Tacrolimus
Capsule · Oral, Topical, Intravenous
Uses
Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy 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 boxed WARNING , WARNINGS and PRECAUTIONS: Pediatric Use ).
Dosage and administration
Adult Tacrolimus Ointment 0.03% and 0.1% Apply a thin layer of Tacrolimus Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve. If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis. Continuous long-term use of topical calcineurin inhibitors, including Tacrolimus Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Tacrolimus Ointment should not be used with occlusive dressings. Pediatric – For Children 2-15 Years Tacrolimus Ointment 0.03% Apply a thin layer of Tacrolimus Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve. If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis. Continuous long-term use of topical calcineurin inhibitors, including Tacrolimus Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Tacrolimus Ointment should not be used with occlusive dressings.
Contraindications
Tacrolimus Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.
Warnings
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Tacrolimus Ointment. Therefore: Continuous long-term use of topical calcineurin inhibitors, including Tacrolimus Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. Tacrolimus Ointment is not indicated for use in children less than 2 years of age. Only 0.03% Tacrolimus Ointment is indicated for use in children 2-15 years of age. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on the information above and the mechanism of action, there is a concern about potential risk with the use of topical calcineurin inhibitors, including Tacrolimus Ointment. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Tacrolimus Ointment. Therefore: Tacrolimus Ointment should not be used in immunocompromised adults and children. If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS: General ). The safety of Tacrolimus Ointment has not been established beyond one year of non-continuous use. (See CLINICAL PHARMACOLOGY , boxed WARNING , INDICATIONS AND USAGE , and DOSAGE AND ADMINISTRATION ).
Precautions
General The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis. The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Oral application is also not recommended. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. The use of Tacrolimus Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. With Tacrolimus Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS ). Bacterial and Viral Skin Infections Before commencing treatment with Tacrolimus Ointment, cutaneous bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of Tacrolimus Ointment in the treatment of clinically infected atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi's varicelliform eruption), treatment with Tacrolimus Ointment may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. Patients with Lymphadenopathy In clinical studies, 112/13494 (0.8%) cases of lymphadenopathy were reported and were usually related to infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Of these 112 cases, the majority had either a clear etiology or were known to resolve. Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive Tacrolimus Ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, Tacrolimus Ointment should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. Sun Exposure During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while Tacrolimus Ointment is not on the skin. It is not known whether Tacrolimus Ointment interferes with skin response to ultraviolet damage. Immunocompromised Patients The safety and efficacy of Tacrolimus Ointment in immunocompromised patients have not been studied. Renal Insufficiency Rare post-marketing cases of acute renal failure have been reported in patients treated with Tacrolimus Ointment. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when Tacrolimus Ointment is applied to large body surface areas. Caution should also be exercised in patients predisposed to renal impairment. Information for Patients (See Medication Guide ) Patients using Tacrolimus Ointment should receive and understand the information in the Medication Guide. Please refer to the Medication Guide for providing instruction and information to the patient. What is the most important information patients 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, instruct patients: Do not use Tacrolimus Ointment continuously for a long time. Use Tacrolimus Ointment only on areas of skin that have eczema. Do not use Tacrolimus Ointment on a child under 2 years old. Tacrolimus Ointment comes in two strengths: Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. Either Tacrolimus Ointment 0.03% or 0.1% can be used by adults and children 16 years and older. Advise patients to talk to their prescriber for more information. How should Tacrolimus Ointment be used? Advise patients to: Use Tacrolimus Ointment exactly as prescribed. Use Tacrolimus Ointment only on areas of skin that have eczema. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed. Follow their doctor's advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Call their doctor if: Their symptoms get worse with Tacrolimus Ointment. They get an infection on their skin. Their symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema. To apply Tacrolimus Ointment: Advise patients: Wash their hands before applying Tacrolimus Ointment. Apply a thin layer of Tacrolimus Ointment twice daily to the areas of skin affected by eczema. Use the smallest amount of Tacrolimus Ointment needed to control the signs and symptoms of eczema. If they are a caregiver applying Tacrolimus Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying Tacrolimus Ointment. This should remove any ointment left on the hands. Do not bathe, shower, or swim right after applying Tacrolimus Ointment. This could wash off the ointment.
