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lupin pharmaceuticals,inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 10 mg - metoclopramide orally disintegrating tablets is indicated in adults for the: - treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (gerd) who fail to respond to conventional therapy. - relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis). limitations of use : metoclopramide orally disintegrating tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see use in specific populations ( 8.4)] metoclopramide orally disintegrating tablets is contraindicated: - in patients with a history of tardive dyskinesia (td) or a dystonic reaction to metoclopramide [see warnings and precautions (5.1, 5.2)]. - when stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction,

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lupin pharmaceuticals, inc. - rufinamide (unii: wfw942pr79) (rufinamide - unii:wfw942pr79) - rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with lennox-gastaut syndrome in pediatric patients 1 year of age and older and in adults. rufinamide is contraindicated in patients with familial short qt syndrome [see warnings and precautions (5.3) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as rufinamide, during pregnancy. encourage women who are taking rufinamide 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 use of rufinamide in pregnant women. in animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see data]. in the u.s. general population, the estimated background risk of m

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lupin pharmaceuticals, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical  studies (14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult

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lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - tri-lo-marzia™ tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. tri-lo-marzia is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:    o  smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]    o  have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]    o  have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]    o  have cerebrovascular disease [see warnings and precautions (5.1)]    o  have coronary artery disease [see warnings and precautions (5.1)]    o  have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)]    o  have uncontrolled hypertension [see warnings and precautions (5.4)]    o  have diabetes mellitus with vascular disease [see warnings and precautions (5.6)]    o  have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.7)]          o women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.3)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early 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 low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of tri-lo-marzia tablets have been established in women of reproductive age. efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. tri-lo-marzia has not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of tri-lo-marzia has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded. [see contraindications (4) and warnings and precautions (5.2).] the pharmacokinetics of tri-lo-marzia has not been studied in women with renal impairment. tri-lo-marzia [try-low-mar-zee-uh] (norgestimate and ethinyl estradiol tablets usp) important information about taking tri-lo-marzia - take 1 pill every day at the same time. take the pills in the order directed on your blister. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take tri-lo-marzia, talk to your healthcare provider. when you first start taking tri-lo-marzia, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking tri-lo-marzia. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see what should i do if i miss any tri-lo-marzia pills? below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken tri-lo-marzia according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking tri-lo-marzia. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister. if you do not have an extra blister, take the next pill in your blister. continue taking all your remaining pills in order. start the first pill of your next blister the day after finishing your current blister. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking tri-lo-marzia at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking tri-lo-marzia: - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking tri-lo-marzia? if you start taking tri-lo-marzia and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take tri-lo-marzia. you do not need back-up contraception if you use the day 1 start. if you start taking tri-lo-marzia and you are switching from another birth control pill: - start your new tri-lo-marzia pack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking tri-lo-marzia and previously used a vaginal ring or transdermal patch: - start using tri-lo-marzia on the day you would have reapplied the next ring or patch. if you start taking tri-lo-marzia and you are switching from a progestin-only method such as an  implant or injection: - start taking tri-lo-marzia on the day of removal of your implant or on the day when you would have had your next injection. if you start taking tri-lo-marzia and you are switching from an intrauterine device or system (iud or ius): - start taking tri-lo-marzia on the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take tri-lo-marzia. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, "when should i start taking tri-lo-marzia?" above. follow these instructions for either a sunday start or a day 1 start . sunday start : you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts . - if your period starts on a sunday, take pill "1 " that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister at the same time each day for 28 days. - after taking the last pill on day 28 from the blister, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take tri-lo-marzia. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period. - take 1 pill every day in the order of the blister, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. instructions for using your blister: each new blister has 28 pills - 7 white to off white pills with hormone, for days 1 to 7 - 7 light blue pills with hormone, for days 8 to 14 - 7 blue pills with hormones, for days 15 to 21 - 7 green pills (without hormones), for days 22 to 28 . step 1. set the day on your blister sunday start: each blister has been preprinted with the days of the week, starting with sunday, to facilitate a sunday-start regimen. day 1 start: - six different day label strips of the week have been provided with this pack in order to accommodate a day-1 start regimen. - pick the day label strip that starts with the first day of your period. place this day label strip over the area that has the days of the week (starting with sunday) pre-printed on the blister (refer figure below). step 2. remove pill "1" by pushing down on the pill. the pill will come out through a hole in the back of the strip. step 3. swallow the pill. you will take 1 pill every day, at the same time each day. step 4. wait 24 hours to take your next pill. continue to take 1 pill each day until all the pills have been taken. step 5. take your pill at the same time every day. it is important to take the correct pill each day and not miss any pills. to help you remember, take your pill at the same time as another daily activity, like turning off your alarm clock or brushing your teeth. step 6. when your blister is empty . you will start a new blister on the day after pill "28." remember to take your first pill in every refill on the same day of the week, no matter when your next period starts. what should i do if i miss any tri-lo-marzia pills? if you miss 1 pill in weeks 1, 2, or 3, follow these steps: - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 pills in a row in week 3, or you miss 3 or more pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter: - throw out the rest of the pill pack and start a new pack that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - if you are a sunday starter: - keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. distributed by: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) - 454 775 india this patient information and instructions for use has been approved by the u.s. food and drug administration. revised: july 2022                                                                             id#: 270926

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lupin pharmaceuticals, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine tablet is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy   lamotrigine tablet is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine tablet have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine tablet is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed

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lupin pharmaceuticals, inc. - ciprofloxacin (unii: 5e8k9i0o4u) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg in 5 ml - ciprofloxacin for oral suspension is indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, proteus vulgaris, providencia stuartii, morganella morganii, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. ciprofloxacin for oral suspension is indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin for oral suspension is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. ciprofloxacin for oral suspension is indicated in adult patients for treatment of infectious diarrhea caused

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lupin pharmaceuticals, inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine tablets are contraindicated in patients: -   who have the hla-b*5701 allele [see warnings and precautions (5.1)]. -   with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)] or lamivudine. -   with moderate or severe hepatic impairment [see use in specific populations (8.7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the (apr) show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defe

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lupin pharmaceuticals, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg in 1.5 ml - testosterone topical solution usp is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone topical solution usp in men with "age-related hypogonadism" (als

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lupin pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin tablets are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.   pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin tablets, during pregnancy. encourage women who are taking gabapentin tablets during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 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 gabapentin tablets in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapent

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lupin pharmaceuticals, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1)]. bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets (xl) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials i