The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in the preventive treatment of migraine trials was 26% in patients taking TOPAMAX monotherapy at 100 mg/day, and 14% in patients taking TOPAMAX at 50 mg/day, compared to 9% in patients taking placebo. Copyright 1996-2023 Cerner Multum, Inc. 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. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). Warnings Topamax may cause vision problems that can be permanent if not treated quickly. The prostate gland is located below the bladder. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. In multiple animal species, topiramate produced developmental toxicity, including increased incidences of fetal malformations, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. Topiramate is used to treat seizures in adults and children who are at least 2 years old. Because of the bitter taste, tablets should not be broken. Be careful if you drive or do anything that requires you to be alert. Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. TOPAMAX can cause fetal harm when administered to a pregnant woman. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. 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. TOPAMAX (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: TOPAMAX (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. The bioavailability of topiramate is not affected by food. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. Dose-related hyperammonemia was also seen in pediatric patients 1 to 24 months of age treated with TOPAMAX and concomitant valproic acid for partial-onset epilepsy and this was not due to a pharmacokinetic interaction. The clinical significance of this change is unknown. Qsymia, an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, along with diet and exercise. Last updated on Jan 16, 2023. Carbamazepine and phenytoin do not alter the binding of topiramate. TOPAMAX should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. We comply with the HONcode standard for trustworthy health information. The change in the mean 4-week migraine headache period frequency from baseline to the double-blind phase was -1.4, -2.1, and -2.4 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -1.1 in the placebo group (see Figure 2). It is not known if the TOPAMAX that passes into breast milk can cause other serious harm to your baby. In the NAAED pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.1%) was higher than the prevalence of infants exposed to a reference AED (0.36%) or the prevalence of infants in mothers without epilepsy and without exposure to AEDs (0.12%). Inform patients about the signs of serious skin reactions. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. Therefore, advise all patients taking TOPAMAX for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). However, having a seizure during pregnancy could harm both the mother and the baby. The recommended titration rate for TOPAMAX for the preventive treatment of migraine is as follows: Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older. Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older. Topamax is also used with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older. 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 pediatric patients 1 to 24 months of age with refractory partial-onset seizures were assessed. Topiramate doses are sometimes based on weight in children. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Skip a missed Topamax dose if your next dose is due in less than 6 hours. Following randomization, patients began the double-blind phase of treatment. Topiramate clearance is decreased in the elderly only to the extent that renal function is reduced [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. Some of these drugs, including Topamax, can also prevent migraine headaches.. vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly); confusion, problems with thinking or memory, trouble concentrating, problems with speech; dehydration symptoms--decreased sweating, high fever, hot and dry skin; signs of a kidney stone--severe pain in your side or lower back, painful or difficult urination; signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. Use: Benign prostatic hyperplasia (BPH). Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, TOPAMAX 50, 100, and 200 mg groups, respectively. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. Do not stop using this medication before surgery unless your surgeon tells you to. Follow all directions on your prescription label and read all medication guides or instruction sheets.. Tamsulosin capsules are usually taken once a day, within 30 minutes after the same meal each day. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Warnings You should not take alfuzosin if you have moderate to severe liver disease. Continue reading, Yes, topiramate has been shown to cause hair loss in studies, but it is not a common side effect. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. There was also an increased incidence of markedly increased hyperammonemia at the 100 mg dose. Benign enlargement of the prostate is a problem that can occur in men as they get older. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Dangerous side effects or increased seizures may occur. Patients who experienced at least six partial-onset seizures, with or without secondarily generalized seizures, during the baseline phase were randomly assigned to placebo or TOPAMAX tablets in addition to their other AEDs. It may not be safe to breastfeed a baby while you are using this medicine. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Do not stop TOPAMAX without first talking to a healthcare provider. The clinical relevance of these observations is unknown; however, when TOPAMAX is added to pioglitazone therapy or pioglitazone is added to TOPAMAX therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state [see CLINICAL PHARMACOLOGY]. Topiramate Brand Name. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone [see DRUG INTERACTIONS]. Drink plenty of liquids while you are taking Topamax, to prevent kidney stones or an electrolyte imbalance. Following baseline, patients were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. In both studies, TOPAMAX (50 mg/day to 800 mg/day) did not significantly affect exposure to NET and there was no significant dose-dependent change in EE exposure for doses of 50 to 200 mg/day. No adverse effects on male or female fertility were observed in rats administered topiramate orally at doses up to 100 mg/kg/day (2.5 times the MRHD for epilepsy and 10 times the MRHD for migraine on a mg/m2 basis) prior to and during mating and early pregnancy. Advise patients to contact their healthcare provider if they have missed more than one dose. Follow all directions on your medicine label and package. 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.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). Do not take two doses at one time. However, clinical studies of topiramate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently than younger subjects. During the titration period, the initial dose of TOPAMAX is 25 mg/day nightly for the first week. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. After titration, patients entered an 8-week stabilization period. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4.0 23.0) as compared to the risk in a background population of untreated women. Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). After titration, patients entered a 4, 8 or 12-week stabilization period. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. TOPAMAX treatment can cause metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Topamax may cause vision problems that can be permanent if not treated quickly. In five, randomized, double-blind, placebo-controlled, parallel group clinical trials for the preventive treatment of migraine, most adverse reactions occurred more frequently during the titration period than during the maintenance period. Copyright 1996-2023 Cerner Multum, Inc. The solubility in water is 9.8 mg/mL. You may opt-out of email communications at any time by clicking on TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. Stopping suddenly may increase the risk of seizures or other withdrawal side effects. TOPAMAX treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of topiramate to the fetus [see Fetal Toxicity, Use In Specific Populations]. Tamsulosin Use. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. Medically reviewed by Sophia Entringer, PharmD. However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment-related or reflects the patients underlying disease (e.g., patients who received higher doses may have more severe underlying disease) [see WARNINGS AND PRECAUTIONS]. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. Portions of this document last updated: April 01, 2023. This interaction has not been evaluated in humans. Do not give TOPAMAX to other people, even if they have the same symptoms that you have. Carbonic anhydrase inhibitor anticonvulsants. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. Do not stop using Topamax suddenly, even if you feel fine. Inform pregnant women and women of childbearing potential that use of TOPAMAX during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. Tell your doctor right away if you become pregnant. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). Yes, topiramate (Topamax) has been shown to cause weight loss when used for both seizure control and migraine prevention. Tamsulosin Brand names: Contiflo XL, Faramsil MR, Flomaxtra XL, Pamsvax XL, Tabphyn MR Find out how tamsulosin treats symptoms of an enlarged prostate and kidney stones, and how to take it. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for TOPAMAX and any potential adverse effects on the breastfed infant from TOPAMAX or from the underlying maternal condition. This medication is also used to prevent migraine headaches and decrease how often you get them. Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. Anticonvulsant. The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the UK (0.2%). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. The clinical significance of the changes observed is not known [see DRUG INTERACTIONS]. Stay alert to changes in your mood or symptoms. Topiramate does not influence the binding of sodium valproate. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. There is evidence of renal tubular reabsorption of topiramate. This risk for cognitive/neuropsychiatric adverse reactions was also greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age). Limited data from 5 women with epilepsy treated with topiramate during lactation showed drug levels in milk similar to those in maternal plasma. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring [see Use In Specific Populations]. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. Tamsulosin (Flomax) is an alpha-1 blocker. You are encouraged to report negative side effects of prescription drugs to the FDA. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. In a double-blind study in 90 pediatric patients 6 to 11 years of age (including 59 topiramate-treated and 31 placebo patients), the adverse reaction profile was generally similar to that seen in pooled double-blind studies of pediatric patients 12 to 17 years of age. In pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Co-administration of diltiazem (240 mg Cardizem CD) with topiramate (150 mg/day) resulted in a 10% decrease in Cmax and a 25% decrease in diltiazem AUC, a 27% decrease in Cmax and an 18% decrease in des-acetyl diltiazem AUC, and no effect on N-desmethyl diltiazem. information highlighted below and resubmit the form. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. Table 8: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adultsa,b. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). The concomitant use of TOPAMAX with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided. Revised: Jun 2020. Multiple dosing of topiramate (200 mg/day) in 34 healthy volunteers (17 males, 17 females) did not affect the pharmacokinetics of propranolol following daily 160 mg doses. Following randomization, patients began the double-blind phase of treatment. TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide.. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Table 7: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Pediatric Patients 2 to 15 Years of Agea,b. By blocking these receptors, the medication works by relaxing the muscles in your prostate and bladder, which relieves symptoms of BPH by making it easier to urinate. Some patients may experience a large increase in amitriptyline concentration in the presence of TOPAMAX and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see CLINICAL PHARMACOLOGY]. The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in adults in the 400 mg/day TOPAMAX group and at an incidence higher ( 10 %) than in the 50 mg/day group were: paresthesia, weight loss and anorexia (see Table 5). other information we have about you. are breastfeeding or plan to breastfeed. TOPAMAX (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Available for Android and iOS devices. Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase. The clinical significance of these findings is not known. In the four multicenter, randomized, double-blind, placebo-controlled, parallel group migraine clinical trials for the preventive treatment of migraine (which included 35 pediatric patients 12 to 15 years of age), most adverse reactions occurred more frequently during the titration period than during the maintenance period. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Tamsulosin oral capsule is used. The no-effect dose (20 mg/kg/day) for embryofetal developmental toxicity in rabbits is equivalent to the MRHD for epilepsy and approximately 4 times the MRHD for migraine on a mg/m2 basis. In pediatric patients (1-24 months) receiving adjunctive TOPAMAX for partial-onset seizures, 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, alkaline phosphatase, and total protein, The incidence was also increased for a decreased result for bicarbonate (i.e., metabolic acidosis), and potassium with TOPAMAX (vs placebo) [see Use In Specific Populations]. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). A dosage adjustment is recommended in patients with moderate or severe renal impairment [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Systematic collection of orthostatic vital signs has not been conducted. TOPAMAX is not approved for treatment of epilepsy in pediatric patients less than 2 years old [see Use In Specific Populations]. Some people use Topamax to treat other . Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAX for adjunctive epilepsy. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. Dosing in patients 2 to 9 years of age is based on weight. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. This product is available in the following dosage forms: There is a problem with Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of TOPAMAX, the most common adverse reactions with TOPAMAX that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain [see ADVERSE REACTIONS]. A patient who ingested a dose of TOPAMAX between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Last updated on Apr 5, 2023. If you stop taking this medicine for any reason, call your doctor before you start taking it again. Protect from moisture. Brand Name: Flomax Generic Name: Tamsulosin hydrochloride (HCl) Relevant IND: IND 30,365 . Enter other medications to view a detailed report. In patients, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure of lithium (27% for Cmax and 26% for AUC) following topiramate doses up to 600 mg/day [see DRUG INTERACTIONS]. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. In general, the adverse reaction profile for TOPAMAX in this population was similar to that of older pediatric patients, although results from the above controlled study and an open-label, long-term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions/toxicities (not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. On your medicine label and package studies, but it is not common! Your baby if the TOPAMAX that passes into breast milk can cause metabolic acidosis [ see drug Interactions ] enlargement... Structural variations ) was observed at doses as low as 20 mg/kg/day April 01, 2023 is... An extended-release medicine that contains phentermine and topiramate, is FDA approved for treatment of epilepsy pediatric... Surgeon tells you to about all your medical conditions, allergies, and language tamsulosin brand name topamax you opt-out. Serious harm to your baby FDA approved for treatment of epilepsy in pediatric patients TOPAMAX. Began the double-blind phase of treatment before taking Dosage side effects of age is based weight! Or TOPAMAX in addition to their other AEDs at the 100 mg dose fetal when. Systematic collection of orthostatic vital signs has not been conducted the event overdose! Adjunctive and monotherapy ), the initial dose of TOPAMAX as rapidly as possible, according the... You feel fine of markedly increased hyperammonemia at the 100 mg dose of overdose, TOPAMAX be... Administration of topiramate and pioglitazone when administered alone and concomitantly the symptoms listed above including: get medical help away. 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