Tacrolimus (Tacrolimus)

Trade Name : Tacrolimus

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

OINTMENT

Strength 1 mg/g

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 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 1 mg/g 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

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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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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
  • Fougera
  • Rx only
  • FOR DERMATOLOGIC USE ONLY
  • NOT FOR OPHTHALMIC USE
  • Prescribing Information
  • See concerning long-term safety of topical calcineurin inhibitors
  • Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by .
  • It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3[3n [(1n ,3n ,4n )],4n ,5n ,8n ,9,12n ,14n ,15n ,16n ,18n ,19n ,26an ]]-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-][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.
  • It has the following structural formula:
  • Tacrolimus has a molecular formula of CHNO u2022HO and a formula weight of 822.03.
  • Each gram of tacrolimus ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.
  • The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding 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 is inhibited. This effect has been shown to 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). Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-u03b1, all of which are involved in the early stages of T-cell activation.
  • Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to down regulate the expression of Fcu03b5RI on Langerhans cells.
  • No data
  • Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate tacrolimus ointment for the treatment of patients with moderate to severe atopic dermatitis. One (Pediatric) study included 351 patients 2-15 years of age, and the other two (Adult) studies included a total of 632 patients 15-79 years of age. Fifty-five percent (55%) of the patients were women and 27% were black. At baseline, 58% of the patients had severe disease and the mean body surface area (BSA) affected was 46%. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. In these studies, patients applied either tacrolimus ointment 0.03%, tacrolimus ointment 0.1%, or vehicle ointment twice daily to 10% - 100% of their BSA for up to 12 weeks.
  • In the pediatric study, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician's global evaluation of clinical response (the pre-defined primary efficacy endpoint) in the tacrolimus ointment 0.03% treatment group compared to the vehicle treatment group, but there was insufficient evidence that tacrolimus ointment 0.1% provided more efficacy than tacrolimus ointment 0.03%.
  • In both adult studies, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician's global evaluation of clinical response in the tacrolimus ointment 0.03% and tacrolimus ointment 0.1% treatment groups compared to the vehicle treatment group. There was evidence that tacrolimus ointment 0.1% may provide more efficacy than tacrolimus ointment 0.03%. The difference in efficacy between tacrolimus ointment 0.1% and 0.03% was particularly evident in adult patients with severe disease at baseline, adults with extensive BSA involvement, and black adults. Response rates for each treatment group are shown below by age groups. Because the two adult studies were identically designed, the results from these studies were pooled in this table.
  • A statistically significant difference in the percentage of adult patients with u2265u00a090% improvement was achieved by week 1 for those treated with tacrolimus ointment 0.1%, and by week 3 for those treated with tacrolimus ointment 0.03%.
  • A statistically significant difference in the percentage of pediatric patients with u2265u00a090% improvement was achieved by week 2 for those treated with tacrolimus ointment 0.03%.
  • In adult patients who had achieved u2265u00a090% improvement at the end of treatment, 35% of those treated with tacrolimus ointment 0.03% and 41% of those treated with tacrolimus ointment 0.1%, regressed from this state of improvement at 2 weeks after end-of-treatment. In pediatric patients who had achieved u2265u00a090% improvement, 54% of those treated with tacrolimus ointment 0.03% regressed from this state of improvement at 2 weeks after end-of-treatment. Because patients were not followed for longer than 2 weeks after end-of-treatment, it is not known how many additional patients regressed at periods longer than 2 weeks after cessation of therapy.
  • In both tacrolimus ointment treatment groups in adults and in the tacrolimus ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared to vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percent body surface area involved, patient evaluation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification.
  • The following two graphs depict the time course of improvement in the percent body surface area affected in adult and in pediatric patients as a result of treatment.
  • Figure 1 - Adult Patients Body Surface Area Over Time
  • Figure 2 u2013 Pediatric Patients Body Surface Area Over Time
  • The following two graphs depict the time course of improvement in erythema in adult and in pediatric patients as a result of treatment.
  • Figure 3 - Adult Patients Mean Erythema Over Time
  • Figure 4 - Pediatric Patients Mean Erythema Over Time
