In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. The most common side effects of Topamaxinclude: Tell the doctor if you have any side effect that bothers you or that does not go away. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. In the NAAED pregnancy registry, 19.7% of topiramate-exposed newborns were SGA compared to 7.9% of newborns exposed to a reference AED and 5.4% of newborns of mothers without epilepsy and without AED exposure. It may causes side effects like confusion, drowsiness, dizziness, or blurred vision. Your family or other caregivers should also be alert to changes in your mood or symptoms. Tamsulosin may lower your blood pressure and may cause dizziness or fainting, especially when you first start taking it or your dose changes. Adverse bleeding reactions reported with TOPAMAX ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). 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". Two hundred fifty-five patients completed the entire 26-week double-blind phase. Higher daily doses (400 mg/day) of topiramate were associated with greater rates of hair loss than lower doses (50 mg/day) in both age groups. 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. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. 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. 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]. information submitted for this request. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. US Brand Name Flomax Descriptions 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). Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. 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. Brand name: Flomax Continue reading, Yes, topiramate has been shown to cause hair loss in studies, but it is not a common side effect. 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). Dosing in patients 2 to 9 years of age is based on weight. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). In pediatric patients (ranging from 6-17 years of age) receiving TOPAMAX for the preventive treatment of migraine, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils, The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils [see Use In Specific Populations]. The risk for cognitive adverse reaction was greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age) [see WARNINGS AND PRECAUTIONS]. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. How can I watch for early symptoms of suicidal thoughts and actions? 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. Breastfed babies may be sleepy or have diarrhea. have a history of metabolic acidosis (too much acid in the blood). Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment-related or reflects the patients underlying disease (e.g., patients who received higher doses may have more severe underlying disease) [see WARNINGS AND PRECAUTIONS]. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. To provide you with the most relevant and helpful information, and understand which Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. There was a mean dose-related increase in alkaline phosphatase. Use: Benign prostatic hyperplasia (BPH). 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. This medicine will only prevent migraine headaches or reduce the number of attacks. There may be other medicines to treat your condition that have a lower chance of birth defects. 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. 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). The recommended dose for TOPAMAX monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. 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. Topiramate will not treat a migraine headache once it occurs. Although the effect of TOPAMAX on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus ability to tolerate labor. 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. 3 Sources. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. It will not treat a headache that has already begun. side effects drug center topamax (topiramate) drug. 15 mg capsule with TOP and 15 mg on the side, 25 mg capsule with TOP and 25 mg on the side. It should not be stored for future use. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg/day (approximately 3 times the MRHD for epilepsy and 12 times the MRHD for migraine on a mg/m2 basis). are breastfeeding or plan to breastfeed. Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. 6. 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 For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions). If you take too much TOPAMAX, call your healthcare professional or poison control center right away or go to an emergency room. Warn patients about the possible development of hyperammonemia with or without encephalopathy. If required, longer intervals between dose adjustments can be used. Call your doctor right away if you have a sudden decrease in vision. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. The significance of these findings is uncertain. Tell your doctor about all your other medicines, especially: other glaucoma medications, including eye drops. Some people have thoughts about suicide while taking seizure medicine. Do not save it for later use. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. Topamax may be used alone or with other medications. The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use. Objective: To compare the efficacy and tolerability of the alpha 1 A-subtype selective drug tamsulosin with the nonsubtype-selective agent alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. A no-effect dose for embryofetal developmental toxicity in mice was not identified. Some people use Topamax to treat other . Avoid the use of a ketogenic or "ketosis" diet (high in fat, low in carbohydrates) while you are taking Topamax. information is beneficial, we may combine your email and website usage information with Hydration is recommended to reduce new stone formation. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial. If you miss a single dose of TOPAMAX, take it as soon as you can. The no-effect dose (90 mg/kg/day) for adverse developmental effects is approximately 2 times the maximum recommended pediatric dose (9 mg/kg/day) on a body surface area (mg/m2) basis. This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX. 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]. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. However, having a seizure during pregnancy could harm both the mother and the baby. Qsymia, an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, along with diet and exercise. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant. Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? The gelatin capsules are white and clear. 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