Tamsulosin Class. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Do not stop using Topamax suddenly, even if you feel fine. We comply with the HONcode standard for trustworthy health information. The effects of these interactions on mean plasma AUCs are summarized in Table 10. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. Protect from moisture. Warnings Topamax may cause vision problems that can be permanent if not treated quickly. 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]. Overdoses of TOPAMAX have been reported. Some of these drugs, including Topamax, can also prevent migraine headaches.. 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. TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide.. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. 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. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. Benign enlargement of the prostate is a problem that can occur in men as they get older. 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]. Version: 23.01. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 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. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. Safety and effectiveness of topiramate for the preventive treatment of migraine was studied in 5 double-blind, randomized, placebo-controlled, parallel-group trials in a total of 219 pediatric patients, at doses of 50 to 200 mg/day, or 2 to 3 mg/kg/day. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period. This medication is also used to prevent migraine headaches and decrease how often you get them. If you miss a single dose of TOPAMAX, take it as soon as you can. Patients and methods: The study comprised 256 patients with benign . The no-effect dose (90 mg/kg/day) for adverse developmental effects is approximately 2 times the maximum recommended pediatric dose (9 mg/kg/day) on a body surface area (mg/m2) basis. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. 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. Figure 1: Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure in Study 1. Because most patients were Caucasian, there were insufficient numbers of patients from different races to make a meaningful comparison of race. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. Topiramate is a white crystalline powder with a bitter taste. You and your doctor will decide how long you stay on treatment. information submitted for this request. Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Store TOPAMAX Tablets at room temperature between 59F to 86F (15C to 30C). 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]. 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. Tamsulosin is not approved for use in women. This may help increase the flow of urine or decrease the symptoms. Topamax. The significance of these findings is uncertain. There was also an increased incidence of markedly increased hyperammonemia at the 100 mg dose. 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 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]. It is not known if the TOPAMAX that passes into breast milk can cause other serious harm to your baby. Portions of this document last updated: April 01, 2023. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. Encourage pregnant women using TOPAMAX, to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Warn patients about the possible development of hyperammonemia with or without encephalopathy. Your blood pressure will need to be checked often. It will not treat a headache that has already begun. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. 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. 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. A dosage adjustment is recommended in patients with moderate or severe renal impairment [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- To provide you with the most relevant and helpful information, and understand which If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in pediatric patients in the 400 mg/day TOPAMAX group and at an incidence higher (10%) than in the 50 mg/day group were fever and weight loss (see Table 5). Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. The mean reduction from baseline to the last 12 weeks of the double-blind phase in average monthly attack rate, a key secondary efficacy endpoint in Study 13 (and the primary efficacy endpoint in Studies 11 and 12, of adults) was 3.0 for 100 mg TOPAMAX dose and 1.7 for placebo. Do not take two doses at one time. 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. (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. 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. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. Tamsulosin Brand names: Contiflo XL, Faramsil MR, Flomaxtra XL, Pamsvax XL, Tabphyn MR Find out how tamsulosin treats symptoms of an enlarged prostate and kidney stones, and how to take it. 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. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. 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. SGA has been observed at all doses and appears to be dose-dependent. Description and Brand Names. 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. Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trial (Study 1) in Adult and Pediatric Patients. 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). Infrequent reports of shortness of breath, palpitations, low blood pressure ( hypotension ), atrial fibrillation, irregular heartbeat ( arrhythmia ), and fast heart rate. Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). include protected health information. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). If you miss a single dose of TOPAMAX, take it as soon as you can. Call your doctor right away if you have a sudden decrease in vision. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. TOPAMAX can cause fetal harm when administered to a pregnant woman. 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. What should I avoid while taking TOPAMAX? The relevance of this finding to human carcinogenic risk is uncertain. (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. 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). Get emergency medical help if you have signs of an allergic reaction to tamsulosin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Figure 2: Reduction in 4-Week Migraine Headache Frequency Most important fact about this drug A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. Hypothermia, defined as a drop in body core temperature to <35C (95F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. 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). Topiramate is designated chemically as 2,3:4,5- Di-O-isopropylidene--D-fructopyranose sulfamate and has the following structural formula: TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide. Tamsulosin comes only as a capsule you take by mouth. alpha 1 receptor antagonist. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Call your doctor for medical advice about side effects. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future. 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. TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. 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. Maternal toxicity (decreased body weight gain, clinical signs) was evident at 100 mg/kg/day or greater. Controlled trials of adjunctive TOPAMAX treatment of adults for partial-onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% TOPAMAX versus 2% placebo), markedly increased serum alkaline phosphatase (3% TOPAMAX versus 1% placebo), and decreased serum potassium (0.4 % TOPAMAX versus 0.1 % placebo). Do not save it for later use. 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. Dose and titration rate should be guided by clinical outcome. (topiramate) The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. TOPAMAX (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: TOPAMAX (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. In both studies, there were no apparent differences in treatment effect within age or gender subgroups. Newborns of mothers treated with TOPAMAX should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Copyright 1996-2023 Cerner Multum, Inc. The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in the preventive treatment of migraine trials was 26% in patients taking TOPAMAX monotherapy at 100 mg/day, and 14% in patients taking TOPAMAX at 50 mg/day, compared to 9% in patients taking placebo. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period. In clinical trials, 3% of patients were over age 60. privacy practices. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. This content does not have an Arabic version. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. There may be other medicines to treat your condition that have a lower chance of birth defects. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. The prostate may continue to get larger. 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