Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Topiramate treatment also produced a dose-related increase in the percentage of patients who had a shift from normal at baseline to high/increased (above the normal reference range) in total eosinophil count at the end of treatment. Tamsulosin belongs to a class of medications called alpha blockers. include protected health information. Inform pregnant women and women of childbearing potential that use of TOPAMAX during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Patients received active drug beginning at 50 mg/day for four weeks; the dose was then increased by 50 mg to 150 mg/day increments every other week until the assigned dose of 175, 225, or 400 mg/day based on patients' body weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. 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. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. The percent reduction from baseline to the last 12 weeks of the double-blind phase in average monthly migraine attack rate is shown in Table 13. Topamax is the brand name for the drug topiramate.Topamax is approved to treat seizure disorders, like epilepsy, and to prevent migraine in adults.. Evidence of maternal toxicity (decreased body weight gain, clinical signs, and/or mortality) was seen at 35 mg/kg/day and above. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. The prostate gland is located below the bladder. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. This interaction has not been evaluated in humans. Materials and methods: Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age. The most common ( 2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Advise patients to contact their healthcare provider if they have missed more than one dose. 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. Your healthcare provider may change your dose. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Suicidal thoughts or actions can be caused by things other than medicines. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. Multiple dosing of venlafaxine (150 mg) did not affect the pharmacokinetics of topiramate. privacy practices. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. 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. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. Consequently, the plasma drug concentration for the same mg/kg/day dose would be lower in pediatric patients compared to adults and also in younger pediatric patients compared to older pediatric patients. Benign enlargement of the prostate is a problem that can occur in men as they get older. 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. These drugs work in your brain to help prevent seizures. . The effects of these interactions on mean plasma AUCs are summarized in Table 10. 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. This list is not complete. 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. Be careful if you drive or do anything that requires you to be alert. Controlled Substances Act (CSA). The effectiveness of TOPAMAX as initial monotherapy in adults and pediatric patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial (Study 1). TOPAMAX overdose has resulted in severe metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. This medication is also used to prevent migraine headaches and decrease how often you get them. Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The recommended titration rate for TOPAMAX for the preventive treatment of migraine is as follows: Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older. [7] It is taken by mouth. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Last updated on Jan 16, 2023. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You may need a dose adjustment. USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). 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. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. Taking topiramate during pregnancy may increase the risk of cleft lip and/or cleft palate, a birth defect that can develop early in pregnancy even before you know you are pregnant. You may report side effects to FDA at 1-800-FDA-1088. 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. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Description and Brand Names. TOPIRAMATE - ORAL. any sudden decrease in vision with or without eye pain and redness. Tamsulosin helps relax the muscles in the prostate and the opening of the bladder. Carbonic anhydrase inhibitor anticonvulsants. Using Topamax with other drugs that make you drowsy can worsen this effect. 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. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH. The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. Specific dosing in pediatric patients 2 to 9 years of age was derived from simulations utilizing plasma exposure ranges observed in pediatric and adult patients treated with TOPAMAX initial monotherapy [see DOSAGE AND ADMINISTRATION]. Changes (increases and decreases) from baseline in vital signs (systolic blood pressure-SBP, diastolic blood pressure-DBP, pulse) occurred more frequently in pediatric patients (6 to 17 years) treated with various daily doses of topiramate (50 mg, 100 mg, 200 mg, 2 to 3 mg/kg) than in patients treated with placebo in controlled trials for the preventive treatment of migraine. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. 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%). Store at cool room temperature away from moisture, light, and high heat. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. The change in the mean 4-week migraine headache frequency from baseline to the double-blind phase was -1.3, -2.1, and -2.2 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). These are not all the possible side effects of Topamax. Call your doctor if your seizures get worse or you have them more often while taking Topamax. Similarly, topiramate half-life was longer (13%) in the elderly. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. You should not drink alcohol while taking TOPAMAX. Take Topamax exactly as it was prescribed for you. The median average daily dosages were 47 mg/day, 86 mg/day, and 150 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. Carefully follow the swallowing instructions for your medicine. TOPAMAX can slow your thinking and motor skills, and may affect vision. vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly); confusion, problems with thinking or memory, trouble concentrating, problems with speech; dehydration symptoms--decreased sweating, high fever, hot and dry skin; signs of a kidney stone--severe pain in your side or lower back, painful or difficult urination; signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or. Decreased sweating and an elevation in body temperature above normal characterized these cases. You should talk to your doctor about the best kind of birth control to use while you are taking TOPAMAX. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. The long-term consequences of the SGA findings are not known. Keep TOPAMAX in a tightly closed container. 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). Continue reading, Trokendi XR, Topiragen, Eprontia, Qudexy XR. Usual Adult Dose for Benign Prostatic Hyperplasia: 0.4 mg orally once a day; the dose may be increased to 0.8 mg orally once a day in patients who fail to respond to 0.4 mg once a day within 2 to 4 weeks 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.). If you are a Mayo Clinic patient, this could The gelatin capsules are white and clear. Insomnia. If you stop using tamsulosin for several days in a row, do not start it again without your doctor's advice. The Cambridge Neuropsychological Test Automated Battery (CANTAB) was administered to adolescents (12 to 17 years) to assess the effects of topiramate on cognitive function at baseline and at the end of the Study 13 [see Clinical Studies]. drugs a-z list The most common (2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion. A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). 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. 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