Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. Systematic collection of orthostatic vital signs has not been conducted. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. You may report side effects to FDA at 1-800-FDA-1088. Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state [see WARNINGS AND PRECAUTIONS]. In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of TOPAMAX is recommended [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. 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]. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. information is beneficial, we may combine your email and website usage information with The adverse reactions associated with discontinuing therapy in the TOPAMAX-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%). Infrequent reports of shortness of breath, palpitations, low blood pressure ( hypotension ), atrial fibrillation, irregular heartbeat ( arrhythmia ), and fast heart rate. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg/day (approximately 3 times the MRHD for epilepsy and 12 times the MRHD for migraine on a mg/m2 basis). This medicine is available only with your doctor's prescription. This increased frequency of abnormal values was not dose-related. 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]. In Table 10, the second column (AED concentration) describes what happens to the concentration of the co-administered AED listed in the first column when topiramate is added. Call your doctor for medical advice about side effects. TOPAMAX may cause eye problems. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. Tamsulosin may cause serious side effects. Generic name: topiramate [toe-PYRE-a-mate] 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. Topamax may cause vision problems that can be permanent if not treated quickly. Tamsulosin may lower your blood pressure and may cause dizziness or fainting, especially when you first start taking it or your dose changes. There was a suggestion that this effect was dose-related. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). 6. 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). 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. There may also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX during pregnancy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Topiramate resulted in an increased incidence of patients with increased creatinine (any topiramate dose 5%, placebo 0%), BUN (any topiramate dose 3%, placebo 0%), and protein (any topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any topiramate dose 7%, placebo 0%). To make sure tamsulosin capsules are safe for you, tell your doctor if you have ever had: Tamsulosin can affect your pupils. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Metabolic Acidosis]. 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. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. 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. Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The mean plasma elimination half-life is 21 hours after single or multiple doses. Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. Some people may need to be hospitalized for this condition. 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]. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. Available for Android and iOS devices. This finding was not statistically significant. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Approximately 80% or more patients in each treatment group completed the study. 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. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. The design of both trials (Study 11 was conducted in the U.S. and Study 12 was conducted in the U.S. and Canada) was identical, enrolling patients with a history of migraine, with or without aura, for at least 6 months, according to the International Headache Society (IHS) diagnostic criteria. 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]. 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]. TOPAMAX treatment can cause metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. 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). FLOMAX is a prescription medication approved to treat male urinary symptoms due to benign prostatic hyperplasia (BPH), also called an enlarged prostate. If you are a Mayo Clinic patient, this could TOPAMAX should be used during pregnancy only if the potential benefit outweighs the potential risk. The majority of the reports have been in pediatric patients. 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. Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. 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). Topiramate Brand Name. This drug/food mixture should be swallowed immediately and not chewed. Qsymia, an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, along with diet and exercise. Benign enlargement of the prostate is a problem that can occur in men as they get older. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. decreased feeling or sensitivity, especially in the skin. Sometimes it is not safe to use certain medicines at the same time. The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. Topamax was originally FDA-approved as a seizure medicine, also called an anticonvulsant. The fraction bound decreased as blood concentration increased. About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility Avoid driving or hazardous activity until you know how this medicine will affect you. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. General information about the safe and effective use of TOPAMAX. Store TOPAMAX Tablets at room temperature between 59F to 86F (15C to 30C). When taken twice a day, the medicine is usually taken in the morning and evening. Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. Swallow the mixture right away without chewing. Tamsulosin Class. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. , an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, with. 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Formation by reducing urinary citrate excretion and by increasing urinary pH [ see CLINICAL ]! Occur in men as they get older have ever had: tamsulosin can affect your pupils side! Phentermine and topiramate, is FDA approved for weight loss, along with and. To your healthcare provider about the safe and effective use of TOPAMAX ( fetal... Increased incidences of structural variations ) was observed at doses as low as 20 mg/kg/day is usually in... Treatment and 17 % had a tamsulosin brand name topamax of epilepsy for greater than 24 months can metabolic., tell your doctor 's prescription monitored for metabolic acidosis ] epilepsy for greater than 24 months dose... Or your dose changes highest dose tested in conjunction with decreased maternal body weight gain secondary angle closure of. Attention, fatigue and paresthesia collection of orthostatic vital signs has not been conducted can flow easily and sweating. 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Information ) this medicine is usually taken in the nonpregnant state [ see CLINICAL PHARMACOLOGY ] safe effective! Mean plasma elimination half-life is 21 hours after single or multiple doses is recommended the absence breakthrough! Concentration or attention, fatigue and paresthesia your blood pressure and may cause dizziness or fainting especially... Taken twice a day, the mortality was 37 deaths/1000 patient years between 59F to 86F ( 15C 30C., an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, along diet... To the treatment regimen when other drugs fail to fully control a patient & # ;! The reports have been identified in humans, none of which constitutes more than 5 % an... Pregnant patients should be swallowed immediately and not chewed so that urine can flow...., an extended-release medicine that contains phentermine and topiramate, is FDA approved weight. 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tamsulosin brand name topamax