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

denton pharma, inc. dba northwind pharmaceuticals - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets are indicated for the treatment of major depressive disorder.    the efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ).   a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentra

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

nucare pharmaceuticals,inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

Philippines - English - FDA (Food And Drug Administration)

nutra berde incorporated - ascobic acid , zinc - capsule - 500 mg (equivalent to 562.4 mg sodium ascorbate)/ 10 mg (equivalent to 27.5 mg zinc sulfate monohydrate)

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

mylan pharmaceuticals inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlafa

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

breckenridge pharmaceutical, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide 50 mg - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data) . the background risk of major birth defects and miscarriage for the indicated population 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 2-4% and 15-20%, respectively. data animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations) . there is no information on the effects of lacosamide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide tablets for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)]. safety and effectiveness in pediatric patients below 1 month of age have not been established. animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide tablets dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5) and clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr less than 30 ml/min/1.73m2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] . in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)] . the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment. lacosamide tablets contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. dispense with medication guide available at: www.bpirx.com/products/patientinformation read this medication guide before you start taking lacosamide tablets and each time you get a refill. there may be new information. this medication guide describes important safety information about lacosamide tablets. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is the most important information i should know about lacosamide tablets? do not stop taking lacosamide tablets without first talking to your healthcare provider. stopping lacosamide tablets suddenly can cause serious problems. stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). lacosamide tablets can cause serious side effects, including: - thoughts about suicide or dying - attempt to commit suicide - new or worse depression - new or worse anxiety - feeling agitated or restless - panic attacks - trouble sleeping (insomnia) - new or worse irritability - acting aggressive, being angry, or violent - acting on dangerous impulses - an extreme increase in activity and talking (mania) - other unusual changes in behavior or mood - pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. - keep all follow-up visits with your healthcare provider as scheduled. - call your healthcare provider between visits as needed, especially if you are worried about symptoms. - suicidal thoughts or actions can be caused by things other than medicines. if you have suicidal thoughts or actions, your healthcare provider may check for other causes. - have a fast, slow, or pounding heartbeat or feel your heart skip a beat - have shortness of breath - have chest pain - feel lightheaded - fainted or if you feel like you are going to faint what are lacosamide tablets? lacosamide tablets are a prescription medicine used: - to treat partial-onset seizures in people 4 years of age and older. it is not known if lacosamide tablets are safe and effective for partial-onset seizures in children under 1 month of age. what should i tell my healthcare provider before taking lacosamide tablets? before you take lacosamide tablets, tell your healthcare provider about all of your medical conditions, including if you: - have or have had depression, mood problems or suicidal thoughts or behavior. - have heart problems. - have kidney problems. - have liver problems. - have abused prescription medicines, street drugs or alcohol in the past. - are pregnant or plan to become pregnant. it is not known if lacosamide tablets can harm your unborn baby. tell your healthcare provider right away if you become pregnant while taking lacosamide tablets. you and your healthcare provider will decide if you should take lacosamide tablets while you are pregnant. if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - if you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can enroll in this registry by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. - are breastfeeding or plan to breastfeed. lacosamide passes into breast milk. breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. - breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. if this happens, contact your baby's healthcare provider. - talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking lacosamide tablets with certain other medicines may cause side effects or affect how well they work. do not start or stop other medicines without talking to your healthcare provider. know the medicines you take. keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. how should i take lacosamide tablets? - take lacosamide tablets exactly as your healthcare provider tells you. - your healthcare provider will tell you how many lacosamide tablets to take and when to take them. - your healthcare provider may change your dose if needed. - do not stop lacosamide tablets without first talking to a healthcare provider. stopping lacosamide tablets suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). - lacosamide tablets may be taken with or without food. - swallow lacosamide tablets whole with liquid. do not cut lacosamide tablets. - if you take too many lacosamide tablets, call your healthcare provider or local poison control center right away. what should i avoid while taking lacosamide tablets? do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affect you. lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. what are the possible side effects of lacosamide tablets? - see "what is the most important information i should know about lacosamide tablets? " lacosamide tablets may cause other serious side effects including: - a serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells . call your healthcare provider right away if you have: - a skin rash, hives - fever or swollen glands that do not go away - shortness of breath - tiredness (fatigue) - swelling of the legs - yellowing of the skin or whites of the eyes - dark urine the most common side effects of lacosamide tablets include : - double vision - headache - dizziness - nausea - sleepiness these are not all of the possible side effects of lacosamide tablets. for more information ask your healthcare provider or pharmacist. tell your healthcare provider about any side effect that bothers you or that does not go away. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store lacosamide tablets? - store lacosamide tablets at room temperature between 68°f to 77°f (20°c to 25°c). keep lacosamide tablets and all medicines out of the reach of children. general information about the safe and effective use of lacosamide tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use lacosamide tablets for a condition for which it was not prescribed. do not give lacosamide tablets to other people, even if they have the same symptoms that you have. it may harm them. this medication guide summarizes the most important information about lacosamide tablets. if you would like more information, talk with your healthcare provider. you can ask your pharmacist or healthcare provider for information about lacosamide tablets that is written for health professionals. for more information, contact breckenridge pharmaceutical, inc. at 1-800-367-3395 or at www.bpirx.com. what are the ingredients in lacosamide tablets? active ingredient : lacosamide tablet inactive ingredients : colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, lecithin, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and additional ingredients listed below: - 50 mg tablets: red iron oxide, black iron oxide, fd&c blue #2 / indigo carmine aluminum lake - 100 mg tablets: yellow iron oxide - 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide - 200 mg tablets: fd&c blue #2 / indigo carmine aluminum lake additional pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) tablets. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. manufactured by: msn laboratories private limited telangana – 509 228, india distributed by: breckenridge pharmaceutical, inc. berlin, ct 06037, usa this medication guide has been approved by the u.s. food and drug administration trademarks are the property of their respective owners. revised: 11/2023

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

mylan pharmaceuticals inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14) ] . 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. there are no published studies on desvenlafaxine extended-release tablets in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with exposure to snris and ssris, including desvenlafaxine extended-release tablets, during pregnancy (see clinical considerations). in reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of

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

physicians total care, inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - neomycin sulfate 3.5 mg in 1 g - neomycin and polymyxin b sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. they are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. the use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see clinical pharmacology: microbiology ). the particular anti-infect

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

physicians total care, inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - neomycin sulfate 3.5 mg in 1 g - neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. neomycin and polymyxin b sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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

nucare pharmaceuticals,inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ).  a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.  the effectiveness of mirtazapine tablets i

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

nucare pharmaceuticals,inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 60 mg in 2 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and   adverse reactions ). patie