This will be based on how well it is working for you and any side effects you may experience. If required, longer intervals between dose adjustments can be used. 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 following adverse reactions were observed in at least 3% of patients on topiramate and were 3% to 7% more frequent than in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. In five of the six studies, patients received active drug beginning at 100 mg per day; the dose was then increased by 100 mg or 200 mg/day increments weekly or every other week until the assigned dose was reached, unless intolerance prevented increases. Comparison of the Kaplan-Meier survival curves of time to first seizure favored the TOPAMAX 400 mg/day group over the TOPAMAX 50 mg/day group (Figure 1). 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. Topiramate Brand Name. 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. Maternal toxicity (decreased body weight gain, clinical signs) was evident at 100 mg/kg/day or greater. 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. Patients and methods: The study comprised 256 patients with benign . Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Adverse bleeding reactions reported with TOPAMAX ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. information and will only use or disclose that information as set forth in our notice of Table 6 presents the incidence of adverse reactions occurring in at least 3% of adult patients treated with 200 to 400 mg/day TOPAMAX and was greater than placebo incidence. 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). There was a suggestion that this effect was dose-related. 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. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Does tamsulosin interact with my other drugs? Because of the bitter taste, tablets should not be broken. Your child's dose needs may change if the child gains or loses weight. 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). COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). 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%). 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. There was a 12% increase in AUC and Cmax for amitriptyline (25 mg per day) in 18 healthy subjects (9 males, 9 females) receiving 200 mg/day of TOPAMAX. have kidney problems, have kidney stones, or are getting kidney. The risk for hyperammonemia with topiramate appears dose-related. Topamax pregnancy and breastfeeding warnings. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. This medication is also used to prevent migraine headaches and decrease how often you get them. Most important fact about this drug Some people may need to be hospitalized for this condition. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. Keep TOPAMAX and all medicines out of the reach of children. Alfuzosin may also be used for purposes not listed in this medication guide. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Call your doctor for medical advice about side effects. Any medical care provider who treats you should know that you take seizure medication. TOPAMAX treatment can cause metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Patients who were experiencing at least 60 seizures per month before study entry were stabilized on optimum dosages of their concomitant AEDs during a 4-week baseline phase. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. 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]. Call your doctor for medical advice about side effects. Do not start a new medicine without talking with your healthcare provider. We comply with the HONcode standard for trustworthy health information. Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX-treated patient were fatigue (1%), headache (1%), and somnolence (1%). It will not treat a headache that has already begun. In patients, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure of lithium (27% for Cmax and 26% for AUC) following topiramate doses up to 600 mg/day [see DRUG INTERACTIONS]. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. Reflecting the primary renal elimination of topiramate, topiramate plasma and renal clearance were reduced 21% and 19%, respectively, in elderly subjects, compared to young adults. Topamax may be used alone or with other medications. A generally similar profile was observed in older pediatric patients [see ADVERSE REACTIONS]. 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. Table 5 presents the incidence of adverse reactions occurring in at least 3% of adult and pediatric patients treated with 400 mg/day TOPAMAX and occurring with greater incidence than 50 mg/day TOPAMAX. The no-effect dose (2.5 mg/kg/day) for embryofetal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years. Do not take two doses at one time. 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. The effectiveness of TOPAMAX as an adjunctive treatment for pediatric patients 2 to 16 years of age with partial-onset seizures was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 8), comparing TOPAMAX and placebo in patients with a history of partial-onset seizures, with or without secondarily generalized seizures (see Table 12). This approach consisted of first showing a similar exposure response relationship between pediatric patients down to 2 years of age and adults when TOPAMAX was given as adjunctive therapy. to prevent migraine headaches in adults and adolescents 12 years and older. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Topamax dosage for migraines. 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). Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. 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). 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. Generic drugs are thought to be as safe and effective as the brand-name drug they're based on. Copyright: Merative US L.P. 1973, 2023. Not all possible drug interactions are listed here. 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. Warnings You should not take alfuzosin if you have moderate to severe liver disease. Do not stop using Topamax suddenly, even if you feel fine. In some patients, hyperammonemia can be asymptomatic. It improves the flow of urine by relaxing. 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. Of the total drug interactions, 32 are major, 248 are moderate, and 4 are minor. The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. This rate appeared to increase at dosages above 400 mg/day. There may be other medications that are safer to use. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Do not stop using Topamax suddenly or you could have increased seizures. 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. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 5 mg to 9 mg/kg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: fatigue and somnolence (Table 7). Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. The clinical relevance of this observation has not been established. TOPAMAX and alcohol can affect each other causing side effects such as sleepiness and dizziness. If you stop using tamsulosin for several days in a row, do not start it again without your doctor's advice. 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. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- A 15% decrease in the AUC,ss of pioglitazone with no alteration in Cmax,ss was observed. Brand names: Topamax, Topamax Sprinkle, Topiragen, Trokendi XR, Qudexy XR Sprinkle, Topiramate ER (Eqv-Qudexy XR), Eprontia Dosage forms: oral capsule (15 mg; 25 mg), oral capsule, extended release (100 mg; 150 mg; 200 mg; 25 mg; 50 mg), oral solution (25 mg/mL), oral tablet (100 mg; 200 mg; 25 mg; 50 mg) Brand name: Flomax. Postmarketing side effects of tamsulosin reported include: Prolonged erection (rare) Signs and symptoms of low blood pressure, including lightheadedness and fainting. Protect from moisture. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. Avoid driving or hazardous activity until you know how this medicine will affect you. TOPAMAX is a carbonic anhydrase inhibitor. When increasing your dose at the start of treatment, your dose may be taken only at night for one week. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. Topamax can be prescribed for weight loss. 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]. You may report side effects to FDA at 1-800-FDA-1088. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Do not stop TOPAMAX without first talking to a healthcare provider. Co-administration of topiramate 400 mg/day with risperidone resulted in a 14% increase in Cmax and a 12% increase in AUC12 of topiramate. any sudden decrease in vision with or without eye pain and redness. Topiramate is a sulfamate-substituted monosaccharide. a painful erection that lasts 4 hours or longer. The bioavailability of topiramate is not affected by food. Know how Topamax may affect you before driving or performing other hazardous activities. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. What are the possible side effects of TOPAMAX? 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 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. Symptoms include acute onset of decreased visual acuity and/or ocular pain. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring [see Use In Specific Populations]. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions). 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 also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topiramate is excreted in human milk [see Data]. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. Topamax may cause blurred vision and may impair your thinking or reactions. In multiple animal species, topiramate produced developmental toxicity, including increased incidences of fetal malformations, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. The results of 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials established the effectiveness of TOPAMAX in the preventive treatment of migraine. [5] [6] [7] The evidence for benefit with a kidney stone is better when the stone is larger. 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