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patriot pharmaceuticals, llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 100 mg - tramadol hcl extended-release tablets is 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. limitations 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 opioid formulations [see warnings and precautions (5.1)] , reserve tramadol hcl extended-release tablets 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 hcl extended-release tablets is not indicated as an as-needed (prn) analgesic. tramadol hcl extended-release tablets is contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.3)] - post-operative management in children younger than 1

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

patriot pharmaceuticals, llc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hcl extended-release tablets are 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)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hcl extended-release tablets. therefore, methylphenidate hcl extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . methylphenidate hcl extended-release tablets are contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits whe

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

patriot pharmaceuticals, llc - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20 mg in 1 ml - ketoconazole 2% shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by pityrosporum orbiculare (also known as malassezia furfur or m. orbiculare ). note: tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in normalization of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. ketoconazole 2% shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

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

patriot pharmaceuticals, llc - almotriptan malate (unii: pjp312605e) (almotriptan - unii:1o4xl5sn61) - almotriptan 6.25 mg

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patriot pharmaceuticals, llc - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. pregnancy category b. there are no adequate and well-controlled studies using oxybutynin chloride extended release tablets in pregnant wom

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patriot pharmaceuticals, llc - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine er is indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine er is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine er or galantamine tablets in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral doses of 2, 8, or 16

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

patriot pharmaceuticals, llc - paliperidone (unii: 838f01t721) (paliperidone - unii:838f01t721) - paliperidone 3 mg - paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see clinical studies (14.1)] . the efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see clinical studies (14.2)] . the efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults. paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients t

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

patriot pharmaceuticals llc - haloperidol (unii: j6292f8l3d) (haloperidol - unii:j6292f8l3d) - haloperidol 5 mg in 1 ml - haloperidol is indicated for the treatment of patients with schizophrenia. haloperidol is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies).

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

patriot pharmaceuticals llc - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol 50 mg in 1 ml - haloperidol decanoate 50 and haloperidol decanoate 100 are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haloperidol decanoate 50 and haloperidol decanoate 100 are attributed to haloperidol as the active medication, contraindications, warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. haloperidol is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or

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

patriot pharmaceuticals, llc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see clinical pharmacology: special populations, warnings, and adverse reactions: post-marketing experiencefor more information.) itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf except for the treatment of life-threatening or other serious infections. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole oral solution. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), er