Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Proficient Rx LP
TOPIRAMATE
TOPIRAMATE 50 mg
ORAL
PRESCRIPTION DRUG
Monotherapy Epilepsy Topiramate Tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Adjunctive Therapy Epilepsy Topiramate Tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. Topiramate is contraindicated in patients with a history of hypersensitivity to any component of this product. The abuse and dependence potential of Topiramate has not been evaluated in human studies.
Topiramate Tablets are available containing 50 mg, of topiramate USP. The 50 mg tablets are yellow, round, biconvex tablets de-bossed with IG on one side and 279 on other. They are available as follows: NDC 63187-228-30 bottles of 30 tablets NDC 63187-228-60 bottles of 60 tablets NDC 63187-228-90 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Protect from moisture. PATIENT INFORMATION Topiramate Tablets What do TOPIRAMATE Tablets look like? TOPIRAMATE Tablets Yellow Note: The pictures above show the shapes and lettering of TOPIRAMATE tablets. The wording describes the strength and colors of the medication. Before taking your medicine, it is important to compare the tablets you receive from your healthcare professional or pharmacist with these pictures to make sure you have received the correct medicine. Please read this patient information carefully before you take TOPIRAMATE and each time you obtain a refill, in case any information has changed. This summary does not contain all the information about TOPIRAMATE and is not meant to take the place of talking with your healthcare professional. If you have any questions about TOPIRAMATE, discuss them with your healthcare professional or pharmacist. What is TOPIRAMATE? TOPIRAMATE is a prescription medicine used: Who Should Not Take TOPIRAMATE? Do not take TOPIRAMATE if you are allergic to anything in it. See the end of this leaflet for a complete list of ingredients in TOPIRAMATE. What Should I Tell My Healthcare Professional Before Taking TOPIRAMATE? Tell your healthcare professional about all of your medical conditions, including if you: Tell your healthcare professional about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. TOPIRAMATE and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or TOPIRAMATE will have to be adjusted. Especially, tell your healthcare professional if you are taking: Keep a list of all the medicines you take. Show this list to your healthcare professionals and pharmacists before you start a new medicine. How Should I Take TOPIRAMATE? What Should I Avoid While Taking TOPIRAMATE? What are the Possible Side Effects of TOPIRAMATE? TOPIRAMATE may cause the following side effects which can be serious: Call your healthcare professional right away if you have a loss in vision or get eye pain. These problems can lead to blindness if not treated right away. Your healthcare professional will probably stop TOPIRAMATE and may recommend other therapy. Other side effects with TOPIRAMATE include loss of appetite, nausea, a change in the way foods taste, diarrhea, weight loss, nervousness, aggression, upper respiratory tract infection. Call your healthcare professional if you have any symptoms that concern you or that do not go away. These are not all the side effects with TOPIRAMATE. For more information, ask your healthcare professional or pharmacist. What Should I Do If I Get Pregnant While Taking TOPIRAMATE? It is not clear if there is a risk to the fetus/baby if you are exposed to TOPIRAMATE and you are pregnant. Various abnormalities have been described in the offspring of animals exposed to TOPIRAMATE during pregnancy. If you use TOPIRAMATE while you are pregnant, ask your healthcare professional about reporting your experience to the North American Drug Pregnancy Registry at Massachusetts General Hospital (Boston, MA). This registry collects information about the babies born to women who are taking drugs to treat various conditions. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/ . You can also join the registry by calling 1-877-376-3872. How Should I Store TOPIRAMATE? General Information About TOPIRAMATE. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use TOPIRAMATE for a condition for which it was not prescribed. Do not give TOPIRAMATE to other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about TOPIRAMATE. If you would like more information, talk to your healthcare professional.You can ask your health care professional or pharmacist for information about TOPIRAMATE that is written for health professionals. What Are the Ingredients of TOPIRAMATE? Active Ingredient: topiramate
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET Proficient Rx LP ---------- MEDICATION GUIDE Topiramate Tablets, USP (toe pir’a mate). Read this Medication Guide before you start taking topiramate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about topiramate tablets, talk to your healthcare provider or pharmacist. What is the most important information I should know about topiramate tablets? Topiramate tablets may cause eye problems. Serious eye problems include: • any sudden decrease in vision with or without eye pain and redness, • a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). • These eye problems can lead to permanent loss of vision if not treated. • You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. Topiramate tablets may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating. Topiramate tablets can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: • feel tired • not feel hungry (loss of appetite) • feel changes in heartbeat • have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during yo Lestu allt skjalið
TOPIRAMATE- TOPIRAMATE TABLET PROFICIENT RX LP ---------- TOPIRAMATE TABLETS RX ONLY DESCRIPTION Topiramate is a sulfamate-substituted monosaccharide. Topiramate Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate USP has the molecular formula C H NO S and a molecular weight of 339.37. Topiramate USP is designated chemically as 2,3:4,5-Di-O- isopropylidene-β-Dfructopyranose sulfamate and has the following structural formula: Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, lactose monohydrate, sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and), opadry pink (titanium dioxide, hypromellose 6cp, PEG 400, iron oxide red) for 200 mg tablets. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: The precise mechanisms by which topiramate exerts its anticonvulsant effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy. 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, a Lestu allt skjalið