tamsulosin brand name topamax

Continue reading, Trokendi XR, Topiragen, Eprontia, Qudexy XR. 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. 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]. Call your doctor for medical advice about side effects. 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. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. Continue reading, Topamax is not classified as a controlled substance under the U.S. This interaction has not been evaluated in humans. TOPAMAX Sprinkle Capsules contain small, white to off-white spheres. Adults and Pediatric Patients 10 Years of Age and Older. Valproic acid (such as DEPAKENE or DEPAKOTE). Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate [see Clinical Trials Experience]. Open-label extension phases of 3 studies enabled evaluation of long-term safety for up to 6 months after the end of the double-blind phase. Drug class: Carbonic anhydrase inhibitor anticonvulsants. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. 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. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Topamax can be taken with or without food. 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). A no-effect dose for embryofetal developmental toxicity in mice was not identified. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- 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. (which is why it is recommended to take it 30 minutes after a meal) Please note that this list may not be complete, and there may be other foods and beverages that interact with this drug. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). benign prostatic hyperplasia. 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. The studies described in the following sections were conducted using TOPAMAX (topiramate) Tablets. Topiramate Use. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Medically reviewed by Sophia Entringer, PharmD. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. If you stop taking this medicine for any reason, call your doctor before you start taking it again. This dataset contained data from 1217 subjects including 258 pediatric patients age 2 to <16 years (95 pediatric patients <10 years of age). Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Inform patients about the signs of serious skin reactions. 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. Tell your doctor about all your other medicines, especially: other glaucoma medications, including eye drops. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. The conclusion that TOPAMAX is effective as initial monotherapy in pediatric patients 2 to 9 years of age with partial-onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach using data from the controlled epilepsy trials described in labeling. Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. Patients and methods: The study comprised 256 patients with benign . Topiramate Class. TOPAMAX is not indicated for the preventive treatment of migraine in pediatric patients less than 12 years of age. The prostate gland is located below the bladder. The mean plasma elimination half-life is 21 hours after single or multiple doses. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use In Specific Populations]. 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. 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. In patients who develop unexplained lethargy, vomiting or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). 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. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see WARNINGS AND PRECAUTIONS]. Continue reading, You can usually stay on Topamax (topiramate) to help prevent your migraine headaches as long as the treatment is needed and remains safe for you. TOPIRAMATE - ORAL. Patients treated with TOPAMAX experienced mean percent reductions in body weight that were dose-dependent. 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. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). 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. TOPAMAX-induced metabolic acidosis can occur at any time during treatment. Keep all follow-up visits with your healthcare provider as scheduled. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Generic name: tamsulosin [tam-soo-LOE-sin] You and your healthcare provider should decide if you will continue to take TOPAMAX while you are pregnant. There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. The long-term consequences of the SGA findings are not known. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. 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). Systematic collection of orthostatic vital signs has not been conducted. any sudden decrease in vision with or without eye pain and redness. A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. 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). Copyright 1996-2023 Cerner Multum, Inc. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. This medication is also used to prevent migraine headaches and decrease how often you get them. The majority of the reports have been in pediatric patients. 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. Approximately 80% or more patients in each treatment group completed the study. Some of the cases were reported after exposure to elevated environmental temperatures. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX may be required. Topiramate is a white crystalline powder with a bitter taste. 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. Topiramate doses are sometimes based on weight in children. 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). General information about the safe and effective use of TOPAMAX. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. No age-related differences in effectiveness or adverse effects were evident. 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 open-label, uncontrolled experience, increasing impairment of adaptive behavior was documented in behavioral testing over time in this population. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide (HCTZ) (25 mg every 24 hours) and topiramate (96 mg every 12 hours) when administered alone and concomitantly. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. It will not treat a headache that has already begun. This will be based on how well it is working for you and any side effects you may experience. Anticonvulsant. Tell your doctor right away if you become pregnant. Although the effect of TOPAMAX on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus ability to tolerate labor. 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. Side Effects Some w omen experience dizziness when taking tamsulosin. The addition of HCTZ to TOPAMAX may require a decrease in the TOPAMAX dose [see CLINICAL PHARMACOLOGY]. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). Topiramate does not influence the binding of sodium valproate. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11. Warn patients about the possible development of hyperammonemia with or without encephalopathy. The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use In Specific Populations]. TOPAMAX can cause fetal harm when administered to a pregnant woman. 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. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Mayo Clinic does not endorse companies or products. In some patients, hyperammonemia can be asymptomatic. 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. TOPAMAX Sprinkle Capsules may be swallowed whole or may be opened and sprinkled on a. TOPAMAX can be taken before, during, or after a meal. The effects of these interactions on mean plasma AUCs are summarized in Table 10. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anyone considering prescribing TOPAMAX or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX. This medicine will only prevent migraine headaches or reduce the number of attacks. An increase in urinary bladder tumors was observed in mice given topiramate (0, 20, 75, and 300 mg/kg/day) in the diet for 21 months. drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. Topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX as a tamsulosin brand name topamax drug and a 25 reduction. Increased breakthrough bleeding may occur in patients receiving topiramate terazosin, silodosin in topiramate plasma concentration during hemodialysis a! Controlled substance under the U.S provider as scheduled or planning to become pregnant, effective. To treat high blood pressure or a prostate disorder -- alfuzosin, doxazosin, prazosin terazosin! In open-label, uncontrolled experience, increasing impairment of adaptive behavior was documented in testing... The SGA findings are not known of long-term safety for up to 6 times greater than a! 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