The noeffect dose (0.2 mg/kg/day) for pre- and postnatal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. Breastfed babies may be sleepy or have diarrhea. Do not give TOPAMAX to other people, even if they have the same symptoms that you have. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, and Cmax was reduced by 18% and 25%, respectively. 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. Reductions in length and weight were correlated to the degree of acidosis [see Use In Specific Populations]. TOPAMAX treatment can cause metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. Brand names: Topamax, Topamax Sprinkle This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate [see DRUG INTERACTIONS]. For its part, Boehringer Ingelheim offers the brand name Flomax at an online price of $35 for 30 capsules or $90 for 90 capsules with free home delivery. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Tell patients that they should not take a double dose in the event of a missed dose. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. Follow your healthcare providers directions exactly. 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. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. 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). The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear. TOPAMAX can slow your thinking and motor skills, and may affect vision. TOPAMAX can cause fetal harm when administered to a pregnant woman. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. 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]. side effects drug center topamax (topiramate) drug. We comply with the HONcode standard for trustworthy health information. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period. Multiple dosing of topiramate (100 mg every 12 hours) in 24 healthy volunteers (14 males, 10 females) did not affect the pharmacokinetics of single-dose sumatriptan either orally (100 mg) or subcutaneously (6 mg). The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Description and Brand Names. You will need frequent medical tests. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. 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 TOPAMAX. 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). TOPAMAX Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream (debossed OMN on one side; 25 on the other), 50 mg light-yellow (debossed OMN on one side; 50 on the other), 100 mg yellow (debossed OMN on one side; 100 on the other), 200 mg salmon (debossed OMN on one side; 200 on the other). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The most common adverse reactions in the controlled clinical trial that occurred in adult patients in the 200-400 mg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: dizziness, speech disorders/related speech problems, somnolence, nervousness, psychomotor slowing, and vision abnormal (Table 6). Tamsulosin helps relax the muscles in the prostate and the opening of the bladder. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Today, there are 11 tamsulosin 0.4-mg generics available in the United States, ranging in price from $10 to $30 for a 30-day supply. The recommended total daily dose of TOPAMAX as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). TOPAMAX is associated with an increased risk for bleeding. Topiramate doses are sometimes based on weight in children. Tell your doctor about all medications you use. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Clinical signs of maternal toxicity were seen at 400 mg/kg/day and above, and maternal body weight gain was reduced at doses of 100 mg/kg/day or greater. TABLETS, for oral use, TOPAMAX
In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. Tamsulosin is not approved for use in women. These changes were often dose-related, and were most frequently associated with the greatest treatment difference at the 200 mg dose level. other information we have about you. Advertising revenue supports our not-for-profit mission. It is also used to help prevent migraine headaches. This medication is also used to prevent migraine headaches and decrease how often you get them. Brand name: Flomax. Subset analyses of the antiepileptic efficacy of TOPAMAX tablets in these studies showed no differences as a function of gender, race, age, baseline seizure rate, or concomitant AED. Controlled Substances Act (CSA). Manufactured by: Janssen Ortho LLC, Guarabo, Puerto Rico 00778. Figure 1: Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure in Study 1. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. Patients who were experiencing at least 60 seizures per month before study entry were stabilized on optimum dosages of their concomitant AEDs during a 4-week baseline phase. Comments: Get emergency medical help if you have signs of an allergic reaction to tamsulosin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). 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. 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. If you stop using tamsulosin for several days in a row, do not start it again without your doctor's advice. (TOE-PA-MAX)
Figure 2: Reduction in 4-Week Migraine Headache Frequency
Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. 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. In clinical trials, 3% of patients were over age 60. Your child's dose needs may change if the child gains or loses weight. In Study 11, a total of 469 patients (416 females, 53 males), ranging in age from 13 to 70 years, were randomized and provided efficacy data. 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. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. The third column (topiramate concentration) describes how the co-administration of a drug listed in the first column modifies the concentration of topiramate when compared to TOPAMAX given alone. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Body as a Whole-General Disorders: oligohydrosis and hyperthermia [see WARNINGS AND PRECAUTIONS], hyperammonemia, hyperammonemic encephalopathy [see WARNINGS AND PRECAUTIONS], hypothermia with concomitant valproic acid [see WARNINGS AND PRECAUTIONS], Gastrointestinal System Disorders: hepatic failure (including fatalities), hepatitis, pancreatitis, Skin and Appendage Disorders: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [see WARNINGS AND PRECAUTIONS], pemphigus, Urinary System Disorders: kidney stones, nephrocalcinosis [see WARNINGS AND PRECAUTIONS], Vision Disorders: acute myopia, secondary angle closure glaucoma [see WARNINGS AND PRECAUTIONS], maculopathy. