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Rx Item-Astagraf XL 1mg tacrolimus Cap 30 by Astellas Pharma

NDC No. 00469-0677-73 UPC/GTIN No. 3-04690-67773-4 MPN 67773 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.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 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.

Rx Item-Astagraf XL 1mg tacrolimus Cap 30 by Astellas Pharma

$196.03$179.99

RX239355 239355 NDC No. 00469-0677-73 0469-0677-73 00469067773 0469067773 UPC/GTIN No. 3-04690-67773-4 304690-677734 304690677734 MPN 67773 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 scope of practice can order this RX Item. Rx Item No. Rx239355 Astagraf Xl 1mg Cap 30 by Astellas Pharma Item No. 3239355 NDC No. 00469067773 UPC No. 304690677734

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Clinical Information
Gen. Code and Des.
62897 tacrolimus ORAL CAP ER 24H 1 MG
GCN and Des.
98663 tacrolimus ORAL CAP ER 24H 1 MG
Strength
1MG
Dose Form
CAPSULE, EXT RELEASE 24 HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92440000 IMMUNOSUPPRESSIVE AGENTS
Active Ingredients
4446 tacrolimus 109581933
Inactive Ingredients
2432 lactose 64044515
2549 gelatin 9000708






PROGRAF- tacrolimus anhydrous capsule, gelatin coated

WARNING
Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. 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 info. requisite for the follow-up of the patient.



DESCRIPTION
Prograf is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, mg or mg of anhydrous tacrolimus. Inactive ingredients include lactose, hydroxypropyl methylcellulose, croscarmellose sodium, and magnesium stearate. The 0.5 mg capsule shell contains gelatin, titanium dioxide and ferric oxide, the mg capsule shell contains gelatin and titanium dioxide, and the mg capsule shell contains gelatin, titanium dioxide and ferric oxide.
Prograf is also available as sterile solution (tacrolimus injection) containing the equivalent of mg anhydrous tacrolimus in 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 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 and 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.
Mechanism of Action
Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.
INDICATIONS AND USAGE
Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally. In heart and kidney transplant recipients, it is recommended that Prograf be used in conjunction with azathioprine or mycophenolate mofetil (MMF)
CONTRAINDICATIONS
Prograf is contraindicated in patients with hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).
WARNINGS
Post-Transplant Diabetes Mellitus
Insulin-dependent post-transplant diabetes mellitus (PTDM) was reported in 20% of Prograf-treated kidney transplant patients without pretransplant history of diabetes mellitus in the Phase III study (See Tables Below). The median time to onset of PTDM was 68 days. Insulin dependence was reversible in 15% of these PTDM patients at one year and in 50% at years post transplant. Black and Hispanic kidney transplant patients were at an increased risk of development of PTDM.
Nephrotoxicity
Prograf can cause nephrotoxicity, particularly when used in high doses. Nephrotoxicity was reported in approximately 52% of kidney transplantation patients and in 40% and 36% of liver transplantation patients receiving Prograf in the U.S. and European randomized trials, respectively, and in 59% of heart transplantation patients in European randomized trial. Use of Prograf with sirolimus in heart transplantation patients in US study was associated with increased risk of renal function impairment, and is not recommended More overt nephrotoxicity is seen early after transplantation, characterized by increasing serum creatinine and decrease in urine output. Patients with impaired renal function should be monitored closely as the dosage of Prograf may need to be reduced. In patients with persistent elevations of serum creatinine who are unresponsive to dosage adjustments, consideration should be given to changing to another immunosuppressive therapy. Care should be taken in using tacrolimus with other nephrotoxic drugs. In particular, to avoid excess nephrotoxicity, Prograf should not be used simultaneously with cyclosporine. Prograf or cyclosporine should be discontinued at least 24 hours prior to initiating the other. In the presence of elevated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed.
Hyperkalemia
Mild to severe hyperkalemia was reported in 31% of kidney transplant recipients and in 45% and 13% of liver transplant recipients treated with Prograf in the U.S. and European randomized trials, respectively, and in 8% of heart transplant recipients in European randomized trial and may require treatment Serum potassium levels should be monitored and potassium-sparing diuretics should not be used during Prograf therapy.
Neurotoxicity
Prograf can cause neurotoxicity, particularly when used in high doses. Neurotoxicity, including tremor, headache, and other changes in motor function, mental status, and sensory function were reported in approximately 55% of liver transplant recipients in the two randomized studies. Tremor occurred more often in Prograf-treated kidney transplant patients (54%) and heart transplant patients (15%) compared to cyclosporine-treated patients. The incidence of other neurological events in kidney transplant and heart transplant patients was similar in the two treatment groups
Malignancy and Lymphoproliferative Disorders
As in patients receiving other immunosuppressants, patients receiving Prograf are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent
Latent Viral Infections
Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML) which have been observed in patients receiving tacrolimus. These infections may lead to serious, including fatal, outcomes
Prograf in Combination with Sirolimus
The use of full-dose Prograf with sirolimus g per day) in heart transplant recipients was associated with increased risk of wound healing complications, renal function impairment, and insulin-dependent post-transplant diabetes mellitus, and is not recommended
Anaphylactic Reactions
A few patients receiving Prograf injection have experienced anaphylactic reactions. Patients receiving Prograf injection should be under continuous observation for at least the first 30 minutes following the start of the infusion and at frequent intervals thereafter. If signs or symptoms of anaphylaxis occur, the infusion should be stopped. An aqueous solution of epinephrine should be available at the bedside as well as source of oxygen.
Drugs that May Alter Tacrolimus Concentrations
Since tacrolimus is metabolized mainly by the CYP3A enzyme systems, substances known to inhibit these enzymes may decrease the metabolism or increase bioavailability of tacrolimus as indicated by increased whole blood or plasma concentrations. Drugs known to induce these enzyme systems may result in an increased metabolism of tacrolimus or decreased bioavailability as indicated by decreased whole blood or plasma concentrations. Monitoring of blood concentrations and appropriate dosage adjustments are essential when such drugs are used concomitantly.
*
This table is not all inclusive.
?
In study of normal volunteers, significant increase in tacrolimus oral bioavailability (14?5% vs. 30?8%) was observed with concomitant ketoconazole administration (200 mg). The apparent oral clearance of tacrolimus during ketoconazole administration was significantly decreased compared to tacrolimus alone (0.430?0.129 L/hr/kg vs. 0.148?0.043 L/hr/kg). Overall, IV clearance of tacrolimus was not significantly changed by ketoconazole co-administration, although it was highly variable between patients.
?
Lansoprazole (CYP2C19, CYP3A4 substrate) may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and thereby substantially increase tacrolimus whole blood concentrations, especially in transplant patients who are intermediate or poor CYP2C19 metabolizers, as compared to those patients who are efficient CYP2C19 metabolizers.
Calcium
Channel Blockers
Antifungal
Agents
Macrolide
Antibiotics
diltiazem
clotrimazole
clarithromycin
nicardipine
fluconazole
erythromycin
nifedipine
itraconazole
troleandomycin
verapamil
ketoconazole ?




