The incidence of some adverse reactions (e.g., fatigue, dizziness, paresthesia, language problems, psychomotor slowing, depression, difficulty with concentration/attention, mood problems) was dose-related and much greater at higher than recommended TOPAMAX® dosing (i.e., 600 mg - 1000 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (200 mg to 400 mg daily) range.In controlled clinical trials in adults, 11% of patients receiving TOPAMAX® 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions.
25mg, 50mg and 200mg also present in this leaflet. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol.

Version: 2.01.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Pancreatin is used to replace digestive enzymes when the body does not have enough of its own. Stay alert to changes in your mood or symptoms. Call your doctor at once if you have: joint pain or swelling; or. After titration, patients entered a 4, 8 or 12-week stabilization period. Select one or more newsletters to continue. A generally similar profile was observed in older pediatric patients Topiramate resulted in an increased incidence of patients with increased creatinine (any topiramate dose 5%, placebo 0%), BUN (any topiramate dose 3%, placebo 0%), and protein (any topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any topiramate dose 7%, placebo 0%).

These changes were often dose-related, and were most frequently associated with the greatest treatment difference at the 200 mg dose level. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. Or you may open the capsule and sprinkle the medicine into a spoonful of applesauce or other soft food. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear.A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly.
Topiramate did not affect metformin tmax. Steady-state is thus reached in about 4 days in patients with normal renal function. 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. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by Clearance was independent of dose.As in adults, hepatic enzyme-inducing antiepileptic drugs decrease the steady state plasma concentrations of topiramate.Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy.

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.

Your doctor may occasionally change your dose.

Read More. To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. There is evidence of renal tubular reabsorption of topiramate. We comply with the HONcode standard for trustworthy health information - Do not give TOPAMAX to other people, even if they have the same symptoms that you have. A dosage adjustment may be required Topiramate is a sulfamate-substituted monosaccharide. The elderly subject population had reduced renal function (creatinine clearance [-20%]) compared to young adults. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Two hundred sixty-five patients completed the entire 26-week double-blind phase. The following adverse reactions were observed in at least 3% of patients on topiramate and were 3% to 7% more frequent than in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. After titration, patients entered an 8-week stabilization period.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).Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX® or placebo. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736).Topiramate is a sulfamate-substituted monosaccharide.  Revised: Jun 2020The following serious adverse reactions are discussed in more detail in other sections of the labeling:The data described in the following sections were obtained using TOPAMAX® Tablets.Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice.The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in adults in the 400 mg/day TOPAMAX® group and at an incidence higher (≥ 10 %) than in the 50 mg/day group were: paresthesia, weight loss and anorexia (see Table 5).Approximately 21% of the 159 adult patients in the 400 mg/day group who received TOPAMAX® as monotherapy in Study 1 discontinued therapy due to adverse reactions. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, 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.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Copyright 1996-2020 Cerner Multum, Inc.