Upadacitinib 15 mg

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Upadacitinib is a medication used to treat moderately to severely active rheumatoid arthritis in adults who have not responded well to methotrexate. It works by inhibiting Janus kinases (JAKs), which are involved in the signaling pathways of pro-inflammatory cytokines. This helps to reduce inflammation and manage symptoms of rheumatoid arthritis. Upadacitinib is typically taken orally once daily in the form of sustained-release tablets. It should be used cautiously in patients with severe infections or malignancies, and regular monitoring is recommended due to potential side effects such as gastrointestinal perforation, thrombosis, and changes in laboratory parameters.

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    Upadacitinib

    Composition: Each sustained-release tablet contains 15mg of upadacitinib.

    Each sustained-release tablet contains 15 mg of upadacitinib hemihydrate.

    Pharmacology:Upadacitinib is a disease-modifying antirheumatic drug (DMARD) that acts by inhibiting Janus kinases (JAKs), crucial downstream cellular signaling mediators of pro-inflammatory cytokines. It is believed that these pro-inflammatory cytokines play a role in many autoimmune inflammatory diseases, such as rheumatoid arthritis. In clinical trials, upadacitinib reduced pro-inflammatory activity interleukins, transiently increased lymphocyte levels, without significant reduction in immunoglobulins from baseline checks.

    Indications: It is a Janus kinase (JAK) inhibitor used in the treatment of adult patients with moderately to severely active rheumatoid arthritis who have responded inadequately or are intolerant to methotrexate.

    Dosage and Administration:The recommended dose of Upadacitinib INN is 15 mg once daily. It can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Avoid initiation or interruption of Rematib if the absolute lymphocyte count is less than 500 cells/mm³ or neutrophil count is less than 1000 cells/mm³ or hemoglobin level is less than 8 g/dL. Alternatively, as per the prescribing physician.

    Contraindications: Contraindicated in patients known to be allergic to upadacitinib or any ingredient of this product.

    Precautions: Severe infections: Avoid use in patients with active severe infections, including localized infections. *Malignancies: Consider the risks and benefits of upadacitinib therapy before starting treatment in patients with known malignancies.* Thrombosis: Consider the risks and benefits before treatment in patients where treatment may increase the risk of thrombosis. Timely assessment and appropriate treatment for patients with symptoms of thrombosis. *Gastrointestinal perforation: Use with caution in patients at increased risk.* Laboratory Monitoring: Due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. *Embryo-Fetal Toxicity: Based on animal studies, upadacitinib may cause fatal harm. Women of reproductive potential should be advised of potential risks to the fetus and use effective contraception.* Vaccination: Avoid the use of live vaccines with upadacitinib.*Concomitant use of Upadacitinib INN with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Adverse Reactions: Adverse reactions (≥1%) include upper respiratory tract infection, nausea, cough, and fever.

    Use in Pregnancy and Lactation: There are insufficient and adequate controlled studies in pregnant women. Avoid during pregnancy. Upadacitinib should be avoided during lactation.

    Use in Children: The safety and efficacy of Upadacitinib in children under 18 years of age have not been established.

    Drug Interactions: Caution is advised when using Upadacitinib with strong CYP3A4 inhibitors (such as ketoconazole) in patients receiving treatment for chronic prostatitis. Co-administration with potent CYP3A4 inducers (such as rifampin) is not recommended when using upadacitinib.

    Overdosage: In case of overdosage, patients should seek immediate medical attention. Treatment should be symptomatic and supportive care provided based on symptoms.

    Storage: Store at 30°C in a dry place.

    Packaging: Each box contains 10 blister packs.

     

    Product Name:

    Upatini

    Generic Name:

    Upadacitinib

    Formulation:

    Sustained-release tablets

    Available Pack Size:

    30 tablet

    Available Strength:

    15 mg tablets

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