Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole is indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (includi

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 54 mg - methylphenidate hydrochloride extended-release tablets usp is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] . a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; lo

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see clinical studies (14)] . methylphenidate hydrochloride extended-release tablets are contraindicated in patients: - with a known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6.2)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), and also within 14 days following discontinuation of treatment with a maoi, because of the risk of hypertensive crisis [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, inclu

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 100 mg - tramadol hydrochloride extended-release capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. limitation of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions (5.1) ], reserve tramadol hydrochloride extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - tramadol hydrochloride extended-release capsules are not indicated as an as-needed (prn) analgesic. tramadol hydrochloride extended-release capsules are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 10 mg - aripiprazole orally disintegrating tablets, usp are indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information.  aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary   neonates exposed

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - 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 precauti

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - metoprolol tartrate 50 mg - metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension this fixed-combination drug is not indicated for initial therapy of hypertension. if the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components. metoprolol metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings). hypersensitivity to metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). sick-sinus syndrome. severe peripheral arterial circulatory disorders. hydrochlorothiazide hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs (see warnings).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - avo creamtm topical emulsion is indicated for use in: - full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers - superficial wounds - 1st and 2nd degree burns, including sunburns - dermal donor and graft site management - radiation dermatitis - minor abrasions avo creamtm topical emulsion is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known. avo creamtm topical emulsion is for topical use only as directed by a healthcare professional. wounds, abrasions, full thickness wounds, dermal graft site management and donor site management. - wash the affected area(s) with saline, clean water, or a suitable wound cleanser. - apply avo creamtm topical emulsion on and around the affected area(s) in thick layers 1/4 to 1/2 inch thick. - if applying gauze dressing, moisten the dressing lightly before application. - reapply avo creamtm topical emulsion as described above every 24 to 48 hours or as

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - chlorzoxazone (unii: h0de420u8g) (chlorzoxazone - unii:h0de420u8g) - chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. chlorzoxazone does not directly relax tense skeletal muscles in man. chlorzoxazone is contraindicated in patients with known intolerance to the drug.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

trigen laboratories, llc - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride 16 mg - hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see warnings and precautions (5.1 )] , reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immed