Two hundred fifty-five patients completed the entire 26-week double-blind phase. . Rarely, someone with von Willebrand disease may experience uncontrolled bleeding that can be life-threatening and needs emergency medical attention. Advise patients to contact their healthcare provider if they have missed more than one dose. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. Other Adverse Reactions Observed During Clinical Trials Other adverse reactions seen during clinical trials were: abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, and visual field defect.Next
The effect of Topiramate on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Geriatric Use In clinical trials, 3% of patients were over age 60. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Topiramate tablets may cause eye problems. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11.
Newborns of mothers treated with Topiramate should be monitored for metabolic acidosis because of transfer of Topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. After titration, patients entered an 8-week stabilization period. Do not start a new medicine without talking with your healthcare provider. The most common adverse reactions that occurred in Topiramate -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. Topiramate tablets may make your birth control pills less effective.Next
You need only one mutated gene to be affected by this type of disorder. When female rats were treated during the latter part of gestation and throughout lactation 0. But unlike hemophilia, which mainly affects males, von Willebrand disease affects males and females and is usually milder. Nursing Mothers Limited data on 5 breastfeeding infants exposed to Topiramate showed infant plasma Topiramate levels equal to 10-20% of the maternal plasma level. Women who experience heavy menstrual bleeding can develop iron deficiency anemia.Next
Migraine Adults In the four multicenter, randomized, double-blind, placebo-controlled, parallel group migraine prophylaxis clinical trials which included 35 pediatric patients 12 to 15 years of age , most adverse reactions occurred more frequently during the titration period than during the maintenance period. These disorders are usually passed on by two carriers. Migraine Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. Animal Data Topiramate has demonstrated selective developmental toxicity, including teratogenicity, in multiple animal species at clinically relevant doses. The steady-state pharmacokinetics of Topiramate were unaffected by concomitant administration of glyburide.Next
Use child-resistant closure as required. Hyperammonemia has been reported more frequently when Topiramate is used concomitantly with valproic acid. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. National Heart, Lung, and Blood Institute. Pediatric Patients 12 to 17 Years of Age In five, randomized, double-blind, placebo-controlled, parallel group migraine prophylaxis clinical trials, most adverse reactions occurred more frequently during the titration period than during the maintenance period.Next
Sumatriptan Multiple dosing of Topiramate 100 mg every 12 hours in 24 healthy volunteers 14 males, 10 females did not affect the pharmacokinetics of single-dose sumatriptan either orally 100 mg or subcutaneously 6 mg. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. In a double-blind study in 90 pediatric patients 6 to 11 years of age including 59 Topiramate-treated and 31 placebo patients , the adverse reaction profile was generally similar to that seen in pooled double-blind studies of pediatric patients 12 to 17 years of age. Table 8 includes those adverse reactions that occurred in the placebo-controlled trials where the incidence in any Topiramate treatment group was at least 3% and was greater than that for placebo patients. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation.Next
After titration, patients entered a 12-week stabilization period. Patients received either no or a combination of other antiepileptic drugs. Prevention Because von Willebrand disease is usually an inherited disorder, consider having genetic counseling if you have a family history of this condition and you're planning to have children. Topiramate tablets Because of the bitter taste, tablets should not be broken. Hepatic Impairment Plasma clearance of Topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. In acute Topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis.Next