Topiramate Tablet
Product Images NDC 72865-313

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 72865-313). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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100 mg-1000 (100 mg 1000s)

This text provides information on Topiramate Tablets, USP 100 mg manufactured by XLCare Pharmaceuticals Inc. It includes details on dosage, prescription verification, dispensing, storage instructions, precautions, and manufacturing information. Topiramate is used for various medical conditions and must be dispensed with caution and accompanied by a Medication Guide for each patient. The product should be stored in specific temperature conditions and protected from moisture. It also emphasizes keeping the medication out of reach of children.*

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100 mg-60 (100 mg 60s)

This is a description of a prescription medication called Topiramate Tablets, USP in 100 mg strength manufactured by Ascent Pharmaceuticals for XLCare Pharmaceuticals Inc. It includes instructions for dispensing, storage, dosage, and other prescribing information. The medication should be kept in a tight container away from moisture at a temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted up to 30°C (86°F). The packaging includes 60 tablets and a caution to verify the prescription before dispensing.*

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200 mg-1000 (200 mg 1000s)

This is a description about Topiramate Tablets, USP 200 mg manufactured by XLcare Pharmaceuticals Inc. It is important to verify the prescription before dispensing. Pharmacists should dispense the medication individually to each patient. Each tablet contains Topiramate USP 200 mg and should be stored in a tight container with a child-resistant closure. The tablets should be stored at controlled room temperature and protected from moisture. It is crucial to keep the medication out of reach of children. The tablets are manufactured by Ascent Pharmaceuticals, Inc. for XLCare Pharmaceutical, Inc. located in Lawrenceville, GA.*

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200 mg-60 (200 mg 60s)

XLcare Pharmaceuticals Inc. produces Topiramate Tablets, USP, with each tablet containing 200 mg of Topiramate USP. The medication should be dispensed with caution and in accordance with the prescription guidelines. Pharmacists are required to provide a Medication Guide to each patient. The tablets should be stored between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). It is essential to keep the medication in a tightly sealed container with a child-resistant closure and protect it from moisture. The product is manufactured by Ascent Pharmaceuticals, Inc. for XLCare Pharmaceuticals, Inc.*

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25 mg-1000 (25 mg 1000s)

This text provides information about Topiramate tablets, USP 25 mg, manufactured by Ascent Pharmaceuticals and distributed by XLcare Pharmaceuticals Inc. The medication guide should be dispensed to each patient along with the tablets. Storage guidelines advise keeping the tablets in a tight container at 20°C to 25°C with excursions permitted to 15°C to 30°C. Protect the tablets from moisture and keep them out of reach of children.*

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25 mg-60 (25 mg 60s)

This text provides information on Topiramate Tablets, USP 25 mg, manufactured by Ascent Pharmaceuticals Inc. and distributed by XLCare Pharmaceuticals Inc. It includes dosage instructions, storage guidelines, and safety precautions. Each bottle contains 60 tablets, and pharmacists are advised to dispense medication guide to each patient. Topiramate is used for various medical conditions and should be stored in a tight container away from moisture and out of reach of children.*

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50 mg-1000 (50 mg 1000s)

Each tablet contains Topiramate USP 50 mg. This medication is dispensed by XLCare Pharmaceuticals, Inc. It is important to store the tablets at a temperature between 20°C to 25°C and to keep them out of reach of children. For dosage and prescribing information, refer to the accompanying product literature. The tablets should be dispensed in a tight container with a child-resistant closure as described in the USP guidelines. Topiramate should be used as prescribed, and caution is advised to verify the prescription before dispensing.*

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50 mg-60 (50 mg 60s)

This is a description of a pharmaceutical product called Topiramate Tablets, USP, with a concentration of 50 mg per tablet. The text includes cautionary instructions for pharmacists, dosage information, storage conditions, manufacturer details, and contact information for the company XLcare Pharmaceuticals Inc. It also highlights the importance of verifying the prescription before dispensing and providing a medication guide to each patient separately. It is recommended to keep the tablets in a tight container with a child-resistant closure, store them at a temperature between 20°C to 25°C, and protect them from moisture.*

