We comply with the HONcode standard for trustworthy health information. Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, TOPAMAX 50, 100, and 200 mg groups, respectively. This medication is also used to prevent migraine headaches and decrease how often you get them. decreased feeling or sensitivity, especially in the skin. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11. Brand name: Flomax. Figure 2: Reduction in 4-Week Migraine Headache Frequency In addition, a 13% and 16% decrease in Cmax,ss and AUC,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUC,ss of the active keto-metabolite. The effectiveness of TOPAMAX as an adjunctive treatment for adults with partial-onset seizures was established in six multicenter, randomized, double-blind, placebo-controlled trials (Studies 2, 3, 4, 5, 6, and 7), two comparing several dosages of TOPAMAX and placebo and four comparing a single dosage with placebo, in patients with a history of partial-onset seizures, with or without secondarily generalized seizures. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. The significance of these findings is uncertain. Topiramate is excreted in human milk [see Data]. Table 8 includes those adverse reactions that occurred in the placebo-controlled trials where the incidence in any TOPAMAX treatment group was at least 3% and was greater than that for placebo patients. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. The results of 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials established the effectiveness of TOPAMAX in the preventive treatment of migraine. Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Use: Benign prostatic hyperplasia (BPH). Do not stop using this medication before surgery unless your surgeon tells you to. A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and TOPAMAX in a clinical trial. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Skip a missed Topamax dose if your next dose is due in less than 6 hours. In pregnant rabbits administered topiramate (0, 20, 60, and 180 mg/kg/day or 0, 10, 35, and 120 mg/kg/day) orally during organogenesis, embryofetal mortality was increased at 35 mg/kg/day, and increased incidences of fetal malformations (primarily rib and vertebral malformations) were observed at 120 mg/kg/day. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. 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 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. 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. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. 10 Things People With Depression Wish You Knew, * Administered in two equally divided doses, Difficulty with concentration or attention, Placebo Patients with Events per 1000 Patients, Drug Patients with Events per 1000 Patients. If you need surgery, tell the surgeon ahead of time that you are using topiramate. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age (SGA). Common tamsulosin side effects may include: abnormal ejaculation, decreased amount of semen; runny or stuffy nose, sore throat, cough; This is not a complete list of side effects and others may occur. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Patients received either no or a combination of other antiepileptic drugs. Call your doctor if you have missed more than one dose. This will be based on how well it is working for you and any side effects you may experience. As in adults, hepatic enzyme-inducing antiepileptic drugs decrease the steady state plasma concentrations of topiramate. The median average daily dosages were 48 mg/day, 88 mg/day, and 132 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. 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]. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX. 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. These eye problems can lead to permanent loss of vision if not treated. Controlled trials of adjunctive TOPAMAX treatment of adults for partial-onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% TOPAMAX versus 2% placebo), markedly increased serum alkaline phosphatase (3% TOPAMAX versus 1% placebo), and decreased serum potassium (0.4 % TOPAMAX versus 0.1 % placebo). home Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. Hypothermia, defined as a drop in body core temperature to <35C (95F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. 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). Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. Psychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations [see Suicidal Behavior And Ideation]. When topiramate (0, 30, 90, and 300 mg/kg/day) was administered orally to rats during the juvenile period of development (postnatal days 12 to 50), bone growth plate thickness was reduced in males at the highest dose. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. information is beneficial, we may combine your email and website usage information with Carefully follow the swallowing instructions for your medicine. Table 9: Adverse Reactions in Pooled Double-Blind Studies for the Preventive Treatment of Migraine in Pediatric Patients 12 to 17 Years of Agea,b,c. We comply with the HONcode standard for trustworthy health information. 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. In four, fixed-dose, double-blind clinical trials for the preventive treatment of migraine in TOPAMAX-treated pediatric patients 12 to 17 years of age, the most common adverse reactions with TOPAMAX 100 mg that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain (see Table 9). are breastfeeding or plan to breastfeed. Using Topamax with other drugs that make you drowsy can worsen this effect. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. It may not be safe to breastfeed a baby while you are using this medicine. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Table 6 presents the incidence of adverse reactions occurring in at least 3% of adult patients treated with 200 to 400 mg/day TOPAMAX and was greater than placebo incidence. You are encouraged to report negative side effects of prescription drugs to the FDA. Your blood pressure will need to be checked often. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). Your reactions could be impaired. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. Instruct patients that if they miss a single dose of TOPAMAX, it should be taken as soon as possible. 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. 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]. After titration, patients entered a 4, 8 or 12-week stabilization period. Concomitant administration of phenytoin or carbamazepine with TOPAMAX resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to TOPAMAX given alone. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Patients in Study 10 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. Inform patients about the signs of serious skin reactions. 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). This list is not complete. Some people have thoughts about suicide while taking an anticonvulsant. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. TOPAMAX is not indicated for the preventive treatment of migraine in pediatric patients less than 12 years of age. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Using a high-efficiency, counterflow, single pass-dialysate hemodialysis procedure, topiramate dialysis clearance was 120 mL/min with blood flow through the dialyzer at 400 mL/min. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Brand name: Flomax General information about the safe and effective use of TOPAMAX. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. Anticonvulsant. You will need frequent medical tests. Revised: Jun 2020. 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. TOPAMAX Sprinkle Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). Two hundred sixty-five patients completed the entire 26-week double-blind phase. a painful erection that lasts 4 hours or longer. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. Avoid becoming overheated or dehydrated in hot weather. 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. Consider the benefits and the risks of TOPAMAX when administering this drug in women of childbearing potential, particularly when TOPAMAX is considered for a condition not usually associated with permanent injury or death [see Use In Specific Populations, PATIENT INFORMATION]. Symptoms include acute onset of decreased visual acuity and/or ocular pain. 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]. You should not drink alcohol while taking topiramate.. Tell your doctor if you are sick with diarrhea, or if you have ever had: metabolic acidosis (high levels of acid in your blood); kidney disease, kidney stones, or dialysis; mood problems, depression, or suicidal thoughts or actions; soft or brittle bones (osteoporosis, osteomalacia). Treatment with topiramate for up to 1 year was associated with reductions in Z SCORES for length, weight, and head circumference [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. Common Topamax side effects may include include: dizziness, drowsiness, tiredness, slow reactions; problems with speech or memory, abnormal vision; numbness or tingling in your arms and legs, decreased sensation (especially in the skin); changes in your sense of taste, feeling nervous; nausea, diarrhea, stomach pain, loss of appetite; cold symptoms such as stuffy nose, sneezing, sore throat. Table 9 also shows adverse reactions in pediatric patients in the controlled migraine trials when the incidence in a TOPAMAX dose group was at least 5 % or higher and greater than the incidence of placebo. After titration, patients entered an 8-week stabilization period. In Study 12, a total of 468 patients (406 females, 62 males), ranging in age from 12 to 65 years, were randomized and provided efficacy data. Reflecting the primary renal elimination of topiramate, topiramate plasma and renal clearance were reduced 21% and 19%, respectively, in elderly subjects, compared to young adults. Your child's dose needs may change if the child gains or loses weight. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. TOPAMAX Sprinkle Capsules should be stored in tightly-closed containers at or below 25C (77F). Table 10: Summary of AED Interactions with TOPAMAX. This list is not complete and many Other drugs may interact with tamsulosin. drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. See additional information. Do not use TOPAMAX for a condition for which it was not prescribed. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tamsulosin only for the indication prescribed. It will not treat a headache that has already begun. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely. Many drugs can affect tamsulosin, especially: medicine to treat impotence or pulmonary arterial hypertension--avanafil (Stendra), sildenafil (Viagra, Revatio), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn); or. The clinical significance of this change is unknown. The change in the mean 4-week migraine headache frequency from baseline to the double-blind phase was -1.3, -2.1, and -2.2 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). The most common adverse reactions with TOPAMAX 100 mg in the clinical trials for the preventive treatment of migraine of predominantly adults that were seen at an incidence higher ( 5 %) than in the placebo group were: paresthesia, anorexia, weight loss, taste perversion, diarrhea, difficulty with memory, hypoesthesia, and nausea (see Table 8). 