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

bora pharmaceutical laboratories inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: - the use of propafenone hydrochloride extended-release capsules in patients with permanent af or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (psvt) has not been evaluated. do not use propafenone hydrochloride extended-release capsules to control ventricular rate during af. - some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional atrioventricular (av) nodal refractory period is recommended. - the effect of propafenone on mortality has not been determined [see boxed warning] . propafenone hydrochloride extended-release capsules are contraindicated in the following circumstances: - heart failure - cardiogenic shock - sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, av block) in the absence of an artificial pacemaker - known brugada syndrome - bradycardia - marked hypotension - bronchospastic disorders or severe obstructive pulmonary disease - marked electrolyte imbalance risk summary in the absence of studies in pregnant women, available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)]. data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, propafenone hydrochloride may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in followup visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)]. the safety and effectiveness of propafenone in pediatric patients have not been established. of the total number of subjects in phase 3 clinical trials of propafenone hydrochloride extended-release capsules 46% were 65 and older, while 16% were 75 and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals at higher doses cannot be ruled out. the effect of age on the pharmacokinetics and pharmacodynamics of propafenone has not been studied.

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

arrotex pharmaceuticals pty ltd - eplerenone, quantity: 25 mg - tablet, film coated - excipient ingredients: titanium dioxide; hypromellose; croscarmellose sodium; magnesium stearate; iron oxide yellow; microcrystalline cellulose; iron oxide red; purified talc; lactose monohydrate; macrogol 6000 - eplerenone is indicated to reduce the risk of: - cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3?14 days of an acute myocardial infarction (see clinical trials and dosage and administration). - cardiovascular mortality and morbidity in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef ? 30% or lvef ? 35% in addition to qrs duration of > 130 msec), in addition to standard optimal therapy (see clinical trials).

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

arrotex pharmaceuticals pty ltd - eplerenone, quantity: 50 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; iron oxide yellow; titanium dioxide; lactose monohydrate; macrogol 6000; hypromellose; purified talc; magnesium stearate; iron oxide red - eplerenone is indicated to reduce the risk of: - cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3?14 days of an acute myocardial infarction (see clinical trials and dosage and administration). - cardiovascular mortality and morbidity in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef ? 30% or lvef ? 35% in addition to qrs duration of > 130 msec), in addition to standard optimal therapy (see clinical trials).

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

physicians total care, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - in patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of as with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional av refractory period is recommended. the use of propafenone hcl in patients with chronic atrial fibrillation has not been evaluated. propafenone hcl should not be used to control ventricular rate during atrial fibrillation. propafenone hcl is also indicated for the treatment of initiation of propafenone hcl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital. propafenone hcl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias. propafenone hcl is contraindicated in the presence of uncontrolled congestive heart failure, cardiogenic shock, s

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

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone and ethinyl estradiol tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal

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

sandoz inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated for use by females of reproductive potential to prevent pregnancy. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium on the breast-fed infant. chcs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for safyral and any potential adverse effects on the breast-fed child from drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium or from the underlying maternal condition. an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416 mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16-week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in postmenopausal women and is not indicated in this population. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50–79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30–49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium-sparing drugs [see clinical pharmacology (12.3)] . drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4)] . the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3)] .

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

zo skin health, inc. - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone 0.04 g in 1 g - for the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. the safety of topical hydroquinone use during pregnancy or in children (21 years and under) has not been established.

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

preferred pharmaceuticals inc. - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone 4% cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. the safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established. safety and effectiveness for pediatric patients below the age of 12 years have not been established.

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

twi pharmaceuticals, inc. - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone usp, 4% time release cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration (such as chloasma, melasma, freckles, and senile lentigines) resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma. prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. the safety of topical hydroquinone use during pregnancy or on children (12 years and under) has not been established.

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

acella pharmaceuticals, llc - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone 4% cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. the safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established. safety and effectiveness for pediatric patients below the age of 12 years have not been established.