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

safecor health, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)] . quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)] . quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week mo

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

safecor health, llc - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules, usp are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy.   omeprazole delayed-release capsules, usp, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults.   omeprazole delayed-release capsules, usp, in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults.   eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [seeclinical studies (14.1) and dosage and administration (2)].   among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared w

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

safecor health, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole oral tablets are indicated for the treatment of: additional pediatric use information is approved for otsuka america pharmaceutical, inc.'s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . teratogenic effects pregnancy category c pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (including aripiprazole) during the third trim

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

safecor health, llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - postherpetic neuralgia gabapentin capsules, usp are indicated for the management of postherpetic neuralgia in adults. epilepsy gabapentin capsules, usp are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin capsules, usp are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. controlled substance gabapentin is not a scheduled drug. abuse gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. a small number of postmarketing cases report gabapentin misuse and abuse. these individuals were taking higher than recommended doses of gabapentin for unapproved uses. most of the individuals described in these reports had a

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

safecor health, llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 20 mg in 1 ml - oxycodone hydrochloride oral solution 100 mg/5 ml (20 mg/ml ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution 100 mg/5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride is contraindicated in patients with known

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

safecor health, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg in 1 ml - morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has

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

safecor health, llc - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 20 mg - citalopram tablets, usp are indicated for the treatment of depression. the efficacy of citalopram tablets, usp in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. the antidepressant action of citalopram tablets, usp in hospitalized depressed patients has not been adequately

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

safecor health, llc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with coronary heart disease (chd) or at high risk of chd, simvastatin tablets, usp can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, usp are indicated to:  simvastatin tablets, usp are indicated to: simvastatin tablets, usp are indicated as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with hefh, if after an adequat

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

safecor health, llc - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see dosage and administration , contraindications , and warnings ). alternatively, treatment can begin within 3 to 10 days of the acute event (see dosage and administration ). 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 derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cr

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

safecor health, llc - prednisone (unii: vb0r961hzt) (prednisone - unii:vb0r961hzt) - prednisone 20 mg - prednisone tablets, usp are indicated in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) congenital adrenal hyperplasia nonsuppurative thyroiditis 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic derznatomyositis