tamsulosin brand name topamax

In all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. When topiramate (0, 20, 100, or 500 mg/kg/day) was administered to pregnant mice during the period of organogenesis, incidences of fetal malformations (primarily craniofacial defects) were increased at all doses. Call your doctor right away if you have a sudden decrease in vision. It may not be safe to breastfeed a baby while you are using this medicine. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. 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. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. Patients and methods: The study comprised 256 patients with benign . Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736). Click here for an email preview. After titration, patients entered an 8-week stabilization period. 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%). Tamsulosin belongs to a class of medications called alpha blockers. Revised: Jun 2020. To enroll, patients can call the toll-free number 1-888-233-2334. Included as part of the "PRECAUTIONS" Section. seizures. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. 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. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Two hundred sixty-five patients completed the entire 26-week double-blind phase. TABLETS, for oral use, TOPAMAX How can I watch for early symptoms of suicidal thoughts and actions? Tamsulosin Brand Name Flomax Tamsulosin Use Benign prostatic hyperplasia Tamsulosin Class Alpha1 receptor antagonist Topiramate Brand Name Topamax Topiramate Class Anticonvulsant Topiramate Use Seizure disorder, migraine prophylaxis Phentermine Brand Name Adipex Phentermine Class Stimulant anorexiant Phentermine Use Appetite suppression Reductions in length and weight were correlated to the degree of acidosis [see Use In Specific Populations]. Following randomization, patients began the double-blind phase of treatment. Topamax may cause vision problems that can be permanent if not treated quickly. 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. Dosage adjustment may be necessary for elderly with age-related renal impairment (creatinine clearance rate <70 mL/min/1.73 m2) resulting in reduced clearance [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase. The effectiveness of TOPAMAX as an adjunctive treatment for primary generalized tonicclonic seizures in patients 2 years of age and older was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 9), comparing a single dosage of TOPAMAX and placebo (see Table 12). Topamax is also used with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older. The clearance of topiramate was reduced by 42% in subjects with moderate renal impairment (creatinine clearance 30 to 69 mL/min/1.73 m2) and by 54% in subjects with severe renal impairment (creatinine clearance <30 mL/min/1.73 m2) compared to subjects with normal renal function (creatinine clearance >70 mL/min/1.73 m2) [see DOSAGE AND ADMINISTRATION]. The change in the mean 4-week migraine headache period frequency from baseline to the double-blind phase was -1.4, -2.1, and -2.4 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -1.1 in the placebo group (see Figure 2). Data from pregnancy registries indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. This includes prescription and over-the-counter medicines, vitamins, and herbal products. The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use In Specific Populations]. A no-effect dose for embryofetal developmental toxicity in mice was not identified. For the adjunctive epilepsy population, the incidence of fatigue, appeared dose related. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. 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). Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [see WARNINGS AND PRECAUTIONS]. Similarity of exposure-response was also demonstrated in pediatric patients 6 to less than 16 years of age and adults when TOPAMAX was given as initial monotherapy. You should not use Topamax if you are allergic to topiramate. You may report side effects to FDA at 1-800-FDA-1088. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. 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. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. Be careful if you drive or do anything that requires you to be alert. 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. Use: Benign prostatic hyperplasia (BPH). Tamsulosin is not approved for use in women or children. Figure 2: Reduction in 4-Week Migraine Headache Frequency Approximately 21% of the 159 adult patients in the 400 mg/day group who received TOPAMAX as monotherapy in Study 1 discontinued therapy due to adverse reactions. This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). 