Eslicarbazepine Acetate Tablet
Product Images NDC 67877-586

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Eslicarbazepine Acetate (NDC 67877-586). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

Eslicarbazepine-200mg-30-tablet (Eslicarbazepine 200mg 30 Tablets)

The text provides information about a tablet containing esicarbazepine acetate 200 mg. It also includes details such as the usual dosage, storage instructions, manufacturer information, and dosage form. It recommends checking the package insert for dosage information and storing the tablets between 15°C to 30°C. The tablets should be kept tightly closed and out of reach of children. The manufacturer is Alkem Laboratories Ltd. from Mumbai, India, and they are distributed by Ascend Laboratories, LLC.*

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Eslicarbazepine-400mg-30-tablet (Eslicarbazepine 400mg 30 Tablets)

This text describes a medication called Esicarbazepine Acetate in the form of tablets containing 400 mg each. It provides information on the proper dosage, storage conditions, and manufacturer details. The tablets should be stored at a temperature range between 15°C to 30°C, kept tightly closed, and away from children. The medication is distributed by Ascend Laboratories.*

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Eslicarbazepine-600mg-60-tablets (Eslicarbazepine 600mg 60 Tablets)

This text contains information about tablets with eslicarbazepine acetate 600 mg dosage, including storage instructions, manufacturer details, dosage guidelines, and precautions. The tablets are distributed by Ascend Laboratories, LLC, and the usual dosage instruction can be found in the package insert. The tablets are meant for once daily use and are intended for pharmacy dispensing with a Medication Guide to be provided to each patient.*

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Eslicarbazepine-800mg-30-tablets (Eslicarbazepine 800mg 30 Tablets)

This text provides information about tablets containing eslicarbazepine acetate 800 mg, along with details on dosage, storage conditions, manufacturer, distributor, and instructions for pharmacists to dispense the Medication Guide. The tablets are meant for once-daily use and come in a package containing 30 tablets. The storage temperature should be between 20°C to 25°C (68°F to 77°F). The tablet packaging includes the NDC code and additional label specifications.*

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Eslicarbazepine-fig-1 (Eslicarbazepine Fig 1)

This text provides information on the recommended dose adjustments of eslicarbazepine based on various factors like age, gender, hepatic impairment, and renal impairment. It also includes recommendations for dose adjustments depending on the condition and the level of impairment. The guidance suggests that no dose adjustment is necessary in certain cases, while in others, dose reduction is recommended. Overall, this text serves as a reference guide for determining the appropriate dosage of eslicarbazepine in different patient populations.*

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Eslicarbazepine-fig-2-1 (Eslicarbazepine Fig 2 1)

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Eslicarbazepine-fig-3a (Eslicarbazepine Fig 3a)

This text outlines changes in fold change and 90% CI for various antiepileptic drugs. The listed AEDs include Carbamazepine, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, and Valproate. It also provides recommendations such as potential pharmacodynamic interactions, the need for dose adjustments, and monitoring plasma phenytoin concentrations for epilepsy.*

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Eslicarbazepine-fig-3b (Eslicarbazepine Fig 3b)

This text provides recommendations for adjusting drug doses based on changes in lipid levels or other factors. It includes advice for non-Antiepileptic drugs like Digoxin and Metformin, statins such as Simvastatin and Rosuvastatin, oral contraceptives, and anticoagulant Warfarin. It also emphasizes the importance of monitoring patients taking Warfarin to maintain the INR level. It suggests using additional or alternative non-hormonal birth control when taking oral contraceptives.*

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Eslicarbazepine-fig-4.jpg (Eslicarbazepine Fig 4)

This is a partial text mentioning the KM estimate of exit rate for two different doses of Eslicarbazepine Acetate Tablets (1200 mg and 1600 mg), with a sample size of 54 for the 1200 mg dose. The text also refers to historical controls and two different studies.*

FDA Label Image

Eslicarbazepine-fig-5.jpg (Eslicarbazepine Fig 5)

This text provides information on a clinical study comparing the reduction in seizure frequency among patients taking a placebo and two different doses of Eslicarbazepine Acetate Tablets (800 mg and 1200 mg). The study included 408 patients in the placebo group, 375 patients in the 800 mg group, and 352 patients in the 1200 mg group. The text shows the proportion of patients achieving various levels of reduction in seizure frequency from baseline: less than 25%, 25% to less than 50%, and 50% to less than 75%.*

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