Tacrolimus (Tacrolimus)

Trade Name : Tacrolimus

REMEDYREPACK INC.

CAPSULE

Strength 1 mg/1

TACROLIMUS Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tacrolimus (Tacrolimus) which is also known as Tacrolimus and Manufactured by REMEDYREPACK INC.. It is available in strength of 1 mg/1 per ml. Read more

Tacrolimus (Tacrolimus) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. (n n n n n n , n n n n n n ) n n n n n n
  • WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
  • See full prescribing information for complete boxed warning.
  • Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. (n n n n n n , n n n n n n ) n n n n n n
  • Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant n n n n n n , liver transplants n n n n n n and heart transplant n n n n n n , in combination with other immunosuppressants.n n nn n nn
  • Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. (n n n n n n )n nn n nn
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  • Intravenous (IV) use recommended for patients who cannot tolerate oral formulations (capsules or suspension). (n n n n n n , n n n n n n )n n n n n n
  • Administer capsules consistently with or without food. (n n n n n n )n n n n n n
  • Therapeutic drug monitoring is recommended. (n n n n n n , n n n n n n )n n n n n n
  • Avoid eating grapefruit or drinking grapefruit juice. (n n n n n n )n n n n n n
  • See dosing adjustments for African-American patients (n n n n n n ), hepatic and renal impaired. (n n n n n n , n n n n n n )n n n n n n
  • For complete dosing information, see the full prescribing information.n
  • Tacrolimus capsules, USP are available in 0.5 mg, 1 mg, and 5 mg strengths.
  • Oblong, hard capsule for oral administration contains tacrolimus as follows:
  • Capsules: 0.5 mg, 1 mg and 5 mg (n n n n n n ) n n n n n n
  • Tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome n n n n n n . n nn n nn
  • Hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil). (n n n n n n ) n n n n n n
  • No data
  • Not Interchangeable with Extended-Release Tacrolimus Products- Medication Errors. Instruct patients or caregivers to recognize the appearance of tacrolimus capsules. (n n n n n n )n n n n n n
  • New Onset Diabetes After Transplant: Monitor blood glucose. (n n n n n n ) n n n n n n
  • Nephrotoxicity (acute and/or chronic): Reduce the dose; use caution with other nephrotoxic drugs. (n n n n n n ) n n n n n n
  • u2022tNeurotoxicity: Including risk of Posterior Reversible Encephalopathy Syndrome (PRES), monitor for neurologic abnormalities; reduce or discontinue tacrolimus. (n n n n n n ) n n n n n n
  • Hyperkalemia: Monitor serum potassium levels. Consider carefully before using with other agents also associated with hyperkalemia. (n n n n n n )n n n n n n
  • Hypertension: May require antihypertensive therapy. Monitor relevant drug-drug interactions. (n n n n n n ) n n n n n n
  • Anaphylactic Reactions with IV formulation: Observe patients receiving tacrolimus injection for signs and symptoms of anaphylaxis. (n n n n n n )n n n n n n
  • Not recommended for use with sirolimus: Not recommended in liver and heart transplant due to increased risk of serious adverse reactions. (n n n n n n )n n n n n n
  • Myocardial Hypertrophy: Consider dose reduction/discontinuation. (n n n n n n )n n n n n n
  • Immunizations: Avoid live vaccines. (n n n n n n )n n n n n n
  • Pure Red Cell Aplasia: Consider discontinuation of tacrolimus. (n n n n n n ) n n n n n n
  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
  • The most common adverse reactions (u2265 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia. (n n n n n n )n nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or www.accordhealthcare.us or FDA at 1-800-FDA-1088 n n n n n n n
  • No data
  • Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to tacrolimus; monitor for MPA-related adverse reactions and adjust MMF or MPA dose as needed. (n n n n n n ) n n n n n n
  • Nelfinavir and Grapefruit Juice: Increased tacrolimus concentrations via CYP3A inhibition; avoid concomitant use. (n n n n n n ) n n n n n n
  • CYP3A Inhibitors: Increased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. (n n n n n n , n n n n n n ) n n n n n n
  • CYP3A4 Inducers: Decreased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. (n n n n n n , n n n n n n ) n n n n n n
  • No data
  • Pregnancy: Can cause fetal harm. Advise pregnant women of the potential risk to the fetus. (n n n n n n , n n n n n n ) n n n n n n
  • Limited overdosage experience is available. Acute overdosages of up to 30 times the intended dose have been reported. Almost all cases have been asymptomatic and all patients recovered with no sequelae. Acute overdosage was sometimes followed by adverse reactions consistent with those listed in n n n n n n (including tremors, abnormal renal function, hypertension, and peripheral edema); in one case of acute overdosage, transient urticaria and lethargy were observed. Based on the 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. n nn n nn
  • In acute oral and IV toxicity studies, mortalities were seen at or above the following doses: in adult rats, 52 times the recommended human oral dose; in immature rats, 16 times the recommended oral dose; and in adult rats, 16 times the recommended human IV dose (all based on body surface area corrections).
  • Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by n n n n n n . Chemically, tacrolimus is designated as (-)-(3n n n n n n ,4n n n n n n ,5n n n n n n ,8n n n n n n ,9n n n n n n ,12n n n n n n ,14n n n n n n ,15n n n n n n ,16n n n n n n ,18n n n n n n ,19n n n n n n ,26an n n n n n )-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(n n n n n n )-2-[(1n n n n n n ,3n n n n n n ,4n n n n n n )-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethyoxy-4,10,12,18-tetramethyl-15,19-epoxy-3n n n n n n -pyrido[2,1-n n n n n n ][1,4]oxaazacyclotricosine-1,7,20,21(4n n n n n n ,23n n n n n n )-tetrone)monohydrate.n nn n nn
  • The chemical structure of tacrolimus is:
  • Tacrolimus has an empirical formula of Cn n n n n n Hn n n n n n NOn n n n n n u2022Hn n n n n n 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. n nn n nn
  • Tacrolimus capsules, USP are available for oral administration containing 0.5 mg, 1 mg or 5 mg of tacrolimus. Inactive ingredients include lactose monohydrate, hypromellose E5, croscarmellose sodium, and magnesium stearate.
  • The 0.5 mg capsule shell contains gelatin, titanium dioxide, iron oxide yellow and sodium lauryl sulfate, the 1 mg capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate, and the 5 mg capsule shell contains gelatin, titanium dioxide, iron oxide red and sodium lauryl sulfate.
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  • Advise the patient to read the FDA-approved patient labeling (n n n n n n ). n nn n nn
  • No data
  • DRUG: Tacrolimus
  • GENERIC: Tacrolimus
  • DOSAGE: CAPSULE
  • ADMINSTRATION: ORAL
  • NDC: 70518-2124-0
  • COLOR: white
  • SHAPE: CAPSULE
  • SCORE: No score
  • SIZE: 11 mm
  • IMPRINT: TCR;1
  • PACKAGING: 30 in 1 BLISTER PACK
  • ACTIVE INGREDIENT(S):
  • INACTIVE INGREDIENT(S):

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