Quantopic ointment 0.1% treatment of atopic dermatitis (10g)

Dosage form Tube
Specifications Tacrolimus

Ingredient

Composition information	Content
Tacrolimus	0.010g

Uses

Indications

0.1%Quantopic Drug is indicated in the case:

Treatment Allergic dermatitis (organ eczema) Short -term or treatment of moderate, severe dermatitis in patients who do not respond or intolerant to conventional treatments. Liver, kidney transplant, heart transplant. The drug is also used in the skin to treat atopic dermatitis (eczema) in the case of conventional treatments.

tacrolimus inhibits T cell lymphocytes by inhibiting the production of Interleukin-2 in the body. Tacrolimus has a 100 times stronger immunosuppressive effect than cyclosporine.

proved that Tacrolimus inhibits the activity of T lymphocytes by cohesion to an intracellular protein, FKBP-12. Tacrolimus FKBP-12 complex, calcium, calcium ions and calcineurin ions are formed and thus the phosphatase activity of Calcineurin is inhibited. This effect has been shown to be able to prevent the process of Dephosphorylation and the process of transporting the nucleus of T cells (NF-AT), a component of the cell nucleus through the launch of the transcription process to form lymphokines (for example, Interleukin-2, Gamma Interferon).

Tacrolimus also inhibits the transcription of genes with symbols IL-3, IL-4, IL-5, GM-CSF and TNF -σ. All of these genes are involved in the active process at the initial stage of T cells.

In addition, it has been proven that Tacrolimus has the ability to inhibit the release of intermediate substances that have been formed from skin moisturizers and alkaline craving and reducing the expression of high -teech receptors on IGE in Langerhans cells. While Tacrolimus does not be toxic to the gene and does not interact directly with AND, the drug can cause damage to local immunity.

Pharmacokinetics

absorption

Skin exterior: The plasma concentration from unable to detect up to 20 nanogam/ml (less than 5 nanogam/ml per number of adult patients is studied).

But in young children apply on the spot of 0.1% ointment only once for chronic treatment, high serum concentration (24 nanogam/ml).

Birth:

Time to reach the peak concentration (in blood): 0.5 to 4 hours.

Distribution

tacrolimus binds to plasma proteins about 99% and does not depend on the concentration of Tacrolimus in the range of 5 - 50 nanogam/ml. Tacrolimus is mainly linked to albumin and alpha-1-glycoprotein acid and has a high level of combination with red blood cells.

The distribution of Tacrolimus with whole blood and plasma depends on a number of factors, such as the ratio of hemocl There are hemorrhage, temperature when separating plasma, tacrolimus concentration, plasma protein levels. On the basis of researching the concentration of Tacrolimus in the blood, there is no evidence of the accumulation of Tacrolimus after interrupted drug use within 1 year. As with other topical medications containing Calcineurin inhibitors, it is unknown whether Tacrolimus is distributed into the lymphatic system.

Metabolism

Tacrolimus metabolizes very strongly through the oxidase enzyme system with a mixed function, first of all the Cytochrom P-450 system (CYP3A). Demethylation and hydroxylation are identified as the main metabolic mechanisms in vitro.

Metabolic mainly through the liver through CYP3A4 into 8 metabolites (the main metabolites are 31-Demethyl tacrolimus, which is similar to Tacrolimus in vitro).

Before taking Quantopic ointment 0.1% treatment of atopic dermatitis (10g)

How to use

ointment topical skin.

Dosage

Apply ointment once or twice daily in damaged skin areas. Tacrolimus ointment can be used in any area of the body, including face, neck and skin areas with folds except mucosa. Do not use tacrolimus ointment in the form of icy because it has not been studied in patients.

If possible, try to use ointment with lower content or reduce frequency of use, need to continue treating until signs or symptoms disappear. If the symptoms are not seen after 6 weeks of treatment, it is necessary to check again to determine the diagnosis.

0.1% tacrolimus ointment used to treat children aged 16 and older and adults.

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 overdose?

When taking ointment may experience side effects related to the absorption of Tacrolimus' circulation.

Need to notify the anti -toxic center or emergency center immediately if swallowed or suspected of overdose.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using 0.1%Quantopic medicine , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Central nervous system: headache, blushing.

Skin: Hot (tend to decrease with healing), itching, erythema, local infection.

Respiratory: Cough a lot.

Other: influenza syndrome, allergic reaction, alcohol intolerance.

