You may report side effects to FDA at 1-800-FDA-1088. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Know the medicines you take. Caution should be used when TOPAMAX is given with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. benign prostatic hyperplasia. In all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. The lowest dose tested, which was associated with increased malformations, is less than the maximum recommended human dose (MRHD) for epilepsy (400 mg/day) or migraine (100 mg/day) on a body surface area (mg/m2) basis. Propranolol doses of 160 mg/day in 39 volunteers (27 males, 12 females) had no effect on the exposure to topiramate, at a dose of 200 mg/day of topiramate. Of the 1,135 patients exposed to TOPAMAX in the adult placebo-controlled studies, 25% of TOPAMAX-treated patients discontinued due to adverse reactions, compared to 10% of the 445 placebo-treated patients. The purpose of this registry is to collect information about the safety of TOPAMAX and other antiepileptic drugs during pregnancy. It is not known if Topamax is safe and effective in children younger than 2 years of age. Topamax is also used 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. Topamax may be used alone or with other medications. Topiramate produced a dose-related increased incidence of hyperammonemia [see WARNINGS AND PRECAUTIONS]. If you need surgery, tell the surgeon ahead of time that you are using topiramate. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room. This rate appeared to increase at dosages above 400 mg/day. 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. Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraines classified by IHS criteria) from the baseline phase to double-blind treatment period in each TOPAMAX treatment group compared to placebo in the Intent-To-Treat (ITT) population. In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. 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. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Some patients with refractory epilepsy will need to avoid such activities altogether. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Encourage pregnant women using TOPAMAX, to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. Does tamsulosin interact with my other drugs? A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. Stop using this medicine and call your doctor at once if you have: a light-headed feeling, like you might pass out; or. Active Ingredient: tamsulosin hydrochloride TOPIRAMATE - ORAL. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This medication is also used to prevent migraine headaches and decrease how often you get them. The effectiveness of TOPAMAX as an adjunctive treatment for primary generalized tonicclonic seizures in patients 2 years of age and older was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 9), comparing a single dosage of TOPAMAX and placebo (see Table 12). We comply with the HONcode standard for trustworthy health information. Tamsulosin is not approved for use in women or children. This is not a complete list of side effects and others may occur. In Study 11, a total of 469 patients (416 females, 53 males), ranging in age from 13 to 70 years, were randomized and provided efficacy data. 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. Take Topamax exactly as it was prescribed for you. The significance of these findings is uncertain. Be careful if you drive or do anything that requires you to be alert. Using Topamax with other drugs that make you drowsy can worsen this effect. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Your doctor should check your progress at regular visits. Inform patients about the signs of serious skin reactions. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. The incidence of some adverse reactions (e.g., fatigue, dizziness, somnolence, difficulty with memory, difficulty with concentration/attention) 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). Topiramate doses are sometimes based on weight in children. Topamax may cause vision problems that can be permanent if not treated quickly. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4.0 23.0) as compared to the risk in a background population of untreated women. Reductions in length and weight were correlated to the degree of acidosis [see Use In Specific Populations]. Hydration is recommended to reduce new stone formation. other information we have about you. Keep TOPAMAX in a tightly closed container. 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. Review/update the If you take Topamax during pregnancy: The benefit of preventing seizures may outweigh any risks posed by this medicine. 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. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TOPAMAX should be used with extreme caution if used in combination with alcohol and other CNS depressants. TOPAMAX Sprinkle Capsules may be swallowed whole or may be opened and sprinkled on a. TOPAMAX can be taken before, during, or after a meal. Do not start a new medicine without talking with your healthcare provider. have or have had depression, mood problems, or suicidal thoughts or behavior. You may opt-out of email communications at any time by clicking on Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. All rights reserved. Topiramate is used to treat seizures in adults and children who are at least 2 years old. If the decision is made to continue patients on TOPAMAX in the face of persistent acidosis, alkali treatment should be considered. By blocking these receptors, the medication works by relaxing the muscles in your prostate and bladder, which relieves symptoms of BPH by making it easier to urinate. The significance of these findings is uncertain. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. 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. decreased feeling or sensitivity, especially in the skin. This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. In pediatric migraine patients, the incidence of cognitive/neuropsychiatric adverse reactions was increased in TOPAMAX-treated patients compared to placebo. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX may be required. TOPAMAX and alcohol can affect each other causing side effects such as sleepiness and dizziness. Last updated on Apr 5, 2023. The clinical significance of these various changes in vital signs has not been clearly established. The higher of the doses not associated with an increase in tumors (75 mg/kg/day) is equivalent to the maximum recommended human dose (MRHD) for epilepsy (400 mg), and approximately 4 times the MRHD for migraine (100 mg) on a mg/m2 basis. alpha 1 receptor antagonist. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Brand names: Topamax, Topamax Sprinkle You can enroll in this registry by calling 1-888-233-2334. 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. If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. Tamsulosin may lower your blood pressure and may cause dizziness or fainting, especially when you first start taking it or your dose changes. Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. There may be other medicines to treat your condition that have a lower chance of birth defects. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. 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]. Medically reviewed by Sophia Entringer, PharmD. Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Topamax is an antiepileptic drug, prescribed to control both the mild attacks known as partial seizures and the severe tonic-clonic convulsions known as grand mal seizures. 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. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. Keep all follow-up visits with your healthcare provider as scheduled. No age-related differences in effectiveness or adverse effects were evident. Take the medicine as soon as you can. The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. Other adverse reactions seen during clinical trials were: abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, and visual field defect. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. A dosage adjustment may be needed [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Concomitant administration of phenytoin or carbamazepine with TOPAMAX resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to TOPAMAX given alone. are breastfeeding or plan to breastfeed. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using TOPAMAX, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [see DRUG INTERACTIONS]. Subset analyses of the antiepileptic efficacy of TOPAMAX tablets in these studies showed no differences as a function of gender, race, age, baseline seizure rate, or concomitant AED. 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. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. All rights reserved. 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). Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. have a history of metabolic acidosis (too much acid in the blood). Tamsulosin belongs to a class of medications called alpha blockers. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. 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. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia. Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places. General information about the safe and effective use of TOPAMAX. 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. Last updated on Jan 16, 2023. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of TOPAMAX, and skip the missed dose. USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. An overdose of topiramate can be fatal. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. 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]. Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. (topiramate) Topiramate Use. Other Antiepileptic drugs during pregnancy: the benefit of preventing seizures may outweigh any risks by. 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