tamsulosin brand name topamaxtamsulosin brand name topamax

In pooled controlled clinical trials in adults with partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, 183 patients received adjunctive therapy with TOPAMAX at dosages of 200 to 400 mg/day (recommended dosage range) and 291 patients received placebo. 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. -This drug should be administered approximately one-half hour following the same meal each day. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. Topiramate clearance is decreased in the elderly only to the extent that renal function is reduced [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. Hypothermia, defined as a drop in body core temperature to <35C (95F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. Revised: Jun 2020. Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAX for adjunctive epilepsy. TOPAMAX Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream (debossed OMN on one side; 25 on the other), 50 mg light-yellow (debossed OMN on one side; 50 on the other), 100 mg yellow (debossed OMN on one side; 100 on the other), 200 mg salmon (debossed OMN on one side; 200 on the other). 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). Tell your doctor if you have decreased sweating, high fever, and hot dry skin. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. benign prostatic hyperplasia. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. Stay alert to changes in your mood or symptoms. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. (TOE-PA-MAX) Evidence of maternal toxicity (decreased body weight gain, clinical signs, and/or mortality) was seen at 35 mg/kg/day and above. The pharmacokinetics of topiramate in elderly subjects (65 to 85 years of age, N=16) were evaluated in a controlled clinical study. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. Ask your doctor about prostate cancer screening before and while taking this medicine. 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.). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Dose titration should be guided by clinical outcome. Topiramate does not influence the binding of sodium valproate. Copyright: Merative US L.P. 1973, 2023. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. 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. Call your doctor for medical advice about side effects. Table 13: Percent Reduction from Baseline to the Last 12 Weeks of Double-Blind Phase in Average Monthly Attack Rate: Study 13 (Intent-to-Treat Analysis Set), TOPAMAX This list is not complete. Metabolic acidosis may have harmful effects on your baby. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant. Steady-state is thus reached in about 4 days in patients with normal renal function. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. TOPAMAX is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Tell your doctor right away if you become pregnant. Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX-treated patient were fatigue (1%), headache (1%), and somnolence (1%). Brand names: Topamax, Topamax Sprinkle It may causes side effects like confusion, drowsiness, dizziness, or blurred vision. This finding was not statistically significant. The bioavailability of topiramate is not affected by food. The most common adverse reactions that occurred in TOPAMAX-treated pediatric patients 6 to 11 years of age, and at least twice as frequently than placebo, were gastroenteritis (12% topiramate, 6% placebo), sinusitis (10% topiramate, 3% placebo), weight loss (8% topiramate, 3% placebo) and paresthesia (7% topiramate, 0% placebo). COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). If you miss a single dose of TOPAMAX, take it as soon as you can. Your reactions could be impaired. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. FLOMAX is a prescription medication approved to treat male urinary symptoms due to benign prostatic hyperplasia (BPH), also called an enlarged prostate. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. Do not save it for later use. It is not known if the TOPAMAX that passes into breast milk can cause other serious harm to your baby. Topamax can be taken with or without food. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Copyright 1996-2023 Cerner Multum, Inc. Store tightly closed at room temperature, away from moisture and heat. The following adverse reactions have been identified during post approval use of TOPAMAX. The effects of topiramate on milk production are unknown. 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). In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. 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. 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]. The long-term consequences of the SGA findings are not known. Click here for an email preview. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. You and your doctor will decide how long you stay on treatment. 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. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. The clinical significance of these various changes in vital signs has not been clearly established. Patients received active drug beginning at 50 mg/day for four weeks; the dose was then increased by 50 mg to 150 mg/day increments every other week until the assigned dose of 175, 225, or 400 mg/day based on patients' body weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. Hydration is recommended to reduce new stone formation. Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The clinical significance of this change is unknown. Psychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations [see Suicidal Behavior And Ideation]. 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. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs) may be additive to the bicarbonate lowering effects of TOPAMAX. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Instruct patients that if they miss a single dose of TOPAMAX, it should be taken as soon as possible. You should not use this medication if you are allergic to tamsulosin. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being SGA [see Human Data]. The effectiveness of TOPAMAX as initial monotherapy in adults and pediatric patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial (Study 1). An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. 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. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. The effectiveness of TOPAMAX for the preventive treatment of migraine in pediatric patients 12 to 17 years of age was established in a multicenter, randomized, double-blind, parallel-group trial (Study 13). Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. 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. 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. . You may report side effects to FDA at 1-800-FDA-1088. 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. Yes, topiramate (Topamax) has been shown to cause weight loss when used for both seizure control and migraine prevention. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients [see WARNINGS AND PRECAUTIONS]. TOPAMAX can be taken without regard to meals. 10 Things People With Depression Wish You Knew, * Administered in two equally divided doses, Difficulty with concentration or attention, Placebo Patients with Events per 1000 Patients, Drug Patients with Events per 1000 Patients. Do not stop using Topamax suddenly, even if you feel fine. Topamax belongs to a class of drugs called anticonvulsants. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX during pregnancy. Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see WARNINGS AND PRECAUTIONS]. The significance of these findings is uncertain. Similarly, topiramate half-life was longer (13%) in the elderly. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. This medicine will only prevent migraine headaches or reduce the number of attacks. The treatment differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p<0.001 for both comparisons). In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. Topiramate Brand Name. Topiramate did not affect metformin tmax. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Infrequent reports of shortness of breath, palpitations, low blood pressure ( hypotension ), atrial fibrillation, irregular heartbeat ( arrhythmia ), and fast heart rate. Tamsulosin Class. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). 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 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. During long-term (up to 1 year) TOPAMAX treatment in an open-label extension study of 284 pediatric patients 1-24 months old with epilepsy, 7% developed kidney or bladder stones. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of TOPAMAX, and to skip the missed dose. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. This product is available in the following dosage forms: There is a problem with These are not all the possible side effects of TOPAMAX. 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 gelatin capsules are white and clear. 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