Talimus 0.1% Ointment

TALIMUS 0.1% OINTMENT is a topical immunosuppressant manufactured by AJANTA PHARMA LIMITED, primarily used for managing moderate to severe atopic dermatitis.

Name

• Brand Name: TALIMUS 0.1% OINTMENT
• Common Name: Tacrolimus Ointment 0.1% w/w

Composition

• Active Ingredient: Tacrolimus 0.1% w/w
• Excipients: Ointment base (q.s.), including Liquid Paraffin BP, White beeswax BP, White soft Paraffin BP, and Butylated Hydroxyanisole BP.

Uses

TALIMUS 0.1% OINTMENT is prescribed for:

• Moderate to Severe Atopic Dermatitis (Eczema): It is used in adults and adolescents (16 years and older) who have not responded adequately to or are intolerant of conventional therapies like topical corticosteroids. It works by suppressing the activity of certain immune cells that cause inflammation, thereby relieving itching, redness, and improving rashes.
• Maintenance Treatment: It can also be used for intermittent long-term management to prevent flare-ups and prolong flare-free intervals in patients experiencing frequent disease exacerbations.

Dosage and Administration

• For external use only.
• Apply a thin layer of the ointment to the affected skin areas.
• Gently massage the ointment into the skin until fully absorbed.
• Typically applied twice daily.
• Wash hands thoroughly before and after application, unless the hands are the treated area.
• Do not cover the treated area with occlusive dressings, bandages, or wraps unless specifically instructed by a doctor, as this may increase the risk of side effects.
• If no improvement is observed after two weeks of treatment or if the condition worsens, a doctor should be consulted.
• Not recommended for children under 16 years of age for the 0.1% strength.

Side Effects

Common Side Effects (usually mild to moderate and may resolve within one week of starting treatment):

• Application site reactions: burning sensation, irritation, itching, redness, warmth, pain, altered sensation, rash.
• Headache
• Hair follicle inflammation (folliculitis)
• Increased sensitivity to sunlight or UV rays
• Tingling sensation at the application site or in hands and feet.

Serious Side Effects (seek immediate medical attention if experienced):

• Signs of a skin infection (e.g., pus, warmth, or swelling)
• Severe allergic reaction (rash, itching/swelling of face/tongue/throat, severe dizziness, breathing difficulty)
• Worsening of skin condition after use.
• Long-term use has been associated with an increased risk of lymphomas (including cutaneous T-cell lymphomas) and skin malignancies.
• Kidney problems, irregular heartbeat, dizziness, severe pain in the stomach.
• Symptoms of a rare brain infection, such as excessive weakness, problems with concentration and thinking, problems with muscle mobility, seizures, and vision issues.

Precautions

• Sun Exposure: Limit exposure to sunlight and artificial UV light sources (like tanning beds). Wear protective clothing and use sunscreen while outdoors, as the ointment may increase skin sensitivity to sunlight.
• Children: The 0.1% strength is not recommended for children below 16 years of age.
• Pregnancy and Breastfeeding: Consult a doctor before using if pregnant, planning a pregnancy, or breastfeeding. It is not known if Tacrolimus passes into breast milk.
• Alcohol Consumption: Avoid alcohol consumption while using TALIMUS OINTMENT as it may cause flushing (sudden reddening and warm sensation of the face or skin).
• Skin Conditions: Avoid using on infected skin, open wounds, cuts, scrapes, or mucous membranes.
• Medical History: Inform your doctor if you have other skin diseases (e.g., skin cancer, skin infections, lesions), a weak immune system, liver problems, or any autoimmune conditions.
• Drug Interactions: Formal topical drug interaction studies have not been conducted. However, systemic exposure from topical application is low. Inform your doctor about all other medications, including antifungal medications, antibiotics, antivirals, blood pressure drugs, and vitamin E supplements.
• Contraindications: Avoid if allergic to Tacrolimus or any of its ingredients. Individuals with infections or Type 2 Diabetes should use with caution.

Storage

• Store below 25°C or below 30°C.
• Do not freeze.
• Keep out of the sight and reach of children.

TALIMUS 0.1% OINTMENT by AJANTA PHARMA LIMITED contains the active ingredient Tacrolimus, which is a topical calcineurin inhibitor. This medication is primarily used to treat moderate to severe atopic dermatitis (eczema).

What is TALIMUS 0.1% Ointment used for?

TALIMUS 0.1% Ointment is used in adults and adolescents aged 16 years and older to treat moderate to severe atopic dermatitis (eczema) when other conventional therapies have not been effective or are not suitable. Eczema is a skin condition that causes dry, itchy, red, and inflamed patches on the skin.

How does TALIMUS 0.1% Ointment work?

TALIMUS 0.1% Ointment works as an immunosuppressant by reducing the activity of the skin's immune system. It belongs to a class of medications called topical calcineurin inhibitors, which block certain immune cells (T-cells) from producing substances that cause inflammation, redness, and itching associated with eczema.

What is the usual dosage for TALIMUS 0.1% Ointment?

For adults and adolescents 16 years of age and older, TALIMUS 0.1% Ointment is typically applied as a thin layer to the affected areas of the skin twice daily, usually once in the morning and once in the evening. Treatment should stop when symptoms clear, and it should not be used continuously for a long time. For children aged 2 to 15 years, only the 0.03% strength of tacrolimus ointment is recommended.

What are the possible side effects of TALIMUS 0.1% Ointment?

Common side effects at the application site include burning, stinging, itching, redness, or soreness. These symptoms are usually mild to moderate, most common during the first few days of treatment, and often improve as the skin heals. Other possible side effects include skin tingling, increased sensitivity of the skin to hot or cold temperatures, headache, muscle pain, or flu-like symptoms. Drinking alcohol while using this ointment may cause skin flushing or redness and a feeling of heat.

Is TALIMUS 0.1% Ointment safe during pregnancy or breastfeeding?

You should tell your doctor if you are pregnant, planning to become pregnant, or are breastfeeding before using TALIMUS 0.1% Ointment. Your doctor will advise if it is safe for you to use.

Can TALIMUS 0.1% Ointment be taken with other medications?

It is important to inform your doctor and pharmacist about all prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Medications that may interact include cimetidine (for stomach ulcers), erythromycin (an antibiotic), certain medications for fungal infections (e.g., ketoconazole, itraconazole), and calcium channel blockers (for heart problems). Avoid alcohol as it can cause facial flushing and redness.

What precautions should be taken while using TALIMUS 0.1% Ointment?

Avoid exposing treated skin to natural or artificial sunlight, including sun lamps and tanning beds, as this ointment can increase skin sensitivity to UV light. Do not apply the ointment to areas with cuts, scrapes, or active skin infections. Do not use bandages, dressings, or wraps over the treated area unless advised by your doctor. The safety of long-term continuous use is not known, and there have been rare reports of skin malignancy and lymphoma with topical calcineurin inhibitors, so use it only on affected areas for short periods, and stop when symptoms clear. Discuss with your doctor if you have a history of cancer, immune system problems, or conditions like Netherton's syndrome.

What happens if a dose of TALIMUS 0.1% Ointment is missed?

If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra ointment to make up for a missed dose.

How should TALIMUS 0.1% Ointment be stored?

Store TALIMUS 0.1% Ointment at room temperature, tightly closed, and out of reach of children. Keep it away from excess heat and moisture (not in the bathroom). Do not freeze the ointment.