Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution, usp is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution, usp is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9)]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ] . - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ]. risk summary use of nsaids, including diclofenac sodium, 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 use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium 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 diclofenac sodium, 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 embryo-fetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. published reproductive and developmental studies of dimethyl sulfoxide (dmso, the solvent used in diclofenac sodium) are equivocal as to potential teratogenicity. in animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac daily during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (mrhd) of diclofenac sodium, despite the presence of maternal and fetal toxicity at these doses [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 diclofenac sodium, 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 diclofenac sodium, 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 diclofenac sodium treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue diclofenac sodium and follow up according to clinical practice ( see data ). labor or delivery there are no studies on the effects of diclofenac sodium topical solution during labor or delivery. in animal studies, nsaids, including diclofenac, 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 and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.6 times the maximum recommended human dose [mrhd] of diclofenac sodium, 154 mg/day, based on body surface area (bsa) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.6 and 1.3 times, respectively, the mrhd based on bsa comparison). published reproductive and developmental studies of dimethyl sulfoxide (dmso, the solvent used in diclofenac sodium) are equivocal as to potential teratogenicity. in rats, maternally toxic doses of diclofenac were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. risk summary based on available data, diclofenac may be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for diclofenac and any potential adverse effects on the breastfed infant from the diclofenac or from the underlying maternal condition. data one woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/l, equivalent to an infant dose of about 0.03 mg/kg/day. diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including diclofenac sodium, 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 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 diclofenac sodium, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients have not been established. elderly patients, compared to younger patients, are a 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) ]. of the 911 patients treated with diclofenac sodium in seven controlled, phase 3 clinical trials, 444 subjects were 65 years of age and over. there was no age-related difference in the incidence of adverse events. of the 793 patients treated with diclofenac sodium in one open-labeled safety trial, 334 subjects were 65 years of age and over including 107 subjects 75 and over. there was no difference in the incidence of adverse events with long-term exposure to diclofenac sodium for this elderly population. read the medication guide that comes with diclofenac sodium topical solution first. be sure that you read, understand and follow these instructions for use before you use diclofenac sodium topical solution for the first time. important: for use on the skin only (topical). do not get diclofenac sodium topical solution in your eyes, nose or mouth. before you use diclofenac sodium topical solution: - apply diclofenac sodium topical solution exactly as your healthcare provider tells you. talk with your healthcare provider or pharmacist if you are not sure. - only use diclofenac sodium topical solution to treat pain from osteoarthritis in your knee or knees. - apply diclofenac sodium topical solution on clean, dry skin that does not have any cuts, infections or rashes. - use diclofenac sodium topical solution 4 times each day on your knee or knees as prescribed. - your total dose for each knee is 40 drops of diclofenac sodium topical solution, each time you use it. - if you get diclofenac sodium topical solution in your eyes, rinse your eyes right away with water or saline. call your healthcare provider if your eyes are irritated for more than one hour. steps for using diclofenac sodium topical solution: step 1. wash your hands with soap and water before applying diclofenac sodium topical solution. step 2. put 10 drops of diclofenac sodium topical solution either on your hand or directly on your knee (see figure a ). step 3. spread diclofenac sodium topical solution evenly on the front, back and sides of your knee (see figures b and c ). repeat steps 2 and 3, three times so that your knee is completely covered with a total of 40 drops of diclofenac sodium topical solution. step 4. if your healthcare provider has prescribed diclofenac sodium topical solution for both knees, repeat steps 2 and 3 for the other knee. after you use diclofenac sodium topical solution: - wash your hands with soap and water right away after applying diclofenac sodium topical solution. do not: - touch the treated knee or allow another person to touch the knee treated with diclofenac sodium topical solution until your knee is completely dry. - cover your knee with clothing until your knee is completely dry. - put sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medicines on your knee until it is completely dry. - take a shower or a bath for at least 30 minutes after you put diclofenac sodium topical solution on your knee. - use heating pads or cover the treated area with bandages where you have applied diclofenac sodium topical solution. - use sunlamps and tanning beds. protect your treated knee from sunlight. wear clothes that cover your skin if you have to be in sunlight. how should i store diclofenac sodium topical solution? - store diclofenac sodium topical solution at room temperature between 68°f to 77°f (20°c to 25°c). keep diclofenac sodium topical solution and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. repackaged by / distributed by: remedyrepack inc. 625 kolter drive, indiana, pa 15701 (724) 465-8762

