Topiramate 100 mg for weight loss
Patients, especially pediatric patients, treated with Topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. 2%. Concomitant administration of Topiramate and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. No patients discontinued treatment due to any adverse reactions in the adjunctive epilepsy double-blind trials. In vitro studies indicate that Topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. The primary treatment to reverse symptoms is discontinuation of Topiramate tablets as rapidly as possible, according to the judgment of the treating physician. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet or specific drugs) may be additive to the bicarbonate lowering effects of Topiramate. Kidney stones have also been reported in pediatric patients taking Topiramate for epilepsy. Topiramate is not approved as adjunctive treatment of partial onset seizures in pediatric patients less than 2 years old. The most frequently reported neuropsychiatric reactions in pediatric patients during adjunctive therapy double-blind studies were somnolence and fatigue. This can be taken with or without food twice a day. Because of the bitter taste, tablets should not be broken. The bioavailability of Topiramate is not affected by food. , aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). Limited data on 5 breastfeeding infants exposed to Topiramate showed infant plasma Topiramate levels equal to 10 to 20% of the maternal plasma level. These dose-related adverse reactions began with a similar frequency in the titration or in the maintenance phase, although in some patients the events began during titration and persisted into the maintenance phase. To provide a meaningful estimate of the proportion of individuals having adverse reactions, similar types of reactions were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole. Decreased sweating and an elevation in body temperature above normal characterized these cases. For comparison, the Centers for Disease Control and Prevention (CDC) reviewed available data on oral clefts in the United States and found a background rate of 0. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. 43%, compared to 0. Paresthesia was more frequently reported in the monotherapy epilepsy trials than in the adjunctive therapy epilepsy trials. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0. Adverse bleeding reactions reported with Topiramateranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. This increased frequency of abnormal values was not dose-related. The major route of elimination of unchanged Topiramate and its metabolites is via the kidney. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia. Such patients will require a longer time to reach steady-state at each dose. In most cases, symptoms and signs abated with discontinuation of either drug. In patients who develop unexplained lethargy, vomiting, or changes in mental status associated with any Topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. The 25 mg tablets are white, film coated, round, biconvex tablets debossed with IG on one side and 278 on other. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients. Measurement of baseline and periodic serum bicarbonate during Topiramate treatment is recommended. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. Take a teaspoonful of any soft food like applesauce, yogurt, ice-cream, oatmeal, custard or pudding. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of Topiramate in the patient being dialyzed. Adults and Pediatric Patients 10 Years and Older. , decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Topiramate treatment. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. There are some specifications that should be followed when using topiramate medicine. In clinical trials, most of these events were reversible after Topiramate discontinuation. should not use this medication. 2, 2. 39% for infants exposed to a reference AED. 0035 deaths per patient year. Behaviors of concern should be reported immediately to healthcare providers. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Those with pre-existing heart diseases, women who are planning to become pregnant (as this leads to increase the risk of birth defects like cleft lip and palate), those who suffers from kidney stones, blood pressure, etc. Rare: upper motor neuron lesion, cerebellar syndrome, tongue paralysis. All Consumer Professional Pill ID Interactions News FDA Alerts Approvals Pipeline Clinical Trials Care Notes Encyclopedia Dictionary Natural Products. Urinary System Disorders: Infrequent: urinary retention, face edema, renal pain, albuminuria, polyuria, oliguria. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Such electrolyte imbalance has been observed with the use of Topiramate in placebo-controlled clinical trials and in the post-marketing period. Skin and Appendages Disorders: Infrequent: urticaria, photosensitivity reaction, abnormal hair texture. 2% compared to a prevalence of 0. Heart Rate and Rhythm Disorders: Infrequent: AV block. Reported reactions are included except those already listed in the previous tables or text, those too general to be informative, and those not reasonably associated with the use of the drug. The clinical consequences were not severe in most cases, but deaths have been reported after poly-drug overdoses involving Topiramate. However many people who take this medicine reports that it makes certain foods taste differently, particularly diet colas. Topiramate, USP is a white crystalline powder with a bitter taste. Although not studied, Topiramate treatment or an interaction of concomitant Topiramate and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. On occasion, the addition of Topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. It suppresses the appetite and makes you feel full. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize). Because these Topiramate treatment difference incidence (Topiramate % - Placebo %) of many adverse reactions reported in this study were markedly lower than those reported in the previous epilepsy studies, they cannot be directly compared with data obtained in other studies. For patients 6 to 11 years, the following were noted to be abnormally increased more frequently with Topiramate than with placebo: alkaline phosphatase, creatinine and eosinophils. With this altered taste sensations, some foods may not seem as appetising, leading you avoidance and weight loss. Similarly, the cited frequencies cannot be directly compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior or thoughts about self-harm. To enroll, patients can call the toll free number 1-888-233-2334. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. Topiramate tablets can be taken without regard to meals. In infants of mothers without epilepsy or treatment with other AEDs, the prevalence was 0. Vascular (Extracardiac) Disorders: Infrequent: flushing, deep vein thrombosis, phlebitis. It is not possible to know whether this mortality rate is related to Topiramate treatment, because the background mortality rate for a similar, significantly refractory, young pediatric population (1 to 24 months) with partial epilepsy is not known. As in the general population, the incidence of stone formation among Topiramate-treated patients was higher in men. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Topiramate (using dose tapering). 5% versus 3. The majority of the reports have been in pediatric patients. During long-term (up to 1 year) Topiramate treatment in an open-label extension study of 284 pediatric patients 1 to 24 months old with epilepsy, 7% developed kidney or bladder stones that were diagnosed clinically or by sonogram. If visual problems occur at any time during Topiramate treatment, consideration should be given to discontinuing the drug. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e. The sprinkle formulation is bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic equivalent. Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Controlled trials of adjunctive Topiramate treatment of adults for partial onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% Topiramate, 2% placebo), markedly increased serum alkaline phosphatase (3% Topiramate, 1% placebo), and decreased serum potassium (0. The hyperammonemia associated with Topiramate treatment appears to be more common when Topiramate is used concomitantly with VPA. Clinical management and assessment should include examination of blood ammonia levels. Topiramate has demonstrated selective developmental toxicity, including teratogenicity, in multiple animal species at clinically relevant doses. Topiramate medicine can be consumed either in tablet or sprinkle capsule (sprinkled on food) form. To avoid rapid drops in Topiramate plasma concentration during hemodialysis, a supplemental dose of Topiramate may be required. Metabolic and Nutritional Disorders: Infrequent: dehydration, hypocalcemia, hyperlipemia, hyperglycemia, xerophthalmia, diabetes mellitus. Concomitant administration of Topiramate with valproic acid has also been associated with hypothermia (with and without hyperammonemia) in patients who have tolerated either drug alone. Rapid titration rate and higher initial dose were associated with higher incidences of these reactions. 24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. Topiramate can cause fetal harm when administered to a pregnant woman. Inspection of these frequencies, however, does provide the prescribing physician with a basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied. Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving Topiramate. Gastrointestinal System Disorders: Infrequent: hemorrhoids, stomatitis, melena, gastritis, esophagitis. Potential interactions between Topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. A reduction in growth rate may eventually decrease the maximal height achieved. 7) of suicidal thinking or behavior compared to patients randomized to placebo. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Some patients who experienced one or more cognitive-related adverse reactions in the titration phase had a dose-related recurrence of these reactions in the maintenance phase. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. Caution should be exercised when administered to a nursing woman. The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts of 3. Just remember that it should be taken as a part of complete weight loss program. The listing is alphabetized: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic failure (including fatalities), hepatitis, maculopathy, pancreatitis, and pemphigus. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Newborns of mothers treated with Topiramate should be monitored for metabolic acidosis because of transfer of Topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Infrequent: euphoria, paranoid reaction, delusion, paranoia, delirium, abnormal dreaming. 0% in adult patients, and 4. 4% versus 2. Activated charcoal has been shown to adsorb Topiramate in vitro. The 100 mg tablets are light yellow, film coated, round, biconvex tablets debossed with IG on one side and 280 on other. The majority of cognitive-related adverse reactions were mild to moderate in severity, and they frequently occurred in isolation. Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers (1 to 24 months). Special Senses Other, Disorders: Infrequent: taste loss, parosmia. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. Additional nonspecific CNS events commonly observed with Topiramate in the add-on epilepsy population include dizziness or ataxia. The hyperammonemia associated with Topiramate treatment occurred with and without encephalopathy in placebo-controlled trials and in an open-label, extension trial of infants with refractory epilepsy. It is not necessary to monitor Topiramate plasma concentrations to optimize Topiramate tablets therapy. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. If the decision is made to continue patients on Topiramate in the face of persistent acidosis, alkali treatment should be considered. No age-related difference in effectiveness or adverse effects was evident. Antiepileptic drugs (AEDs), including Topiramate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Topiramate treatment has produced hyperammonemia (in some instances dose-related) in a clinical investigational program in adolescent patients (12 to 17 years) given Topiramate. To avoid rapid drops in Topiramate plasma concentration during hemodialysis, a supplemental dose of Topiramate may be required. The relative bioavailability of Topiramate from the tablet formulation is about 80% compared to a solution. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy before many women know they are pregnant, all women of childbearing potential should be apprised of the potential hazard to the fetus from exposure to Topiramate. It can be an effective tool that together, with diet and exercise, can be used for weight loss. The prescriber should be aware that these data were obtained when Topiramate was added to concurrent antiepileptic drug therapy and cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. The prevalence of oral clefts among Topiramate-exposed infants was 1.