Side effects
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. Duration of Follow-up in Four Open-label Safety Studies Time on Study Adult Pediatrics Total < 1 year 4682 4481 9163 ≥ 1 year 1185 1349 2534 ≥ 2 years 200 275 475 ≥ 3 years 118 182 300 The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, 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. Incidence of Treatment Emergent Adverse Events 12-Week, Randomized, Double-Blind, Phase 3 Studies 12-Week Adjusted Incidence Rate (%) Open-Label Studies (up to 3 years) 0.1% and 0.03% Tacrolimus Ointment Incidence Rate (%) Adult Pediatric Adult Pediatric Total Vehicle (n=212) % 0.03% Tacrolimus Ointment (n=210) % 0.1% Tacrolimus Ointment (n=209) % Vehicle (n=116) % 0.03% Tacrolimus Ointment (n=118) % (n=4682) % (n=4481) % (n=9163) % Skin Burning May be reasonably associated with the use of this drug product 26 46 58 29 43 28 20 24 Pruritus 37 46 46 27 41 25 19 22 Flu-like symptoms 19 23 31 25 28 22 34 28 Allergic Reaction 8 12 6 8 4 9 13 11 Skin Erythema 20 25 28 13 12 12 7 9 Headache 11 20 19 8 5 13 9 11 Skin Infection 11 12 5 14 10 9 16 12 Fever 4 4 1 13 21 2 14 8 Infection 1 1 2 9 7 6 10 8 Cough Increased 2 1 1 14 18 3 10 6 Asthma 4 6 4 6 6 4 13 8 Herpes Simplex 4 4 4 2 0 4 3 3 Eczema Herpeticum 0 1 1 0 2 0 0 0 Pharyngitis 3 3 4 11 6 4 12 8 Accidental Injury 4 3 6 3 6 6 8 7 Pustular Rash 2 3 4 3 2 2 7 5 Folliculitis 1 6 4 0 2 4 2 3 Rhinitis 4 3 2 2 6 2 4 3 Otitis Media 4 0 1 6 12 2 11 6 Sinusitis 1 4 2 8 3 6 7 6 Diarrhea 3 3 4 2 5 2 4 3 Urticaria 3 3 6 1 1 3 4 4 Lack of Drug Effect 1 1 0 1 1 6 6 6 Bronchitis 0 2 2 3 3 4 4 4 Vomiting 0 1 1 7 6 1 4 3 Maculopapular Rash 2 2 2 3 0 2 1 1 Rash 1 5 2 4 2 2 3 3 Abdominal Pain 3 1 1 2 3 1 3 2 Fungal Dermatitis 0 2 1 3 0 2 4 3 Gastroenteritis 1 2 2 3 0 2 4 3 Alcohol Intolerance 0 3 7 0 0 4 0 2 Acne 2 4 7 1 0 3 2 3 Sunburn 1 2 1 0 0 2 1 1 Skin Disorder 2 2 1 1 4 2 2 2 Conjunctivitis 0 2 2 2 1 3 3 3 Pain 1 2 1 0 1 2 1 2 Vesiculobullous Rash 3 3 2 0 4 2 1 1 Lymphadenopathy 2 2 1 0 3 1 2 1 Nausea 4 3 2 0 1 2 1 2 Skin Tingling 2 3 8 1 2 2 1 1 Face Edema 2 2 1 2 1 1 1 1 Dyspepsia 1 1 4 0 0 2 2 2 Dry Skin 7 3 3 0 1 1 1 1 Hyperesthesia 1 3 7 0 0 2 0 1 Skin Neoplasm Benign Generally "warts". 1 1 1 0 0 1 2 2 Back Pain 0 2 2 1 1 3 0 2 Peripheral Edema 2 4 3 0 0 2 0 1 Varicella Zoster/Herpes Zoster 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. 0 1 0 0 5 1 2 2 Contact Dermatitis 1 3 3 3 4 2 2 2 Asthenia 1 2 3 0 0 1 0 1 Pneumonia 0 1 1 2 0 1 3 2 Eczema 2 2 2 0 0 1 0 1 Insomnia 3 4 3 1 1 2 0 1 Exfoliative Dermatitis 3 3 1 0 0 0 1 0 Dysmenorrhea 2 4 4 0 0 2 1 1 Periodontal Abscess 1 0 1 0 0 1 1 1 Myalgia 0 3 2 0 0 2 1 1 Cyst 0 1 3 0 0 1 0 1 Cellulitis 1 1 1 0 0 1 1 1 Exacerbation of Untreated Area 1 0 1 1 0 1 1 1 Procedural Complication 1 0 0 1 0 1 1 1 Hypertension 0 0 1 0 0 2 0 1 Tooth Disorder 0 1 1 1 0 2 1 1 Arthralgia 1 1 3 2 0 2 1 2 Depression 1 2 1 0 0 1 0 1 Paresthesia 1 3 3 0 0 2 1 2 Alopecia 0 1 1 0 0 1 1 1 Urinary Tract Infection 0 0 1 0 0 2 1 2 Ear Pain 1 0 1 0 1 0 1 1 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. Post-Marketing Events 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 Neoplasms Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma Infections Bullous impetigo, osteomyelitis, septicemia Renal Acute renal failure in patients with or without Netherton's syndrome, renal impairment Skin Rosacea, application site edema
Drug interactions
Drug Interactions Formal topical drug interaction studies with Tacrolimus Ointment have not been conducted. Based on its extent of absorption, interactions of Tacrolimus Ointment with systemically administered drugs are unlikely to occur but cannot be ruled out (see CLINICAL PHARMACOLOGY ). The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Pregnancy
