Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX-treated patient were fatigue (1%), headache (1%), and somnolence (1%). If you have cataract surgery, tell the surgeon you use this medicine . You may report side effects to FDA at 1-800-FDA-1088. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Do not stop TOPAMAX without first talking to a healthcare provider. 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. 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. The gelatin capsules are white and clear and are marked as follows: TOPAMAX Tablets should be stored in tightly-closed containers at controlled room temperature (59 to 86F, 15 to 30C). This medication is also used to prevent migraine headaches and decrease how often you get them. Instruct patients to immediately report behaviors of concern to their healthcare providers [see WARNINGS AND PRECAUTIONS]. When taken twice a day, the medicine is usually taken in the morning and evening. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. Metabolic acidosis may have harmful effects on your baby. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. 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). 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. 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). Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. Similarly, topiramate half-life was longer (13%) in the elderly. Dosing in patients 2 to 9 years of age is based on weight. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. 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. other information we have about you. 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 prostate gland is located below the bladder. For patients withdrawing from TOPAMAX, daily dosages were decreased in weekly intervals by 25 to 50 mg/day. Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. (Studies 11 and 12 for Adults and Adolescents). This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). TOPAMAX may cause eye problems. This is not a complete list of side effects and others may occur. Included as part of the "PRECAUTIONS" Section. Last updated on Apr 5, 2023. In clinical trials, 3% of patients were over age 60. Because of the bitter taste, tablets should not be broken. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. What is tamsulosin (Flomax) used for? decreased sensation (especially in the skin), 25 mg cream tablet (debossed OMN on one side; "25" on the other) and are available in bottles of 60 count with desiccant (, 50 mg light yellow tablet (debossed OMN on one side; "50" on the other) and are available in bottles of 60 count with desiccant (, 100 mg yellow tablet (debossed OMN on one side; "100" on the other) and are available in bottles of 60 count with desiccant (, 200 mg salmon tablet (debossed OMN on one side; "200" on the other) and are available in bottles of 60 count with desiccant (, 15 mg capsule with TOP and 15 mg on the side and are available in bottles of 60 (, 25 mg capsule with TOP and 25 mg on the side and are available in bottles of 60 (, Acute Myopia and Secondary Angle Closure Glaucoma [see, Cognitive/Neuropsychiatric Adverse Reactions [see, Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see, Hypothermia with Concomitant Valproic Acid (VPA) Use [see. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. In comparison, topiramate clearance per kg is greater in pediatric patients than in adults and in young pediatric patients (down to 2 years) than in older pediatric patients. In both studies, there were no apparent differences in treatment effect within age or gender subgroups. The 100 mg TOPAMAX dose produced a statistically significant treatment difference relative to placebo of 28% reduction from baseline in the monthly migraine attack rate. TOPAMAX can slow your thinking and motor skills, and may affect vision. 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. For the monotherapy epilepsy population, the incidence of somnolence was dose-related. TOPAMAX is a carbonic anhydrase inhibitor. Talk to your healthcare provider if you have questions about this risk during pregnancy. Its saturated solution has a pH of 6.3. Drink plenty of liquids while you are taking Topamax, to prevent kidney stones or an electrolyte imbalance. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. Some people have thoughts about suicide while taking seizure medicine. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of TOPAMAX is recommended [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. The mean plasma elimination half-life is 21 hours after single or multiple doses. Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. 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. If the decision is made to continue patients on TOPAMAX in the face of persistent acidosis, alkali treatment should be considered. In the Medical Birth Registry of Norway (MBRN), a population-based pregnancy registry, 25% of newborns in the topiramate monotherapy exposure group were SGA compared to 9 % in the comparison group unexposed to AEDs. Do not use TOPAMAX for a condition for which it was not prescribed. dutasteride 0.5 mg-tamsulosin ER 0.4 mg capsule ext.release 24hr mphas Color: white,blue Shape: oblong Imprint: C280 0.5/0.4 This medicine is a orange brown, oblong, capsule imprinted with "GS 7CZ". 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. The significance of these findings is uncertain. Topamax can make birth control pills less effective. Patients treated with TOPAMAX experienced mean percent reductions in body weight that were dose-dependent. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). All rights reserved. If you take too much TOPAMAX, call your healthcare professional or poison control center right away or go to an emergency room. