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Trokendi XR
Overview
What is Trokendi XR?
Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration.
Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula CHNOS and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di--isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:
TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients:
Sugar Spheres, NFHypromellose (Type 2910), USPMannitol, USPDocusate Sodium, USPSodium Benzoate, NFEthylcellulose, NFOleic Acid, NFMedium Chain Triglycerides, NFPolyethylene Glycol, NFPolyvinyl Alcohol, USPTitanium Dioxide, USPTalc, USPLecithin, NFXanthan Gum, NF
The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants.
The colorants are:
FD&C Blue #1 (all strength capsules)Yellow Iron Oxide, USP (25 mg and 50 mg capsules)FD&C Red #3 (50 mg, 100 mg and 200 mg capsules)FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules)Riboflavin, USP (25 mg capsules)
All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.
What does Trokendi XR look like?
What are the available doses of Trokendi XR?
Extended-release capsules: 25 mg, 50 mg, 100 mg, and 200 mg ()
What should I talk to my health care provider before I take Trokendi XR?
How should I use Trokendi XR?
TROKENDI XR is indicated in patients 6 years of age and older as initial monotherapy for partial onset or primary generalized tonic-clonic seizures [].
What interacts with Trokendi XR?
Sorry No Records found
What are the warnings of Trokendi XR?
Sorry No Records found
What are the precautions of Trokendi XR?
Sorry No Records found
What are the side effects of Trokendi XR?
Sorry No records found
What should I look out for while using Trokendi XR?
TROKENDI XR is contraindicated in patients:
What might happen if I take too much Trokendi XR?
Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate.
Topiramate overdose has resulted in severe metabolic acidosis [].
A patient who ingested a dose of immediate-release topiramate between 96 g and 110 g was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.
Similar signs, symptoms, and clinical consequences are expected to occur with overdosage of TROKENDI XR. Therefore, in acute TROKENDI XR overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate . Hemodialysis is an effective means of removing topiramate from the body.
How should I store and handle Trokendi XR?
TROKENDI XR (topiramate) extended-release capsules should be stored in well closed containers at controlled room temperature [25°C (77°F); excursions 15°C-30°C (59°F-86°F)]. Protect from moisture and light.Product: 50090-2013NDC: 50090-2013-3 30 TABLET in a BOTTLEProduct: 50090-2013NDC: 50090-2013-3 30 TABLET in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanisms by which topiramate exerts its anticonvulsant and migraine prophylaxis effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and migraine prophylaxis. 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.
Non-Clinical Toxicology
TROKENDI XR is contraindicated in patients:Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.
A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. 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. The primary treatment to reverse symptoms is discontinuation of TROKENDI XR as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of TROKENDI XR, may be helpful.
Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
The 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 immediate-release topiramate tablets. TROKENDI XR has not been studied in a randomized, placebo-controlled Phase III clinical study; however, it is expected that TROKENDI XR would produce a similar adverse reaction profile as immediate-release topiramate.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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