The gelatin capsules are white and clear. 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 Alfuzosin is an alpha-adrenergic (AL-fa ad-ren-ER-Jk) blocker that is used to improve urination in men with benign prostatic hyperplasia ( enlarged prostate ). 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 also used to help prevent migraine headaches. Do not take two doses at one time. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. Infrequent reports of shortness of breath, palpitations, low blood pressure ( hypotension ), atrial fibrillation, irregular heartbeat ( arrhythmia ), and fast heart rate. The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73 m2) and severe (creatinine clearance <30 mL/min/1.73 m2) renal impairment. Take Topamax exactly as it was prescribed for you. There were no clinically significant changes in the systemic exposure of risperidone plus 9-hydroxyrisperidone or of topiramate; therefore, this interaction is not likely to be of clinical significance. 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). Of the total drug interactions, 32 are major, 248 are moderate, and 4 are minor. This high clearance (compared to 20 to 30 mL/min total oral clearance in healthy adults) will remove a clinically significant amount of topiramate from the patient over the hemodialysis treatment period [see DOSAGE AND ADMINISTRATION, Use In Specific Populations]. After titration, patients entered a 4, 8 or 12-week stabilization period. 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). 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. For patients withdrawing from TOPAMAX, daily dosages were decreased in weekly intervals by 25 to 50 mg/day. Topamax belongs to a class of drugs called anticonvulsants. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. 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. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. In topiramate-treated pediatric patients (12 to 17 years of age) compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. 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. any sudden decrease in vision with or without eye pain and redness. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. A generally similar profile was observed in older pediatric patients [see ADVERSE REACTIONS]. 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. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. Tell your doctor about all your current medicines. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. 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. home
have a history of metabolic acidosis (too much acid in the blood). Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. During the titration period, the initial dose of TOPAMAX is 25 mg/day nightly for the first week. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Continue reading, Yes, topiramate has been shown to cause hair loss in studies, but it is not a common side effect. Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Decreased sweating and an elevation in body temperature above normal characterized these cases. These eye problems can lead to permanent loss of vision if not treated. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- 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. Drug class: Carbonic anhydrase inhibitor anticonvulsants. 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. Topiramate did not affect metformin tmax. 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. Call your doctor for medical advice about side effects. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Patients treated with TOPAMAX experienced mean percent reductions in body weight that were dose-dependent. What Are the Best PsA Treatments for You? include protected health information. numbness or tingling in your arms and legs. We comply with the HONcode standard for trustworthy health information. Store tightly closed at room temperature, away from moisture and heat. [5] Keep all follow-up visits with your healthcare provider as scheduled. Stopping TOPAMAX suddenly can cause serious problems. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the UK (0.2%). The most frequently reported cognitive/neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue. 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). Following baseline, patients were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. Co-administration of diltiazem (240 mg Cardizem CD) with topiramate (150 mg/day) resulted in a 10% decrease in Cmax and a 25% decrease in diltiazem AUC, a 27% decrease in Cmax and an 18% decrease in des-acetyl diltiazem AUC, and no effect on N-desmethyl diltiazem. 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. 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. To enroll, patients can call the toll-free number 1-888-233-2334. 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. If required, longer intervals between dose adjustments can be used. The most common side effects of TOPAMAX include: Tell your healthcare provider about any side effect that bothers you or that does not go away. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. Tamsulosin capsules are used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Description and Brand Names. are breastfeeding or plan to breastfeed. 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. 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. Multiple dosing of TOPAMAX (150 mg/day) in healthy volunteers did not affect the pharmacokinetics of venlafaxine or O-desmethyl venlafaxine. This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX. 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. This interaction has not been evaluated in humans. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of TOPAMAX, the most common adverse reactions with TOPAMAX that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain [see ADVERSE REACTIONS]. Generic name: topiramate [toe-PYRE-a-mate] Call your doctor for medical advice about side effects. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. 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
Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. None of the pediatric patients who received TOPAMAX adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions. Available for Android and iOS devices. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. Continue reading, Trokendi XR, Topiragen, Eprontia, Qudexy XR. 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. 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]. 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. Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see WARNINGS AND PRECAUTIONS]. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Drink plenty of liquids while you are taking Topamax, to prevent kidney stones or an electrolyte imbalance. The mean plasma elimination half-life is 21 hours after single or multiple doses. Topamax dosage for migraines. Know the medicines you take. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Do not stop using this medication before surgery unless your surgeon tells you to. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. have kidney problems, have kidney stones, or are getting kidney. 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. Overdoses of TOPAMAX have been reported. This includes prescription and over-the-counter medicines, vitamins, and herbal products. This may help increase the flow of urine or decrease the symptoms. dutasteride 0.5 mg-tamsulosin ER 0.4 mg capsule ext.release 24hr mphas Color: white,blue Shape: oblong Imprint: C280 0.5/0.4 This medicine is a orange brown, oblong, capsule imprinted with "GS 7CZ". The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. Breastfed babies may be sleepy or have diarrhea. In some patients, hyperammonemia can be asymptomatic. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. Topiramate does not influence the binding of sodium valproate. In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency [see Clinical Studies]. 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. 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. Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Dosage and ADMINISTRATION, CLINICAL PHARMACOLOGY ] CLINICAL studies the mean plasma half-life... Help prevent migraine headaches ( NAAED ) pregnancy Registry if they become pregnant received TOPAMAX adjunctive therapy double-blind were! Warnings, Drug class: alpha-adrenoreceptor antagonists between dose adjustments can be used you get a new.! Dosages were 45 and 79 mg/day in the North American Antiepileptic Drug NAAED. As 20 mg/kg/day, Topiragen, Eprontia, Qudexy XR 12 years have not been to! Of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks Sprinkle Capsules or... 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