In some instances, abnormalities were also observed at the end of the trial at the final visit and the changes were considered markedly abnormal. The observed rate of oral clefts was 16 times higher than the background rate in the UK, which is approximately 0. Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. 3 ). Dose-related hyperammonemia was observed in the extension trial in pediatric patients up to 2 years old. Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice. Hyperchloremic, non-anion gap, metabolic acidosis (i. Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Adverse reactions most often associated with the use of Topiramate were related to the central nervous system and were observed in the epilepsy population. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of Topiramate on carbonic anhydrase. Generally, Topiramate-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment. Psychiatric Disorders: Frequent: impotence, hallucination, psychosis, suicide attempt. In acute Topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Dose titration should be guided by clinical outcome. Topiramate mechanism for weight loss is not completely know. The dose should be achieved by titration according to the following schedule ( Table 1 ). Hemodialysis is an effective means of removing Topiramate from the body. g. Concomitant administration of Topiramate and valproic acid (VPA) has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone based upon post-marketing reports. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with Topiramate use. Twist off the capsule and pour onto the food. 12%. It will give best results when taken it as a combination with diet, exercise and behaviour modification. This adverse reaction is not due to a pharmacokinetic interaction. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topiramate. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Topamax contains an anti-convulsant property that calms the abnormal excitable nerve cells in the brain. 3% in pediatric patients). Other Adverse Reactions Observed During Double-Blind Epilepsy Adjunctive Therapy Trials. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The data described in the following section were obtained using Topiramate tablets. Concomitant administration of valproic acid and Topiramate has been associated with hyperammonemia with and without encephalopathy. , zonisamide, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. The frequencies presented represent the proportion of patients who experienced a reaction of the type cited on at least one occasion while receiving Topiramate. In open-label, uncontrolled experience, increasing impairment of adaptive behavior was documented in behavioral testing over time in this population. Data from the NAAED Pregnancy Registry (425 prospective Topiramate monotherapy-exposed pregnancies) indicate an increased risk of oral clefts in infants exposed during the first trimester of pregnancy. Topiramate treatment causes non-anion gap, hyperchloremic metabolic acidosis manifested by a decrease in serum bicarbonate and an increase in serum chloride. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. Some of the cases were reported after exposure to elevated environmental temperatures. 2% among infants exposed to Topiramate monotherapy. Topiramate treatment was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies. Paresthesia (usually tingling of the extremities), an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of Topiramate in adult and pediatric patients. In situations where rapid withdrawal of Topiramate is medically required, appropriate monitoring is recommended. The 200 mg tablets are pink, film coated, round, biconvex tablets debossed with IG on one side and 281 on other. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Evaluation of effectiveness and safety in clinical trials has shown no race- or gender- related effects. In clinical trials, 3% of patients were over 60. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. 4% versus 0% for pediatric patients. The following adverse reactions were observed in at least 3% of patients on Topiramate and were 3% to 7% more frequent then in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. The 50 mg tablets are yellow, film coated, round, biconvex tablets debossed with IG on one side and 279 on other. Liver and Biliary System Disorders: Infrequent: SGPT increased, SGOT increased. Drug interactions with some antiepileptic drugs, CNS depressants and oral contraceptives are described here. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1. Adults (17 Years of Age and Over) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome. Steady-state is thus reached in about 4 days in patients with normal renal function. Table 9 also presents the incidence of adverse reactions occurring in at least 1% of pediatric patients treated with Topiramate and occurring with greater incidence than placebo. Topiramate has been administered to 2246 adults and 427 pediatric patients with epilepsy during all clinical studies, only some of which were placebo-controlled. Accordingly, a prolonged period of dialysis may cause Topiramate concentration to fall below that required to maintain an anti-seizure effect. White Cell and Reticuloendothelial System Disorders: Infrequent: lymphadenopathy, eosinophilia, lymphopenia, granulocytopenia. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. In this analysis, the incidence of serious bleeding events for Topiramateand placebo was 0. In general, most patients who experienced adverse reactions during the first eight weeks of these trials no longer experienced them by their last visit. In pooled double-blind studies in pediatric patients (6 to 17 years), an increased risk for certain abnormalities (value outside normal reference range) in selected clinical laboratory analytes measured in blood has been observed during Topiramate treatment of pediatric patients compared to placebo-treated patients. This in turn helps you to get relief from binge eating that further avoids weight gain. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. Hydration is recommended to reduce new stone formation. Anyone considering prescribing Topiramate or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. There is definitely proof that topiramate helps with weight loss, however be sure to check with your doctor before using. Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. 4% Topiramate, 0. In a single randomized, double-blind placebo-controlled investigational trial, the efficacy, safety, and tolerability of Topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in infants 1 to 24 months of age with refractory partial onset seizures were assessed. 3% versus 0. It also gives relief from many other health problems. For other drug interactions, please refer to Clinical Pharmacology ( 12. Topiramate resulted in an increased incidence of patients with increased creatinine (any Topiramate dose 5%, placebo 0%), BUN (any Topiramate dose 3%, placebo 0%), and protein (any Topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any Topiramate dose 7%, placebo 0%). The following adverse reactions are discussed in more detail in other sections of the labeling. Accordingly, a prolonged period of dialysis may cause Topiramate concentration to fall below that required to maintain an anti-seizure effect. Monotherapy Treatment in Partial Onset Epilepsy in Patients. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. In hepatically impaired patients, Topiramate plasma concentrations may be increased. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Topiramate tablets are available containing 25 mg, 50 mg, 100 mg or 200 mg of Topiramate, USP. During these studies, all adverse reactions were recorded by the clinical investigators using terminology of their own choosing. An explanation for the association of Topiramate and kidney stones may lie in the fact that Topiramate is a carbonic anhydrase inhibitor. A patient who ingested a dose between 96 and 110 g Topiramate was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. These very young pediatric patients appeared to experience an increased risk for infections (any Topiramate dose 12%, placebo 0%) and of respiratory disorders (any Topiramate dose 40%, placebo 16%). Consult your health care provider before using this as weight loss aid. Platelet, Bleeding, and Clotting Disorders: Infrequent: gingival bleeding, pulmonary embolism. During the course of premarketing development of Topiramate tablets, 10 sudden and unexplained deaths were recorded among a cohort of treated patients (2796 subject years of exposure). Information about the North American Drug Pregnancy Registry can be found at. This represents an incidence of 0. There was a suggestion that this effect was dose-related. Daily doses above 1,600 mg have not been studied. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse event for Topiramatethan for placebo (4. The incidence of hyperammonemia (above the upper limit of normal reference) at any time in the trial was 9% for placebo, 14% for 50 mg, and 26% for 100 mg Topiramate daily. There was no testing for serum bicarbonate, chloride, ammonia, or phosphorus in these younger patients. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with Topiramate has been reported in pediatric patients as well as adults. In adults, the most frequent of these can be classified into three general categories. 8, 95% CI:1. Hyperammonemia with and without encephalopathy has also been observed in post-marketing reports in patients who were taking Topiramate without concomitant valproic acid (VPA). Although not approved for use in patients under 2 years of age with partial onset seizures, a controlled trial that examined this population revealed that Topiramate produced a metabolic acidosis that is notably greater in magnitude than that observed in controlled trials in older children and adults. g. Other measures, in conjunction with discontinuation of Topiramate, may be helpful. 2% for adult patients, and 0. During this trial, markedly increased ammonia levels returned to normal in all but one patient (in whom the ammonia level fell to high instead of markedly abnormal). Follow the directions given in the prescription label or ask your doctor or pharmacist to get detailed information about the dosage. In the majority of instances, paresthesia did not lead to treatment discontinuation. People who want a Body Mass Index (BMI) of 30 or BMI greater than 27, there are certain cardiac risk factors like high blood pressure, diabetes, high cholesterol, etc. Analytes abnormally decreased were: total white count and neutrophils. 1% placebo). The effects of this exposure on infants are unknown. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. Reproductive Disorders, Male: Infrequent: ejaculation disorder, breast discharge. Concomitant use of Topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e. Topiramate is not approved for treatment of epilepsy in. e. All patients were maintained on concomitant carbamazepine with or without another concomitant antiepileptic drug. 17%. The mean plasma elimination half-life is 21 hours after single or multiple doses. In addition to the adverse experiences reported during clinical testing of Topiramate, the following adverse experiences have been reported worldwide in patients receiving Topiramate post-approval. Other Adverse Reactions Observed During All Epilepsy Clinical Trials. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving Topiramate. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Symptoms typically occur within 1 month of initiating Topiramate therapy. Hyperammonemia with and without encephalopathy has also been observed in post-marketing reports in patients taking Topiramate with VPA. Cardiovascular Disorders, General: Infrequent: hypotension, postural hypotension, angina pectoris. When multiple species of pregnant animals received Topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. However, clinical studies of Topiramate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of Topiramate for adjunctive epilepsy. Absorption of Topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. Topiramate can cause fetal harm when administered to a pregnant woman. The effect of Topiramate on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Increased Risk for Bleeding Topiramate treatment is associated with an increased risk for bleeding.
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