Pregnancy Teratogenic Effects: There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. The experience with Tacrolimus Ointment when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Reproduction studies were carried out with systemically administered tacrolimus in rats and rabbits. Adverse effects on the fetus were observed mainly at oral dose levels that were toxic to dams. Tacrolimus at oral doses of 0.32 and 1.0 mg/kg (0.04×-0.12× MRHD based on BSA) during organogenesis in rabbits was associated with maternal toxicity as well as an increase in incidence of abortions. At the higher dose only, an increased incidence of malformations and developmental variations was also seen. Tacrolimus, at oral doses of 3.2 mg/kg during organogenesis in rats, was associated with maternal toxicity and caused an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability. Tacrolimus, given orally at 1.0 and 3.2 mg/kg (0.04×-0.12× MRHD based on BSA) to pregnant rats after organogenesis and during lactation, was associated with reduced pup weights. No reduction in male or female fertility was evident. There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. Tacrolimus is transferred across the placenta. The use of systemically administered tacrolimus during pregnancy has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus Ointment should be used during pregnancy only if the potential benefit to the mother justifies a potential risk to the fetus.
Pediatric use
Pediatric Use Tacrolimus Ointment is not indicated for children less than 2 years of age. Only the lower concentration, 0.03%, of Tacrolimus Ointment is recommended for use as a second-line therapy for short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised children 2 to 15 years of age who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. The long-term safety and effects of Tacrolimus Ointment on the developing immune system are unknown (see boxed WARNING , WARNINGS and INDICATIONS and USAGE ). Four studies were conducted involving a total of about 4,400 patients 2-15 years of age: one 12-week randomized vehicle-controlled study and three open-label safety studies of one to three years duration. About 2,500 of these patients were 2 to 6 years of age. The most common adverse events from these studies associated with Tacrolimus Ointment application in pediatric patients were skin burning and pruritus (see ADVERSE REACTIONS ). In addition to skin burning and pruritus, the less common events (<5%) of varicella zoster (mostly chicken pox), and vesiculobullous rash were more frequent in patients treated with Tacrolimus Ointment 0.03% compared to vehicle. In the open-label safety studies, the incidence of adverse events, including infections, did not increase with increased duration of study drug exposure or amount of ointment used. In about 4,400 pediatric patients treated with Tacrolimus Ointment, 24 (0.5%) were reported with eczema herpeticum. Since the safety and efficacy of Tacrolimus Ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. In an open-label study, immune response to a 23-valent pneumococcal polysaccharide vaccine was assessed in 23 children 2 to 12 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03%. Protective antibody titers developed in all patients. Similarly, in a seven-month, double-blind trial, the vaccination response to meningococcal serogroup C was equivalent in children 2 to 11 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03% (n=121), a hydrocortisone ointment regimen (n=111), or normal children (n=44).
Geriatric use
Geriatric Use Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.
