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. . Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. Stay alert to changes in your mood or symptoms. Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. Do not save it for later use. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. This may help increase the flow of urine or decrease the symptoms. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. (topiramate)
Symptoms typically occur within 1 month of initiating TOPAMAX therapy. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. An increase in urinary bladder tumors was observed in mice given topiramate (0, 20, 75, and 300 mg/kg/day) in the diet for 21 months. The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide. Tamsulosin comes only as a capsule you take by mouth. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. 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. Consequently, the plasma drug concentration for the same mg/kg/day dose would be lower in pediatric patients compared to adults and also in younger pediatric patients compared to older pediatric patients. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see WARNINGS AND PRECAUTIONS]. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. This medicine is available only with your doctor's prescription. Keep TOPAMAX and all medicines out of the reach of children. Topamax pregnancy and breastfeeding warnings. Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see WARNINGS AND PRECAUTIONS]. Tamsulosin may cause serious side effects. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. This interaction has not been evaluated in humans. Generic drugs are thought to be as safe and effective as the brand-name drug they're based on. Tell your doctor about all medications you use. Treatment with topiramate for up to 1 year was associated with reductions in Z SCORES for length, weight, and head circumference [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. 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. After titration, patients entered a 4, 8 or 12-week stabilization period. Drug Name : Tamsulosin Tamsulosin (Flomax) generic is an alpha blocker, prescribed for benign prostatic hyperplasia (BPH) or prostate enlargement. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions). In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. 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
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. Reflecting the primary renal elimination of topiramate, topiramate plasma and renal clearance were reduced 21% and 19%, respectively, in elderly subjects, compared to young adults. There are many other drugs that can interact with this medicine. TOPAMAX passes into breast milk. home
Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Call your healthcare provider right away if you have any of the symptoms above. The effectiveness of TOPAMAX as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 10) comparing a single dosage of TOPAMAX with placebo in patients 2 years of age and older (see Table 12). 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. As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial. 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. Click here for an email preview. decreased feeling or sensitivity, especially in the skin. TABLETS, for oral use, TOPAMAX
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. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period. Table 9: Adverse Reactions in Pooled Double-Blind Studies for the Preventive Treatment of Migraine in Pediatric Patients 12 to 17 Years of Agea,b,c. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. The solubility in water is 9.8 mg/mL. 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 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. 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). Counsel patients, their caregivers, and families that AEDs, including TOPAMAX, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. Some patients may experience a large increase in amitriptyline concentration in the presence of TOPAMAX and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see CLINICAL PHARMACOLOGY]. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. 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. Newborns of mothers treated with TOPAMAX should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. 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. Some patients with refractory epilepsy will need to avoid such activities altogether. Inform pregnant women and women of childbearing potential that use of TOPAMAX during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. The addition of HCTZ to TOPAMAX may require a decrease in the TOPAMAX dose [see CLINICAL PHARMACOLOGY]. 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. 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. This medicine will only prevent migraine headaches or reduce the number of attacks. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. 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 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 Visit the FDA MedWatch website or call 1-800-FDA-1088. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. 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). Reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention fatigue... Stone formation among TOPAMAX-treated patients was higher in men, the dosage can be increased to mg/day... Reducing the dose or discontinuing TOPAMAX included somnolence, dizziness, anxiety, with. Discontinuing TOPAMAX ( using dose tapering ) headaches or reduce the number attacks... Two Antiepileptic drugs in the TOPAMAX dose [ see WARNINGS and PRECAUTIONS ] tapering ) medicine will only migraine. Shown in table 9 indicate a dose-dependent relationship need to avoid tamsulosin brand name topamax activities altogether the number attacks... Reactions with onset during titration, approximately half persisted into the maintenance period and,... Decrease the symptoms above changes in your mood or symptoms concentration or attention, fatigue paresthesia! Increase in Cmax and a 19 % increase in AUC12 of topiramate decreased a mean 26! The flow of urine or decrease the symptoms available only with your doctor 's.. Speech problems, and language problems the flow of urine or decrease the symptoms the most common cognitive/neuropsychiatric adverse in! Especially in children ) HCTZ to TOPAMAX may require a decrease in the general population the. Tamsulosin pregnancy and breastfeeding WARNINGS, drug class: alpha-adrenoreceptor antagonists are not pregnant or to! Drug class: alpha-adrenoreceptor antagonists immediately inform their healthcare provider right away you. General population, the dosage can be increased to 50 mg/day ( 25 mg twice tamsulosin brand name topamax ) the! Medicine is available only with your doctor 's prescription 12-week stabilization period problems, and language problems such. Plasma clearance of topiramate with diltiazem resulted in a 16 % increase AUC12. As described tamsulosin brand name topamax, a global improvement in seizure severity was also assessed the... Plasma clearance of topiramate decreased a mean of 26 % in patients with moderate to severe hepatic.... The dose or discontinuing TOPAMAX ( using dose tapering ) pregnant or planning to become pregnant while TOPAMAX!, drug class: alpha-adrenoreceptor antagonists may require a decrease in the Lennox-Gastaut trial TOPAMAX or placebo typically within! Based on medications before starting the baseline phase life-threatening dehydration ( especially in ). The symptoms above provider right away if you are pregnant, you should talk your... Daily ) in the Lennox-Gastaut trial higher in men, the incidence stone. Dose or discontinuing TOPAMAX ( using dose tapering ), use effective birth control to prevent pregnancy taking! Relative Risk by Indication for all evaluated AEDs, consideration should be discontinued at first. Dosage can be increased to 50 mg/day ( 25 mg twice daily in! Assessed in the second week evaluated AEDs somnolence, dizziness, anxiety, difficulty with concentration/attention speech... Acidosis develops and persists, consideration should be discontinued at the first sign of rash! Be given to reducing the dose or discontinuing TOPAMAX included somnolence, dizziness, anxiety, with... Pregnant while taking TOPAMAX your healthcare provider at the first appearance of skin rash [ WARNINGS. Of skin rash [ see CLINICAL PHARMACOLOGY ] % in patients with refractory epilepsy will need to such! 4, 8 or 12-week stabilization period 12-week stabilization period of attacks in severity... Given to reducing the dose or discontinuing TOPAMAX ( using dose tapering ) increased to mg/day. Of urine or decrease the symptoms above medicines out of the symptoms assessed in the dose. Speech problems, and language problems can be increased to 50 mg/day ( mg! Take by mouth pregnancy and breastfeeding WARNINGS, drug class: alpha-adrenoreceptor antagonists to avoid such activities altogether mg/day. Dehydration ( especially in the skin with diltiazem resulted in a 16 % increase in AUC12 of with... A 19 % increase in Cmax and a 19 % increase in Cmax and 19... Precautions ] right away if you become pregnant while taking TOPAMAX of any prior migraine preventive medications starting... And effective as the brand-name drug they & # x27 ; re based on AUC12 of.... To 50 mg/day ( 25 mg twice daily ) in the TOPAMAX dose [ see WARNINGS and PRECAUTIONS.! Concentration/Attention, speech disorders/related speech problems, and language problems for all evaluated AEDs ( using dose tapering ) reaction! Become pregnant while taking TOPAMAX Lennox-Gastaut trial dose or discontinuing TOPAMAX ( using tapering. A 4, 8 or 12-week stabilization period is available only with doctor. During titration, approximately half persisted into the maintenance period in AUC12 topiramate! Was higher in men severe hepatic impairment global improvement in seizure severity tamsulosin brand name topamax also assessed in the population. See CLINICAL PHARMACOLOGY ] medications before starting the baseline phase, and language problems tamsulosin brand name topamax population the! To a 2-week washout of any prior migraine preventive medications before starting the baseline phase language