Tacrolimus 0.1% Ointment 60gm
Overview
What is this medicine?
How to Use This Medicine
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Only apply the medication to the affected skin, avoiding healthy skin.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Avoid bathing, showering, or swimming immediately after applying the medication.
Continuing Treatment
Stop using the medication when your skin condition has improved.
To help manage skin reactions, moisturize your skin as directed by your doctor.
If your symptoms do not improve after 6 weeks of treatment, consult your doctor.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply a thin layer of ointment only to the affected areas of your skin.
- Do not use occlusive dressings (like bandages or wraps) over the treated areas, as this can increase absorption.
- Avoid excessive exposure to natural or artificial sunlight (e.g., tanning beds) while using this medication. Use sunscreen and wear protective clothing.
- Do not use on skin that is broken, infected, or has open wounds.
- Wash your hands thoroughly after applying the ointment, unless your hands are the treated area.
- This medication is for short-term and intermittent use; avoid continuous long-term application.
Available Forms & Alternatives
Available Strengths:
- Tacrolimus 1mg Capsules
- Tacrolimus 0.5mg (half Mg) Capsules
- Tacrolimus 5mg (five Mg) Capsules
- Tacrolimus 1mg Caps (bx)
- Tacrolimus 0.5mg (half Mg) Cap(bx)
- Tacrolimus 5mg (five Mg)caps (bx)
- Tacrolimus 0.03% Ointment 30gm
- Tacrolimus 0.03% Ointment 60gm
- Tacrolimus 0.03% Ointment 100gm
- Tacrolimus 0.1% Ointment 30gm
- Tacrolimus 0.1% Ointment 60gm
- Tacrolimus 0.1% Ointment 100gm
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Fever
Ear pain
Skin lump or growth
Swollen gland
Muscle pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Skin tingling
Skin irritation
Sensitivity to heat or cold
Headache
Cough
Stuffy nose
Flu-like symptoms
Pimples (acne)
Hair bumps
Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening skin condition or no improvement after a few weeks of use.
- Signs of a skin infection (e.g., pus, fever, spreading redness, warmth, pain).
- Swollen lymph nodes (glands) in your neck, armpits, or groin.
- Development of any new or unusual skin lesions, moles, or changes in existing ones.
- Severe burning, stinging, or itching that does not subside after the first few days of treatment.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Certain health conditions, including:
+ Skin areas with cancer or precancerous lesions
+ Netherton's syndrome, a specific skin disease
+ Other skin problems that may compromise skin integrity
+ Active skin infections, such as chickenpox or herpes
+ A weakened immune system
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems, including those not listed above
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
To minimize the risk of adverse effects, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen with a high sun protection factor (SPF) and wear protective clothing and eyewear to shield your skin from the sun. Additionally, refrain from undergoing any form of light therapy while using this medication.
Before consuming alcohol, consult with your doctor to discuss potential interactions and risks. It is also crucial to talk to your doctor before using any other medications or products on your skin, including soaps, to avoid potential interactions.
Regular skin checks are vital; follow your doctor's instructions for scheduling these examinations. Common side effects of this medication may include burning, stinging, soreness, or itching at the application site. These effects typically occur during the initial days of treatment and subside as your skin improves. However, if these side effects are severe, persistent, or bothersome, contact your doctor for guidance.
In the event that this medication is ingested, it can cause harm. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- If ingested (swallowed): Nausea, vomiting, abdominal pain, headache, tremor, paresthesia (tingling/numbness), and potential kidney dysfunction.
- Topical overdose is unlikely to cause systemic toxicity due to poor absorption.
What to Do:
If swallowed, seek immediate medical attention or call Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Live vaccines (theoretical concern if significant systemic absorption occurs, but generally not an issue for topical use)
- Other immunosuppressants (additive immunosuppression, but unlikely to be clinically relevant with topical use due to minimal systemic absorption)
Monitoring
Baseline Monitoring
Rationale: To establish baseline severity of atopic dermatitis and identify any contraindications (e.g., skin infections, malignancy).
Timing: Prior to initiation of therapy.
Rationale: Due to potential, though unproven, association with malignancy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Regularly during treatment and follow-up
Target: Reduction in erythema, pruritus, and inflammation
Action Threshold: Worsening symptoms, signs of infection, or development of new skin lesions warrant re-evaluation.
Frequency: At each follow-up visit and as reported by patient
Target: Absence of infection
Action Threshold: Presence of infection requires appropriate treatment and potential temporary discontinuation of tacrolimus.
Frequency: Periodically
Target: Absence of persistent or significant lymphadenopathy
Action Threshold: Persistent or significant lymphadenopathy should be investigated.
Symptom Monitoring
- Burning sensation at application site (common, usually transient)
- Itching
- Stinging
- Erythema (redness)
- Folliculitis
- Acne
- Herpes simplex infection (cold sores, eczema herpeticum)
- Varicella zoster infection (chickenpox, shingles)
- Lymphadenopathy (swollen lymph nodes)
- Unusual skin changes or new skin lesions
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from topical application is minimal, data are limited.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Tacrolimus is excreted in breast milk after systemic administration. While systemic absorption from topical application is minimal, caution is advised. Consider the potential for infant exposure versus the maternal benefit. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Approved for children 2 years and older. Tacrolimus 0.03% ointment is typically used for children aged 2-15 years. Tacrolimus 0.1% ointment is indicated for adults and adolescents 16 years and older. Contraindicated for children younger than 2 years of age. Long-term safety in children is still under investigation.
Geriatric Use
No specific dosage adjustments are needed. However, geriatric patients may have more fragile skin or other comorbidities, so monitor for skin integrity and potential for increased systemic absorption if the skin barrier is compromised.
Clinical Information
Clinical Pearls
- Tacrolimus ointment is a second-line therapy for atopic dermatitis, typically used when first-line therapies (e.g., topical corticosteroids) are ineffective or not tolerated, or for sensitive areas like the face and skin folds.
- Patients may experience transient burning, stinging, or itching upon initial application, which usually subsides within a few days of continued use.
- Emphasize the black box warning regarding potential malignancy risk; advise patients on intermittent, short-term use and limiting application to affected areas.
- Strict sun protection (sunscreen, protective clothing) is crucial due to theoretical increased risk of skin cancer.
- Avoid use on acutely infected skin lesions; treat infections before initiating tacrolimus.
- Avoid bathing immediately after application to prevent washing off the ointment.
Alternative Therapies
- Topical corticosteroids (e.g., hydrocortisone, triamcinolone, fluocinonide)
- Pimecrolimus cream (another topical calcineurin inhibitor)
- Crisaborole ointment (Eucrisa)
- Topical ruxolitinib cream (Opzelura)
- Phototherapy (UVB)
- Systemic immunosuppressants (e.g., cyclosporine, methotrexate, azathioprine) for severe cases
- Biologic agents (e.g., dupilumab, tralokinumab) for severe cases