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remedyrepack inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . levetiracetam blood levels may decrease during pregnancy [see warnings and precautions ( 5.10)].   pregnancy category c there are no adequate and controlled studies in pregnant wome

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amneal pharmaceuticals llc - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: -    brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. -    multiple myeloma in combination with prednisone. -    relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. -    relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic i

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zydus lifesciences limited - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca's crestor (rosuvastatin calcium) tablets. however, due to astrazeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium is contraindicated in the following conditions: -   patients with a known hypersensitivity to any component of th

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sanofi pasteur inc. - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen (unii: flv5i5w26r) (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen - unii:flv5i5w26r) - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - acthib® is a vaccine indicated for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. acthib is approved for use in children 2 months through 5 years of age. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of acthib vaccine [see description (11)] . acthib is not approved for use in individuals 6 years of age and older. no human or animal data are available to assess vaccine-associated risks in pregnancy. acthib is not approved for use in individuals 6 years of age and older. human or animal data are not available to assess the impact of acthib on milk production, its presence in breast milk, or its effects on the breastfed infant. safety and effectiveness of acthib have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see dosage and administration (2.1)] .

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cardinal health - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam 1 mg - lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma.

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west-ward pharmaceutical corp - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone 250 mg - primidone tablets, usp used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: - patients with porphyria and - patients who are hypersensitive to phenobarbital (see clinical pharmacology ).

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kaiser foundation hospitals - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg - metronidazole tablets usp are indicated for the treatment of t. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). metronidazole tablets usp are indicated in the treatment of asymptomatic t. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.  since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. t. vaginalis infection is a venereal disease. therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. in ma

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boiron - colchicum autumnale bulb (unii: 993qhl78e6) (colchicum autumnale bulb - unii:993qhl78e6) - indigestion with nausea, sensitivity to odors* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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deseret biologicals, inc. - anaplasma phagocytophilum (unii: bhe5668847) (anaplasma phagocytophilum - unii:bhe5668847), babesia microti (unii: 1948x6keg3) (babesia microti - unii:1948x6keg3), bartonella henselae (unii: 84pg7w9845) (bartonella henselae - unii:84pg7w9845), borrelia burgdorferi (unii: 0j8nv9v5q8) (borrelia burgdorferi - unii:0j8nv9v5q8), ehrlichia canis (unii: 970y8t1jzy) (ehrlichia canis - unii:970y8t1jzy), japanese encephalitis virus (unii: p07e7xwu9d) (japanese encephalitis virus - unii:p07e7xwu9d), mycoplasma p - for the temporarily relief of symptoms related to lyme disease or other co-infections including joint pain, severe headaches, fever, severe muscle aches/pain, flu-like feelings of headache, stiff neck, muscle aches, and change in smell/taste, difficulty chewing, swallowing or speaking, hoarseness of vocal cord problems.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. for the temporarily relief of symptoms related to lyme disease or other co-infections including joint pain, severe headaches, fever, severe muscle aches/pain, flu-like feelings of headache, stiff neck, muscle aches, and change in smell/taste, difficulty chewing, swallowing or speaking, hoarseness of vocal cord problems.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.

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hf acquisition co llc, dba healthfirst - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - 1.1 hypertension nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.6)]. 4.1 advanced aortic stenosis do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. 8.1 pregnancy pregnancy category c. there are no adequate and well-controlled studies of nicardipine use in pregnant women. there are limited human data in pregnant women with pre-eclampsia and preterm labor. in animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproduction stud