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Figure1 (Figure 1)

This text provides numeric values around 18114, 10, 0501, 000, 400, 450, 500, 360, 260 related to "Time (Days)". It also mentions "SajeY SATEINLING". This data seems to be part of a chart or table, possibly representing some kind of time series or numerical relationship.*

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Figure2 (Figure 2)

This text provides data on the change from baseline in average monthly migraine period rate during a double-blind phase for the drugs Tepiamate, Tapicsmsic, and Taplrsmuis. The values are measured in units of time (e.g., minutes, hours, days). The text also includes significance levels represented by p-values.*

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Mg1 (Mg1)

This text describes common symptoms related to physical and mental health. It mentions feeling tired, changes in heartbeat, loss of appetite, and trouble thinking clearly. These symptoms could be signs of various health issues and should be addressed with a healthcare professional for proper evaluation and treatment.*

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Mg2 (Mg2)

This text appears to be a list of warning signs and symptoms related to mental health issues, such as thoughts of suicide or dying, attempts to commit suicide, new or worsening depression, anxiety, agitation, restlessness, panic attacks, trouble sleeping (insomnia), irritability, aggression, anger, violence, acting on dangerous impulses, extreme increase in activity and talking (mania), and other unusual changes in behavior or mood. These symptoms can be indicative of various mental health conditions and require attention and support from mental health professionals.*

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Mg3 (Mg3)

This text provides information on possible symptoms related to a medical condition or side effects of medication. Symptoms include tingling of the arms and legs, hunger, nausea, changes in taste, diarrhea, weight loss, nervousness, respiratory tract infection, speech problems, tiredness, dizziness, sleepiness, slow reactions, memory difficulties, abdominal pain, fever, abnormal vision, and decreased sensation or sensitivity, particularly in the skin.*

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Tab1 (Tab1)

This text provides a monotherapy titration schedule for adults and pediatric patients aged 10 years and older. It outlines the dosages of medication to be taken in the morning and evening over a period of six weeks, starting from 2 mg in the morning on week 1 to 200 mg in the morning on week 6. This information can be useful for healthcare professionals and patients to understand the dosage escalation plan for the medication.*

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Tab2 (Tab2)

This is a table showing the recommended total daily maintenance dosing of a certain medication for patients aged 2 to 9 years based on their weight. The dosages range from 150mg to 400mg per day, divided into two equal doses.*

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Tab3 (Tab3)

This is a table showing the preventive treatment of migraine for patients 12 years of age and older. It lays out a titration schedule for morning and evening doses over a 4-week period, starting with no morning dose and a 25mg evening dose in week 1, and gradually increasing to 50mg morning and evening doses by week 4. This schedule can be followed to help manage migraines effectively.*

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Tab4 (Tab4)

This appears to be a table presenting the risk analysis of different indications for Antiepileptic Drugs based on a pooled analysis. The table includes data on the number of events per 1000 patients for placebo and drug patients in different indications such as Epilepsy, Psychiatric, and Other. It also shows the relative risk and risk difference for each indication. The information in this table can be used to evaluate the risk of events associated with the use of Antiepileptic Drugs in different medical conditions.*

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Structural (Structural Formula)

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Tab12 (Table 12)

This text provides a detailed summary of the topiramate dosage used during the stabilization periods of six double-blind, placebo-controlled trials for adults with partial-onset seizures. The table shows the target topiramate dosages in milligrams per day for each study, along with the number of participants, mean doses, and median doses achieved. It also mentions that no dose-response studies were conducted for other indications of pediatric partial-onset seizures. Additionally, it outlines the placebo dosages given in each trial protocol.*

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Tab13 (Table 13)

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Tab14 (Table 14)

This is a table showing the percent reduction from baseline to the last 12 weeks of a double-blind phase in average monthly attack rate for three different groups: Placebo, Topiramate 50mg/day, and Topiramate 100mg/day, in Study 13. The table includes baseline data and final data for each group, as well as the percent reduction in attacks. P-values are also provided for comparisons with placebo and between the two dose groups.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.