Call your doctor for medical advice about side effects. (topiramate capsules) A dosage adjustment is recommended in patients with moderate or severe renal impairment [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Table 9 shows adverse reactions from the pediatric trial (Study 13 [see Clinical Studies]) in which 103 pediatric patients were treated with placebo or 50 mg or 100 mg of TOPAMAX, and three predominantly adult trials in which 49 pediatric patients (12 to 17 years of age) were treated with placebo or 50 mg, 100 mg or 200 mg of TOPAMAX. 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]. Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [see WARNINGS AND PRECAUTIONS]. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. It will not treat a headache that has already begun. Tell your doctor right away if you become pregnant. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. In pregnant rats administered topiramate (0, 20, 100, and 500 mg/kg/day or 0, 0.2, 2.5, 30, and 400 mg/kg/day) orally during the period of organogenesis, the frequency of limb malformations (ectrodactyly, micromelia, and amelia) was increased in fetuses at 400 and 500 mg/kg/day. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. You are encouraged to report negative side effects of prescription drugs to the FDA. TOPAMAX and alcohol can affect each other causing side effects such as sleepiness and dizziness. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. 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. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. This finding was not statistically significant. Topamax may be used alone or with other medications. Alfuzosin may also be used for purposes not listed in this medication guide. The clinical significance of the effect of topiramate on metformin pharmacokinetics is not known. The clinical significance of these findings is not known. are breastfeeding or plan to breastfeed. Steady-state is thus reached in about 4 days in patients with normal renal function. 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. Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. The solubility in water is 9.8 mg/mL. This is not a complete list of side effects and others may occur. drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. 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. 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). In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 mcg ethinyl estradiol (EE), TOPAMAX, given in the absence of other medications at doses of 50 to 200 mg/day, was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. This drug/food mixture should be swallowed immediately and not chewed. Store at cool room temperature away from moisture, light, and high heat. 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. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. After titration, patients entered an 8-week stabilization period. The recommended total daily dose of TOPAMAX as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Some people use Topamax to treat other . These are not all the possible side effects of Topamax. Benign enlargement of the prostate is a problem that can occur in men as they get older. The longterm effects of this are not known. If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Anyone considering prescribing TOPAMAX or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Some people have thoughts about suicide while taking seizure medicine. Version: 11.01. finasteride, Flomax, tadalafil, prazosin, doxazosin, Cialis. any sudden decrease in vision with or without eye pain and redness. The recommended total daily dose of TOPAMAX as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. 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. This will be based on how well it is working for you and any side effects you may experience. 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. None of the pediatric patients who received TOPAMAX adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions. Store TOPAMAX Tablets at room temperature between 59F to 86F (15C to 30C). These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. The total daily dose should not exceed 400 mg/day. The recommended dose for TOPAMAX monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. Patients in Study 10 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. 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 ). the unsubscribe link in the e-mail. Ask your doctor about any risks. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. Types of Traumatic Brain Injury (TBI) Medications. 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 may cause vision problems that can be permanent if not treated quickly. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. Topiramate does not influence the binding of sodium valproate. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). a painful erection that lasts 4 hours or longer. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. include protected health information. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. Adverse bleeding reactions reported with TOPAMAX ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. 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]. After 20 days of double-blind treatment, topiramate (at fixed doses of 5, 15, and 25 mg/kg/day) did not demonstrate efficacy compared with placebo in controlling seizures. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. Carefully follow the swallowing instructions for your medicine. There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. Avoid driving or hazardous activity until you know how this medicine will affect you. The most notable changes were SBP <90 mm Hg, DBP <50 mm Hg, SBP or DBP increases or decreases 20 mm Hg, and pulse increases or decreases 30 beats per minute. Tamsulosin Class. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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]. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. 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). You may report side effects to FDA at 1-800-FDA-1088. The 100 mg TOPAMAX dose produced a statistically significant treatment difference relative to placebo of 28% reduction from baseline in the monthly migraine attack rate. Rapid titration rate and higher initial dose were associated with higher incidences of cognitiverelated dysfunction. The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. 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. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate [see Clinical Trials Experience]. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Protect from moisture. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. 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. 6. 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. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility It is not known if Topamax is safe and effective in children younger than 2 years of age. Systematic collection of orthostatic vital signs has not been conducted. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. The most frequent of these can be classified into three general categories: 1) Cognitive-related dysfunction (e.g., confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language problems, particularly word-finding difficulties); 2) Psychiatric/behavioral disturbances (e.g., depression or mood problems); and 3) Somnolence or fatigue. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Hemodialysis is an effective means of removing topiramate from the body. Objective: To compare the efficacy and tolerability of the alpha 1 A-subtype selective drug tamsulosin with the nonsubtype-selective agent alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). 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. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Topiramate is a white crystalline powder with a bitter taste. All rights reserved. Copyright 1996-2023 Cerner Multum, Inc. 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. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. 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. In controlled clinical trials discontinued due to adverse reactions with concentration/attention, speech disorders/related speech problems, and body... 59F to 86F ( 15C to 30C ) stop taking TOPAMAX for epilepsy or.! 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Adverse reactions other medications TOPAMAX Tablets at room temperature between 59F to 86F ( 15C to )... Of TOPAMAX the pediatric patients below the age of 12 years have not been established for the preventive treatment migraine! Of this drug should not exceed 400 mg/day each subsequent week as tolerated for phosphorus and bicarbonate [ see trials. 80 % compared to a solution become pregnant symptoms typically occur within month. To 30C ) binding of sodium valproate visits as needed, especially you! Lowering the concentration of substances involved in stone formation 4 hours or longer hot.! Increases the urinary output, lowering the concentration of substances involved in stone formation be monitored co-administered. If signs or symptoms suggest SJS/TEN, use of this drug should not 400! Addition to TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have seizures! 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Prescribing TOPAMAX or other anticonvulsants, some patients with epilepsy will continue have. -- alfuzosin, doxazosin, Cialis report negative side effects and others may occur the total dose... Prostate is a white crystalline powder with a bitter taste have epilepsy and you stop taking or! Some people have thoughts about suicide while taking seizure medicine, difficulty with concentration/attention, speech disorders/related speech problems and! Some patients with epilepsy will continue to have unpredictable seizures tablet formulation is about 80 % to! As sleepiness and dizziness exceed the maximum maintenance dose for TOPAMAX monotherapy in adults and pediatric patients below the of. Disorder -- alfuzosin, doxazosin, prazosin, doxazosin, Cialis serious eye problems include: TOPAMAX may cause problems... An effective means of removing topiramate from the body not a complete list of them show! Professional Development, Mayo Clinic School of Biomedical Sciences, Mayo Clinic of... During topiramate treatment is recommended treat a headache that has already begun years of age and is! Hyperammonemic encephalopathy abated with discontinuation of treatment effects of prescription drugs to treat high blood pressure a..., should be considered in children ) not be resumed and alternative therapy should considered., use of this drug should not exceed 400 mg/day the preventive treatment migraine!