  • The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower.
  • Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
  • Tacrolimus ointment is not indicated for children younger than 2 years of age (see n n- Array
  • Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.
  • No data
  • No data
  • No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study. In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with tacrolimus ointment.
  • The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below.
  • The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, and tacrolimus ointment 0.03%, and tacrolimus ointment 0.1% treatment groups. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug.
  • * May be reasonably associated with the use of this drug product u2020 Generally u201cwartsu201d. u2021 All the herpes zoster cases in the pediatric 12-week study and the majority of cases in the open-label pediatric studies were reported as chicken pox.
  • Other adverse events which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include: abnormal vision, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo.
  • The following adverse reactions have been identified during postapproval use of tacrolimus ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • CNS
  • Seizures
  • Infections
  • Bullous impetigo, osteomyelitis, septicemia
  • Neoplasms
  • Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma
  • Renal
  • Acute renal failure in patients with or without Netherton's syndrome, renal impairment
  • Skin
  • Rosacea, application site edema
  • Tacrolimus ointment is not for oral use. Oral ingestion of tacrolimus ointment may lead to adverse effects associated with systemic administration of tacrolimus. If oral ingestion occurs, medical advice should be sought.
  • No data
  • Tacrolimus ointment 0.03%
  • Tacrolimus ointment 0.1%
  • Store at room temperature 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F).
  • TACROLIMUS (ta-KROE-li-mus)
  • Ointment 0.03%
  • Ointment 0.1%
  • Read the Medication Guide every time you or a family member gets tacrolimus ointment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. If you have questions about tacrolimus ointment, ask your doctor or pharmacist.
  • What is the most important information I should know about tacrolimus ointment?
  • The safety of using tacrolimus ointment for a long period of time is not known. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). However, a link with tacrolimus ointment has not been shown.
  • Because of this concern:
  • Tacrolimus ointment comes in two strengths:
  • Talk to your doctor for more information.
  • What is tacrolimus ointment?
  • Tacrolimus ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis).
  • Tacrolimus ointment is in a class of medicines called topical calcineurin inhibitors. It is for adults and children 2 years of age and older who do not have a weakened immune system. Tacrolimus ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between.
  • Tacrolimus ointment is for use after other prescription medicines have not worked for you, or if your doctor recommends that other prescription medicines should not be used.
  • Who should not use tacrolimus ointment?
  • Tacrolimus ointment should not be used:
  • What should I tell my doctor before starting tacrolimus ointment?
  • Before you start using tacrolimus, you and your doctor should talk about all of your medical conditions, including if you:
  • Tell your doctor about all the medicines you take and skin products you use including prescription and nonprescription medicines, vitamins, and herbal supplements.
  • Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.
  • How should I use tacrolimus ointment?
  • To apply tacrolimus ointment:
  • What should I avoid while using tacrolimus ointment?
  • What are the possible side effects of tacrolimus ointment?
  • Please read the first section of this Medication Guide.
  • The most common side effects
  • Other side effects
  • Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you. While you are using tacrolimus, drinking alcohol may cause the skin or face to become flushed or red and feel hot. These are not all the side effects with tacrolimus ointment. Ask your doctor or pharmacist for more information.
  • Call your doctor for medical side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store tacrolimus ointment?
  • General advice about tacrolimus ointment
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tacrolimus ointment for a condition for which it was not prescribed. Do not give tacrolimus ointment to other people, even if they have the same symptoms you have. It may not be right for them.
  • This Medication Guide summarizes the most important information about tacrolimus ointment. If you would like more information, talk with your doctor.
  • Your doctor or pharmacist can give you information about tacrolimus ointment that is written for health care professionals. To download the professional package insert you can also visit the tacrolimus ointment website at www.fougera.com or call 1-800-645-9833.
  • What are the ingredients in tacrolimus ointment?
  • Active Ingredient
  • Inactive Ingredients
  • E. FOUGERA & CO.
  • Fougera
  • 46160664BR06/16#234
  • FOUGERAn
  • Rx only
  • NET WT. 60 grams
  • Rx only
  • FOUGERAn
  • NET WT. 60 grams
  • FOUGERAn
  • Rx only
  • NET WT. 60 grams
  • Rx only
  • FOUGERAn
  • NET WT. 60 grams

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