Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - amitriptyline hydrochloride - oral tablet - 25mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

arrow generics ltd - amitriptyline hydrochloride - oral tablet - 25mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - amitriptyline hydrochloride - oral tablet - 25mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - amitriptyline hydrochloride - oral tablet - 25mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - venlafaxine hydrochloride - modified-release capsule - 225mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

genesis pharmaceuticals ltd - amitriptyline hydrochloride - oral tablet - 25mg

Verenigde Staten - Engels - NLM (National Library of Medicine)

a-s medication solutions - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (sr) are indicated as an aid to smoking cessation treatment. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see warnings and precautions (5.3)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see warnings and precautions (5.3), drug interactions (7.3)] . - the use of maois (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (sr) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (sr) is contraindicated. there is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (sr) are used concomitantly with maois. the use of bupropion hydrochloride extended-release tablets (sr) within 14 days of discontinuing treatment with an maoi is also contraindicated. starting bupropion hydrochloride extended-release tablets (sr) in a patient treated with reversible maois such as linezolid or intravenous methylene blue is contraindicated [see dosage and administration (2.8), warnings and precautions (5.4), drug interactions (7.6)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (sr). anaphylactoid/anaphylactic reactions and stevens-johnson syndrome have been reported [see warnings and precautions (5.8)] . risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. bupropion hydrochloride extended-release tablets (sr) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical considerations pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before pharmacological approaches are used. data human data: data from the international bupropion pregnancy registry (675 first trimester exposures) and a retrospective cohort study using the united healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. no increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. the prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international pregnancy registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). data from the united healthcare database and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) from the national birth defects prevention study (nbdps) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (lvoto) are inconsistent and do not allow conclusions regarding a possible association. the united healthcare database lacked sufficient power to evaluate this association; the nbdps found increased risk for lvoto (n = 10; adjusted or = 2.6; 95% ci: 1.2, 5.7), and the slone epidemiology case control study did not find increased risk for lvoto. study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (vsd) are inconsistent and do not allow conclusions regarding a possible association. the slone epidemiology study found an increased risk for vsd following first trimester maternal bupropion exposure (n = 17; adjusted or = 2.5; 95% ci: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including lvoto as above). the nbdps and united healthcare database study did not find an association between first trimester maternal bupropion exposure and vsd. for the findings of lvoto and vsd, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies. an imal data: in studies conducted in rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg per kg per day, respectively (approximately 15 and 10 times the mrhd respectively, on a mg per m2 basis). no clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg per kg per day, approximately 2 times the mrhd on a mg per m2 basis) and greater. decreased fetal weights were observed at 50 mg per kg and greater. when rats were administered bupropion at oral doses of up to 300 mg per kg per day (approximately 10 times the mrhd on a mg per m2 basis) prior to mating and throughout pregnancy and lactation, there were no apparent adverse effects on offspring development. bupropion and its metabolites are present in human milk. in a lactation study of 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. the average daily infant exposure (assuming 150 ml per kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. exercise caution when bupropion hydrochloride extended-release tablets (sr) are administered to a nursing woman. safety and effectiveness in the pediatric population have not been established [see boxed warning, warnings and precautions (5.1)]. of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged greater than or equal to 65 years and 47 were aged greater than or equal to 75 years. in addition, several hundred subjects aged greater than or equal to 65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). no overall differences in safety or effectiveness were observed between these subjects and younger subjects. reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see dosage and administration (2.7), use in specific populations (8.6), clinical pharmacology (12.3)] . consider a reduced dose and/or dosing frequency of bupropion hydrochloride extended-release tablets (sr) in patients with renal impairment (glomerular filtration rate: less than 90 ml per min). bupropion and its metabolites are cleared renally and may accumulate in such patients to a greater extent than usual. monitor closely for adverse reactions that could indicate high bupropion or metabolite exposures [see dosage and administration (2.7), clinical pharmacology (12.3)] . in patients with moderate to severe hepatic impairment (child-pugh score: 7 to 15), the maximum dose of bupropion hydrochloride extended-release tablets (sr) is 150 mg every other day. in patients with mild hepatic impairment (child-pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see dosage and administration (2.6), clinical pharmacology (12.3)] . bupropion is not a controlled substance. humans controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, often typical of central stimulant activity. in a population of individuals experienced with drugs of abuse, a single oral dose of 400 mg of bupropion produced mild amphetamine-like activity as compared with placebo on the morphine-benzedrine subscale of the addiction research center inventories (arci) and a score greater than placebo but less than 15 mg of the schedule ii stimulant dextroamphetamine on the liking scale of the arci. these scales measure general feelings of euphoria and drug liking which are often associated with abuse potential. findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. nonetheless, evidence from single-dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or cns stimulant abusers. however, higher doses (which could not be tested because of the risk of seizure) might be modestly attractive to those who abuse cns stimulant drugs. bupropion hydrochloride extended-release tablets (sr) are intended for oral use only. the inhalation of crushed tablets or injection of dissolved bupropion has been reported. seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. an imals studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. in rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule-controlled behavior paradigms. in primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. in rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs. the possibility that bupropion may induce dependence should be kept in mind when evaluating the desirability of including the drug in smoking cessation programs of individual patients.

Verenigde Staten - Engels - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. a physician considering bupropion hydrochloride tablets for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). this incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. this relative risk is only an approximate estimate because no direct comparative studies have been conducted (see warnings ). the efficacy of bupropion hydrochloride tablets has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. the depressive disorder of the patients studied corresponds most closely to the major depression category of the apa diagnostic and statistical manual iii. major depression implies a prominent and relatively p

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

northstar healthcare unlimited company - amitriptyline hydrochloride - oral tablet - 25mg

Australië - Engels - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - imipramine hydrochloride, quantity: 25 mg - tablet, sugar coated - excipient ingredients: titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; sucrose; magnesium stearate; stearic acid; lactose monohydrate; hypromellose; maize starch; glycerol; povidone; iron oxide red; macrogol 8000; carnauba wax; purified talc; copovidone - major depression. nocturnal enuresis (from the age of 5 years onwards and provided the possibility of organic causes has first been excluded).