Common Side Effects of Topamax (Topiramate) Drug Center. SIDE EFFECTSThe following serious adverse reactions are discussed in. The data described in the following sections were. TOPAMAX. The most common. The most common ( . Patients in these trials were receiving 1 to 2 concomitant. ![]() ![]() Welcome: What is TOPAMAX ®? TOPAMAX ® is indicated for: Migraine. Adults and adolescents 12 years of age and older for the prophylaxis of migraine headache.![]() TOPAMAX. The incidence of some. TOPAMAX. This rate appeared to increase at dosages above 4. Patients may have reported more than one adverse reaction. None of the pediatric patients who received TOPAMAX. The. incidence of some adverse reactions (e. TOPAMAX. Patients may have reported more than one adverse reaction. Blurred vision was an included term that accounted for > 5. ![]() ![]() ![]() Learn about the potential side effects of Topamax (topiramate). Includes common and rare side effects information for consumers and healthcare professionals. Find patient medical information for Topamax Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Topamax is the brand name of the drug called topiramate. This drug is being used in the treatment of epilepsy and migraine. Being an anticonvulsant, topamax is also. Find out if Topiramate is effective for treating eating disorders and for weight loss with information from the medical experts at Consumer Reports Health. Topamax has induced weight loss at a variety of different doses. Doses as low as 64 mg a day have been effective, though doses of at least 150 mg. Related Article How to Lose Weight Fast: Easy Weight Loss Tips. Here are the best ways to lose weight for men and women. These fast facts show weight loss is possible. She is a journalist and managing editor for "Paranormal. Includes: what is topamax?, how does topamax contribute to weight loss?, side effects of topamax, what is the right topamax dosage for weight loss, and other factors. ![]() Of the 1,1. 35 patients exposed to TOPAMAX. The. adverse reactions associated with discontinuing therapy in the TOPAMAX. This change was not seen in. Mean changes of 0%, - 2%, - 3%, and - 4% were seen for the. TOPAMAX. Among adverse reactions with onset during titration. In four, fixed- dose, double- blind migraine prophylaxis. TOPAMAX. Table 9 also shows adverse reactions in pediatric. TOPAMAX. Many adverse reactions shown in Table 9 indicate a dose- dependent. The incidence of some adverse reactions (e. TOPAMAX. Adverse reactions associated. TOPAMAX. In a pooled analysis of placebo- controlled studies of approved and. TOPAMAX. In this analysis, the. TOPAMAX. In patients with serious bleeding events. Other Adverse Reactions Observed During Clinical Trials. Other adverse reactions seen during clinical trials were. Laboratory Test Abnormalities. Adult Patients. In addition to changes in serum bicarbonate (i. TOPAMAX. Because these reactions are reported. Body as a Whole- General Disorders: oligohydrosis. Side Effects, Interactions, Warning, Dosage & Uses. WARNINGSIncluded as part of the PRECAUTIONS section. PRECAUTIONSAcute Myopia And Secondary Angle Closure Glaucoma. A syndrome consisting of acute myopia associated with. TOPAMAX. Symptoms include acute onset of decreased visual acuity and/or. Ophthalmologic findings can include myopia, anterior chamber. This syndrome may be associated with. Symptoms typically occur within 1 month. TOPAMAX. In contrast to primary narrow angle. The primary treatment to reverse symptoms is discontinuation of. TOPAMAX. Other measures, in conjunction with discontinuation of TOPAMAX. In clinical trials, most of these events were. If visual problems occur at any. Oligohidrosis And Hyperthermia. Oligohidrosis (decreased sweating), infrequently. TOPAMAX. Decreased sweating and an elevation in body temperature above normal. Some of the cases were reported after exposure to. The majority of the reports have been in pediatric. Patients (especially pediatric patients) treated with TOPAMAX. Caution should be used when. TOPAMAX. Bicarbonate decrements are usually mild- moderate. Eq/L at daily doses of 4. Eq/L. Conditions or therapies. TOPAMAX. The incidence of. Lennox- Gastaut syndrome or refractory partial onset seizures was as high as 6. TOPAMAX. The incidence. Eq/L and > 5 m. Eq/L decrease from pretreatment) in these trials was up to. Manifestations of acute or chronic metabolic acidosis may. Chronic. untreated metabolic acidosis may increase the risk for nephrolithiasis or. Chronic metabolic acidosis in pediatric patients may also reduce. The effect of. TOPAMAX. Long- term, open- label. Reductions in length and weight were. If metabolic acidosis develops and. TOPAMAX. If the decision is made to continue patients on. TOPAMAX. Patients treated with any AED for any indication should be. Pooled analyses of 1. AEDs showed that patients. AEDs had approximately twice the risk (adjusted. Relative Risk 1. 