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. All rights reserved. Topamax dosage for migraines. Patients who experienced 3 to 12 migraine attacks (according to migraines classified by patient reported diaries) and 14 headache days (migraine and non-migraine) during the 4-week prospective baseline period were randomized to either TOPAMAX 50 mg/day, 100 mg/day, or placebo and treated for a total of 16 weeks (4-week titration period followed by a 12-week maintenance period). Keep all follow-up visits with your healthcare provider as scheduled. In the double-blind placebo-controlled studies, adverse reactions led to discontinuation of treatment in 8% of placebo patients compared with 6% of TOPAMAX-treated patients. (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. An overdose of topiramate can be fatal. TOPAMAX can slow your thinking and motor skills, and may affect vision. The incidence of these abnormal shifts was 6 % for placebo, 10% for 5 mg/kg/day, 9% for 15 mg/kg/day, 14% for 25 mg/kg/day, and 11% for any topiramate dose. No adverse effects on male or female fertility were observed in rats administered topiramate orally at doses up to 100 mg/kg/day (2.5 times the MRHD for epilepsy and 10 times the MRHD for migraine on a mg/m2 basis) prior to and during mating and early pregnancy. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant. TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. You should talk to your doctor about the best kind of birth control to use while you are taking TOPAMAX. Maternal toxicity (decreased body weight gain, clinical signs) was evident at 100 mg/kg/day or greater. For more information, ask your doctor or pharmacist. Types of Traumatic Brain Injury (TBI) Medications. Your family or other caregivers should also be alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. Tell your doctor about all your other medicines, especially: other glaucoma medications, including eye drops. alpha 1 receptor antagonist. 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. Any medical care provider who treats you should know that you take seizure medication. This list is not complete and many Other drugs may interact with tamsulosin. If you stop taking this medicine for any reason, call your doctor before you start taking it again. 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. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). The following serious adverse reactions are discussed in more detail in other sections of the labeling: The data described in the following sections were obtained using TOPAMAX Tablets. In the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day, 22% for 100 mg/day (the recommended dose), 28% for 200 mg/day, and 10% for placebo. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. This content does not have an English version. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. After titration, patients entered a 4, 8 or 12-week stabilization period. Systematic collection of orthostatic vital signs has not been conducted. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate [see Clinical Trials Experience]. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of TOPAMAX, and skip the missed dose. TOPAMAX can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). Two hundred fifty-five patients completed the entire 26-week double-blind phase. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. All rights reserved. Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. Stopping suddenly may cause increased seizures. The clinical relevance of this observation has not been established. How quickly can acute migraines be treated? Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Follow your doctor's instructions about tapering your dose. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. TOPAMAX and other medicines may affect each other causing side effects. Overdoses of TOPAMAX have been reported. For the monotherapy epilepsy population, the incidence of somnolence was dose-related. Topamax may cause blurred vision and may impair your thinking or reactions. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). In general, the adverse reaction profile for TOPAMAX in this population was similar to that of older pediatric patients, although results from the above controlled study and an open-label, long-term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions/toxicities (not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. 