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Rx Item-Tacrolimus 0.5Mg Cap 100 By Mylan Pharma Gen Prograf

NDC No.378204501 00378204501 0378-2045-01 0378204501  UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501NDC No.378204501 00378204501 0378-2045-01 0378204501  UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.NDC 00378-2045-01 UPC/GTIN No.3-03782-04501-7 Mfg.Part No.204501BRAND: TACROLIMUS NDC: 00378-2045-01,378204501 UPC: 3-03782-04501-7,303782045017

Rx Item-Tacrolimus 0.5Mg Cap 100 By Mylan Pharma Gen Prograf

$222.98$149.99

Item No.: RX026221 026221 NDC No.378204501 00378204501 0378-2045-01 0378204501 UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx026221 Tacrolimus 0.5mg Cap 100 by Mylan Pharma Item No. 3026221 NDC

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PROGRAF- tacrolimus capsule, gelatin coated
PROGRAF- tacrolimus injection, solution
Astellas Pharma US, Inc.

BOXED WARNING � MALIGNANCIES AND SERIOUS INFECTIONS


Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2)].

Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.3, 5.4, 5.5)].

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE

1.1 Prophylaxis of Organ Rejection in Kidney Transplant


Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that Prograf 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 Prograf [see Dosage and Administration (2.6)].

1.2 Prophylaxis of Organ Rejection in Liver Transplant
Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)]. Therapeutic drug monitoring is recommended for all patients receiving Prograf [see Dosage and Administration (2.6)].

1.3 Prophylaxis of Organ Rejection in Heart Transplant
Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Prograf 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 Prograf [see Dosage and Administration (2.6)].

1.4 Limitations of Use
Prograf should not be used simultaneously with cyclosporine [see Dosage and Administration (2.5)].

Prograf injection should be reserved for patients unable to take Prograf capsules orally [see Dosage and Administration (2.1) and Warnings and Precautions (5.11)].

Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of Prograf with sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Kidney, Liver, or Heart Transplant Patients
The initial oral dosage recommendations for adult patients with kidney, liver, or heart transplants along with recommendations for whole blood trough concentrations are shown in Table 1. The initial dose of Prograf should be administered no sooner than 6 hours after transplantation in the liver and heart transplant patients. In kidney transplant patients, the initial dose of Prograf may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered. For blood concentration monitoring details see Dosage and Administration (2.6).
Prograf injection should be used only as a continuous IV infusion and when the patient cannot tolerate oral administration of Prograf capsules. Prograf injection should be discontinued as soon as the patient can tolerate oral administration of Prograf capsules, usually within 2-3 days. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion.

The observed trough concentrations described above pertain to oral administration of Prograf only; while monitoring Prograf concentrations in patients receiving Prograf injection as a continuous IV infusion may have some utility, the observed concentrations will not represent comparable exposures to those estimated by the trough concentrations observed in patients on oral therapy.

The recommended starting dose of Prograf injection is 0.03-0.05 mg/kg/day in kidney and liver transplant and 0.01 mg/kg/day in heart transplant given as a continuous IV infusion. Adult patients should receive doses at the lower end of the dosing range. Concomitant adrenal corticosteroid therapy is recommended early post-transplantation.

Anaphylactic reactions have occurred with injectables containing castor oil derivatives, such as Prograf injection [see Warnings and Precautions (5.11)].

DESCRIPTION

Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF.

Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use.

Tacrolimus, previously known as FK506, is the active ingredient in Prograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S -[3R *[E (1S *,3S *,4S *)], 4S *,5R *,8S *,9E ,12R *,14R *,15S *,16R *,18S *,19S *,26aR *]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c ][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.
Tacrolimus has an empirical formula of C44 H69 NO12 �H2 O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).

NDC No.378204501 00378204501 0378-2045-01 0378204501  UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501
Tacrolimus 0.5Mg Mylan
NDC No.378204501 00378204501 0378-2045-01 0378204501 UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501

NDC No.378204501 00378204501 0378-2045-01 0378204501  UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501
Tacrolimus 0.5Mg Mylan
NDC No.378204501 00378204501 0378-2045-01 0378204501 UPC No.:303782045017 NDC No. 00378-2045-01 UPC/GTIN No. 3-03782-04501-7 303782-045017 MPN 204501

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Prograf
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

NDC 00378-2045-01 UPC/GTIN No.3-03782-04501-7 Mfg.Part No.204501
RX ITEM-Tacrolimus 0.5Mg Cap 100 By Myla
NDC 00378-2045-01 UPC/GTIN No.3-03782-04501-7 Mfg.Part No.204501

BRAND: TACROLIMUS NDC: 00378-2045-01,378204501 UPC: 3-03782-04501-7,303782045017
Tacrolimus 0.5Mg Cap 100 By Mylan Pharma
BRAND: TACROLIMUS NDC: 00378-2045-01,378204501 UPC: 3-03782-04501-7,303782045017