Uncommon, 1/1000

Reduction of vision, abscess, anemia , anxiety, arthritis, osteoarthritis, hyperkemin blood, chest tightness, dizziness, dry eyes, dry mouth/nose, eye pain, gastritis, digestive disorders , hyperchemical cholesterol, muscle tone, hypothyroidism, neck pain, skin inflammation, skin inflammation, skin ulcers, skin ulcers Dao, blood vessels, and dizziness.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

0.1%Quantopic Drug contraindicated in the following cases:

Patients with allergies to Tacrolimus, Macrolid in general and the excipients of the ointment.

Children under 16 years old.

Be cautious when using

Tacrolimus inhibits immunity so it is easy to cause infections and capable of developing lymphoma and other tumors. Therefore, the manufacturer recommends careful when coordinating immunosuppressive drugs.

Tacrolimus increases the risk of opportunistic infections, including potential bacterial regeneration, such as causing kidney disease due to BK virus. Patients must be monitored to detect signs of kidney disease due to BK virus (BKVN), including impaired renal function while treating with tacrolimus. Some clinical houses recommend doing test screening for copying virus polyma. The most important thing is to intervene early; Reduce immunosuppressive therapy. In addition, it is necessary to study more antiviral therapies such as Cidofovir, Leflunomid, Immunoglobulin, Fluoroquinolon antibiotics.

When using Tacrolimus ointment, avoid sunlight, avoid using ultraviolet rays (UV) and artificial sunbathing ... The physician should guide the patient to use Tacrolimus ointment to use sunscreen preparations and wear suitable costumes when in the sun.

Should avoid simultaneous use of Tacrolimus ointment with treatment therapy with UVA, UVB or combined with Psoralen (Puva). Avoid the Tacrolimus ointment in contact with the eyes and mucosa. If the drug sticks to the eyes and the mucosa, it is necessary to clean and wash it with water.

Do not use Tacrolimus ointment in patients whose skin barrier has been damaged: Netherton syndrome, peeled psoriasis, body erythema or graft waste. In these diseases, skin lesions increase the absorption of Tacrolimus into the body. Do not use oral tacrolimus to treat skin diseases.

The ability to drive and operate machinery

does not affect.

pregnancy

tacrolimus can go into the placenta and reach the concentration of the placenta 4 times higher than the plasma concentration. There have been reports on high blood potassium and kidney failure in newborns. Doctors should consider when prescribing the drug.

Breastfeeding period

tacrolimus can go to breast milk. Recommendation not to breastfeed while using 0.1%of Quantopic ointment.

Interactive drug

Medications that affect the liver's urine enzymes

Because Tacrolimus is mainly metabolized by Cytochrom P-450, Tacrolimus's blood concentration, or Tacrolimus metabolites will change depending on the inhibitors or reduce the activity of this enzymc in patients who have previously treated stably with Tacrolimus. The simultaneous use of Tacrolimus with the above drugs requires monitoring of the concentration of Tacrolimus in the whole blood to adjust the tacrohmus dose accordingly.

The drugs are metabolized by the liver enzymes of the liver

Simultaneous use of Tacrolimus with phenytoin may increase the plasma concentration of phenytoin.

Immune inhibitors

Due to the risk of excessive inhibition of the immune system related to the possibility of patients susceptible to infection and the risk of lymphoma (lymphoma), the manufacturer recommends that it should be very careful when using combined immunosuppressive therapy. Do not combine using tacrolimus and syrolimus.

Poison with kidneys

Due to the potential for force and the potential co -operating to weaken the kidney function, tacrolimus should be carefully used in patients who use other toxic drugs with the kidneys (aminoglycoside antibiotics, amphotericin B, cisplastin, ganciclovir).

cyclosporine

Simultaneous use of Cyclosporine and Tacrolimus will lead to force toxicity and/or co -transportation to the kidneys. To avoid excessive toxicity for the kidneys, do not use simultaneously tacrolimus and cyclosporine. The manufacturer recommends that at least 24 hours after stopping using Cyclosporine to start using Tacrolimus.

Grapefruit juice

Due to the grapefruit juice, it affects the metabolism of Tacrolimus through the intermediary of the enzyme CYP3A, the patient must not use foods and drinks containing grapefruit.

Diuretics reduce potassium consumption

Simultaneous use of Tacrolimus and diuretics reduces potassium consumption or potassium supplements can cause serious increased blood potassium, so it should be avoided.

vaccines

It should be noted the possibility of the patient's body's immune system using Tacrolimus decreased in response to vaccination. The manufacturer recommends that avoid vaccinations such as measles vaccines, mumps, rubella, polio oral vaccines, BCG, yellow fever (Yellowfever), tychilding 21A.

Storage

Store in a dry place, avoid light at a temperature below 30 ° C.

Other drugs

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