Application Nr Approved Date Route Status External Links
ANDA090596 2010-09-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tacrolimus Capsules, Usp Are A Calcineurin-Inhibitor Immunosuppressant Indicated For: •prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Liver, Kidney Or Heart Transplants (1.1, 1.2, 1.3) •use Concomitantly With Adrenal Corticosteroids; In Kidney And Heart Transplant, Use In Conjunction With Azathioprine Or Mycophenolate Mofetil (mmf) (1.1, 1.2, 1.3) •limitations Of Use (1.4): •do Not Use Simultaneously With Cyclosporine •intravenous Use Reserved For Patients Who Cannot Tolerate Capsules Orally •use With Sirolimus Is Not Recommended In Liver And Heart Transplant; Use With Sirolimus In Kidney Transplant Has Not Been Established 1.1 Prophylaxis Of Organ Rejection In Kidney Transplant Tacrolimus Capsules, Usp Are Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Kidney Transplants. It Is Recommended That Tacrolimus Capsules Be Used Concomitantly With Azathioprine Or Mycophenolate Mofetil (mmf) And Adrenal Corticosteroids [see Clinical Studies (14.1)]. Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus Capsules [see Dosage And Administration (2.6)]. 1.2 Prophylaxis Of Organ Rejection In Liver Transplant Tacrolimus Capsules Are Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Liver Transplants. It Is Recommended That Tacrolimus Capsules Be Used Concomitantly With Adrenal Corticosteroids [see Clinical Studies (14.2)]. Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus Capsules [see Dosage And Administration (2.6)]. 1.3 Prophylaxis Of Organ Rejection In Heart Transplant Tacrolimus Capsules Are Indicated For The Prophylaxis Of Organ Rejection In Patients Receiving Allogeneic Heart Transplants. It Is Recommended That Tacrolimus Capsules Be Used Concomitantly With Azathioprine Or Mycophenolate Mofetil (mmf) And Adrenal Corticosteroids [see Clinical Studies (14.3)]. Therapeutic Drug Monitoring Is Recommended For All Patients Receiving Tacrolimus Capsules [see Dosage And Administration (2.6)]. 1.4 Limitations Of Use Tacrolimus Capsules Should Not Be Used Simultaneously With Cyclosporine [see Dosage And Administration (2.5)]. Tacrolimus Injection Should Be Reserved For Patients Unable To Take Tacrolimus Capsules Orally [see Warnings And Precautions (5.11)]. Use With Sirolimus Is Not Recommended In Liver And Heart Transplant. The Safety And Efficacy Of Tacrolimus Capsules With Sirolimus Has Not Been Established In Kidney Transplant [see Warnings And Precautions (5.12)].

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Gelatin GELATIN Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tacrolimus TACROLIMUS ZINC85537027

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