Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 75 mg - acticlate® and acticlate® cap are indicated for treatment of rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsial pox, and tick fevers caused by rickettsiae . acticlate and acticlate cap are indicated for treatment of the following sexually transmitted infections: - uncomplicated urethral, endocervical or rectal infections caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - lymphogranuloma venereum caused by chlamydia trachomatis . - granuloma inguinale caused by klebsiella granulomatis . - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - chancroid caused by haemophilus ducreyi . acticlate and acticlate cap are indicated for treatment of the following respiratory tract infections: - respiratory tract infections caused by mycoplasma pneumoniae . - psittacosis (ornithosis) caused by chlamydophila psittaci . - because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, c

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20 mg in 1 g - xolegel is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. safety and efficacy of xolegel for treatment of fungal infections have not been established. none. risk summary there are no available data on xolegel use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis (see data ). the available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of xolegel. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other advers

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - verdeso® (desonide) foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. patients should be instructed to use verdeso foam for the minimum amount of time necessary to achieve the desired results because of the potential for verdeso foam to suppress the hypothalamic-pituitary-adrenal (hpa) axis. treatment should not exceed 4 consecutive weeks. none. risk summary there are no available data on verdeso foam use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, topical administration of a desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans aft

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 10 mg in 1 g - veltin™ (clindamycin phosphate and tretinoin) gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. veltin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled studies in pregnant women treated with veltin gel. veltin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a limit teratology study performed in sprague dawley rats treated topically with veltin gel or 0.025% tretinoin gel at a dose of 2 ml/kg during gestation days 6 to 15 did not result in teratogenic effects. although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. these abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison. for p

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

almirall ltd - aceclofenac - oral tablet - 100mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - eflornithine monohydrate chloride - cream - 115mg/1gram

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - sarecycline hydrochloride (unii: 36718856jr) (sarecycline - unii:94o110cx2e) - seysara® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. limitations of use efficacy of seysara beyond 12 weeks and safety beyond 12 months have not been established. seysara has not been evaluated in the treatment of infections [see clinical studies (14)] . to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, seysara should be used only as indicated [see warnings and precautions (5.6)] . seysara is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. risk summary seysara, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see warnings and precautions (5.1) and use in specific populations (8.4)] . the limited available human data are not sufficient to inform a drug-associated

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - aczone® (dapsone) gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none. risk summary there are no available data on aczone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. the systemic absorption of aczone in humans following topical application is low relative to oral dapsone administration [see clinical pharmacology (12.3)] . in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 7.5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. these dosages resulted in systemic exposures that represented approximately 1407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the mrhd of aczone gel, 7.5%, based on auc comparisons. these effects were probably secondary to maternal toxicity. dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the mrhd of aczone gel, 7.5%, based on auc comparisons). no effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. risk summary there is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant or the effects on milk production. orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with g6pd deficiency. systemic absorption of dapsone following topical application is low relative to oral dapsone administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for aczone gel, 7.5% and any potential adverse effects on the breastfed child from aczone gel, 7.5% or from the underlying maternal condition. the safety and effectiveness of aczone gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. use of aczone gel, 7.5% in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 to 11 years of age from an open label study of 100 subjects with acne [see adverse reactions (6.1), and clinical pharmacology (12.3)] . the safety profile for aczone gel, 7.5% in clinical trials was similar to the vehicle control group. safety and effectiveness of aczone gel, 7.5%, have not been established in pediatric patients below the age of 9 years. clinical trials of aczone gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. individuals with glucose-6-phosphate dehydrogenase (g6pd) deficiency may be more prone to methemoglobinemia and hemolysis [see warnings and precautions (5.1)] . aczone gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study of 64 subjects with g6pd deficiency and acne vulgaris. subjects were black (88%), asian (6%), hispanic (2%) or of other racial origin (5%). blood samples were taken at baseline, week 2, and week 12 during both vehicle and aczone gel, 5% treatment periods. some of these subjects developed laboratory changes suggestive of hemolysis, but there was no evidence of clinically significant hemolytic anemia in this study [see warnings and precautions (5.1)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - flurandrenolide (unii: 8eul29xuqt) (flurandrenolide - unii:8eul29xuqt) - for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions. topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. use of cordran tape is not recommended for lesions exuding serum or in intertriginous areas.

Verenigde Staten - Engels - NLM (National Library of Medicine)

almirall, llc - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazorac® (tazarotene) cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. tazorac (tazarotene) cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris. tazorac cream is contraindicated in: - pregnancy. retinoids may cause fetal harm when administered to a pregnant female [see warnings and precautions (5.1), use in specific populations (8.1, 8.3)] . - individuals who have known hypersensitivity to any of its components [see warnings and precautions (5.2)] . risk summary based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazorac cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. safety in pregnant females has not been established. the potential risk to the fetus outweighs the potential benefit to the mother from tazorac cream during pregnancy; therefore, tazorac cream should be discontinued as soon as pregnancy is re