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

par pharmaceutical, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophe

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

par pharmaceutical, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophe

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

par pharmaceutical, inc. - propylthiouracil (unii: 721m9407iy) (propylthiouracil - unii:721m9407iy) - propylthiouracil 50 mg - propylthiouracil is indicated: - in patients with graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option - to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

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

par pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use : patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. it has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. tolvaptan tablets are contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2) ] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5) ] - anuria - hypersensitivity (e.g., anap

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

par pharmaceutical, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets, usp are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares : colchicine tablets, usp are indicated for prophylaxis of gout flares. - treatment of gout flares : colchicine tablets, usp are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets, usp are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets, usp in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fe

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

par pharmaceutical, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares : colchicine tablets are indicated for prophylaxis of gout flares. colchicine tablets are indicated for prophylaxis of gout flares. - treatment of gout flares : colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in pregn

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

par pharmaceutical inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: - posaconazole delayed-release tablets : adults and pediatric patients 2 years of age and older who weigh greater than 40 kg - posaconazole oral suspension: adults and pediatric patients 13 years of age and older posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and o

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

teva pharmaceuticals usa, inc. - zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) - zinc cation 25 mg - zinc acetate therapy is indicated for maintenance treatment of patients with wilson’s disease who have been initially treated with a chelating agent (see precautions: monitoring patients). zinc acetate capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.

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par pharmaceutical, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy lamotrigine orally disintegrating tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine orally disintegrating tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine orally disintegrating tablets are indicated for the maintenance treatment of bipolar i dis

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

par pharmaceutical inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy. ( 1) none pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [mrhd] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the mrhd