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SANDOZ TACROLIMUS is a brand name for Tacrolimus, supplied as a capsule (immediate release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Transplantation Sandoz Tacrolimus (tacrolimus immediate-release capsule) is indicated for: • prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. • treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants. Sandoz Tacrolimus is to be…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Due to intersubject variability following dosing with tacrolimus, individualization of the dosing regimen is necessary for optimal therapy. Additional factors that may impact dosing include pre-existing conditions, such as renal or hepatic impairment, race, pediatric use and the concomitant use of other medications.
Tacrolimus has been used in combination with azathioprine. Tacrolimus has been used in combination with mycophenolate mofetil (MMF) in patients receiving deceased donor kidney transplants and heart transplants. Medication errors, including inadvertent, unintentional or unsupervised substitution of Tacrolimus capsule (immediate-release) or Tacrolimus capsule (extended-release) tacrolimus formulations, have been observed.
This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over-exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the Sandoz Tacrolimus (tacrolimus) Page 7 of 99 corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist.
Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained. 2 Recommended Dose and Dosage Adjustment The initial dose of Sandoz Tacrolimus should be administered no sooner than 6 hours after transplantation.
Adult patients should receive doses at the lower end of the dosing range. Concomitant adrenal corticosteroid therapy is recommended early post-transplantation. 3 mg/kg/day administered every 12 hours in two divided doses. The initial dose of tacrolimus may be administered within 24 hours of transplantation but should be delayed until renal function has recovered (as indicated, for example, by a serum creatinine < 4 mg/dL).
Black patients may require higher doses to achieve comparable blood levels. Dosage and typical tacrolimus whole blood trough concentrations are shown in the table below; blood concentration details are described under 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Blood Concentration Monitoring.
3 mg/kg/day Dosing Regimen two divided doses, q12h Typical tacrolimus whole blood trough concentrations Month 1-3 Month 4-12 7 - 20 ng/mL 5 - 15 ng/mL Liver Transplantation It is recommended that patients be converted from IV to oral tacrolimus as soon as oral therapy can be tolerated.
), including mild elevations of renal function markers (creatinine), nausea, headache, hyperreflexia, oliguria, hypotension, tremor and elevations in liver enzymes. In one case, transient urticaria and lethargy were observed, and in another case, acute anuric renal insufficiency developed.
Based on its high molecular weight, poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion.
The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.
In acute oral and intravenous toxicity studies, mortalities were seen at or above the following doses: in adult rats, 52X the recommended human oral dose: in immature rats, 16X the recommended oral dose, and in adult rats, 16X the recommended human intravenous dose (all based on body surface area corrections).
5mg). 5 mg, 1 mg or 5 mg of anhydrous tacrolimus. 5 mg” in black. Supplied in bottles of 100 capsules. Sandoz Tacrolimus 1 mg White to off-white powder filled in size “4” capsule with white opaque body imprinted with “Z” in black and white opaque cap imprinted with “1 mg” in black.
Supplied in bottles of 100 capsules. Sandoz Tacrolimus 5 mg White to off-white powder filled in size “3” capsule with Swedish orange opaque body imprinted with “Z” in black and Swedish orange opaque cap imprinted with “5 mg” in black.
Supplied in bottles of 100 capsules. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P450 system (CYP3A).
, Hematologic 04/2023 7 WARNINGS AND PRECAUTIONS, Immune 04/2023 7 WARNINGS AND PRECAUTIONS, Renal 04/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..............................................................................................
2 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...........................................................................................................
2 Geriatrics ........................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations ........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ................................................................................................... 5 Missed Dose.......................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 10 7 WARNINGS AND PRECAUTIONS ..................................................................................
Sandoz Tacrolimus is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
Sandoz Tacrolimus (tacrolimus) Page 6 of 99
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This usually occurs within 2-3 days. The first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion. 15 mg/kg/day administered in two divided daily doses every 12 hours. The initial dose of tacrolimus should be administered no sooner than 6 hours after transplantation.
Adult patients should receive doses at the lower end of the dosing range. Some centres use lower tacrolimus doses during maintenance therapy post-transplantation. Dosing should be titrated based on clinical assessment of rejection and tolerability.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. 075 mg/kg/day administered every 12 hours in two divided doses. It is recommended that patients initiate oral therapy with tacrolimus capsules if possible.
If IV therapy is necessary, conversion from IV to oral tacrolimus is recommended as soon as oral therapy can be tolerated. This usually occurs within 2-3 days. The initial dose of tacrolimus should be administered no sooner than 6 hours after transplantation.
In a patient receiving an IV infusion, the first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion1. Dosing should be titrated based on clinical assessments of rejection and tolerability. Lower tacrolimus dosages may be sufficient as maintenance therapy.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. Rheumatoid Arthritis The recommended adult oral dose of tacrolimus is 3 mg, administered once a day. Regular monitoring of tacrolimus-treated patients for occurrence of adverse events is mandatory.
Patients with Hepatic or Renal Dysfunction Due to the potential for nephrotoxicity, patients with renal or hepatic impairment should receive doses at the lowest value of the recommended oral dosing ranges. Further reductions in dose below these ranges may be required.
Conversion from Cyclosporine to Tacrolimus Tacrolimus should not be used simultaneously with cyclosporine. Patients converted from cyclosporine to tacrolimus should receive the first tacrolimus dose no sooner than 24 hours after the last cyclosporine dose.
Dosing may be further delayed in the prese nce of elevated cyclosporine levels. Conversion from Tacrolimus to Cyclosporine Patients converted from tacrolimus to cyclosporine should receive the first cyclosporine dose no sooner than 24 hours after the last tacrolimus dose.
Dosing may be further delayed in the presence of elevated tacrolimus levels. Pediatric Patients Pediatric liver transplantation patients without pre-existing renal or hepatic dysfunction have required and tolerated higher doses than adults to achieve similar blood concentrations.
20 mg/kg/day. Dose adjustments may be required. Experience in pediatric kidney and heart transplantation patients is limited. 1 Sandoz Tacrolimus is not available in the intravenous form Sandoz Tacrolimus (tacrolimus) Page 9 of 99 Race […]
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 with resultant increases in whole blood or plasma levels.
Drugs known to induce these enzyme systems may result in an increased metabolism of tacrolimus or Sandoz Tacrolimus (tacrolimus) Page 11 of 99 decreased bioavailability as indicated by decreased whole blood or plasma levels. 2 Recommended Dose and Dosage Adjustment, and
1 Special Populations .......................................................................................... 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................
3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 20 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview .............................................................................. 2 Clinical Trial Adverse Reactions......................................................................... 3 Less Common Clinical Trial Adverse Reactions...................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions ........................................................................
36 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview .............................................................................. 3 Drug-Behavioural Interactions ..........................................................................
4 Drug-Drug Interactions ..................................................................................... 5 Drug-Food Interactions..................................................................................... 6 Drug-Herb Interactions .....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 45 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action........................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 46 11 STORAGE, STABILITY AND DISPOSAL ...........................................................................
56 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 56 PART II: SCIENTIFIC INFORMATION.........................................................................................
57 13 PHARMACEUTICAL INFORMATION .............................................................................. 57 14 CLINICAL TRIALS ..........................................................................................................
1 Trial Design and Study Demographics ............................................................... 2 Study Results ................................................................................................... 3 Comparative Bioavailability Studies ..................................................................
70 15 MICROBIOLOGY .......................................................................................................... 74 16 NON-CLINICAL TOXICOLOGY .......................................................................................
74 17 SUPPORTING PRODUCT MONOGRAPHS […]