3 Sources. Steady-state is thus reached in about 4 days in patients with normal renal function. Multiple dosing of topiramate (200 mg/day) in 24 healthy volunteers (12 males, 12 females) did not affect the pharmacokinetics of a 1 mg subcutaneous dose of dihydroergotamine. Benign enlargement of the prostate is a problem that can occur in men as they get older. Drink plenty of fluids during the day to prevent kidney stones while taking TOPAMAX. 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. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. There may be other medications that are safer to use. In the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day, 22% for 100 mg/day (the recommended dose), 28% for 200 mg/day, and 10% for placebo. Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. The elderly subject population had reduced renal function (creatinine clearance [-20%]) compared to young adults. Clinical management and assessment should include examination of blood ammonia levels. Medically reviewed by Sophia Entringer, PharmD. It blocks a specific type of receptor found in the prostate. Tell your doctor about all your current medicines. SGA has been observed at all doses and appears to be dose-dependent. Of the total drug interactions, 32 are major, 248 are moderate, and 4 are minor. 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. 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). 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. Hydration is recommended to reduce new stone formation. In five, randomized, double-blind, placebo-controlled, parallel group clinical trials for the preventive treatment of migraine, most adverse reactions occurred more frequently during the titration period than during the maintenance period. 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 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, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. The dose should be achieved by titration according to the following schedule (Table 1): Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older. The risk for hyperammonemia with topiramate appears dose-related. 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 Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). Effectiveness of treatment was assessed by comparing each TOPAMAX treatment group to placebo (ITT population) for the percent reduction from baseline to the last 12 weeks of the double-blind phase in the monthly migraine attack rate (primary endpoint). 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. Does tamsulosin interact with my other drugs? 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. 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. Many drugs can affect tamsulosin, especially: medicine to treat impotence or pulmonary arterial hypertension--avanafil (Stendra), sildenafil (Viagra, Revatio), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn); or. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Two hundred sixty-five patients completed the entire 26-week double-blind phase. Topiramate Use. Any medical care provider who treats you should know that you take seizure medication. Topiramate Brand Name. Stopping TOPAMAX suddenly can cause serious problems. Advise patients to contact their healthcare provider if they have missed more than one dose. Be careful if you drive or do anything that requires you to be alert. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. 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). The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. 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. TOPAMAX can increase the level of acid in your blood (metabolic acidosis). A no-effect dose for embryofetal developmental toxicity in mice was not identified. Do not save it for later use. Tamsulosin Class. You and your healthcare provider should decide if you will continue to take TOPAMAX while you are pregnant. Swallow the mixture right away without chewing. If you miss a single dose of TOPAMAX, take it as soon as you can. This includes prescription and over-the-counter medicines, vitamins, and herbal products. TOPAMAX is not approved for treatment of epilepsy in pediatric patients less than 2 years old [see Use In Specific Populations]. In a single randomized, double-blind, placebo-controlled investigational trial, the efficacy, safety, and tolerability of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in pediatric patients 1 to 24 months of age with refractory partial-onset seizures were assessed. Follow all directions on your prescription label and read all medication guides or instruction sheets. In this rapid titration regimen, these dose-related adverse reactions began in the titration or in the maintenance phase, and in some patients these events began during titration and persisted into the maintenance phase. Therefore, patients given TOPAMAX concomitantly with another carbonic anhydrase inhibitor should be monitored particularly closely for the appearance or worsening of metabolic acidosis [see CLINICAL PHARMACOLOGY]. An overdose of topiramate can be fatal. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. health information, we will treat all of that information as protected health a painful erection that lasts 4 hours or longer. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. any sudden decrease in vision with or without eye pain and redness. 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. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. Patients who experienced 3 to 12 migraine headaches over the 4 weeks in the baseline phase were randomized to either TOPAMAX 50 mg/day, 100 mg/day, 200 mg/day, or placebo and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). Topamax can be taken with or without food. Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 to 250 g/mL. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. Tamsulosin systemic 0.4 mg (ZA-18 0.4 mg). For its part, Boehringer Ingelheim offers the brand name Flomax at an online price of $35 for 30 capsules or $90 for 90 capsules with free home delivery. Carbamazepine and phenytoin do not alter the binding of topiramate. After titration, patients entered an 8-week stabilization period. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age. Reductions in length and weight were correlated to the degree of acidosis [see Use In Specific Populations]. We comply with the HONcode standard for trustworthy health information. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. Patients who experienced a pre-specified minimum number of partial-onset seizures, with or without secondary generalization, during the baseline phase (12 seizures for 12-week baseline, 8 for 8-week baseline or 3 for 4-week baseline) were randomly assigned to placebo or a specified dose of TOPAMAX tablets in addition to their other AEDs. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. seizures. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Following randomization, patients began the double-blind phase of treatment. Tamsulosin (Flomax) is an alpha-1 blocker. 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]. It should not be stored for future use. 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. Common tamsulosin side effects may include: abnormal ejaculation, decreased amount of semen; runny or stuffy nose, sore throat, cough; This is not a complete list of side effects and others may occur. (topiramate capsules) Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies, capsule, white, imprinted with TEVA, 7335, capsule, white, imprinted with TEVA, 7336, capsule, white, imprinted with TOP, 25 mg, capsule, white, imprinted with TOP, 15 mg, capsule, white, imprinted with ZA 64, 25mg, round, yellow, imprinted with TOPAMAX, 100, round, peach, imprinted with TOPAMAX, 200, round, yellow, imprinted with APO, TP 100, capsule, brown/gray, imprinted with UPSHER-SMITH, 100 mg, capsule, gray/yellow, imprinted with UPSHER-SMITH, 150 mg, capsule, brown/gray, imprinted with UPSHER-SMITH, 200 mg, capsule, gray/pink, imprinted with UPSHER-SMITH, 25 mg, capsule, gray/yellow, imprinted with UPSHER-SMITH, 50 mg. (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. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on TOPAMAX to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see WARNINGS AND PRECAUTIONS]. When administered concomitantly with topiramate at escalating doses of 100, 250, and 400 mg/day, there was a reduction in risperidone systemic exposure (16% and 33% for steady-state AUC at the 250 and 400 mg/day doses of topiramate). Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. Drug Name : Tamsulosin Tamsulosin (Flomax) generic is an alpha blocker, prescribed for benign prostatic hyperplasia (BPH) or prostate enlargement. Infrequent reports of shortness of breath, palpitations, low blood pressure ( hypotension ), atrial fibrillation, irregular heartbeat ( arrhythmia ), and fast heart rate. The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. 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]. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. 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. This increased frequency of abnormal values was not dose-related. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. The primary measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure severity. The prostate gland is located below the bladder. Last updated on Apr 5, 2023. In pediatric patients (1-24 months) receiving adjunctive TOPAMAX for partial-onset seizures, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, alkaline phosphatase, and total protein, The incidence was also increased for a decreased result for bicarbonate (i.e., metabolic acidosis), and potassium with TOPAMAX (vs placebo) [see Use In Specific Populations]. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Two hundred fifty-five patients completed the entire 26-week double-blind phase. Inform patients about the signs of serious skin reactions. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. TOPAMAX overdose has resulted in severe metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Bicarbonate decrements are usually mild-moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Keep TOPAMAX and all medicines out of the reach of children. 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. 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