Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. 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. Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received TOPAMAX as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. 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). Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- The long-term consequences of the SGA findings are not known. 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. Topamax can be taken with or without food. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. . This product is available in the following dosage forms: There is a problem with 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. 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. This risk for cognitive/neuropsychiatric adverse reactions was also greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age). Store tightly closed at room temperature, away from moisture and heat. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone [see DRUG INTERACTIONS]. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. 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. Data from pregnancy registries indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. 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 ). If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. You should not drink alcohol while taking TOPAMAX. Using Topamax with other drugs that make you drowsy can worsen this effect. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Metabolic Acidosis]. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. If you stop taking this medicine for any reason, call your doctor before you start taking it again. Breastfed babies may be sleepy or have diarrhea. It will not treat a headache that has already begun. It is not possible to know whether this mortality rate is related to topiramate treatment, because the background mortality rate for a similar, significantly refractory, young pediatric population (1-24 months) with partial epilepsy is not known. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). TOPAMAX may cause serious side effects including: See What is the most important information I should know about TOPAMAX?. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may opt-out of email communications at any time by clicking on This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate [see DRUG INTERACTIONS]. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. Avoid driving or hazardous activity until you know how this medicine will affect you. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. 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. Call your doctor for medical advice about side effects. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Study with Quizlet and memorize flashcards containing terms like Vardenafil Brand Name, Vardenafil Class, Vardenafil Use and more. Your blood pressure will need to be checked often. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and >5 mEq/L decrease from pretreatment) in these trials was up to 11%, compared to 2% for placebo. If you miss a single dose of TOPAMAX, take it as soon as you can. After titration, patients entered an 8-week stabilization period. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). There are 284 drugs known to interact with tamsulosin, along with 4 disease interactions, and 2 alcohol/food interactions. How long do you stay on Topamax for migraines? TOPAMAX passes into breast milk. drugs a-z list Version: 23.01. For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. 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). Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. 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. Tamsulosin is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Co-administration of topiramate 400 mg/day with risperidone resulted in a 14% increase in Cmax and a 12% increase in AUC12 of topiramate. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use In Specific Populations]. 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. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). Call your healthcare provider between visits as needed, especially if you are worried about symptoms. 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. Stay alert to changes in your mood or symptoms. 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]. There was a suggestion that this effect was dose-related. 6. Before taking TOPAMAX, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Call your doctor for medical advice about side effects. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Similarly, topiramate half-life was longer (13%) in the elderly. The gelatin capsules are white and clear. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. The adverse reactions associated with discontinuing therapy in the TOPAMAX-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%). In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. Last updated on Apr 5, 2023. Does tamsulosin interact with my other drugs? health information, we will treat all of that information as protected health Some people may need to be hospitalized for this condition. This will be based on how well it is working for you and any side effects you may experience. The purpose of this registry is to collect information about the safety of TOPAMAX and other antiepileptic drugs during pregnancy. In Table 10, the second column (AED concentration) describes what happens to the concentration of the co-administered AED listed in the first column when topiramate is added. Click here for an email preview. TOPAMAX can slow your thinking and motor skills, and may affect vision. Copyright 1996-2023 Cerner Multum, Inc. Comments: 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). Patients in Study 10 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. Topiramate Use. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. Clearance of topiramate in adults was not affected by gender or race. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. are breastfeeding or plan to breastfeed. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Topamaxbelongs to a class of drugs called Anticonvulsants, Other, Antimigraine Agents. Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state [see WARNINGS AND PRECAUTIONS]. 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. 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). The mean reduction from baseline to the last 12 weeks of the double-blind phase in average monthly attack rate, a key secondary efficacy endpoint in Study 13 (and the primary efficacy endpoint in Studies 11 and 12, of adults) was 3.0 for 100 mg TOPAMAX dose and 1.7 for placebo. 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. Tell your doctor right away if you become pregnant. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. 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. 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. Open-label extension phases of 3 studies enabled evaluation of long-term safety for up to 6 months after the end of the double-blind phase. 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. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. The mean plasma elimination half-life is 21 hours after single or multiple doses. Table 7 presents the incidence of adverse reactions that occurred in at least 3% of pediatric patients 2 to 15 years of age receiving 5 mg to 9 mg/kg/day (recommended dose range) of TOPAMAX and was greater than placebo incidence. Use: Benign prostatic hyperplasia (BPH). This medicine will only prevent migraine headaches or reduce the number of attacks. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX may be required. 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. Keep TOPAMAX in a tightly closed container. 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 In clinical trials, 3% of patients were over age 60. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. have or have had depression, mood problems, or suicidal thoughts or behavior. 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. Therefore, advise all patients taking TOPAMAX for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). 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. Tamsulosin can affect your pupils during cataract surgery. have kidney problems, have kidney stones, or are getting kidney. Steady-state is thus reached in about 4 days in patients with normal renal function. Your doctor may occasionally change your dose. 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. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. In the NAAED pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.1%) was higher than the prevalence of infants exposed to a reference AED (0.36%) or the prevalence of infants in mothers without epilepsy and without exposure to AEDs (0.12%). 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