Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets usp are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.1) ] none. [see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

celgene corporation - thalidomide (unii: 4z8r6ors6l) (thalidomide - unii:4z8r6ors6l) - thalidomide 50 mg - thalomid in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (mm) [see clinical studies (14.1)] . thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence [see clinical studies (14.2)]. thalomid is contraindicated in females who are pregnant. thalomid can cause fetal harm when administered to a pregnant female [see boxed warning, warnings and precautions (5.1) and use in specific populations (8.1)] . thalomid is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see boxed warning] . mortality at or shortly after birth has been reported in about 40% of infants.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules, usp are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies ( 14.1)]. - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies ( 14.2)]. - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies ( 14.3)]. - acute treatment of panic disorder, with or without agoraphobia [see clinical studies ( 14.4)]. fluoxetine capsules, usp and olanzapine in combination is indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. - treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - prevacid and prevacid solutab are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: prevacid or prevacid solutab/amoxicillin/clarithromycin prevacid or prevacid solutab in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: prevacid or prevacid solutab/amoxicillin prevacid or prevacid solutab in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (ac

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

contract pharmacy services-pa - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies (14.1)] . -  acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies (14.2)] . -  acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies (14.3)] . - acute treatment of panic disorder, with or without agoraphobia [see clinical studies (14.4)] . fluoxetine capsules and olanzapine in combination are indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associate

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy actos is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use actos exerts its antihyperglycemic effect only in the presence of endogenous insulin. actos should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . risk summary limited data with actos in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5- and 35-times the 45 mg

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - mobic is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. mobic is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. mobic is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [ see dosage and administration ( 2.4) and clinical studies ( 14.2) ]. mobic is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 15 mg - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [ see dosage and administration ( 2.4) and clinical studies ( 14.2) ]. meloxicam tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reac

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)].   risk summar y tamsulosin hydrochloride is not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data].  in the u.s. general population, the estim

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 50 mg - celecoxib is indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ]. for the management of the signs and symptoms of ra [see clinical studies (14.2) ]. for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ]. for the management of the signs and symptoms of as [see clinical studies (14.4) ]. for the management of acute pain in adults [see clinical studies (14.5) ]. for the management of primary dysmenorrhea [see clinical studies (14.5) ]. celecoxib is contraindicated in the following patients: ·               known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions)to celecoxib, any components of the drug product [see warnings and precautions (5.7,   5.9) ]. ·               history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other   nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids, have been        reported in such patients [see warnings and pr