Rocimus skin ointment 0.03% Mega We Care for atopic dermatitis (10g)

Dosage form Tube
Specifications Tacrolimus

Ingredient

Composition information	Content
Tacrolimus	0.03%

Uses

Indications

Rocimus pills are indicated in the following cases:

Treatment for patients with eczema Organs (atopic dermatitis). The study

The mechanism of action of Tacrolimus on eczema is not known. However, Tacrolimus has been shown to inhibit the activity of T lymphocytes by connecting with intracellular protein, FXBP - 12.

Then, forming the complex of Tacrolimus - FXBP - 12, Calcium, Calmodulin and Calcineurin and inhibit the phosphorus reduction of calcineurin. This impact prevents Dephosphorylation and prevents the transformation of the cellular factor of activated T cells (NF - AT), part of the cell nucleus has the effect of initiating the star code of lymphokaes (such as interleukin - 2, gama interferon).

tacrolimus also inhibits the synthetic gene codes IL - 3, IL - 4, IL - 5, GM - CSF and TNF - α, all of these factors are involved in the process of T -cell activity in the early stages. In addition, Tacrolimus also has the effect of inhibiting the release of intermediate substances that cause inflammation from skin care and alkaline leukemia.

pharmacokinetic

absorption

Human research shows that Tacrolimus is not easy to absorb when applied on healthy skin (no damage). However, when applied on the burning or damaged skin, the drug is absorbed in sufficient amount to work on the spot.

Distribution

Clinical data shows that Tacrolimus concentration during the circulation after use is low and when measured is only fleeting.

tacrolimus does not accumulate in tissues in the body when treating skin in the long run.

Metabolism

tacrolimus is metabolized in the liver via CYP450 3A4. Currently, there have been 8 in vitro metabolites, of which 13 - 0 - Demethylated metabolites show superior in vitro. However, low pharmacological effects, only about 6.4% compared to Tacrolimus. In vitro research results on human skin show that there is no evidence of the metabolism of Tacrolimus at the skin.

Official research on the interaction of topical drugs for Tacrolimus ointment has not been conducted. The drug is not metabolized in the skin so there is no ability to interact metabolic under the skin affects the effect of the drug.

Elimination

When using all -body tacrolimus, the honey is considered the main elimination road with a total clearance of 2.25 l/hour and the sale time is about 40 hours.

Before taking Rocimus skin ointment 0.03% Mega We Care for atopic dermatitis (10g)

How to use

Apply tacrolimus ointment 0.03% on the damaged skin and massage.

Tacrolimus ointment can be used on any part of the body, including on the face, neck and folds, except for the mucosa.

Safety when using Tacrolimus ointment on the sealed skin has not been evaluated, but this use may increase the level of body exposure. Tacrolimus ointment should not be applied on the sealed skin.

Dosage

Adults

Apply a thin layer of 0.03% Tacrolimus ointment to the damaged skin twice a day and massage. Treatment should be continued for 1 week after the signs and symptoms of eczema.

Children

Apply a thin layer of 0.03% Tacrolimus ointment to the damaged skin twice a day and massage. Treatment should be continued for 1 week after the signs and symptoms of the disease are expired.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

If swallowed, can use supportive treatments. These measures include checking the signs of survival and observing the clinical status.

What to do when forgetting 1 dose?

Without information.

Side Effects

When using Rocimus pills , you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Common disorders and condition at the position of drug use: hot and itching at the drug position.

Common, 1/100

Common disorders and condition at the position of drugs: hot, erythema, pain, irritation, paresthesia, rash at the position of drug use.

Infections and parasites: Herpes virus infection [Dermatitis Herpes Simplex (Herpes infection), cold ulcers (herpes lip), Kaposi chickenpox blister].

Skin and subcutaneous tissue: folliculitis, itching

Nervous system: Perception, sensory disorders (increase sensation, burning sensation).

Disorders of metabolism and nutrition: Alcohol intolerance (blushing or skin irritation after alcoholic drinks).

Uncommon, 1/1000

Without information.

Rare, ADR

Skin and subcutaneous tissue: Acne .

Instructions on how to handle ADR

Notify the doctor the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Rocimus drug contraindicated in the following cases:

Hypersensitivity to drugs belonging to the macrolide group, with tacrolimus or any ingredients of the drug.

Precautions when using

There is no evaluation of the use of Tacrolimus ointment in children under 2 years old.

The exposure of the skin in the sun should minimize and the use of ultraviolet light (UV) from sunbathing, UVB or UVA treatment in combination with Psoralene (PUVA) should avoid during treatment with Tacrolimus ointment.

Doctors should recommend patients to use appropriate measures to avoid sunlight, such as minimizing sunlight exposure time, using sunscreen products and skin covering with appropriate costumes. Do not use moisturizer in the same position for the first 2 hours after applying Tacrolimus ointment.

Concomitant use with other skin -to -skin preparations has not been evaluated. There is no experience in simultaneous use with systemic steroids or other immunosuppressive drugs.

Safety and effectiveness of Tacrolimus drugs on eczema with clinical infections have not been evaluated. Therefore, before starting treatment with Tacrolimus ointment clinical infections at the location of the lesion should be cured.

Patients with eczema occur, skin infections. Tacrolimus treatment may increase the risk of herpes virus infection. When infections, there should be assessments between the risk and benefits of using Tacrolimus.

After 4 years of treatment, the effect of inhibiting immunosuppressants (which can lead to infection or malignant tumor) is not known.

Be careful when used, avoid exposure to the eyes and mucosa. If unfortunately applied to these areas, should wipe off the drug completely or rinse with water.

The use of Tacrolimus ointment on the sealed skin has not been studied. Closed bandage is not recommended.

Similar to other skin -based topical medications, patients should wash their hands after applying the drug if the hand does not need treatment.

Tacrolimus metabolizes mainly in the liver and although the blood concentration in the blood is low when applied to the skin, Tacrolimus ointment should still be used carefully for patients with liver failure. The safety of Tacrolimus ointment has not been determined in patients with systemic erythema.

The ability to drive and operate machinery

No information.

Pregnancy

The use of Tacrolimus in pregnant women has not been fully studied and controlled. Tacrolimus passed the placenta fence and can excrete in breast milk. Although clinical figures show that the system exposure due to the use of tacrolimus ointment is low, only tacrolimus ointment for pregnant women when the benefit gives the mother is truly higher than the risk of the fetus.

Breastfeeding period

tacrolimus through the placenta fence and can be excreted into breast milk. Only use Tacrolimus ointment for breastfeeding women when the benefit gives mothers truly higher than the risk that can occur for children.

Drug interaction

There is no official study of the interaction of topical skin with Tacrolimus ointment. The drug is not metabolized in the skin, so it is not possible to interact metabolic under the skin, affecting the effect of the drug.

The ability to interact between vaccination and applying the tacrolimus ointment has not been studied. Due to the potential risk and failure when vaccinating, the vaccination should be performed before the start of treatment or during the period of stopping treatment with a 14 -day distance between the last tacrolimus and the vaccination date.

In case of vaccination by Vaccine to reduce toxicity, this time gap should be extended to 28 days or should consider using the vaccine instead.

Storage

Under 25 ° C, in a cool dry place, avoid light and moist.

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