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

ingenus pharmaceuticals, llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation). diclofenac potassium tablets are indicated: - for treatment of primary dysmenorrhea - for relief of mild to moderate pain - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac potassium tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings; anaphylactic reactions, serious skin reactions). - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have bee

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

ingenus pharmaceuticals, llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation). diclofenac sodium extended-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis diclofenac sodium extended-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see warnings; anaphylactic reactions, serious skin reactions). - history of asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such pat

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

ingenus pharmaceuticals, llc - dofetilide (unii: r4z9x1n2nd) (dofetilide - unii:r4z9x1n2nd) - maintenance of normal sinus rhythm (delay in af/afl recurrence) dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [af/afl]) in patients with atrial fibrillation/atrial flutter of greater than one-week duration who have been converted to normal sinus rhythm. because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. in general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. recurrence is expected in some patients (see clinical studies ). conversion of atrial fibrillation/flutter dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation. dofetilide is contraindicated in pati

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

ingenus pharmaceuticals, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets usp, 5 mg and 10 mg are indicated for: - narcolepsy - attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group

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

ingenus pharmaceuticals, llc - desipramine hydrochloride (unii: 1y58do4my1) (desipramine - unii:tg537d343b) - desipramine hydrochloride 10 mg - desipramine hydrochloride tablets, usp is indicated for the treatment of depression. the use of maois intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of desipramine hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration). starting desipramine hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration). desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. it should not be used in those who have shown prior hypersensitivity to the drug. cross-sensitivity between this and other dibenzazepines is a possibility.

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

ingenus pharmaceuticals, llc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modaf

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

ingenus pharmaceuticals, llc - quinine sulfate (unii: kf7z0e0q2b) (quinine - unii:a7v27phc7a) - quinine sulfate 324 mg - quinine sulfate capsules, usp is an antimalarial drug indicated only for treatment of uncomplicated plasmodium falciparum malaria. quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see clinical studies (14)].   limitations of use: quinine sulfate is not approved for: - treatment of severe or complicated p. falciparum malaria. - prevention of malaria. - treatment or prevention of nocturnal leg cramps [see warnings and precautions (5.1)]. quinine sulfate is contraindicated in patients with the following: - prolonged qt interval. one case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged qt interval at baseline, who received quinine sulfate intravenously for p. falciparum malaria [see warnings and precautions (5.4) ]. - known hypersensitivity reactions to quinine. these include, but are not limited to, the following [see warnings and precautions (5.

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

ingenus pharmaceuticals, llc - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. triazolam is contraindicated in: - patients with known hypersensitivity to triazolam, any of component of triazolam tablets, or other benzodiazepines. reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. - concomitant administration of strong cytochrome p450 (cyp 3a) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [ see warnings and precautions ( 5.8 ), drug interactions (7.1) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. risk

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

ingenus pharmaceuticals, llc - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: - nausea and vomiting associated with motion sickness. - post-operative nausea and vomiting (ponv) associated with recovery from anesthesia and/or opiate analgesia and surgery. scopolamine transdermal system is contraindicated in patients with: - angle closure glaucoma [see warnings and precautions (5.1)]. - hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. reactions have included rash generalized and erythema [see adverse reactions (6.2), description (11)] . risk summary available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see dat

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

ingenus pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin 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 fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1) ] risk summary use of nsaids, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of pre