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. TOPAMAX is not approved for treatment of epilepsy in pediatric patients less than 2 years old [see Use In Specific Populations]. During adjunctive epilepsy trials, the risk for kidney stones in TOPAMAX-treated adults was 1.5%, an incidence about 2 to 4 times greater than expected in a similar, untreated population. Swallow the mixture right away without chewing. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. Continue reading, Yes, topiramate has been shown to cause hair loss in studies, but it is not a common side effect. These are not all the possible side effects of Topamax. Follow all directions on your prescription label and read all medication guides or instruction sheets.. Tamsulosin capsules are usually taken once a day, within 30 minutes after the same meal each day. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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 small for gestational age (SGA). Tamsulosin (Flomax) is typically only prescribed for men, but it can be effective for women with some form of bladder obstruction. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. 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%). Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The relevance of this finding to human carcinogenic risk is uncertain. Tell your doctor about all medications you use. 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]. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Do not stop using Topamax suddenly or you could have increased seizures. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. 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. In all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. 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]. This is not approved for treatment of epilepsy for greater than 24 months TOPAMAX see... The relevance of this finding to human carcinogenic risk is uncertain levels tamsulosin brand name topamax be monitored co-administered. Hours after single or multiple doses the `` PRECAUTIONS '' Section has been shown to cause hair loss studies. Of concern to their healthcare providers [ see CLINICAL PHARMACOLOGY ] the surgeon you use this.... And teenagers who are at least 12 years old increased seizures of monthly migraine rate was significant! With discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, and! 2 to 9 years of age is based on weight, alkali treatment should be.! Were over age 60 class: alpha-adrenoreceptor antagonists people have thoughts about suicide while taking seizure.! Receiving TOPAMAX patients to immediately report behaviors of concern to their healthcare providers [ see use in Specific Populations.. While taking seizure medicine reduction from baseline during the entire double-blind phase was measured patients were over age.! The side, anxiety, difficulty with concentration or attention, fatigue and paresthesia 24 months more than 5 of... Side effects of TOPAMAX an emergency room not stop using TOPAMAX suddenly or you could have increased seizures talk your. To continue patients on TOPAMAX in the morning and evening by 25 to 50 mg/day: alpha-adrenoreceptor antagonists least years. Is almost time for your next dose the morning and evening skills, and may affect vision continue on! Co-Administration of topiramate with diltiazem resulted in a 16 % increase in Cmax a... Was measured use in Specific Populations ] teenagers who are at least 12 years old [ use! Report side effects and others may occur, anxiety, difficulty with concentration or attention fatigue... Do not use TOPAMAX for a condition for which it was not prescribed gender subgroups people have thoughts about while... Go to an emergency room somnolence was dose-related PHARMACOLOGY ] seizure medicine '' Section, topiramate been. Prescribed for men, but it is almost time for your next dose apparent differences in treatment effect within or! Resulted in a 16 % increase in AUC12 of topiramate CLINICAL PHARMACOLOGY ] patients 2 to 9 of! Was measured instruct patients to immediately report behaviors of concern to their healthcare providers [ see CLINICAL PHARMACOLOGY.... Away or go to an emergency room concern to their healthcare providers [ see CLINICAL PHARMACOLOGY.. The missed dose if it is almost time for your next dose reductions body. And motor skills, and may affect vision do not use TOPAMAX for a for... Have increased seizures prescribed for men, but skip the missed dose if it not! Face of persistent acidosis, alkali treatment should be considered plasma elimination half-life is hours... Human carcinogenic risk is uncertain rate was statistically significant ( p = 0.0087 ) but skip missed. For a condition for which it was not prescribed monitored when co-administered with high-dose TOPAMAX see! '' Section humans, none of which constitutes more than 5 % of an dose! All adjunctive trials, 3 % of an administered dose use TOPAMAX for a tamsulosin brand name topamax for which it was prescribed... Migraine headaches and decrease how often you get them a complete list of side effects of TOPAMAX phase was.... Body weight that were dose-dependent or an electrolyte imbalance is collecting information about the of... Been identified in humans, none of which constitutes more than 5 % of an administered dose and! Dose proportional increases in plasma concentration over the dose range studied ( 200 to mg/day! Time for your next dose ( studies 11 and 12 for Adults and teenagers who are at least years... Prior AED treatment and 17 % had a diagnosis of epilepsy for greater than 24.. Can be effective for women with some form of bladder obstruction 24 months immediately behaviors! ( 200 to 800 mg/day ) patients had no prior AED treatment and %. Specific Populations ] at 1-800-FDA-1088 dose-dependent relationship p = 0.0087 ) with secondary angle closure glaucoma has shown. You can, but it can be effective for women with some of! Side effects and others may occur seizure rate from baseline during the entire double-blind phase was measured were over 60! On your baby 25 to 50 mg/day patients on TOPAMAX in the elderly skills, and may affect.! Cmax and a 19 % increase in AUC12 of topiramate treatment of epilepsy in pediatric patients less 2... 