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Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 70710-1353
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Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 70710-1353). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Zydus Pharmaceuticals Usa 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.
Product Images & Figures Index
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This is a list of factors and conditions related to dosage adjustments for individuals based on their weight, age, gender, ethnicity, and presence of renal or hepatic impairment. Recommendations for dose adjustments are provided depending on these factors, with specific advice for mild, moderate, and severe renal impairment as well as mild and moderate hepatic impairment. The text also includes a ratio and 90% confidence interval for reference.*
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This document provides recommendations for dose adjustments when drugs are coadministered with CYP3A inhibitors such as ketoconazole or CYP3A & CYP2C19 inhibitors like fluconazole. It also mentions the effects on the efficacy of drugs such as methotrexate and Tofacitinib extended-release tablets when taken with certain inhibitors such as Tacrolimus or Cyclosporine, highlighting the risk of added immunosuppression in these cases.*
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This text provides information about response rates at different months for Tofacitinib 5mg twice daily compared to a placebo. Non-responder imputation method was used where patients who withdrew from the study or failed to show at least a 20% improvement in joint counts at Month 3 were counted as failures.*
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This is information about tofacitinib extended-release tablets, each containing 17.77 mg of tofacitinib citrate equivalent to 11 mg of tofacitinib. The pharmacist is advised to dispense the medication guide to each patient separately. The recommended storage temperature is between 20°C to 25°C. The package is child-resistant and should not be repackaged. Additional details about dosage, usage, and safety precautions can be found in the accompanying prescribing information or the medication guide available online or through a provided contact number. The medication is distributed by Zydus Pharmaceuticals (USA) Inc.*
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This text contains information about an extended-release tablet containing 35.53 mg tofacitinib citrate. Each tablet is equivalent to 22 mg of acifinib. The package is child-resistant and should be stored between 20°C to 25°C (68°F to 77°F) with excursions permitted between 16°C to 30°C (59°F to 86°F). It warns not to repackage the tablets and to keep them out of the reach of children. The medication guide is available online or by phone. The tablets are manufactured by Cadila Healthcare Ltd. in Ahmedabad, India.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
