Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quinapril hydrochloride, quantity: 10.832 mg (equivalent: quinapril, qty 10 mg) - tablet, film coated - excipient ingredients: calcium sulfate dihydrate; magnesium stearate; magnesium carbonate hydrate; colloidal anhydrous silica; crospovidone; povidone; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - hypertension: quinapril hydrochloride tablets are indicated for the treatment of hypertension. it may be used alone or in combination with thiazide diuretics. sufficient data have not been provided to support the use of quinapril tablets in renovascular hypertension. congestive heart failure: quinapril hydrochloride tablets are indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quinapril hydrochloride, quantity: 5.416 mg (equivalent: quinapril, qty 5 mg) - tablet, film coated - excipient ingredients: magnesium stearate; magnesium carbonate hydrate; calcium sulfate dihydrate; povidone; crospovidone; colloidal anhydrous silica; titanium dioxide; xanthan gum; iron oxide yellow; purified talc; polyvinyl alcohol; lecithin - hypertension: quinapril hydrochloride tablets are indicated for the treatment of hypertension. it may be used alone or in combination with thiazide diuretics. sufficient data have not been provided to support the use of quinapril tablets in renovascular hypertension. congestive heart failure: quinapril hydrochloride tablets are indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

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

lake erie medical dba quality care products llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 150 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (see clinical trials ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessne

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

amneal pharmaceuticals llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hydrochloride (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 when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. a reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate hcl extended-release tablets on a mg/kg and mg/m2 basis, respectively. the approximate plasma exposure to methylphenidate plus its main metabolite ppaa in pregnant rats was 1 to 2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hcl extended-release tablets based on the auc. the safety of methylphenidate for use during human pregnancy has not been established. there are no adequate and well-controlled studies in pregnant women. methylphenidate hcl extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hcl extended-release tablets on labor and delivery in humans is unknown. it is not known whether methylphenidate is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised if methylphenidate hcl extended-release tablets are administered to a nursing woman. in lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. methylphenidate hcl extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. long-term effects of methylphenidate in children have not been well established. methylphenidate hcl extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate hydrochloride extended-release tablets contain methylphenidate a schedule ii controlled substance. methylphenidate hcl extended-release tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . methylphenidate hcl extended-release tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. 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. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hcl extended-release tablets, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hcl extended-release tablets were compared to single oral doses of immediate-release methylphenidate (ir mph) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. for the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. in one study (n=40), both methylphenidate hcl extended-release tablets (108 mg) and 60 mg ir mph compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. in comparisons between the two active treatments, however, methylphenidate hcl extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (abuse potential, drug liking, amphetamine and morphine benzedrine group [euphoria]) or statistically less than (stimulation – euphoria) responses produced by 60 mg ir mph. in another study (n=49), both doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) and both doses of ir mph (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (drug liking, euphoria). when doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hcl extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hcl extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by ir mph (50 mg). differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate extended-release tablets are available for immediate release from the drug overcoat [see system components and performance (11.1)] . although these findings reveal a relatively lower response to methylphenidate hcl extended-release tablets on subjective measures suggestive of abuse potential compared to ir mph at roughly equivalent total mph doses, the relevance of these findings to the abuse potential of methylphenidate hcl extended-release tablets in the community is unknown. physical dependence methylphenidate hcl extended-release tablets may produce physical dependence. 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. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hcl extended-release tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hcl extended-release tablets may produce tolerance. 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).

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

granules pharmaceuticals inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)]. • hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)]. • concomitant treatment with monoamine oxidase inhibitors (maois) or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy regist

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

lake erie medical dba quality care products llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.2 mg - clonidine hydrochloride tablets, usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see precautions).

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

wockhardt limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (see clinical trials ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessn

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

avkare - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin is contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia ( see warnings and precautions ). - known hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function ( see

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

nucare pharmaceuticals,inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride is indicated in the treatment of hypertension. clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

golden state medical supply, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride tablets, usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets, usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see precautions ).