8, 9. CI: 1. 2, 2. 7) of suicidal thinking or behavior compared. In these trials, which had a median. AED- treated patients was 0. There were four suicides in drug- treated patients in the trials and. The increased risk of suicidal thoughts or behavior with. AEDs was observed as early as one week after starting drug treatment with AEDs. Because most trials. The risk of suicidal thoughts or behavior was generally. The finding of increased risk with. AEDs of varying mechanisms of action and across a range of indications suggests. AEDs used for any indication. The risk did not. Table 4 shows absolute and relative risk by indication. AEDs. Table 4: Risk by Indication for Antiepileptic Drugs in. Pooled Analysis. Indication. Placebo Patients with Events per 1. Patients. Drug Patients with Events per 1. Patients. Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients. Risk Difference: Additional Drug Patients with Events per 1. Patients. Epilepsy. Psychiatric. 5. 7. Other. 1. 0. 1. 8. Total. 2. 4. 4. 3. The relative risk for suicidal thoughts or behavior was. Anyone considering prescribing TOPAMAX. Epilepsy and many other illnesses for which AEDs are. Should suicidal thoughts and. Cognitive/Neuropsychiatric Adverse Reactions. TOPAMAX. The most frequent of these can be classified into three general. Cognitive- related dysfunction (e. Psychiatric/behavioral disturbances (e. Somnolence or fatigue. Adult Patients. Cognitive- Related Dysfunction. Rapid titration rate and higher initial dose were. In adult epilepsy add- on controlled trials, which used. TOPAMAX. In this rapid. In the monotherapy epilepsy controlled trial, the. TOPAMAX. Cognitive adverse. Psychiatric/Behavioral Disturbances. Psychiatric/behavioral disturbances (e. For the adjunctive epilepsy population, the incidence of fatigue. For the monotherapy epilepsy population, the incidence. For the migraine population, the incidences of. Pediatric Patients. In pediatric epilepsy trials (adjunctive and. These reactions included. The most frequently. The. most frequently reported cognitive/neuropsychiatric reactions in pediatric. In pediatric migraine patients, the incidence of. TOPAMAX. This risk. Cognitive adverse reactions most. The Cambridge Neuropsychological Test Automated Battery. CANTAB) was administered to adolescents (1. Study 1. 2 . Mean change from baseline in certain CANTAB tests. Fetal Toxicity. TOPAMAX. Data from pregnancy registries indicate that infants exposed. When multiple species of. If this drug is. used during pregnancy, or if the patient becomes pregnant while taking this. In situations where rapid withdrawal of TOPAMAX. The risk for. hyperammonemia with topiramate appears dose- related. Hyperammonemia has been. Postmarketing cases of hyperammonemia with or without encephalopathy have. In most cases, hyperammonemic encephalopathy. The incidence of hyperammonemia in pediatric patients 1. TOPAMAX. There was also an increased. Dose- related hyperammonemia was also seen in pediatric. TOPAMAX. Although not studied, topiramate treatment or. In patients who develop unexplained lethargy, vomiting or. Kidney Stones. TOPAMAX. During. adjunctive epilepsy trials, the risk for kidney stones in TOPAMAX. As in the general population, the incidence of. TOPAMAX. Kidney. stones have also been reported in pediatric patients taking TOPAMAX. During long- term (up to 1 year) TOPAMAX. Hydration. is recommended to reduce new stone formation. Hypothermia With Concomitant Valproic Acid Use. Hypothermia, defined as a drop in body core temperature. This adverse reaction in patients using concomitant. Clinical management and assessment should include examination of blood. Patient Counseling Information. Advise the patient to read the FDA- approved patient. Medication Guide). Eye Disorders. Instruct patients taking TOPAMAX. Counsel patients to contact