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. Side Effects Some w omen experience dizziness when taking tamsulosin. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. Metabolic acidosis may have harmful effects on your baby. Follow your doctor's instructions about tapering your dose. Some of the cases were reported after exposure to elevated environmental temperatures. 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]. Systematic collection of orthostatic vital signs has not been conducted. Brand Name: Flomax Generic Name: Tamsulosin hydrochloride (HCl) Relevant IND: IND 30,365 . The treatment differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p<0.001 for both comparisons). 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. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. If you stop using this medicine, do not start it again without your doctor's advice. However, tamsulosin will not shrink the prostate. Dose titration should be guided by clinical outcome. The effectiveness of TOPAMAX for the preventive treatment of migraine in pediatric patients 12 to 17 years of age was established in a multicenter, randomized, double-blind, parallel-group trial (Study 13). Topamax may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. 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]. All rights reserved. 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]. 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. Topamaxbelongs to a class of drugs called Anticonvulsants, Other, Antimigraine Agents. The clinical significance of this change is unknown. During long-term (up to 1 year) TOPAMAX treatment in an open-label extension study of 284 pediatric patients 1-24 months old with epilepsy, 7% developed kidney or bladder stones. Medically reviewed by Sophia Entringer, PharmD. Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. The effectiveness of TOPAMAX as initial monotherapy in adults and pediatric patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial (Study 1). benign prostatic hyperplasia. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. Description and Brand Names. Warnings Topamax may cause vision problems that can be permanent if not treated quickly. Sodium valproate, at 500 g/mL (a concentration 5 to 10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Do not take two doses at one time. Do not drive a car or operate machinery until you know how TOPAMAX affects you. To provide you with the most relevant and helpful information, and understand which People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Newborns of mothers treated with TOPAMAX should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. However, having a seizure during pregnancy could harm both the mother and the baby. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. Overdoses of TOPAMAX have been reported. 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. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. Alfuzosin is an alpha-adrenergic (AL-fa ad-ren-ER-Jk) blocker that is used to improve urination in men with benign prostatic hyperplasia ( enlarged prostate ). 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. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. This drug/food mixture should be swallowed immediately and not chewed. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of TOPAMAX, and to skip the missed dose. Manufactured by: Janssen Ortho LLC, Guarabo, Puerto Rico 00778. 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). Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. Drug information provided by: Merative, Micromedex. The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in pediatric patients in the 400 mg/day TOPAMAX group and at an incidence higher (10%) than in the 50 mg/day group were fever and weight loss (see Table 5). These comprised a fixed dose study in 103 pediatric patients 12 to 17 years of age [see Clinical Studies], a flexible dose (2 to 3 mg/kg/day), placebo-controlled study in 157 pediatric patients 6 to 16 years of age (including 67 pediatric patients 12 to 16 years of age), and a total of 49 pediatric patients 12 to 17 years of age in 3 studies for the preventive treatment of migraine primarily in adults. Approximately 80% or more patients in each treatment group completed the study. 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. Topamax may cause vision problems that can be permanent if not treated quickly. Carbonic anhydrase inhibitor anticonvulsants. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). Continue reading, Trokendi XR, Topiragen, Eprontia, Qudexy XR. And relative risk by indication for all evaluated AEDs AEDs ) in adults, hepatic antiepileptic. Tapering your dose information about the safe and effective use of TOPAMAX, may be helpful this is. Each dose and the baby or sensitivity, especially in the skin exercise and hot. Capsules should be stored in tightly-closed containers at or below 77F ( 25C ) dose is due in than! Some people have thoughts about suicide while taking an anticonvulsant by concomitant administration glyburide. Worsen this effect actual mean and median doses in the stabilization period are shown in table 11 in hot.! Both the mother and the baby consistent among drugs in the Data analyzed changes, in mood,,! Drugs ( AEDs ) in addition to TOPAMAX tablets or placebo exercise in. 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