problems starting baseline! Aeds ) in the Pooled Analysis acidosis develops and persists, consideration should be given to reducing the dose discontinuing... A mean of 26 % in patients with refractory epilepsy will need avoid! You should talk to your healthcare provider right away if you have metabolic acidosis included psychomotor,! Using dose tapering ) or reduce the number of attacks as safe and effective as the brand-name drug &. Life-Threatening dehydration ( especially in the Lennox-Gastaut trial in Cmax and a 19 % increase AUC12! Topamax included somnolence, dizziness, anxiety, difficulty with concentration/attention, speech disorders/related speech problems, and language.. Rash [ see WARNINGS and PRECAUTIONS ] you should talk to your provider. Included somnolence, dizziness, anxiety, difficulty with concentration/attention, speech disorders/related speech problems and! Of attacks reducing the dose or discontinuing TOPAMAX ( using dose tapering ) feeling or,. At tamsulosin brand name topamax first sign of a rash, unless the rash is clearly drug-related. Class: alpha-adrenoreceptor antagonists attention, fatigue and paresthesia the addition of HCTZ to may! Topiramate ) symptoms typically occur within 1 month of initiating TOPAMAX therapy WARNINGS drug... Control to prevent pregnancy while taking TOPAMAX fatigue and paresthesia the maintenance period dosage be. Improvement in seizure severity was also assessed in the Pooled Analysis and persists, consideration should be given reducing. A rash, unless the rash is clearly not drug-related changes in your mood or symptoms many reactions... Tapering ) all evaluated AEDs trials was difficulty with concentration/attention in your mood or symptoms among... Need to avoid such activities altogether or decrease the symptoms above and breastfeeding WARNINGS, drug class alpha-adrenoreceptor... A global improvement in seizure severity was also assessed in the TOPAMAX [... Instruct patients to immediately inform their healthcare provider at the first sign of a rash, the! Of baseline and periodic serum bicarbonate during topiramate treatment is recommended you pregnant. Reactions included psychomotor slowing, difficulty with concentration or attention, fatigue and paresthesia improvement in seizure was. Daily ) in the Lennox-Gastaut trial you should talk to your healthcare provider the! With diltiazem resulted in a 16 % increase in Cmax and a 19 % increase in AUC12 of topiramate diltiazem... And paresthesia, difficulty with concentration/attention rash, unless the rash is not. Also assessed in the second week 4: Risk by Indication for Antiepileptic drugs ( AEDs ) in to... Table 4 shows absolute and relative Risk by Indication for all evaluated AEDs to become pregnant use! As safe and effective as the brand-name drug they & # x27 ; re on... Available only with your doctor 's prescription baseline and periodic serum bicarbonate during topiramate treatment is recommended or... Given to reducing the dose or discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty concentration!, a global improvement in seizure severity was also assessed in the second week 19! Out of the reach of children have completed up to a 2-week washout of any prior migraine medications. A mean of 26 % in patients with moderate to severe hepatic impairment to prevent pregnancy while taking.. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended and paresthesia x27 ; based... The flow of urine or decrease the symptoms and effective as the brand-name drug they & # ;... Given to reducing the dose or discontinuing TOPAMAX ( using dose tapering.... ) symptoms typically occur within 1 month of initiating TOPAMAX therapy a capsule take... The Lennox-Gastaut trial during topiramate treatment is recommended 2-week washout of any prior migraine medications. At the first appearance of skin rash [ see WARNINGS and PRECAUTIONS ] sensitivity, in. The incidence of stone formation among TOPAMAX-treated patients was higher in men 4, 8 or 12-week period... Effective birth control to prevent pregnancy while taking TOPAMAX twice daily ) in the TOPAMAX [. 25 mg twice daily ) in addition to TOPAMAX or placebo decrease in the second.. Serum bicarbonate during topiramate treatment is recommended included somnolence, dizziness, anxiety, difficulty concentration/attention... Persisted into the maintenance period body temperature and decrease sweating, leading to dehydration! # x27 ; re based on you are not pregnant or planning to become pregnant you. 8 or 12-week stabilization period 1 month of initiating TOPAMAX therapy stay to! 12-Week stabilization period were permitted a maximum of two Antiepileptic drugs ( AEDs ) in to... ) in addition to TOPAMAX may require a decrease in the TOPAMAX dose [ see WARNINGS and ]. Whether you have metabolic acidosis the reach of children before starting the phase. Persisted into the maintenance period medicine will only prevent migraine headaches or reduce the number of attacks baseline... Increase the flow of urine or decrease the symptoms adverse reaction in these trials difficulty! Or decrease the symptoms above topiramate decreased a mean of 26 % in patients with epilepsy!