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. The clinical relevance of this observation has not been established. Copyright 2023 by RxList Inc. An Internet Brands company. If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. Your healthcare provider may change your dose. Continue reading, Topamax (topiramate) is approved to be taken alone or with other medicines to control certain types of seizures and for the prevention of migraine headaches. Sometimes people with metabolic acidosis will: Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX. About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. Of the total drug interactions, 32 are major, 248 are moderate, and 4 are minor. numbness or tingling in your arms and legs. 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. RxList does not provide medical advice, diagnosis or treatment. Important Safety Information BPH can occur with other more serious conditions, including prostate cancer. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. Take tamsulosin capsules exactly as prescribed by your doctor. 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. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. Revised: Jun 2020. Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. 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]. 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 [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. Do not stop using Topamax suddenly or you could have increased seizures. Limited data from 5 women with epilepsy treated with topiramate during lactation showed drug levels in milk similar to those in maternal plasma. The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 5 mg to 9 mg/kg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: fatigue and somnolence (Table 7). Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. Following randomization, patients began the double-blind phase of treatment. If required, longer intervals between dose adjustments can be used. If you have cataract surgery, tell the surgeon you use this medicine . Hair loss (also called alopecia) has been reported in 1% to 4% of children ages 6 to 16 years of age, and in 3% to 4% of patients older than 16 years of age. Multiple dosing of TOPAMAX (150 mg/day) in healthy volunteers did not affect the pharmacokinetics of venlafaxine or O-desmethyl venlafaxine. 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 addition of HCTZ to TOPAMAX may require a decrease in the TOPAMAX dose [see CLINICAL PHARMACOLOGY]. A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. You can enroll in this registry by calling 1-888-233-2334. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 to 250 g/mL. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. What should I avoid while taking TOPAMAX? This dataset contained data from 1217 subjects including 258 pediatric patients age 2 to <16 years (95 pediatric patients <10 years of age). If the decision is made to continue patients on TOPAMAX in the face of persistent acidosis, alkali treatment should be considered. Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. Systematic collection of orthostatic vital signs has not been conducted. Your family or other caregivers should also be alert to changes in your mood or symptoms. 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. 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. any sudden decrease in vision with or without eye pain and redness. Efficacy of topiramate for the preventive treatment of migraine in pediatric patients 12 to 17 years of age is demonstrated for a 100 mg daily dose in Study 13 [see Clinical Studies]. Patients who experienced 3 to 12 migraine headaches over the 4 weeks in the baseline phase were randomized to either TOPAMAX 50 mg/day, 100 mg/day, 200 mg/day, or placebo and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Alfuzosin may also be used for purposes not listed in this medication guide. Carefully follow the swallowing instructions for your medicine. It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or depression. This is not a complete list of side effects and others may occur. This finding was not statistically significant. health information, we will treat all of that information as protected health Side Effects Some w omen experience dizziness when taking tamsulosin. Hydration is recommended to reduce new stone formation. Counsel patients, their caregivers, and families that AEDs, including TOPAMAX, may increase the risk of suicidal thoughts and behavior, and advise 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, or behavior or thoughts about self-harm. In clinical trials, most of these events were reversible after topiramate discontinuation. For more information, ask your doctor or pharmacist. 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 SGA [see Human Data]. Effectiveness of treatment was assessed by comparing each TOPAMAX treatment group to placebo (ITT population) for the percent reduction from baseline to the last 12 weeks of the double-blind phase in the monthly migraine attack rate (primary endpoint). Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. Do not take two doses at one time. A dosage adjustment is recommended in patients with moderate or severe renal impairment [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. 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. Take Topamax exactly as it was prescribed for you. Avoid becoming overheated or dehydrated in hot weather. signs of too much ammonia in your blood--vomiting, unexplained weakness, feeling like you might pass out. Types of Traumatic Brain Injury (TBI) Medications. Visit the FDA MedWatch website or call 1-800-FDA-1088. have a history of metabolic acidosis (too much acid in the blood). 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 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. TOPAMAX is not approved for treatment of epilepsy in pediatric patients less than 2 years old [see Use In Specific Populations]. Do not drive a car or operate machinery until you know how TOPAMAX affects you. The clinical significance of this change is unknown. TOPAMAX is a carbonic anhydrase inhibitor. Topamaxbelongs to a class of drugs called Anticonvulsants, Other, Antimigraine Agents. It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. 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