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teva pharmaceuticals usa, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - cyclosporine capsules usp modified are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. cyclosporine capsules usp modified have been used in combination with azathioprine and corticosteroids. cyclosporine capsules usp modified are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. cyclosporine capsules usp modified can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. cyclosporine capsules usp modified are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., puva, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. while rebound rarely occurs, most patients will experience relapse with cyclosporine capsules usp modified as with other therapies upon cessation of treatment. cyclosporine capsules usp modified are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules usp modified. psoriasis patients who are treated with cyclosporine capsules usp modified should not receive concomitant puva or uvb therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules usp modified.

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

mylan pharmaceuticals inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology (12.3) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data ]. at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by increased pre-

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

kvk-tech, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcl) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. no evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. these doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose. an oral dose of 45 mg/kg/day cyclosporine administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. this dose is 7,000 times greater than the daily recommended human dose. no adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose). risk summary cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion [see clinical pharmacology ( 12.3 )] , caution should be exercised when cyclosporine ophthalmic emulsion is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cyclosporine ophthalmic emulsion  and any potential adverse effects on the breast-fed child from cyclosporine. safety and efficacy have not been established in pediatric patients below the age of 16. no overall difference in safety or effectiveness has been observed between elderly and younger patients.

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

apotex corp - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcl) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. no evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. these doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose. an oral dose of 45 mg/kg/day cyclosporine administered to rats from day 15 of pregnancy until day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. this dose is 7,000 times greater than the daily recommended human dose. no adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose). risk summary cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion [see clinical pharmacology ( 12.3 )] , caution should be exercised when cyclosporine ophthalmic emulsion is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cyclosporine ophthalmic emulsion  and any potential adverse effects on the breast-fed child from cyclosporine. safety and efficacy have not been established in pediatric patients below the age of 16. no overall difference in safety or effectiveness has been observed between elderly and younger patients.

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

lupin pharmaceuticals, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. cyclosporine ophthalmic emulsion, 0.05% is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion, 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp

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

a-s medication solutions - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 0.5 mg in 1 ml - restasis ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. restasis ® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see  data ]. data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (usp) was teratogenic as indicated by i

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

eon labs, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - cyclosporine capsules usp (modified) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. cyclosporine capsules usp (modified) have been used in combination with azathioprine and corticosteroids. cyclosporine capsules usp (modified) are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. cyclosporine capsules usp (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. cyclosporine capsules usp (modified) are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., puva, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. while rebound rarely occurs, most patie

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

physicians total care, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 100 mg - cyclosporine capsules, usp are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. it is always to be used with adrenal corticosteroids. the drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.    cyclosporine capsules are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.

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

padagis us llc - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 50 mg in 1 ml - cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. it is always to be used with adrenal corticosteroids. the drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. because of the risk of anaphylaxis, cyclosporine injection should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. cyclosporine injection is contraindicated in patients with a hypersensitivity to cyclosporine and/or cremophor® el (polyoxyethylated castor oil).

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

american health packaging - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - cyclosporine capsules, usp (non-modified) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. it is always to be used with adrenal corticosteroids. the drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. cyclosporine capsules are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.