voriconazole








Gastrointestinal Prokinetic Agents
Other
Drugs


cisapride
bromocriptine


metoclopramide
chloramphenicol




cimetidine




cyclosporine




danazol




ethinyl estradiol




methylprednisolone




lansoprazole ?




omeprazole




protease inhibitors




nefazodone




magnesium-aluminum-hydroxide


St. John?s Wort (Hypericum perforatum) induces CYP3A4 and P-glycoprotein. Since tacrolimus is substrate for CYP3A4, there is the potential that the use of St. John?s Wort in patients receiving Prograf could result in reduced tacrolimus levels.
Pregnancy: Category C
HOW SUPPLIED
strength
0.5 mg
(containing the equivalent of 0.5 mg anhydrous tacrolimus)
1 mg
(containing the equivalent of mg anhydrous tacrolimus)
5 mg
(containing the equivalent of mg anhydrous tacrolimus)








shape/color
oblong/light yellow
oblong/white
oblong/grayish red








branding on capsule cap/body
f
f
f
















100 count bottle
NDC 0469-0607-73
NDC 0469-0617-73
NDC 0469-0657-73
10 blister cards of 10 capsules


NDC 0469-0617-11
NDC 0469-0657-11
Made in Japan
Store and Dispense
Store at 25?C (77?F); excursions permitted to 15?C-30?C (59?F-86?F).
Prograf injection (tacrolimus injection)
(for IV infusion only)
NDC 0469-3016-01 Product Code 301601
5 mg/mL (equivalent of mg of anhydrous tacrolimus per mL) supplied as sterile solution in 1 mL ampule, in boxes of 10 ampules



NDC No. 00469-0677-73 UPC/GTIN No. 3-04690-67773-4 MPN 67773 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap
Astagraf XL 1mg Cap 30 by Astellas Pharm
NDC No. 00469-0677-73 UPC/GTIN No. 3-04690-67773-4 MPN 67773 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Astellas USA, Inc.
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

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 TACROLIMUS
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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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.