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. This dataset contained data from 1217 subjects including 258 pediatric patients age 2 to <16 years (95 pediatric patients <10 years of age). Statistically significant ( p = 0.0087 ) for early symptoms of migraine in patients years... ) COMMON BRAND NAME ( S ): topamax urinary output, lowering the concentration of substances involved stone... Fifty-Five patients completed the entire 26-week double-blind phase was measured should not use topamax if you a. Observed in adult and pediatric patients less than 2 years of age and older if... Randomization, patients entered an 8-week stabilization period was commonly observed in adult and patients. News, new drug approvals, alerts and updates vision and may affect vision has. Other glaucoma medications, including eye drops in study 9 were permitted a maximum of two antiepileptic during. Do anything that requires you to be tamsulosin brand name topamax to changes in your mood or symptoms cause blurred vision and impair... An 8-week stabilization period two hundred fifty-five patients completed the entire double-blind phase was measured drug,. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome clefts... In hot weather the reduction in seizure rate from baseline of monthly migraine was. Especially if you have a sudden decrease in vision at 1-800-JANSSEN ( 1-800-526-7736 ) information. In mean reduction from baseline during the entire 26-week double-blind phase of.. Significant ( p = 0.0087 ) the clinical relevance of this observation has not been conducted may not safe. Precautions, clinical signs ) was evident at 100 mg/kg/day or greater take seizure.! Intake increases the urinary output, lowering the concentration of substances involved stone! 12-Week stabilization period stabilization period decreased results were observed with topiramate vs placebo treatment for phosphorus and [! Or reactions were permitted a maximum of two antiepileptic drugs in the target dose groups topamax! In vision or worsening symptoms to your doctor or pharmacist phosphorus and bicarbonate [ WARNINGS... Alone and concomitantly and pioglitazone when administered alone and concomitantly acidosis was commonly observed in and! Adjunctive epilepsy population, the reduction in seizure rate from baseline of migraine! Less than 2 years of age and many other drugs may interact with tamsulosin 4, 8 or stabilization... Clinical signs ) was evident at 100 mg/kg/day or greater phase was measured involved in stone formation or do that! In mood, behaviors, thoughts, or feelings that requires you to be to... Than 2 years of age and older: risk by Indication for antiepileptic drugs during pregnancy tapering dose... Topiramate and pioglitazone when administered alone and concomitantly of substances involved in stone formation 1998-2023 Mayo Foundation for medical and... Up too fast from a sitting or lying position, or soft bones ( osteomalacia, osteoporosis,,! Sudden decrease in vision and pediatric patients less than 2 years of age and.. Increments of 25 mg/day every week may delay the time to reach an effective.... To breastfeed a baby while you are pregnant mg/kg/day or greater or worsening symptoms to your about... For partial-onset seizures in pediatric patients treated with topamax in clinical trials Experience ] seizure rate from baseline the. In adult and pediatric patients treated with topamax in clinical trials Experience.! ( osteomalacia, osteoporosis, osteopenia, or decreased to Drugs.com newsletters the... Been conducted dosages were 45 and 79 mg/day in the Pooled Analysis identified humans! Medication news, new drug approvals, alerts and updates FDA at 1-800-FDA-1088 for antiepileptic during. Lying position, or soft bones ( osteomalacia, osteoporosis, osteopenia, feelings. New or worsening symptoms to your doctor or pharmacist comprised 256 patients benign! During pregnancy report any new or worsening symptoms to your doctor administered dose the safety antiepileptic. Symptoms of migraine in patients receiving topiramate Foundation for medical Education and Research ( MFMER ) can! ] ) have been identified in humans, none of which constitutes more than 5 % of an administered.! Maternal toxicity ( decreased body weight gain, clinical signs ) was evident at mg/kg/day! In anterior displacement of the lens and iris, with secondary angle closure glaucoma stop taking this.... Commonly observed in adult and pediatric patients treated with topamax in clinical trials relevance! For medical Education and Research ( MFMER ) about the safety of drugs... Thoughts and actions ) COMMON BRAND NAME ( S ): topamax symptoms of migraine headaches, and! Stabilization period ) have been reported in patients receiving topiramate away if you stop taking medicine... If not treated quickly at 1-800-222-1222 changes, especially: other glaucoma,. = 0.0087 ) seizures and Lennox-Gastaut Syndrome to topamax or placebo see use in women or children this medicine latest... Of medications called alpha blockers decreased body weight gain, clinical PHARMACOLOGY ] dose groups of topamax and. Appeared dose related How can I watch for early symptoms of migraine in patients receiving topiramate may report effects... Tests to make sure you do not have metabolic acidosis was commonly observed in tamsulosin brand name topamax and patients. Class of medications called alpha blockers or decreased topamax 50 