Tacrol 0.3% Ointment 30gm

Uses of Tacrol 0.3% Ointment

• Treatment of Atopic dermatitis

How does Tacrol 0.3% Ointment work?

Side Effects of Tacrol 0.3% Ointment

Common side effects include:

• Skin burning
• Pruritus
• Flu-like symptoms
• Allergic reactions
• Skin erythema
• Skin infections
• Headache

Quick Suggestions:

• Tacrol 0.1% Ointment is effective at treating eczema (atopic dermatitis) when other treatment options have failed.
• It works by decreasing itching, redness, and skin rashes.
• Apply thinly, to affected areas of skin only. Clean the affected area and dry well before applying Tacrol 0.1% Ointment. Avoid contact with water after application.
• Inform your doctor if there's no improvement after two weeks of treatment or if the skin worsens.
• Don't cover the area being treated with airtight dressings such as bandages unless directed by a doctor, as this may increase the risk of side effects.
• Stop using Tacrol 0.1% Ointment and consult your doctor if your eczema becomes infected.
• Continuous long-term use of the ointment should be avoided. Use as prescribed by your doctor.

Eczema

Eczema, also known as atopic dermatitis, is a condition characterized by rough, inflamed patches of skin that may itch or bleed.

Types of Eczema

Infantile Eczema:

• Begins during infancy.
• Itchy patches typically develop on the scalp and face.
• Often resolves by age 2.

Hand Eczema:

• Increased risk in individuals with a history of atopic dermatitis.
• It may develop later in life even if atopic dermatitis clears during adolescence.

Causes and Risk Factors

Common causes and triggers include:

1. Certain foods and juices.
2. Everyday objects like wool and other fabrics.
3. Jewelry.
4. Overexposure to irritants or allergens.

Signs and Symptoms

1. In infants, patches usually appear on the scalp and face.
2. In teenagers and young adults, patches often develop on the:
   • Elbows and knees.
   • Hands, feet, ankles, wrists.
   • Face, neck, upper chest.
   • Around the eyes and on the eyelids.
3. Patches are typically dry, red to brownish-gray, and may be scaly or thickened.

Scratching Complications

• Redness
• Swelling
• Cracking
• Release of clear fluid
• Crusting and scaling of the skin

Complications

• Severe infections due to scratching.
• Dark pigmentation on healed skin.
• Psychological trauma from frustration.
• Irritation due to irritable skin.

Investigations

1. Skin and Blood Tests: Can identify food allergies, asthma, and hay fever but are seldom helpful for identifying the cause of eczema.
2. Long-term Steroid and Immunosuppressant Use: Can cause complications such as skin atrophy, secondary infections, weight gain, and diabetes.

Prevention

• Avoid triggers.
• Protect hands from soaps, cleansers, and chemicals by wearing gloves.
• Use lukewarm water and less soap when washing hands.
• Apply moisturizers throughout the day to keep hands soft and supple.

Treatment

1. Combination of Therapies and Lifestyle Changes: Essential for managing the disease.
2. Topical Medications: Corticosteroids or newer immunomodulators may be recommended to reduce inflammation and itch.
3. Antibiotics: May be prescribed if there is an infection.
4. Severe Cases: Ultraviolet (UV) light therapy or oral immunosuppressing agents may be given.

Pharmacology

Tacrolimus is a macrolide immunomodulator produced by the fungus Streptomyces tsukubaensis. It inhibits T-lymphocyte activation by binding to an intracellular protein, FKBP-12. The Tacrolimus-FKBP-12 complex inhibits the phosphatase activity of calcineurin, decreasing the entire inflammatory cascade.

Dosage & Administration of Tacrol 0.1% Ointment

Adults:

• Apply a thin layer of Tacrolimus ointment to the affected skin areas twice daily and rub in gently and completely.
• Continue treatment for one week after symptoms clear.
• Do not use with occlusive dressings.

Children:

• Tacrolimus 0.03% ointment: For pediatric patients 2 years of age and older.
• Tacrolimus 0.1% ointment: For children 16 years of age and older.

Elderly Patients:

• Patients >65 years old received Tacrolimus ointment in phase 3 studies, showing a similar adverse event profile to other adults.

Interaction

No formal topical drug interaction studies have been conducted. Caution is advised when using CYP3A4 inhibitors (e.g., erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, and cimetidine) in patients with widespread or erythrodermic disease.

Contraindications

Contraindicated in patients with a history of hypersensitivity to Tacrolimus or any component of the preparation.

Pregnancy & Lactation

• No adequate and well-controlled studies of topically administered Tacrolimus in pregnant women.
• Tacrolimus is excreted in human milk. Consider discontinuing nursing or the drug due to potential adverse reactions in nursing infants.

Precautions & Warnings

• Exercise caution in patients with atopic dermatitis predisposed to superficial skin infections.
• Safety is not established in patients with generalized erythroderma.
• Avoid oral ingestion.
• Tacrolimus ointment is not for oral use.
• Accidental oral ingestion may lead to adverse effects associated with systemic administration. Seek medical advice if ingestion occurs.

Storage:

• Store below 30°C.
• Keep away from light and out of the reach of children.

Q. What is Tacrol 0.3% Ointment used for?
Tacrol 0.1% Ointment is an immunomodulator used to treat moderate to severe eczema (atopic dermatitis) in adults who do not respond to steroids or develop side effects from their use. It decreases the overactive immune response in the skin, reducing inflammation, itchiness, redness, and dryness.

Q. What are the side effects of Tacrol 0.3% Ointment?
Common side effects of Tacrol 0.1% Ointment include skin irritation, burning sensation, itching, redness, sensation of warmth, pain, altered sensation, and rash at the application site. It can also increase the risk of inflamed or infected hair follicles, cold sores, acne, and generalized herpes simplex infections. These side effects are usually mild to moderate and resolve within a week.

Q. Is Tacrol 0.3% Ointment safe?
Yes, Tacrol 0.1% Ointment is considered safe and effective for short-term treatment of atopic dermatitis. When applied to the skin, its absorption into the bloodstream is minimal, resulting in fewer side effects compared to oral immunosuppressants.