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - seizure disorders: clonazepam tablets are useful alone or as an adjunct in the treatment of the lennox- gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect). panic disorder: clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets was established in two 6- to 9-week trials  in panic disorder patients whose diagnoses corresponded to the dsm-lilr category of panic disorder (see clinical pharmacology: clinical trials). panic disorder (dsm-v) is characterized by recurrent unexpected panic attacks, i.e., a discrete  period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness  or tingling  sensations); (13) chills or hot flushes. the effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. the physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see dosage and administration). clonazepam tablets are contraindicated in patients with the following conditions: - history of sensitivity to benzodiazepines - clinical or biochemical evidence of significant liver disease - acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy). controlled substance class: clonazepam tablets contain clonazepam, a schedule iv controlled substance. abuse: clonazepam tablet is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to  drug  use  than other  activities  and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse  may  lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse  and/or  misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or  misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing  difficulty, and  death. death is more often associated with polysubstance use  (especially benzodiazepines  with other  cns depressants such as opioids and alcohol) . dependence: physical dependence clonazepam tablets may produce physical dependence from continued therapy. 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 discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or  rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions) to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clonazepam tablets and warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle  pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have  included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g.,  weakness,  tremor,  muscle twitches), paresthesia, and tinnitus that persists beyond 4 to  6  weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more  than 12 months . as  a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to clonazepam tablets  may  develop  from continued  therapy.  tolerance is a physiological state characterized by a reduced response to  a drug  after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of clonazepam tablets may  develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. following the short-term treatment of patients with panic disorder in studies 1 and 2 (see clinical pharmacology: clinical trials) , patients were gradually withdrawn during a 7-week downward- titration (discontinuance) period. overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. however, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use. what is the most important information i should know about clonazepam tablets? - clonazepam tablet is a benzodiazepine medicine. taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (cns) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. get emergency help right away if any of the following happens: - shallow or slowed breathing - breathing stops (which may lead to the heart stopping) - excessive sleepiness (sedation) do not drive or operate heavy machinery until you know how taking clonazepam tablets with opioids affects you. - risk of abuse, misuse, and addiction . there is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam tablet which can lead to overdose and serious side effects including coma and death. - serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including clonazepam tablets. these serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. - you can develop an addiction even if you take clonazepam tablets as prescribed by your healthcare provider. - take clonazepam tablets exactly as your healthcare provider prescribed. - do not share your clonazepam tablets with other people. - keep clonazepam tablets in a safe place and away from children. - physical dependence and withdrawal reactions. clonazepam tablets can cause physical dependence and withdrawal reactions. do not suddenly stop taking clonazepam tablets . stopping clonazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. physical dependence is not the same as drug addiction. your healthcare provider can tell you more about the differences between physical dependence and drug addiction. do not take more clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed. - do not suddenly stop taking clonazepam tablets . stopping clonazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. - some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. - physical dependence is not the same as drug addiction. your healthcare provider can tell you more about the differences between physical dependence and drug addiction. - do not take more clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed. - clonazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. this may get better over time. do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. - do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. - clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. - do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. when taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse. - like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: - 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 how can i watch for early symptoms of suicidal thoughts and actions? - 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. do not stop clonazepam tablets without first talking to a healthcare provider. - stopping clonazepam tablets suddenly can cause serious problems. stopping clonazepam tablets - suddenly can cause seizures that will not stop (status epilepticus). what are clonazepam tablets? - clonazepam tablets are prescription medicine used alone or with other medicines to treat: certain types of seizure disorders (epilepsy) in adults and children panic disorder with or without fear of open spaces (agoraphobia) in adults - certain types of seizure disorders (epilepsy) in adults and children - panic disorder with or without fear of open spaces (agoraphobia) in adults clonazepam tablet is a federally controlled substance (c-iv) because it contains clonazepam that can be abused or lead to dependence. keep clonazepam tablets in a safe place to prevent misuse and abuse. selling or giving away clonazepam tablets may harm others, and is against the law. tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. it is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old. who should not take clonazepam tablets? do not take clonazepam tablets if you: - are allergic to benzodiazepines - have significant liver disease - have an eye disease called acute narrow angle glaucoma ask your healthcare provider if you are not sure if you have any of the problems listed above. before you take clonazepam tablets, tell your healthcare provider if you: - have liver or kidney problems - have lung problems (respiratory disease) - have or have had depression, mood problems, or suicidal thoughts or behavior - have any other medical problems - are pregnant or plan to become pregnant. it is not known if clonazepam tablets can harm your unborn baby. tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. you and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant. - studies in pregnant animals have shown harmful effects of benzodiazepine medications (including the active ingredient in clonazepam tablets) on the developing fetus. - children born to mothers receiving benzodiazepine medications (including clonazepam tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms. - if you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can register by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy - are breastfeeding or plan to breastfeed. clonazepam can pass into breast milk. you and your healthcare provider should decide how you will feed your baby while you take clonazepam tablets. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. do not start or stop other medicines without talking to your healthcare provider. how should i take clonazepam tablets? - take clonazepam tablets exactly as your healthcare provider tells you. if you take clonazepam tablets for seizures, your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms. - clonazepam is available as a tablet. - do not stop taking clonazepam tablets without first talking to your healthcare provider. stopping clonazepam tablets suddenly can cause serious problems. - clonazepam tablets should be taken with water and swallowed whole. - if you take too much clonazepam tablets, call your healthcare provider or local poison control center right away. what should i avoid while taking clonazepam tablets? - clonazepam tablets can slow your thinking and motor skills. do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. - do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. when taken with alcohol or medicines that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness much worse. what are the possible side effects of clonazepam tablets? see “what is the most important information i should know about clonazepam tablets?” clonazepam tablets can also make your seizures happen more often or make them worse. call your healthcare provider right away if your seizures get worse while taking clonazepam tablets. the most common side effects of clonazepam tablets include: - drowsiness • dizziness • fatigue - problems with walking and coordination • depression • problems with memory these are not all the possible side effects of clonazepam tablets. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 or contact advagen pharma ltd, at 866-488-0312. how should i store clonazepam tablets? - store clonazepam tablets at 20°c to 25°c (68°f -77°f) [see usp controlled room temperature]. - keep clonazepam tablets and all medicines out of the reach of children. general information about the safe and effective use of clonazepam tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use clonazepam tablets for a condition for which it was not prescribed. do not give clonazepam tablets to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals. for more information, contact advagen pharma ltd, at 866-488-0312. what are the ingredients in clonazepam tablets? active ingredient: clonazepam inactive ingredients: - 0.5 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fd & c yellow 6 al lake, d & c yellow 10 al lake - 1 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fd & c blue 1 al lake and fd & c blue 2 al lake - 2 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate this medication guide has been approved by the u.s. food and drug administration. repackaged by / distributed by: remedyrepack inc. 625 kolter drive, indiana, pa 15701 (724) 465-8762

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - seizure disorders: clonazepam tablets are useful alone or as an adjunct in the treatment of the lennox- gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect). panic disorder: clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets was established in two 6- to 9-week trials  in panic disorder patients whose diagnoses corresponded to the dsm-lilr category of panic disorder (see clinical pharmacology: clinical trials). panic disorder (dsm-v) is characterized by recurrent unexpected panic attacks, i.e., a discrete  period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness  or tingling  sensations); (13) chills or hot flushes. the effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. the physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see dosage and administration). clonazepam tablets are contraindicated in patients with the following conditions: - history of sensitivity to benzodiazepines - clinical or biochemical evidence of significant liver disease - acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy). controlled substance class: clonazepam tablets contain clonazepam, a schedule iv controlled substance. abuse: clonazepam tablet is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to  drug  use  than other  activities  and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse  may  lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse  and/or  misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or  misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing  difficulty, and  death. death is more often associated with polysubstance use  (especially benzodiazepines  with other  cns depressants such as opioids and alcohol) . dependence: physical dependence clonazepam tablets may produce physical dependence from continued therapy. 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 discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or  rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions) to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clonazepam tablets and warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle  pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have  included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g.,  weakness,  tremor,  muscle twitches), paresthesia, and tinnitus that persists beyond 4 to  6  weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more  than 12 months . as  a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to clonazepam tablets  may  develop  from continued  therapy.  tolerance is a physiological state characterized by a reduced response to  a drug  after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of clonazepam tablets may  develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. following the short-term treatment of patients with panic disorder in studies 1 and 2 (see clinical pharmacology: clinical trials) , patients were gradually withdrawn during a 7-week downward- titration (discontinuance) period. overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. however, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use. what is the most important information i should know about clonazepam tablets? - clonazepam tablet is a benzodiazepine medicine. taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (cns) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. get emergency help right away if any of the following happens: - shallow or slowed breathing - breathing stops (which may lead to the heart stopping) - excessive sleepiness (sedation) do not drive or operate heavy machinery until you know how taking clonazepam tablets with opioids affects you. - risk of abuse, misuse, and addiction . there is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam tablet which can lead to overdose and serious side effects including coma and death. - serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including clonazepam tablets. these serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. - you can develop an addiction even if you take clonazepam tablets as