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lake erie medical dba quality care products llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)] none.  pregnancy category d.[see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregn

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

lake erie medical dba quality care products llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 5 mg - aripiprazole oral tablets are indicated for the treatment of: - schizophrenia[see clinical studies (14.1)] - acute treatment of manic and mixed episodes associated with bipolar i disorder[see clinical studies (14.2)] pediatric use information is approved for otsuka america pharmaceutical, inc.'s aripiprazole product. however, due to otsuka america pharmaceutical, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is 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) ]. 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/pregnancyregistr

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

lake erie medical dba quality care products llc - 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 marrow depression, hype

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

lake erie medical dba quality care products llc - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 160 mg - valsartan tablets 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 the class to which valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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,

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

quality care products, llc - diclofenac epolamine (unii: x5f8ekl9zg) (diclofenac - unii:144o8ql0l1) - diclofenac epolamine 180 mg in 14 g - flector® patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. flector patch is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] - flector patch is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. risk summary published literature reports that use of nsaids, including flector patch, after 30 weeks' gestation increases the risk of premature closu

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

lake erie medical dba quality care products llc - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 8 mg - buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. under the drug addiction treatment act (data) codified at 21 u.s.c. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the secretary of health and human services (hhs) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. buprenorphine sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported. [see warnings and precautions (5.8)]. pregnancy category c risk summary there are no adequate

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

quality care products, llc - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - buprenorphine 8 mg - suboxone sublingual film is indicated for treatment of opioid dependence . suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. suboxone sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9)] . risk summary the data on use of buprenorphine, one of the active ingredients in suboxone sublingual film, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data]. observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but were also not designed appropriately

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

lake erie medical & surgical supply dba quality care products llc - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon 10 mg - zaleplon is indicated for the short-term treatment of insomnia. zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials   under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. hypersensitivity to zaleplon or any excipients in the formulation (see also precautions). zaleplon is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt ces

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

lake erie medical dba quality care products llc - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 2 mg - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. under the drug addiction treatment act (data) codified at 21 u.s.c. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the secretary of health and human services (hhs) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. buprenorphine sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported. [see warnings and precautions (5.7)] teratogenic effects pregnancy category c risk summary : the

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

lake erie medical dba quality care products llc - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate 5 mg - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival tri