Overdosage
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.
Description
Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis . It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3 S -[3 R *[ E (1 S *,3 S *,4 S *)],4 S *,5 R *,8 S *,9 E ,12 R *,14 R *,15 S *,16 R *,18 S *,19 S *,26a R *]]-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. It has the following structural formula: Tacrolimus has an empirical formula of C 44 H 69 NO 12 ∙H 2 O 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 with all- rac -α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax. Chemical Structure
Mechanism of action
Mechanism of Action 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-α, 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 FcɛRI on Langerhans cells.
How supplied
Tacrolimus Ointment 0.03% NDC 45802-390-00 30 gram laminate tube NDC 45802-390-01 60 gram laminate tube NDC 45802-390-02 100 gram laminate tube Tacrolimus Ointment 0.1% NDC 45802-700-00 30 gram laminate tube NDC 45802-700-01 60 gram laminate tube NDC 45802-700-02 100 gram laminate tube Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Storage
Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Patient information
Information for Patients (See Medication Guide ) Patients using Tacrolimus Ointment should receive and understand the information in the Medication Guide. Please refer to the Medication Guide for providing instruction and information to the patient. What is the most important information patients 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, instruct patients: Do not use Tacrolimus Ointment continuously for a long time. Use Tacrolimus Ointment only on areas of skin that have eczema. Do not use Tacrolimus Ointment on a child under 2 years old. Tacrolimus Ointment comes in two strengths: Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. Either Tacrolimus Ointment 0.03% or 0.1% can be used by adults and children 16 years and older. Advise patients to talk to their prescriber for more information. How should Tacrolimus Ointment be used? Advise patients to: Use Tacrolimus Ointment exactly as prescribed. Use Tacrolimus Ointment only on areas of skin that have eczema. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed. Follow their doctor's advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Call their doctor if: Their symptoms get worse with Tacrolimus Ointment. They get an infection on their skin. Their symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema. To apply Tacrolimus Ointment: Advise patients: Wash their hands before applying Tacrolimus Ointment. Apply a thin layer of Tacrolimus Ointment twice daily to the areas of skin affected by eczema. Use the smallest amount of Tacrolimus Ointment needed to control the signs and symptoms of eczema. If they are a caregiver applying Tacrolimus Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying Tacrolimus Ointment. This should remove any ointment left on the hands. Do not bathe, shower, or swim right after applying Tacrolimus Ointment. This could wash off the ointment. Moisturizers can be used with Tacrolimus Ointment. Make sure they check with their doctor first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If they use moisturizers, apply them after Tacrolimus Ointment. What should patients avoid while using Tacrolimus Ointment? Advise patients: Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with Tacrolimus Ointment. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. Doctors should advise what other types of protection from the sun patients should use. Do not cover the skin being treated with bandages, dressings or wraps. Patients can wear normal clothing. Avoid getting Tacrolimus Ointment in the eyes or mouth. Do not swallow Tacrolimus Ointment. Patients should call their doctor if they swallow Tacrolimus Ointment.
Label text from the FDA structured product label by Padagis Israel Pharmaceuticals Ltd (revised Nov 15, 2021). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Tacrolimus in 94 products
Tacrolimus NDC products (94)
Tacrolimus recalls
- D-0219-2024 Jan 17, 2024 · Class II · Terminated
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. - D-0330-2023 Mar 1, 2023 · Class II · Ongoing
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. - D-1304-2022 Aug 10, 2022 · Class III · Ongoing
Defective Container: Tube split from side seam - D-0180-2021 Jan 6, 2021 · Class III · Terminated
Failed Moisture Limits - D-1057-2020 Apr 1, 2020 · Class III · Terminated
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. - D-383-2014 Jan 1, 2014 · Class II · Terminated
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin - D-066-2013 Dec 5, 2012 · Class II · Terminated
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Frequently asked questions
What is Tacrolimus used for?
Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy 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…
What are the side effects of Tacrolimus?
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… See the full label for the complete list.
Who makes Tacrolimus?
Tacrolimus is listed by 34 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Ajenat Pharmaceuticals LLC, American Health Packaging.
Has Tacrolimus been recalled?
The FDA enforcement database lists 7 recalls for Tacrolimus, most recently D-0219-2024 (class ii): Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.