United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cequa ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1) none. (4) risk summary there are no adequate and well-controlled studies of cequa administration in pregnant women to inform a drug-associated risk. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data]. data animal data oral administration of cyclosporine oral solution (usp) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (mrhod) of 1.5 mcg/kg/day, respectively. no adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine duri

United States - English - NLM (National Library of Medicine)

harrow eye, llc - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - vevye is indicated for the treatment of the signs and symptoms of dry eye disease. none. risk summary there are no adequate and well-controlled studies of vevye administration in pregnant women to inform a drug-associated risk. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses. vevye doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration. data animal data oral administration of cyclosporine oral solution to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body weight) were approximately 7,250 and 48,000 times higher than the daily maximum recommended human ophthalmic dose (mrhod) of 0.67 mcg/kg/day, respectively. no adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 4,100 and 14,500 times higher than the mrhod, respectively). an oral dose of 45 mg/kg/day cyclosporine (approximately 10,900 times higher than mrhod) administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. no adverse effects in mothers or offspring were observed at oral doses of up to 15 mg/kg/day (3600 times greater than mrhod). risk summary cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. vevye doses are approximately 4,700 times lower than recommended oral doses of cyclosporine, with blood concentrations being undetectable after topical administration. however, caution should be exercised when vevye is administered to a nursing woman. safety and effectiveness in pediatric patients below the age of 18 years have not been established. no overall difference in safety or effectiveness has been observed between elderly and younger patients.

United States - English - NLM (National Library of Medicine)

dechra veterinary products llc - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - sporimune is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. sporimune is contraindicated for use in dogs with a history of neoplasia. do not use in dogs with a hypersensitivity to cyclosporine.

Canada - English - Health Canada

abbvie corporation - cyclosporine - emulsion - 0.05% - cyclosporine 0.05% - anti-inflammatory agents, miscellaneous

Canada - English - Health Canada

santen incorporated - cyclosporine - emulsion - 0.1% - cyclosporine 0.1% - anti-inflammatory agents, miscellaneous

Canada - English - Health Canada

novartis pharmaceuticals canada inc - cyclosporine - solution - 50mg - cyclosporine 50mg - immunosuppressive agents

Canada - English - Health Canada

novartis pharmaceuticals canada inc - cyclosporine - capsule - 100mg - cyclosporine 100mg - immunosuppressive agents

Canada - English - Health Canada

novartis pharmaceuticals canada inc - cyclosporine - solution - 100mg - cyclosporine 100mg - immunosuppressive agents

Canada - English - Health Canada

novartis pharmaceuticals canada inc - cyclosporine - capsule - 25mg - cyclosporine 25mg - immunosuppressive agents

Canada - English - Health Canada

novartis pharmaceuticals canada inc - cyclosporine - capsule - 50mg - cyclosporine 50mg - immunosuppressive agents