Tacrolimus .3 mg/g Ointment
Other active recalls for Tacrolimus (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Calcineurin Inhibitor Immunosuppressant class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.
Read the full MedlinePlus article ↗- It's used to treat moderate to severe eczema (atopic dermatitis) — the kind that hasn't cleared up well with standard creams like corticosteroids, or where those creams have caused...
- What is tacrolimus ointment actually used for?
- Apply a thin layer directly to the patches of skin affected by eczema — including the face, neck, and skin creases. Use it twice a day, morning and evening, until the eczema clears...
- It's a fair question, and it's right to take it seriously. Rare cases of skin cancer and lymphoma have been reported in people using tacrolimus ointment and similar medicines. Howe...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tacrolimus — tap one for details:
Tacrolimus may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 7QWA1RIO01
A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII 8D08K3S51E
Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
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UNII 7G1J5DA97F
White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.795 | $79.54 / 100 g |
| Medicaid paysCMS SDUD · 12 mo | $0.9603 | $96.03 / 100 g |
| Medicare drug plans payPart D · Q2 2026 | $1.59 | $158.71 / 100 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tacrolimus .3 mg/g 16729-0421-01 | Accord | 1 tube | $0.592 | AB | Availability likely | save 26% |
| Tacrolimus .3 mg/gthis 45802-0390-02 | Padagis | 1 tube | $0.795 | AB | Availability likely | — |
| Tacrolimus .3 mg/g 00168-0417-30 | E. | 1 tube | $0.883 | AB | Availability likely | +11% |
| Tacrolimus .3 mg/g 68462-0881-35 | Glenmark | 1 tube | $0.883 | AB | Availability likely | +11% |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 45802-0390-00 | 1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE | $0.8830 / g | $26.49 | 2014-11-20 | Active |
| 45802-0390-01 | 1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE | $0.9036 / g | $54.21 | 2014-11-20 | Active |
| 45802-0390-02 You're viewing this | 1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE | $0.7954 / g | $79.54 | 2014-11-20 | Active |
This pack has the lowest per-g cost of the 3 priced pack sizes ($0.7954 NADAC).
This pack accounts for about 11% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 45802-0390-02?
What NDC number is used to bill for this package of Tacrolimus .3 mg/g Ointment?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 ▾
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 ▾
CONTRAINDICATIONS Tacrolimus Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.
⚠️ Warnings ▾
WARNINGS WARNING 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 ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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…
🔄 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 ▾
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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. Pharmacokinetics Absorption The pooled results from three pharmacokinetic studies in 88 adult atopic dermatitis patients indicate that tacrolimus is minimally absorbed after the topical application of Tacrolimus Ointment. Peak tacrolimus blood concentrations ranged from undetectable to 20 ng/mL after single or multiple doses of 0.03% and 0.1% Tacrolimus Ointment, with 85% (75/88) of the patients having peak blood concentrations less than 2 ng/mL.
In general as treatment continued, systemic exposure declined as the skin returned to normal. In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed in adult patients, with 90% (1253/1391) of patients having a blood concentration less than 2 ng/mL. The absolute bioavailability of tacrolimus from Tacrolimus Ointment in atopic dermatitis patients is approximately 0.5%.
In adults with an average of 53% BSA treated, exposure (AUC) of tacrolimus from Tacrolimus Ointment is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients. Mean peak tacrolimus blood concentrations following oral administration (0.3 mg/kg/day) in adult kidney transplant (n=26) and liver transplant (n=17) patients are 24.2±15.8 ng/mL and 68.5±30.0 ng/mL, respectively. The lowest tacrolimus blood level at which systemic effects (e.g., immunosuppression) can be observed is not known.
Systemic levels of tacrolimus have also been measured in pediatric patients (see Special Populations: Pediatrics ). Distribution The plasma protein binding of tacrolimus is approximately 99% and is independent of concentration over a range of 5-50 ng/mL. Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes.
The distribution of tacrolimus between whole blood and plasma depends on several factors, such as hematocrit, temperature at the time of plasma separation, drug concentration, and plasma protein concentration. In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67). There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year.
As with other topical calcineurin inhibitors, it is not known whether tacrolimus is distributed into the lymphatic system. Metabolism Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A). A metabolic pathway leading to the formation of 8 possible metabolites has been proposed.
Demethylation and hydroxylation were identified as the primary mechanisms of biotransformation in vitro. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus. In in vitro studies, a 3…
🧬 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 / Storage and Handling ▾
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 and Handling ▾
Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
📋 Description ▾
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
💬 Information for Patients ▾
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.
💬 Medication Guide ▾
MEDICATION GUIDE Tacrolimus 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: Do not use Tacrolimus Ointment continuously for a long time.
Use Tacrolimus Ointment only on areas of your 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. 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: on children younger than 2 years of age. if you are allergic to Tacrolimus Ointment or anything in it. See the end of this Medication Guide for a complete list of ingredients. What should I tell my doctor before starting Tacrolimus Ointment?
Before you start using Tacrolimus Ointment, you and your doctor should talk about all of your medical conditions, including if you: have a skin disease called Netherton's syndrome (a rare inherited condition). have any infection on your skin including chicken pox or herpes. have been told you have a weakened immune system. are pregnant, breastfeeding, or planning to become pregnant. 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?
Use Tacrolimus Ointment exactly as prescribed. Use Tacrolimus Ointment only on areas of your 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 by your doctor. Follow your doctor's advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Call your doctor if : your symptoms get worse with Tacrolimus Ointment. you get an infection on your skin. your symptoms do not improve after 6 weeks of treatment.
Sometimes other skin diseases can look like eczema. To apply Tacrolimus Ointment: Wash your 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 you are a caregiver applying Tacrolimus Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Tacrolimus Ointment. This should remove…