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allergan, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.1 mg in 1 ml - lumigan ®   (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. lumigan ®   0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ] . risk summary there are no adequate and well-controlled studies of lumigan ®   (bimatoprost ophthalmic solution) 0.01% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal developmental studies, administration of bimatoprost to pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure to bimatoprost 0.03% dosed bilaterally once daily (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the huma

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

allergan, inc. - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg), prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - gentamicin 3 mg in 1 g - pred-g ® ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye pathogens: staphyl

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

allergan, inc. - gentamicin (unii: t6z9v48ikg) (gentamicin - unii:t6z9v48ikg), prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - gentamicin 3 mg in 1 ml - pred-g ® suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular anti-infective drug in this product is active against the following common bacterial eye pathogens: staphylococcus aur

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

allergan, inc. - eflornithine hydrochloride (unii: 4nh22ndw9h) (eflornithine - unii:zqn1g5v6sr) - eflornithine hydrochloride anhydrous 139 mg in 1 g - vaniqa ®   (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women. vaniqa ® has only been studied on the face and adjacent involved areas under the chin of affected individuals. usage should be limited to these areas of involvement. vaniqa ® is contraindicated in patients with a history of sensitivity to any components of the preparation.

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allergan, inc. - levobunolol hydrochloride (unii: o90s49ldhh) (levobunolol - unii:g6317aoi7k) - levobunolol hydrochloride 5 mg in 1 ml - betagan ® ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension. betagan ® ophthalmic solution is contraindicated in those individuals with bronchial asthma, or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see warnings); sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure (see warnings); cardiogenic shock; or hypersensitivity to any component of these products.

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allergan, inc. - 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 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 restasis ® ophthalmic emulsion [see clinical pharmacology ( 12.3 )] , caution should be exercised when restasis ® is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for restasis ®   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)

allergan, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - restasis  multidose tm   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  multidose tm is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see adverse reactions (6.2) ]. 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),

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

allergan, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5), prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - blephamide ® ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular antibacterial drug in this product is active against the following common bacterial eye pathog

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

allergan, inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dapsone 50 mg in 1 g - aczone ® gel, 5%, is indicated for the topical treatment of acne vulgaris. none. risk summary there are no available data on aczone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 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

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

allergan, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5), prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - blephamide ®   ophthalmic suspension is a steroid/anti-infective combination drug indicated for steroid- responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. the particular antibacterial drug in this product is active ag