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

novartis pharmaceuticals corporation - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. trileptal is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see warnings and precautions (5.2, 5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as trileptal, during pregnancy. encourage women who are taking trileptal during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of trileptal in pregnant women; however, trileptal is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. data on a limited number of pregnancies from pregnancy registries suggest that trileptal monotherapy use is associated with congenital malformations (e.g., craniofacial defects, such as oral clefts, and cardiac malformations, such as ventricular septal defects). increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (mhd) during pregnancy at doses similar to the maximum recommended human dose (mrhd). 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations an increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine. monitor patients carefully during pregnancy and through the postpartum period [see warnings and precautions (5.10)] . data human data data from published registries have reported craniofacial defects, such as oral clefts and cardiac malformations, such as ventricular septal defects in children with prenatal oxcarbazepine exposure. animal data when pregnant rats were given oxcarbazepine (0, 30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the mrhd on a mg/m2 basis). increased embryofetal death and decreased fetal body weights were seen at the high dose. doses ≥300 mg/kg/day were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. in a study in which pregnant rabbits were orally administered mhd (0, 20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the mrhd on a mg/m2 basis). this dose produced only minimal maternal toxicity. in a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (less than the mrhd on a mg/m2 basis). oral administration of mhd (0, 25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the mrhd on a mg/m2 basis). risk summary oxcarbazepine and its active metabolite (mhd) are present in human milk after trileptal administration. the effects of oxcarbazepine and its active metabolite (mhd) on the breastfed infant or on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trileptal and any potential adverse effects on the breastfed infant from trileptal or from the underlying maternal condition. contraception use of trileptal with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug. advise women of reproductive potential taking trileptal who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see drug interactions (7.3) and clinical pharmacology (12.3)] . trileptal is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years. the safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established. trileptal is also indicated as monotherapy for partial-onset seizures in patients aged 4 to 16 years. the safety and effectiveness for use as monotherapy for partial-onset seizures in pediatric patients below the age of 4 have not been established. trileptal has been given to 898 patients between the ages of 1 month to 17 years in controlled clinical trials (332 treated as monotherapy) and about 677 patients between the ages of 1 month to 17 years in other trials [s ee warnings and precautions (5.11), adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14 ) ]. there were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. following administration of single (300 mg) and multiple (600 mg/day) doses of trileptal in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and area under the curve (auc) values of mhd were 30% to 60% higher than in younger volunteers (18 to 32 years of age). comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see warnings and precautions (5.1) ]. dose adjustment is recommended for renally impaired patients (creatinine clearance < 30 ml/min) [see dosage and administration (2. 7 ) and clinical pharmacology (12.3) ]. the abuse potential of trileptal has not been evaluated in human studies. intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity. trileptal® (oxcarbazepine) oral suspension           300 mg/5 ml each 5 ml contains 300 mg oxcarbazepine instructions for use read these instructions carefully to learn how to use the medicine dispensing system correctly. distributed by: novartis pharmaceuticals corporation east hanover, new jersey 07936 march 2018 t2018-33 © novartis

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

west-ward pharmaceutical corp - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin capsules are indicated for the management of postherpetic neuralgia in adults. gabapentin capsules are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 - 12 years. gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. the abuse and dependence potential of gabapentin has not been evaluated in human studies.

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

west-ward pharmaceuticals corp. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use: because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings] , reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: oxycodone hydrochloride and acetaminophen tablets contain oxycodone, a schedule ii controlled substance. oxycodone hydrochloride and acetaminophen tablets contain oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone hydrochloride and acetaminophen tablets can be abused and are subject to misuse, addiction, and criminal diversion [se

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

west-ward pharmaceutical corp - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone 250 mg - primidone tablets, usp used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: - patients with porphyria and - patients who are hypersensitive to phenobarbital (see clinical pharmacology ).

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

west-ward pharmaceutical corp - propylthiouracil (unii: 721m9407iy) (propylthiouracil - unii:721m9407iy) - propylthiouracil 50 mg - propylthiouracil is indicated: - in patients with graves' disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option. - to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole. propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

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

west-ward pharmaceutical corp - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules, usp are indicated for the management of postherpetic neuralgia in adults. gabapentin capsules, usp are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin capsules are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 -12 years. gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. the abuse and dependence potential of gabapentin capsules has not been evaluated in human studies.

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corporation; distributor: new marketlink pharmaceutical corporation - anti-rabies serum (equine) - solution for injection (im/sc) - 200 iu/ ml (1,000 iu/ 5ml)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: new marketlink pharmaceutical corporation; distributor: new marketlink pharmaceutical corporation - epoetin alfa - solution for injection (i.v/s.c) - 4000iu/0.4ml

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corp. - carmona retusa (vahl.) masam (tsaang gubat leaf) - tablet - 500 mg

Philippines - English - FDA (Food And Drug Administration)

new marketlink pharmaceutical corp. - carmona retusa (vahl.) masam (tsaang gubat leaf) - tablet - 250 mg