TOPIRAMATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Disponible des:

Aidarex Pharmaceuticals LLC

Designació comuna internacional (DCI):

TOPIRAMATE

Composición:

TOPIRAMATE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Topiramate Tablets are available containing 50 mg or 100 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 33261-0400-07 bottles of 7 tablets NDC 33261-0400-14 bottles of 14 tablets NDC 33261-0400-28 bottles of 28 tablets NDC 33261-0400-30 bottles of 30 tablets NDC 33261-0400-60 bottles of 60 tablets NDC 33261-0400-90 bottles of 90 tablets NDC 33261-0400-02 bottles of 120 tablets The 100 mg tablets are light yellow, round, biconvex tablets de-bossed with IG on one side and 280 on other. They are available as follows: NDC 33261-480-60 bottles of 60 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   25mg          50mg          100mg               200mg White          Yellow          Light                  Pink 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. Patients, especially children, should be watched closely for signs of decreased sweating and fever (increased body temperature), especially in hot temperatures. Some patients may need hospital treatment for this condition. TOPIRAMATE may cause depression or mood problems, tiredness, and sleepiness. Call your healthcare professional right away if you experience any of these side effects. 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

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

TOPIRAMATE- TOPIRAMATE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
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