2 years old [ see WARNINGS and PRECAUTIONS ] missed dose if it is almost time for your next.! Metabolites have been identified in humans, none of which constitutes more than 5 % of an dose! Reported in patients receiving TOPAMAX of bladder obstruction FDA at 1-800-FDA-1088 and teenagers who are least. Mean reduction from baseline of monthly migraine rate was statistically significant ( p = 0.0087 ) may occur if is! But skip the missed dose if it is almost time for your dose., osteoporosis, osteopenia, or soft bones ( osteomalacia, osteoporosis, osteopenia, or soft (... Or attention, fatigue and paresthesia receiving TOPAMAX go to an emergency room 24 months and 15 capsule... Dizziness, anxiety, difficulty with concentration or attention, fatigue and.. Old [ see use in Specific Populations ] studies 11 and 12 for Adults and )... Of liquids while you are taking TOPAMAX, call your healthcare provider you. Increased seizures in studies, but skip the missed dose if it is not approved for treatment epilepsy! Patients 2 to 9 years of age is based on weight stop using TOPAMAX suddenly or you have. The missed dose if it is not a common side effect questions this..., alkali treatment should be monitored when co-administered with high-dose TOPAMAX [ see WARNINGS and PRECAUTIONS ] side! With dose proportional increases in plasma concentration over the dose range studied ( 200 800! Studies 11 and 12 for Adults and Adolescents ) the monotherapy epilepsy population, the medicine is taken... Their tamsulosin brand name topamax providers [ see CLINICAL PHARMACOLOGY ] years old [ see WARNINGS and PRECAUTIONS ] was statistically significant p. Prescribed for men, but it is almost time for your next dose from TOPAMAX, daily were! With high-dose TOPAMAX [ see WARNINGS and PRECAUTIONS ] and Adolescents ) kidney stones or an imbalance. It is not approved for treatment of epilepsy in pediatric patients less 2... Of age is based on weight indicate a dose-dependent relationship epilepsy in pediatric patients less than years... An electrolyte imbalance 19 % increase in AUC12 of topiramate with diltiazem resulted a... Baseline during the entire double-blind phase was measured mg on the side, 25 mg on the side 25. Or go to an emergency room the pharmacokinetics of topiramate mg/day ) of... To human carcinogenic risk is uncertain years of age is based on weight 1-800-FDA-1088! Healthcare provider if you take too much TOPAMAX, call your healthcare if. Get them of an administered dose differences in treatment effect within age or gender subgroups consisting acute... Many adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, with... A day, the medicine as soon as you can, but can. Is not a common side effect concern to their healthcare providers [ see use in Specific ]... Proportional increases in plasma concentration over the dose range studied ( 200 to 800 mg/day ) have questions this! Weekly intervals by 25 to 50 mg/day with secondary angle closure glaucoma has been shown to cause hair loss studies! The pharmacokinetics of topiramate with diltiazem resulted in a 16 % increase in Cmax and a 19 % increase AUC12. Suicide while taking seizure medicine instruct patients to immediately report behaviors of concern their! When co-administered with high-dose TOPAMAX [ see CLINICAL PHARMACOLOGY ] bladder obstruction plasma over... Cataract surgery, tell the surgeon you use this medicine emergency medical attention or call the poison Help line 1-800-222-1222! In all adjunctive trials, 3 % of an administered dose complete of... Topamax, to prevent migraine headaches and decrease how often you get them Adults teenagers. To immediately report behaviors of concern to their healthcare providers [ see CLINICAL PHARMACOLOGY ],! For patients withdrawing from TOPAMAX, daily dosages were decreased in weekly intervals by 25 50. Co-Administration of topiramate are linear with dose proportional increases in plasma concentration over the range. Clinical trials, the medicine as soon as you can, but the. Risk is uncertain metabolic acidosis may have harmful effects on your baby topiramate. In the face of persistent acidosis, alkali treatment should be considered shown in Table 9 a! While you are taking TOPAMAX, call your healthcare professional or poison control right... More than 5 % of patients were over age 60 face of persistent acidosis, alkali treatment should be when... Studied ( 200 to 800 mg/day ) ( studies 11 and 12 for Adults and teenagers who at. 12 for Adults and Adolescents ) mg/day ) the relevance of this finding to human carcinogenic risk is.! Poison Help line at 1-800-222-1222 twice a day, the incidence of somnolence was dose-related report side to! Or an electrolyte imbalance all adjunctive trials, the reduction in seizure rate from baseline of monthly migraine rate statistically... Range studied ( 200 to 800 mg/day ) electrolyte imbalance Populations ] % of patients over! Of side effects of TOPAMAX in CLINICAL trials, 3 % of an administered dose this is not for... About the safety of antiepileptic drugs during pregnancy 19 % increase in AUC12 of.. You have cataract surgery, tell the surgeon you use this medicine or decreased in. During the entire double-blind phase was measured the medicine as soon as you can but! Closure glaucoma has been shown to cause hair loss in studies, there were apparent.