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mylan pharmaceuticals inc. - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - prasugrel 5 mg - prasugrel tablets are indicated to reduce the rate of thrombotic cv events (including stent thrombosis) in patients with acute coronary syndrome (acs) who are to be managed with percutaneous coronary intervention (pci) as follows: prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (mi), or nonfatal stroke compared to clopidogrel. the difference between treatments was driven predominantly by mi, with no difference on strokes and little difference on cv death [see clinical studies (14)] . prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ich) [see warnings and precautions (5.1) and adverse reactions (6.1)] . prasugrel tablets are contraindicated in patients with a history of prior transient ischemic attack (tia) or stroke. in triton-timi 38 (tr ial to assess i mprovement in t herapeutic outcomes by o ptimizing platelet inhibition with prasugrel), patients with a history of tia or ischemic stroke (> 3 months prior to enrollment) had a higher rate of stroke on prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ich]) than on clopidogrel (1.2%; all thrombotic). in patients without such a history, the incidence of stroke was 0.9% (0.2% ich) and 1.0% (0.3% ich) with prasugrel tablets and clopidogrel, respectively. patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from triton-timi 38. patients who experience a stroke or tia while on prasugrel tablets generally should have therapy discontinued [see adverse reactions (6.1) and clinical studies (14)] . prasugrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see adverse reactions (6.2)] . there are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. no structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see data] . due to the mechanism of action of prasugrel tablets, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel tablets and possible risks to the fetus when prescribing prasugrel tablets to a pregnant woman [see boxed warning and warnings and precautions (5.1, 5.3)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. in embryo-fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. a slight decrease in fetal body weight was observed, but there were no structural malformations in either species. in prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure. there is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. metabolites of prasugrel were found in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prasugrel tablets and any potential adverse effects on the breastfed child from prasugrel tablets or from the underlying maternal condition. following a 5 mg/kg oral dose of [14 c]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood. safety and effectiveness in pediatric patients have not been established. in a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met. in triton-timi 38, 38.5% of patients were ≥ 65 years of age and 13.2% were ≥ 75 years of age. the risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (prasugrel tablets compared with clopidogrel) was similar across age groups. patients ≥ 75 years of age who received prasugrel tablets 10 mg had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). in patients ≥ 75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received prasugrel tablets and in 3 patients (0.3%) who received clopidogrel. because of the risk of bleeding, and because effectiveness is uncertain in patients ≥ 75 years of age [see clinical studies (14)] , use of prasugrel tablets is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where their effect appears to be greater and their use may be considered [see warnings and precautions (5.1), clinical pharmacology (12.3), and clinical studies (14)] . in triton-timi 38, 4.6% of patients treated with prasugrel tablets had body weight < 60 kg. individuals with body weight < 60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see dosage and administration (2), warnings and precautions (5.1), and clinical pharmacology (12.3)] . consider lowering the maintenance dose to 5 mg in patients < 60 kg. the effectiveness and safety of the 5 mg dose have not been prospectively studied [see dosage and administration (2) and clinical pharmacology (12.3)] . no dosage adjustment is necessary for patients with renal impairment. there is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see warnings and precautions (5.1) and clinical pharmacology (12.3)] . no dosage adjustment is necessary in patients with mild to moderate hepatic impairment (child-pugh class a and b). the pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see warnings and precautions (5.1) and clinical pharmacology (12.3)] . in healthy subjects, patients with stable atherosclerosis, and patients with acs receiving prasugrel, there was no relevant effect of genetic variation in cyp2b6, cyp2c9, cyp2c19, or cyp3a5 on the pharmacokinetics of prasugrel’s active metabolite or its inhibition of platelet aggregation.

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preferred pharmaceuticals inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - • clopidogrel is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. • clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel is indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersens

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mylan pharmaceuticals inc. - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - amnesteem is indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . in addition, amnesteem is indicated only for those patients who are not pregnant, because amnesteem can cause life threatening birth defects (see boxed contraindications and warnings). a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off amn

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pd-rx pharmaceuticals, inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 200 mg - carbamazepine is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marro

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taro pharmaceuticals u.s.a., inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 100 mg - carbamazepine is indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine (see precautions, general). carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. beneficial results have also been reported in glossopharyngeal neuralgia. this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. likewise, on theoretical grounds its use with monoamine oxidase (mao) inhibitors is not recommended. before administration of carbamazepine, mao inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. coadministration of carbamazepine with nefazodone is contraindicated. no evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

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doctors foster and smith - chlorhexidine (unii: r4ko0dy52l) (chlorhexidine - unii:r4ko0dy52l) - chlorhexidine 0.24 g in 24 g

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camber pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmaco

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pd-rx pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 5 mg - amlodipine and benazepril hydrochloride capsules, usp are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - do not coadminister aliskiren with angiotensin receptor blockers (arbs), ace inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes. - amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema, with or without previous ace inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ace inhibitor, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan

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doctors foster and smith - iodoform (unii: kxi2j76489) (iodoform - unii:kxi2j76489) - iodoform 1.4 g in 28 g - drs. foster and smith ear powder gives prompt relief from irritated, itching ears of non-parasitic origin. it stops scratching and aids in the inhibition of bacterial growth. eliminates unpleasant ear odors. drs. foster and smith ear powder dries ear discharge and makes it easy to remove. for topical use within the ears. for dogs and cats.

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nucare pharmaceuticals,inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be