prescribed by your healthcare provider. - take clonazepam tablets exactly as your healthcare provider prescribed. - do not share your clonazepam tablets with other people. - keep clonazepam tablets in a safe place and away from children. - physical dependence and withdrawal reactions. clonazepam tablets can cause physical dependence and withdrawal reactions. do not suddenly stop taking clonazepam tablets . stopping clonazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. physical dependence is not the same as drug addiction. your healthcare provider can tell you more about the differences between physical dependence and drug addiction. do not take more clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed. - do not suddenly stop taking clonazepam tablets . stopping clonazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. - some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. - physical dependence is not the same as drug addiction. your healthcare provider can tell you more about the differences between physical dependence and drug addiction. - do not take more clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed. - clonazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. this may get better over time. do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. - do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. - clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. - do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. when taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse. - like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: - 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 how can i watch for early symptoms of suicidal thoughts and actions? - 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. do not stop clonazepam tablets without first talking to a healthcare provider. - stopping clonazepam tablets suddenly can cause serious problems. stopping clonazepam tablets - suddenly can cause seizures that will not stop (status epilepticus). what are clonazepam tablets? - clonazepam tablets are prescription medicine used alone or with other medicines to treat: certain types of seizure disorders (epilepsy) in adults and children panic disorder with or without fear of open spaces (agoraphobia) in adults - certain types of seizure disorders (epilepsy) in adults and children - panic disorder with or without fear of open spaces (agoraphobia) in adults clonazepam tablet is a federally controlled substance (c-iv) because it contains clonazepam that can be abused or lead to dependence. keep clonazepam tablets in a safe place to prevent misuse and abuse. selling or giving away clonazepam tablets may harm others, and is against the law. tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. it is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old. who should not take clonazepam tablets? do not take clonazepam tablets if you: - are allergic to benzodiazepines - have significant liver disease - have an eye disease called acute narrow angle glaucoma ask your healthcare provider if you are not sure if you have any of the problems listed above. before you take clonazepam tablets, tell your healthcare provider if you: - have liver or kidney problems - have lung problems (respiratory disease) - have or have had depression, mood problems, or suicidal thoughts or behavior - have any other medical problems - are pregnant or plan to become pregnant. it is not known if clonazepam tablets can harm your unborn baby. tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. you and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant. - studies in pregnant animals have shown harmful effects of benzodiazepine medications (including the active ingredient in clonazepam tablets) on the developing fetus. - children born to mothers receiving benzodiazepine medications (including clonazepam tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms. - if you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the north american antiepileptic drug pregnancy registry. you can register by calling 1-888-233-2334. the purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy - are breastfeeding or plan to breastfeed. clonazepam can pass into breast milk. you and your healthcare provider should decide how you will feed your baby while you take clonazepam tablets. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. do not start or stop other medicines without talking to your healthcare provider. how should i take clonazepam tablets? - take clonazepam tablets exactly as your healthcare provider tells you. if you take clonazepam tablets for seizures, your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms. - clonazepam is available as a tablet. - do not stop taking clonazepam tablets without first talking to your healthcare provider. stopping clonazepam tablets suddenly can cause serious problems. - clonazepam tablets should be taken with water and swallowed whole. - if you take too much clonazepam tablets, call your healthcare provider or local poison control center right away. what should i avoid while taking clonazepam tablets? - clonazepam tablets can slow your thinking and motor skills. do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. - do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. when taken with alcohol or medicines that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness much worse. what are the possible side effects of clonazepam tablets? see “what is the most important information i should know about clonazepam tablets?” clonazepam tablets can also make your seizures happen more often or make them worse. call your healthcare provider right away if your seizures get worse while taking clonazepam tablets. the most common side effects of clonazepam tablets include: - drowsiness • dizziness • fatigue - problems with walking and coordination • depression • problems with memory these are not all the possible side effects of clonazepam tablets. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 or contact advagen pharma ltd, at 866-488-0312. how should i store clonazepam tablets? - store clonazepam tablets at 20°c to 25°c (68°f -77°f) [see usp controlled room temperature]. - keep clonazepam tablets and all medicines out of the reach of children. general information about the safe and effective use of clonazepam tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use clonazepam tablets for a condition for which it was not prescribed. do not give clonazepam tablets to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals. for more information, contact advagen pharma ltd, at 866-488-0312. what are the ingredients in clonazepam tablets? active ingredient: clonazepam inactive ingredients: - 0.5 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fd & c yellow 6 al lake, d & c yellow 10 al lake - 1 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fd & c blue 1 al lake and fd & c blue 2 al lake - 2 mg tablets contain lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate this medication guide has been approved by the u.s. food and drug administration. repackaged by / distributed by: remedyrepack inc. 625 kolter drive, indiana, pa 15701 (724) 465-8762

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