Food and drink that may interact with this drug include: Taking tamsulosin with any food may decrease its effectiveness by 30 percent, according to the FDA . This product is available in the following dosage forms: There is a problem with You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. Using Topamax with other drugs that make you drowsy can worsen this effect. 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The incidence of some adverse reactions (e.g., allergy, fatigue, headache, anorexia, insomnia, somnolence, and viral infection) was dose-related and greater at higher than recommended TOPAMAX dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily). Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Topiramate is cleared by hemodialysis. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. A dosage adjustment may be needed [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Mayo Clinic does not endorse companies or products. A patient who ingested a dose of TOPAMAX between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Table 8: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adultsa,b. 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 incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride and ammonia, TOPAMAX was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies [see WARNINGS AND PRECAUTIONS]. The risk for hyperammonemia with topiramate appears dose-related. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. Continue reading, Topamax (topiramate) is approved to be taken alone or with other medicines to control certain types of seizures and for the prevention of migraine headaches. It blocks a specific type of receptor found in the prostate. Dose-related hyperammonemia was also seen in pediatric patients 1 to 24 months of age treated with TOPAMAX and concomitant valproic acid for partial-onset epilepsy and this was not due to a pharmacokinetic interaction. Multiple dosing of topiramate (100 mg every 12 hours) in 24 healthy volunteers (14 males, 10 females) did not affect the pharmacokinetics of single-dose sumatriptan either orally (100 mg) or subcutaneously (6 mg). 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 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). In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). decreased feeling or sensitivity, especially in the skin. 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]. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Clinical signs of maternal toxicity were seen at 400 mg/kg/day and above, and maternal body weight gain was reduced at doses of 100 mg/kg/day or greater. The prostate gland is located below the bladder. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. 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. Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. (Studies 11 and 12 for Adults and Adolescents). The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use In Specific Populations]. 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). Not all possible drug interactions are listed here. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. 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]. Topiramate treatment can cause hyperammonemia with or without encephalopathy [see ADVERSE REACTIONS]. You may opt-out of email communications at any time by clicking on Breastfed babies may be sleepy or have diarrhea. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. For the monotherapy epilepsy population, the incidence of somnolence was dose-related. Do not use TOPAMAX for a condition for which it was not prescribed. 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. 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. 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). It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. Patients who experienced at least six partial-onset seizures, with or without secondarily generalized seizures, during the baseline phase were randomly assigned to placebo or TOPAMAX tablets in addition to their other AEDs. Continue reading, Topamax is not classified as a controlled substance under the U.S. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. 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]. The median average daily dosages were 48 mg/day, 88 mg/day, and 132 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 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. How can I watch for early symptoms of suicidal thoughts and actions? Metabolic acidosis can happen with or without symptoms. Topamax. TOPAMAX can be taken before, during, or after a meal. Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. You should not drink alcohol while taking TOPAMAX. Following randomization, patients began the double-blind phase of treatment. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. Your healthcare provider may do blood tests while you take TOPAMAX. In adult epilepsy adjunctive controlled trials, which used rapid titration (100-200 mg/day weekly increments), and target TOPAMAX doses of 200 mg 1000 mg/day, 56% of patients in the 800 mg/day and 1000 mg/day dose groups experienced cognitive-related dysfunction compared to approximately 42% of patients in the 200-400 mg/day groups and 14% for placebo. Last updated on Apr 5, 2023. 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. In a double-blind study in 90 pediatric patients 6 to 11 years of age (including 59 topiramate-treated and 31 placebo patients), the adverse reaction profile was generally similar to that seen in pooled double-blind studies of pediatric patients 12 to 17 years of age. Benign enlargement of the prostate is a problem that can occur in men as they get older. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase. (TOE-PA-MAX) A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. Dosing in patients 2 to 9 years of age is based on weight. Steady-state is thus reached in about 4 days in patients with normal renal function. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. You may report side effects to FDA at 1-800-FDA-1088. Table 10: Summary of AED Interactions with TOPAMAX. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). Copyright 1996-2023 Cerner Multum, Inc. If you cannot swallow a Topamax Sprinkle Capsule whole, open the capsule and sprinkle the medicine into a spoonful of applesauce or other soft food. You should talk to your doctor about the best kind of birth control to use while you are taking TOPAMAX. Topiramate resulted in an increased incidence of patients with increased creatinine (any topiramate dose 5%, placebo 0%), BUN (any topiramate dose 3%, placebo 0%), and protein (any topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any topiramate dose 7%, placebo 0%). Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. TOPAMAX (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. The prostate gland is located below the bladder. Call your doctor if you have missed more than one dose. Table 9 also shows adverse reactions in pediatric patients in the controlled migraine trials when the incidence in a TOPAMAX dose group was at least 5 % or higher and greater than the incidence of placebo. Topamax can increase the level of acid in your blood (metabolic acidosis). 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. Patients received active drug beginning at 25 or 50 mg/day; the dose was then increased by 25 mg to 150 mg/day increments every other week until the assigned dosage of 125, 175, 225, or 400 mg/day based on patients' weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. [5] Keep TOPAMAX in a tightly closed container. 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. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. There may also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX during pregnancy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Version: 11.01. finasteride, Flomax, tadalafil, prazosin, doxazosin, Cialis. This change was not seen in the placebo group. Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. have kidney problems, have kidney stones, or are getting kidney. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Topamax only for the indication prescribed. In pregnant rabbits administered topiramate (0, 20, 60, and 180 mg/kg/day or 0, 10, 35, and 120 mg/kg/day) orally during organogenesis, embryofetal mortality was increased at 35 mg/kg/day, and increased incidences of fetal malformations (primarily rib and vertebral malformations) were observed at 120 mg/kg/day. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. Data from pregnancy registries indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Important Safety Information BPH can occur with other more serious conditions, including prostate cancer. 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. The prostate may continue to get larger. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. 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. 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. Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. TOPAMAX and other medicines may affect each other causing side effects. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. 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. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. This Medication Guide has been approved by the U.S. Food and Drug Administration. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. Report any new or worsening symptoms to your doctor. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg/day (approximately 3 times the MRHD for epilepsy and 12 times the MRHD for migraine on a mg/m2 basis). (topiramate capsules) 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. Tamsulosin (Flomax) is an alpha-1 blocker. 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