Īrija - angļu - HPRA (Health Products Regulatory Authority)

glenmark generics (europe) ltd - ropinirole hydrochloride - film coated tablet - 0.25 milligram

Īrija - angļu - HPRA (Health Products Regulatory Authority)

glenmark generics (europe) ltd - ropinirole hydrochloride - film coated tablet - 0.5 milligram

Īrija - angļu - HPRA (Health Products Regulatory Authority)

glenmark generics (europe) ltd - ropinirole hydrochloride - film coated tablet - 1 milligram

Īrija - angļu - HPRA (Health Products Regulatory Authority)

glenmark generics (europe) ltd - ropinirole hydrochloride - film coated tablet - 2 milligram

Īrija - angļu - HPRA (Health Products Regulatory Authority)

glenmark generics (europe) ltd - ropinirole - film coated tablet - 5 milligram

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 30 mg in 1 g - diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (ak). diclofenac sodium gel is contraindicated in the following patients: risk summary use of nsaids, including diclofenac sodium gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of diclofenac sodium gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium gel use at about 30 weeks of gestation and later in pregnancy. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. premature closure of fetal ductus arteriosus use of nsaids, including diclofenac sodium gel, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal d

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

glenmark therapeutics inc., usa - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . citalopram tablets are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.4) and clinical considerations] . available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 150 mg - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see adverse reactions (6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations]. published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skele

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic‑clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin capsules are indicated for: indomethacin capsules are contraindicated in the following patients: risk summary use of nsaids, including indomethacin capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of indomethacin capsules use between about 20 and 30 weeks of gestation, and avoid indomethacin capsules use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data ). premature closure of fetal ductus arteriosus use of nsaids, including indomethacin capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in animal reproduction studies retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.1 and 0.2 times, respectively, the maximum recommended human dose (mrhd, 200 mg). in published studies in pregnant mice, indomethacin produced maternal toxicity and death, increased fetal resorptions, and fetal malformations at 0.1 times the mrhd. when rat and mice dams were dosed during the last three days of gestation, indomethacin produced neuronal necrosis in the offspring at 0.1 and 0.05 times the mrhd, respectively [see data ]. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as indomethacin, resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is 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 fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including indomethacin capsules, can cause premature closure of the fetal ductus arteriosus (see data ). oligohydramnios/neonatal renal impairment if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if indomethacin capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue indomethacin capsules and follow up according to clinical practice (see data ). labor or delivery there are no studies on the effects of indomethacin capsules during labor or delivery. in animal studies, nsaids, including indomethacin, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data reproductive studies were conducted in mice and rats at dosages of 0.5, 1, 2, and 4 mg/kg/day. except for retarded fetal ossification at 4 mg/kg/day (0.1 times [mice] and 0.2 times [rats] the mrhd on a mg/m2 basis, respectively) considered secondary to the decreased average fetal weights, no increase in fetal malformations was observed as compared with control groups. other studies in mice reported in the literature using higher doses (5 to 15 mg/kg/day, 0.1 to 0.4 times mrhd on a mg/m2 basis) have described maternal toxicity and death, increased fetal resorptions, and fetal malformations. in rats and mice, maternal indomethacin administration of 4 mg/kg/day (0.2 times and 0.1 times the mrhd on a mg/m2 basis) during the last 3 days of gestation was associated with an increased incidence of neuronal necrosis in the diencephalon in the live-born fetuses however no increase in neuronal necrosis was observed at 2 mg/kg/day as compared to the control groups (0.1 times and 0.05 times the mrhd on a mg/m2 basis). administration of 0.5 or 4 mg/kg/day to offspring during the first 3 days of life did not cause an increase in neuronal necrosis at either dose level. risk summary based on available published clinical data, indomethacin may be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for indomethacin capsules and any potential adverse effects on the breastfed infant from the indomethacin capsules or from the underlying maternal condition. data in one study, levels of indomethacin in breast milk were below the sensitivity of the assay (<20 mcg/l) in 11 of 15 women using doses ranging from 75 mg orally to 300 mg rectally daily (0.94 to 4.29 mg/kg daily) in the postpartum period. based on these levels, the average concentration present in breast milk was estimated to be 0.27% of the maternal weight-adjusted dose. in another study indomethacin levels were measured in breast milk of eight postpartum women using doses of 75 mg daily and the results were used to calculate an estimated infant daily dose. the estimated infant dose of indomethacin from breast milk was less than 30 mcg/day or 4.5 mcg/kg/day assuming breast milk intake of 150 ml/kg/day. this is 0.5% of the maternal weight-adjusted dosage or about 3% of the neonatal dose for treatment of patent ductus arteriosus. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including indomethacin capsules, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including indomethacin capsules, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients 14 years of age and younger has not been established. indomethacin capsules should not be prescribed for pediatric patients 14 years of age and younger unless toxicity or lack of efficacy associated with other drugs warrants the risk. in experience with more than 900 pediatric patients reported in the literature or to the manufacturer who were treated with indomethacin capsules, side effects in pediatric patients were comparable to those reported in adults. experience in pediatric patients has been confined to the use of indomethacin capsules. if a decision is made to use indomethacin for pediatric patients two years of age or older, such patients should be monitored closely and periodic assessment of liver function is recommended. there have been cases of hepatotoxicity reported in pediatric patients with juvenile rheumatoid arthritis, including fatalities. if indomethacin treatment is instituted, a suggested starting dose is 1 to 2 mg/kg/day given in divided doses. maximum daily dosage should not exceed 3 mg/kg/day or 150 to 200 mg/day, whichever is less. limited data are available to support the use of a maximum daily dosage of 4 mg/kg/day or 150 to 200 mg/day, whichever is less. as symptoms subside, the total daily dosage should be reduced to the lowest level required to control symptoms, or the drug should be discontinued. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.14) ]. indomethacin may cause confusion or rarely, psychosis [see adverse reactions (6.1)]; physicians should remain alert to the possibility of such adverse effects in the elderly. indomethacin and its metabolites are known to be substantially excreted by the kidneys, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, use caution in this patient population, and it may be useful to monitor renal function [see clinical pharmacology (12.3) ].