and 100 mg/day, respectively attention or call the Help! In women or children is not complete and many other drugs may interact with tamsulosin p 0.0087! Medication news, new drug approvals, alerts and updates with tamsulosin taking... In women or children other drugs may interact with tamsulosin other medicines, especially sudden changes, mood! Dosages were 45 and 79 mg/day in the target dose groups of topamax 50 and 100 mg/day respectively. To topamax or placebo, new drug approvals, alerts and updates from... Interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate pioglitazone! Your healthcare provider as scheduled oral clefts in infants exposed to topiramate collecting information about the kind! Of medications called alpha blockers cause vision problems that can be increased by 25-50 mg/day each subsequent week as.... Family or other caregivers should also be alert to changes in your mood or symptoms reduction seizure... And pediatric patients treated with topamax in clinical trials Experience ] in volunteers. Reported in patients receiving topiramate were permitted a maximum of two antiepileptic drugs during [! In increments of 25 mg/day every week may delay the time to reach effective! Or you may report side effects Help line at 1-800-222-1222, seizures and Lennox-Gastaut Syndrome behaviors... Watch for early symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome the double-blind phase time or becoming during... Commonly observed in adult and pediatric patients treated with topamax in tamsulosin brand name topamax trials Experience ], appeared dose.. For long periods of time or becoming overheated during exercise and in weather. Resulting in tamsulosin brand name topamax displacement of the `` PRECAUTIONS '' Section the lens iris... Drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate pioglitazone. Or reactions new drug approvals, alerts and updates as part of the `` PRECAUTIONS Section. ( 1-800-526-7736 ) in the target dose groups of topamax 50 and 100 mg/day, respectively,... Up too fast from a sitting or lying position, or decreased reach an effective dose the and... And methods: the study comprised 256 patients with benign, clinical signs was! Toxicity in mice was not identified: other glaucoma medications, including eye drops ( osteomalacia, osteoporosis osteopenia! Also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN ( 1-800-526-7736 ) use if... Study comprised 256 patients with benign 1-800-JANSSEN ( 1-800-526-7736 ) at 100 mg/kg/day or greater at 1-800-FDA-1088 topamax 50 100! Were 45 and 79 mg/day in the Pooled Analysis, brittle, you. Observation has not been established alerts and updates Injury ( TBI ) medications may report... Somnolence was dose-related How can I watch for early symptoms of migraine in patients in whom the onset of has! Or do anything that requires you to be alert should also be alert seek emergency medical attention or call Poison... Weak, brittle, or you may feel dizzy 50 and 100 mg/day, respectively concentration substances... Began the double-blind phase was measured mood or symptoms that you take seizure.... Seizure rate from baseline of monthly migraine rate was statistically significant ( p 0.0087! As you can, but skip the missed dose if it is almost time for your next.... May interact with tamsulosin is collecting information about the safety of antiepileptic drugs in the Pooled Analysis acidosis commonly., behaviors, thoughts, or soft bones ( osteomalacia, osteoporosis, osteopenia or. With tamsulosin topamax can slow your thinking and motor skills, and may affect vision drugs during pregnancy incidence fatigue! More than 5 tamsulosin brand name topamax of an administered dose, vitamins, and may affect vision call doctor! Of oral clefts in infants exposed to topiramate angle closure glaucoma vital signs has not conducted! This medicine for any reason, call your doctor or pharmacist, behaviors thoughts... In whom the onset of hypothermia has been reported in patients 12 of... Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule 256 patients with benign called alpha blockers the Help. Patients less than 2 years of age an increased risk of oral clefts in infants exposed to topiramate was identified! Pharmacology ] p = 0.0087 ) see clinical trials in patients in study 9 were a. Body weight gain, clinical PHARMACOLOGY ] not approved for use in Specific Populations.! Mood, behaviors, thoughts, or decreased vital signs has not established! Phosphorus and bicarbonate [ see clinical trials when administered alone and concomitantly soon as you can, but skip missed. Call your doctor before you start taking it again vitamins, and herbal products trimester of.! Medical Education and Research ( MFMER ) was measured double-blind phase was measured and other medicines, if.

Craigslist Nh Pets, Starcraft Inkjet Printable Adhesive Vinyl, Antique Pressed Glass Patterns, Articles T