Sovalimus ointment 0.1% hadiphar atopic eczema treatment (10g)

Dosage form Tube x 10g
Specifications Tacrolimus

Ingredient

Composition informationContent
Tacrolimus0.1%

Uses

Indications

Sovalimus 0.1% is used for adults and children over 15 years old in case of short and long -term non -continuous treatment for patients with medium and severe levels of body treatment, which are not indicated and treated for non -adequate patients. Common treatment.

Pharmacokic of

tacrolimus is a macrolid immunosuppressant, due to the streptomyces tsukubaensis strain.

The drug is only used in dermatitis. The mechanism of action of Tacrolimus in dermatitis is not known. It has been proven that Tacrolimus inhibits the activity of lymphocyt cells because combined with cell protein (FKBP-12).

Tacrolimus-FKBP-12 complex, Calcium, Calmodulin and Calcineurin are formed and the phosphatase activity of Calcineurin is inhibited. This effect has prevented the Dephosphorylation and the permutation of the nuclear factor of T cells, a component in the nucleus, starting the genetic copy to form lympholine lymphols (such as Interleukin-2, Gamma Interferon).

pharmacokinetics

The absorption of drugs into the body of Tacrolimus is very small. After a single dose or many times with 0.1%tacrolimus ointment, the maximum concentration in the blood achieved from 5 - 20 ng/ml. The absolute bioavailability of Tacrolimus is not known. There is no evidence of the accumulation of Tacrolimus in the body when applying non -continuous drugs for 1 year.

Before taking Sovalimus ointment 0.1% hadiphar atopic eczema treatment (10g)

How to use

Sovalimus ointment 0.1% Used on the skin.

Dosage

Adults and children over 15 years of age: Apply a thin layer of Sovalimus to the sick area 2 times/day and massage gently. It is advisable to treat another week after the signs and symptoms of dermatitis have gone. Do not cover wounds when using Sovalimus.

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? Oral use with Sovalimus ointment can lead to unwanted effects that have been determined with Tacrolimus using clear sugar. If you accidentally use oral, you must immediately consult your doctor.

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 Sovalimus 0.1% you may experience unwanted effects (ADR).

Do not detect optical poisoning and allergies due to light in studies.

Unwanted effects that may occur for Herpes simplex , Eczema, bronchial asthma , sore throat, nausea, contact dermatitis, skin peeling.

Unwanted effects that can occur for> 1% of patients in clinical experiments include: Hair loss, increase ALT or AST, Anaphylaxis reaction, angina, angioedema, anxiety, anxiety, arrhythmia, joint pain, hyperburin blood, chest pain, cell inflammation, inflammation, chills, constipation, increased creatinine, water loss, pain, blood, pain, blood, pain, blood, pain, blood, pain Oranges, visual disorders, gastritis, hyperglycemia, hypertension , hypoxemia, hyperlths, neck pain, neck pain, neuritis, tachycardia, peripheral vasoconstriction, light sensitivity, skin discoloration, sweating, loss of taste, dental disease, vaginal monilia, vasodilation 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

Sovalimus 0.1% contraindicated in the following cases:

  • Patients with a history of sensitivity to Tacrolimus or any component of the preparation.
  • Children under 15 years old.
  • Patients with infected dermatitis.
  • Patients with immunodeficiency or risk of increased absorption of tacrolimus.
  • Patients are suffering or risk of malignant dermatitis.

    • Caution when used

    Before the beginning of treatment with Tacrolimus ointment, it is necessary to clean the clinical infection areas at the treatment site. In some cases, malignant skin disease shows like eczema, which should be eliminated before taking the drug. When patients with Eczema Herpeticum dermatitis, treated with Tacrolimus ointment, may increase the risk of Varicella Zoster virus infection (chickenpox or shingles), herpes simplex virus, or Eczema herpeticum.

    In this case, it is necessary to consider the benefits and harms of the treatment with tacrolimus ointment.

    Patients with organ transplantation are taking immunosuppressive drugs (for example, Tacrolimus used in the high risk of lymphoma development, so patients who use tacrolimus ointment and people with lymph nodes must identify the cause of lymphatic disease.

    If there is no clear cause of lymph nodes or mononuclear hyperpens caused by acute bacterial infections, Tacrolimus ointment must be stopped. Patients with lymph nodes, monitoring to determine the solved lymph node disease.

    Patients must be cautious to minimize or avoid exposure to natural or artificial light.

    Tacrolimus ointment can cause local symptoms such as burning skin (burning, irritation, pain) or itching. These symptoms mostly occur in a few days of treatment and significantly improved after treatment of dermatitis.

    Safety of Tacrolimus ointment for patients with unpretermined skin erythematosus.

    The ability to drive and operate machinery

    No information.

    Pregnancy

    There is no information.

    Breastfeeding period

    No information.

    Drug interaction

    has not conducted studies on drug interaction between usual drugs with sovalimus ointment. Due to the small amount of drugs absorbed, the interaction between sovalimus ointment and clear drugs may not occur, but it is not out of the rule, so it must be cautious when combining treatment with CYP3A3 inhibitors (such as with erythromycin, Itraconazole, ketoconazole , fluconazole, Calcoles and Calci channels and channel holes cimetidine ) for patients with widespread dermatitis or redness.

    Storage

    In a cool dry place, temperatures below 30 ° C, avoid light.

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