3u02el437c) - clindamycin 150 mg - clindamycin hcl is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of colitis, as described in the boxed warning , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). anaerobes: serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital trac

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

sagent pharmaceuticals - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin injection, usp is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, streptococcus pneumoniae, other streptococci (except e. faecalis ), and staphylococcus aureus. skin and skin structure infections caused by streptococcus pyogenes, staphylococcus aureus , and anaerobes. gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. septicemia caused by staphylococcus aureus , streptococci (except enterococcus faecalis ), and susceptible anaerobes. bone and joint infections including acute hematogenous osteomyelitis caused by staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin injection, usp and other antibacterial drugs, clindamycin injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. this drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. when clindamycin injection is administered to the pediatric population (birth to 16 years) appropriate monitoring of organ system functions is desirable. clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. however, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to clostridium difficile ) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. these patients should be carefully monitored for the development of diarrhea. pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.