Tacrolimus 0.1% Ointment 30gm
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
- Apply the medication only to the affected skin area. Do not apply it to healthy skin.
- Unless directed by your doctor, do not cover the treated area with bandages or dressings.
- After applying the medication, wait for some time before bathing, showering, or swimming.
- Continue using the medication until the health problem is resolved, as directed by your doctor.
Managing Skin Reactions
To help manage any skin reactions, moisturize your skin as advised by your doctor. If your symptoms do not improve after 6 weeks of treatment, consult with your doctor.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding storage in a bathroom. Keep the container tightly closed and store all medications in a safe location out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or extra doses.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas. Do not apply to healthy skin.
- Wash your hands thoroughly after applying the ointment, unless your hands are the treated area.
- Avoid excessive exposure to natural or artificial sunlight (e.g., tanning beds, sunlamps) while using this medication. Use sunscreen and wear protective clothing.
- Do not cover the treated skin with bandages or other occlusive dressings, as this may increase absorption.
- Avoid alcohol consumption if you experience facial flushing or skin irritation after drinking.
- Do not use on skin that is broken, infected, or has open wounds.
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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 about side effects, 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 of your skin condition or no improvement after 6 weeks.
- Signs of a skin infection (e.g., pus, spreading redness, warmth, fever, pain).
- New or changing skin lesions, moles, or lumps.
- Swollen lymph nodes (glands) in your neck, armpits, or groin.
- Severe burning, stinging, or itching that does not go away.
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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Skin areas with cancer or precancerous lesions
+ Netherton's syndrome, a specific skin disease
+ Other skin problems that may weaken the skin
+ 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 medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 skin products, 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 symptoms are severe, persistent, or bothersome, contact your doctor for guidance.
In the event of accidental ingestion, this medication can be harmful. If you swallow this drug, 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 this medication to both you and your baby to ensure informed decision-making.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption.
- If ingested, symptoms could include systemic tacrolimus effects such as kidney problems, tremor, headache, nausea, vomiting, or diarrhea.
What to Do:
If swallowed, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Management is supportive; activated charcoal may be considered if ingestion is recent.
Drug Interactions
Moderate Interactions
- Live attenuated vaccines (theoretical risk due to potential systemic immunosuppression, though minimal with topical use)
- Other systemic immunosuppressants (caution advised, though systemic absorption is minimal)
- Excessive UV exposure (sunlight, tanning beds, phototherapy) due to theoretical risk of skin malignancy
Minor Interactions
- Alcohol (facial flushing or skin irritation has been reported in some patients)
Monitoring
Baseline Monitoring
Rationale: To evaluate the extent and severity of atopic dermatitis.
Timing: Prior to initiation of treatment.
Routine Monitoring
Frequency: Periodically, as clinically indicated, or at follow-up visits.
Target: Reduction in erythema, pruritus, and lesion severity.
Action Threshold: If no improvement after 6 weeks, re-evaluate diagnosis. If worsening, assess for infection or other causes.
Frequency: With each visit and patient self-monitoring.
Target: Absence of new or worsening signs of infection (e.g., pus, spreading redness, fever).
Action Threshold: Discontinue use and treat infection if present.
Frequency: Periodically, especially with long-term use.
Target: Absence of new or changing skin lesions, or swollen lymph nodes.
Action Threshold: Refer for dermatological evaluation if suspicious lesions or lymphadenopathy develop.
Symptom Monitoring
- Local burning sensation
- Itching (pruritus)
- Erythema (redness)
- Folliculitis
- Acne
- Headache
- Flu-like symptoms
- Alcohol intolerance (facial flushing, irritation)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use.
Trimester-Specific Risks:
Lactation
Caution advised. It is unknown whether tacrolimus is excreted in human milk after topical application. Systemic tacrolimus is excreted into breast milk. Weigh the benefits of breastfeeding against the potential risks to the infant.
Pediatric Use
Approved for children 2 years of age and older. Not recommended for children younger than 2 years due to potential for increased systemic absorption and theoretical risk of malignancy.
Geriatric Use
No specific dosage adjustments are needed for elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, minimal systemic absorption suggests no age-related concerns.
Clinical Information
Clinical Pearls
- Tacrolimus ointment is a second-line treatment for atopic dermatitis, used when other therapies (e.g., topical corticosteroids) are not appropriate or effective.
- Patients may experience transient burning or itching upon initial application, which usually subsides within a week as the skin condition improves.
- Use intermittently for flares of atopic dermatitis, rather than continuously long-term.
- Avoid applying to areas of active skin infection; treat the infection first.
- Educate patients about the black box warning regarding potential malignancy risk and the importance of avoiding excessive sun exposure.
Alternative Therapies
- Topical corticosteroids (e.g., hydrocortisone, triamcinolone, fluticasone)
- Crisaborole ointment (Eucrisa)
- Ruxolitinib cream (Opzelura)
- Pimecrolimus cream (Elidel)
- Phototherapy (UVB, UVA)
- Systemic therapies for severe atopic dermatitis (e.g., dupilumab, tralokinumab, cyclosporine, methotrexate)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which is a valuable resource that provides additional information. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.