Brand Name: Flomax Generic Name: Tamsulosin hydrochloride (HCl) Relevant IND: IND 30,365 . The median percent reductions in seizure rates and the responder rates (fraction of patients with at least a 50% reduction) by treatment group for each study are shown below in Table 12. (Studies 11 and 12 for Adults and Adolescents). Continue reading, Yes, topiramate has been shown to cause hair loss in studies, but it is not a common side effect. Tamsulosin is not approved for use in women. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. 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. Do not stop using Topamax suddenly, even if you feel fine. Following randomization, patients began the double-blind phase of treatment. Copyright 1996-2023 Cerner Multum, Inc. The clinical significance of these various changes in vital signs has not been clearly established. TOPAMAX passes into breast milk. Therefore, advise all patients taking TOPAMAX for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). This medicine is available only with your doctor's prescription. 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. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Instruct patients that if they miss a single dose of TOPAMAX, it should be taken as soon as possible. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. TOPAMAX and other medicines may affect each other causing side effects. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. There was a suggestion that this effect was dose-related. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. Warnings You should not take alfuzosin if you have moderate to severe liver disease. Your doctor may occasionally change your dose. Topiramate doses are sometimes based on weight in children. You may report side effects to FDA at 1-800-FDA-1088. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11. 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. 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. Keep TOPAMAX and all medicines out of the reach of children. This medicine will only prevent migraine headaches or reduce the number of attacks. Topamax was originally FDA-approved as a seizure medicine, also called an anticonvulsant. You may report side effects to FDA at 1-800-FDA-1088. The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. 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]. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. Patients who experienced at least six partial-onset seizures, with or without secondarily generalized seizures, during the baseline phase were randomly assigned to placebo or TOPAMAX tablets in addition to their other AEDs. Topiramate did not affect metformin tmax. Benign enlargement of the prostate is a problem that can occur in men as they get older. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Tamsulosin (Flomax) is an alpha-1 blocker. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. What is the most important information I should know about TOPAMAX? 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. 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]. Drug information provided by: Merative, Micromedex. The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. Call your doctor for medical advice about side effects. Follow all directions on your prescription label and read all medication guides or instruction sheets.. Tamsulosin capsules are usually taken once a day, within 30 minutes after the same meal each day. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. TOPIRAMATE - ORAL. It may causes side effects like confusion, drowsiness, dizziness, or blurred vision. The bioavailability of topiramate is not affected by food. 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. Tamsulosin helps relax the muscles in the prostate and the opening of the bladder. 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. The clinical significance of these findings is not known. Table 13: Percent Reduction from Baseline to the Last 12 Weeks of Double-Blind Phase in Average Monthly Attack Rate: Study 13 (Intent-to-Treat Analysis Set), TOPAMAX Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Metabolic Acidosis]. 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. Copyright 1996-2023 Cerner Multum, Inc. TOPAMAX increases the risk of kidney stones. This product is available in the following dosage forms: There is a problem with Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). 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. Sometimes it is not safe to use certain medicines at the same time. 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). Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TOPAMAX should be used with extreme caution if used in combination with alcohol and other CNS depressants. If required, longer intervals between dose adjustments can be used. Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. You should not drink alcohol while taking TOPAMAX. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. 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. 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. The incidence of some adverse reactions (e.g., allergy, fatigue, headache, anorexia, insomnia, somnolence, and viral infection) was dose-related and greater at higher than recommended TOPAMAX dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and TOPAMAX in a clinical trial. You should not use this medication if you are allergic to tamsulosin. In a rat embryofetal development study which included postnatal assessment of offspring, oral administration of topiramate (0, 0.2, 2.5, 30, and 400 mg/kg) to pregnant animals during the period of organogenesis resulted in delayed physical development in offspring at 400 mg/kg/day and persistent reductions in body weight gain in offspring at 30 mg/kg/day and higher. In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. The prostate gland is located below the bladder. The differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p=0.008 and p <0.001, respectively). Carbonic anhydrase inhibitor anticonvulsants. 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. Topiramate clearance is decreased in the elderly only to the extent that renal function is reduced [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks of oral clefts and SGA [see DRUG INTERACTIONS and Pregnancy]. TOPAMAX can cause fetal harm when administered to a pregnant woman. Store TOPAMAX Tablets at room temperature between 59F to 86F (15C to 30C). Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Know how Topamax may affect you before driving or performing other hazardous activities. In the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day and 26% for 400 mg/day. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus ability to tolerate labor. The effectiveness of TOPAMAX for the preventive treatment of migraine in pediatric patients 12 to 17 years of age was established in a multicenter, randomized, double-blind, parallel-group trial (Study 13). Call your healthcare provider right away if you have any of the symptoms above. Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. The addition of HCTZ to TOPAMAX may require a decrease in the TOPAMAX dose [see CLINICAL PHARMACOLOGY]. TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. The following adverse reactions have been identified during post approval use of TOPAMAX. This may cause the symptoms to become worse over time. [5] US Brand Name Flomax Descriptions Tamsulosin is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Ask your doctor about prostate cancer screening before and while taking this medicine. Tamsulosin belongs to a class of medications called alpha blockers. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX during pregnancy. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. There may be other medications that are safer to use. . Follow all directions on your prescription label and read all medication guides or instruction sheets. Dose and titration rate should be guided by clinical outcome. 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). You may report side effects to FDA at 1-800-FDA-1088. privacy practices. Protect from moisture. 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). Occur within 1 month of initiating TOPAMAX therapy used for commercial purposes your label., including prescription and over-the-counter medicines, vitamins, and herbal products sweating, leading to life-threatening dehydration ( in... At doses as low as 20 mg/kg/day below the age of 2 years have been! In the stabilization period are shown in Table 11 hair loss in studies but... 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