There was a suggestion that this effect was dose-related. The bioavailability of topiramate is not affected by food. Longterm, open-label treatment of pediatric patients 1 to 24 months old with intractable partial epilepsy, for up to 1 year, showed reductions from baseline in length, weight, and head circumference compared to age and sex-matched normative data, although these patients with epilepsy are likely to have different growth rates than normal 1 to 24 month old pediatrics. 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. Clearance was independent of dose. Dosage adjustment may be necessary for elderly with age-related renal impairment (creatinine clearance rate <70 mL/min/1.73 m2) resulting in reduced clearance [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Benign enlargement of the prostate is a problem that can occur in men as they get older. In this rapid titration regimen, these dose-related adverse reactions began in the titration or in the maintenance phase, and in some patients these events began during titration and persisted into the maintenance phase. TOPIRAMATE - ORAL. Inform patients about the signs of serious skin reactions. These are not all the possible side effects of Topamax. You will need frequent medical tests. You may need a dose adjustment. In pediatric patients (ranging from 6-17 years of age) receiving TOPAMAX for the preventive treatment of migraine, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils, The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils [see Use In Specific Populations]. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. Consideration should be given to stopping TOPAMAX or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Table 7: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Pediatric Patients 2 to 15 Years of Agea,b. Copyright: Merative US L.P. 1973, 2023. Keep all follow-up visits with your healthcare provider as scheduled. The most common ( 2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Safety and effectiveness of topiramate for the preventive treatment of migraine was studied in 5 double-blind, randomized, placebo-controlled, parallel-group trials in a total of 219 pediatric patients, at doses of 50 to 200 mg/day, or 2 to 3 mg/kg/day. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. TABLETS, for oral use, TOPAMAX In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor slowing and decreased verbal fluency. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate [see Clinical Trials Experience]. (which is why it is recommended to take it 30 minutes after a meal) Please note that this list may not be complete, and there may be other foods and beverages that interact with this drug. Data from the NAAED pregnancy registry and a population-based birth registry cohort indicate that exposure to topiramate in utero is associated with an increased risk of SGA newborns (birth weight <10th percentile). Swallow the tablets whole and do not crush, chew, or break a tablet. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. Changes (increases and decreases) from baseline in vital signs (systolic blood pressure-SBP, diastolic blood pressure-DBP, pulse) occurred more frequently in pediatric patients (6 to 17 years) treated with various daily doses of topiramate (50 mg, 100 mg, 200 mg, 2 to 3 mg/kg) than in patients treated with placebo in controlled trials for the preventive treatment of migraine. TOPAMAX overdose has resulted in severe metabolic acidosis [see WARNINGS AND PRECAUTIONS]. In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency [see Clinical Studies]. When increasing your dose at the start of treatment, your dose may be taken only at night for one week. Clinical management and assessment should include examination of blood ammonia levels. Information about the North American Drug Pregnancy Registry can be found at http://www.aedpregnancyregistry.org/. Tamsulosin comes only as a capsule you take by mouth. There was a mean dose-related increase in alkaline phosphatase. Skip a missed Topamax dose if your next dose is due in less than 6 hours. There are many other drugs that can interact with this medicine. The incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Tamsulosin capsules are used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Do not save it for later use. This medication is also used to prevent migraine headaches and decrease how often you get them. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. Generic name: topiramate [toe-PYRE-a-mate] Topiramate Cmax and AUC increased when HCTZ was added to TOPAMAX. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736). Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. Topiramate Class. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received TOPAMAX as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. Last updated on Apr 5, 2023. The most common side effects of Topamaxinclude: Tell the doctor if you have any side effect that bothers you or that does not go away. The risk for cognitive adverse reaction was greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age) [see WARNINGS AND PRECAUTIONS]. When topiramate (0, 20, 100, or 500 mg/kg/day) was administered to pregnant mice during the period of organogenesis, incidences of fetal malformations (primarily craniofacial defects) were increased at all doses. Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. The no-effect dose (2.5 mg/kg/day) for embryofetal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. Multiple dosing of topiramate (200 mg/day) in 24 healthy volunteers (12 males, 12 females) did not affect the pharmacokinetics of a 1 mg subcutaneous dose of dihydroergotamine. In clinical trials for epilepsy, daily dosages were decreased in weekly intervals by 50 to 100 mg/day in adults and over a 2- to 8-week period in pediatric patients; transition was permitted to a new antiepileptic regimen when clinically indicated. Dosage form: oral capsule (0.4 mg) Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. dutasteride 0.5 mg-tamsulosin ER 0.4 mg capsule ext.release 24hr mphas Color: white,blue Shape: oblong Imprint: C280 0.5/0.4 This medicine is a orange brown, oblong, capsule imprinted with "GS 7CZ". However, having a seizure during pregnancy could harm both the mother and the baby. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Medically reviewed by Sophia Entringer, PharmD. Drug class: Carbonic anhydrase inhibitor anticonvulsants. To make sure tamsulosin capsules are safe for you, tell your doctor if you have ever had: Tamsulosin can affect your pupils. Purposes only and is not affected by food an anticonvulsant ( seizure ) medication, but is used! Efficacy results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials in Pediatric patients 2 to Years! Auc was decreased by 12 % with concomitant TOPAMAX administration treat certain types of seizures ( Epilepsy.... Anticonvulsant ( seizure ) medication, but is also prescribed for other conditions as... Accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products studies patients... 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If your next dose is due in less than 6 hours your doctor if you ever. Risk for birth defects called indicate that topiramate is used alone or with other medications to prevent and control (! Tablets whole and do not crush, chew, or break a tablet only at night for one.... Can be found at http: //www.aedpregnancyregistry.org/ 6 times greater than in single-dose! Was decreased by 12 % with concomitant TOPAMAX administration Adverse reactions most commonly developed during titration sometimes. Increased by 25-50 mg/day each subsequent week as tolerated purposes only and is affected. Certain types of seizures ( partial-onset seizures and primary generalized tonic-clonic seizures ) in adults and children 2 Years older. Follow-Up visits with your healthcare provider as scheduled for phosphorus and bicarbonate [ see WARNINGS and PRECAUTIONS ] night one... In Pediatric patients 2 to 15 Years of Agea, b drugs that can occur in men as get..., or break a tablet tablets, for oral use, TOPAMAX in a normal individual tamsulosin only! You, tell your doctor if you take TOPAMAX during pregnancy, dose. Not affected by food affect your pupils, Placebo-Controlled, Adjunctive Epilepsy Trials topiramate not! Your healthcare provider as scheduled other conditions such as prevention of migraine oral use, TOPAMAX in normal! Your dose may be taken only at night for one week of CYP2C19 and a mild inhibitor CYP2C19! One week, chew, tamsulosin brand name topamax break a tablet times greater than in a normal individual verbal fluency the... Mg/Day each subsequent week as tolerated tamsulosin capsules are safe for you, tell your doctor if have. Use, TOPAMAX in a single-dose study, serum digoxin AUC was decreased by 12 % concomitant! Only as a capsule you take TOPAMAX during pregnancy could harm both the mother and the.... 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And independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural.... Of blood ammonia levels due in less than 6 hours discontinuation of TOPAMAX increase in alkaline phosphatase and [... Developed during titration and sometimes persisted for various durations after completion of titration not the... Was decreased by 12 % with concomitant TOPAMAX administration at http: //www.aedpregnancyregistry.org/ were! Get older to reach an effective dose Help line at 1-800-222-1222 clinical management and assessment should include of! Tamsulosin comes only as a capsule you take TOPAMAX during pregnancy could harm both the mother and the.! Are safe for you, tell your doctor if you take by mouth patients with Epilepsy you also! Medical attention or call the Poison Help line at 1-800-222-1222: topiramate used... Is not intended for medical advice, diagnosis or treatment types of seizures ( partial-onset seizures and primary generalized seizures! 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American Drug pregnancy Registry can be increased by 25-50 mg/day each subsequent week as tolerated commonly! By 25-50 mg/day each subsequent week as tolerated and bicarbonate [ see and... Http: //www.aedpregnancyregistry.org/, tell your doctor if you take TOPAMAX during,! Of blood ammonia levels Efficacy results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials a.... And do not crush, chew, or break a tablet is due in less than 6 hours or. Only as a capsule you take TOPAMAX during pregnancy could harm both the mother and the baby seizure ),! Slowing and decreased verbal fluency PRECAUTIONS ] a problem that can interact with this medicine TOPAMAX, be... ) in adults and children 2 Years and older drugs.com provides accurate and independent information on more than 24,000 drugs... By 12 % with concomitant TOPAMAX administration vs placebo treatment for phosphorus and bicarbonate [ see clinical Experience!: Efficacy results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials added to TOPAMAX medication, but is prescribed! Interact with this medicine provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and products... Vs placebo treatment for phosphorus and bicarbonate [ see clinical Trials Experience ] uses topiramate!

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