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rpk pharmaceuticals, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - extended phenytoin sodium capsules, usp are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. extended phenytoin sodium capsules are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as extended phenytoin sodium capsules, during pregnancy. physicians are advised to recommend that pr

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

pd-rx pharmaceuticals, inc. - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with: - hypersensitivity to benzodiazepines or to any components of the formulation - acute narrow-angle glaucoma. controlled substance lorazepam tablets contain lorazepam, a schedule iv controlled substance. abuse lorazepam tablets are a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). dependence physical dependence lorazepam tablets may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions) . to reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of lorazepam tablets and warnings) . acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to lorazepam tablets may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of lorazepam tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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nucare pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride tablets are useful for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angiodema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of postoperative pain. sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hydrochloride tablets are contraindicated for use in pediat

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preferred pharmaceuticals, inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - hypertension metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. angina pectoris metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. myocardial infarction metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event( see dosage and administration, contraindications, and warnings) . hypertension and angina metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity to metoprolol and related

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

preferred pharmaceuticals inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 50 mg - hypertension metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. angina pectoris metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. myocardial infarction metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event( see dosage and administration, contraindications, and warnings) . hypertension and angina metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity to metoprolol and related

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

aidarex pharmaceuticals llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 50 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficac

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

preferred pharmaceuticals inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

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

nucare pharmaceuticals, inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - hypertension metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. angina pectoris metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. myocardial infarction metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event ( see dosage and administration, contraindications, and warnings) . hypertension and angina metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity to metoprolol and relate

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

nucare pharmaceuticals, inc. - losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - losartan potassium 50 mg - losartan potassium tablets usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents, including diuretics. hypertensive patients with left ventricular hypertrophy losartan potassium tablets usp are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients. (see precautions, race and clinical pharmacology, pharmacodynamics and clinical effects, reduction in the risk of stroke, race.) losartan potassium tablets usp are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. in this population, losartan potassium tablets usp are reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end st

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

nucare pharmaceuticals, inc. - losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - losartan potassium 50 mg - losartan potassium tablets usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents, including diuretics. hypertensive patients with left ventricular hypertrophy losartan potassium tablets usp are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients. (see precautions, race and clinical pharmacology, pharmacodynamics and clinical effects, reduction in the risk of stroke, race.) losartan potassium tablets usp are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. in this population, losartan potassium tablets usp are reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for di