their. Therefore, advise all patients taking TOPAMAX. Discuss the appropriate level of caution with patients, before. Fetal Toxicity. Inform pregnant women and women of childbearing potential. TOPAMAX. Also inform. There may. also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX. When appropriate, counsel pregnant women and women of. This is. particularly important when TOPAMAX. The. registry is collecting information about the safety of antiepileptic drugs. Although hyperammonemia may be. This hyperammonemia and encephalopathy can develop. TOPAMAX. However, if a patient is. TOPAMAX. Advise patients to contact their healthcare provider if they have missed. Nonclinical Toxicology. Carcinogenesis, Mutagenesis, Impairment Of Fertility. Carcinogenesis. An increase in urinary bladder tumors was observed in. The. elevated bladder tumor incidence, which was statistically significant in males. Plasma. exposures in mice receiving 3. RHD) of 4. 00 mg, and 1. No. evidence of carcinogenicity was seen in rats following oral administration of. RHD. on a mg/m. Topiramate was not. Ames test or the in vitro mouse lymphoma assay; it did not. DNA synthesis in rat hepatocytes in vitro; and it did not. Impairment Of Fertility. No adverse effects on male or female fertility were. RHD on a mg/m. Data from pregnancy registries indicate that infants exposed. When multiple species of. If this drug is used during. To enroll, patients can call the toll- free number. Information about the North American Drug Pregnancy Registry. Human Data. Data from pregnancy registries indicate an increased risk. In the NAAED pregnancy registry, the prevalence of oral clefts among. AED (0. 3. 6%) or the prevalence of infants in mothers. AEDs (0. 1. 2%). It was also higher than. United States (0. Centers. for Disease Control and Prevention (CDC). The relative risk of oral clefts in. NAAED Pregnancy Registry was 9. Confidence Interval . The UK Epilepsy and Pregnancy Register reported. UK (0. 2%). Data from the NAAED pregnancy registry and a population- based. SGA) newborns. (birth weight < 1. In the NAAED pregnancy registry, 1. SGA compared to 7. AED and 5. 4% of newborns of mothers without epilepsy and without AED. In the Medical Birth Registry of Norway (MBRN), a population- based. SGA compared to 9 % in the comparison group unexposed to AEDs. The. long term consequences of the SGA findings are not known. TOPAMAX. The effect of topiramate- induced metabolic acidosis has. Pregnant. patients should be monitored for metabolic acidosis and treated as in the. Newborns of mothers. TOPAMAX. When oral doses of 2. The. low dose is approximately 0. RHD) 4. 00 mg/day. Fetal body weights and skeletal ossification were reduced at. In rat studies (oral doses of 2. RHD on a mg/m. Embryotoxicity (reduced fetal. RHD on a mg/m. Clinical signs. In rabbit studies (2. RHD on a mg/m. Evidence of maternal toxicity (decreased body weight. When female rats were treated during the latter part of. RHD on a mg/m. Maternal toxicity (decreased body weight gain, clinical. In a rat embryo/fetal development study with a postnatal. RHD on a. mg/m. The effects of this exposure on infants are unknown. In a single randomized, double- blind. After 2. 0 days of. In general, the adverse reaction profile for TOPAMAX. The. following adverse reactions were observed in at least 3% of patients on. A generally similar profile was observed in. This increased frequency of abnormal values was not dose- related. The. significance of these findings is uncertain. Topiramate treatment also produced a dose- related. The incidence of these abnormal shifts was 6 % for. There was a mean dose- related increase in alkaline. The significance of these findings is uncertain. Topiramate produced a dose- related increased incidence of. There was a suggestion that this effect was dose- related. It is not possible to know whether this mortality. Monotherapy Treatment In Partial Onset Epilepsy In Patients. Years Old. Safety and effectiveness in patients below the age of 2. Migraine Prophylaxis In Pediatric Patients 1. To 1. 7 Years. Of Age. Safety and effectiveness of topiramate in the prophylaxis. These comprised a fixed dose study in 1. Open- label extension. Efficacy of topiramate for migraine prophylaxis in. Study 1. 2 . Efficacy of topiramate (2 to 3.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
November 2017
Categories |