Protopic ointment appearance. 0.1% 10g tuba

$18.13

Protopic ointment appearance. 0.1% 10g tuba

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Description

Composition
Active substance:
100 g of ointment contains: 0.03 g or 0.1 g of tacrolimus (as tacrolimus monohydrate) ;.
Excipients:
White soft paraffin, liquid paraffin, propylene carbonate, white beeswax, solid paraffin.
Description:
Ointment uniform consistency, white to slightly yellowish.
Product form:
Ointment for external use 0.03% and 0.1%.
10, 30 or 60 grams of the ointment for external use in plastic tubes.
1 tube together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to tacrolimus, to the adjuvants to macrolides.
Pregnancy and breast-feeding.
Protopik® not be used in patients with genetic defects in the epidermal barrier, such as Netherton syndrome, as well as in generalized erythroderma due to the risk of progressive increase systemic absorption of tacrolimus.
Application of ointments Protopik® at a dosage of 0.1% is contraindicated in children and adolescents younger than 16 years, at a dosage of 0.03% – in children younger than 2 years.
Carefully
Protopik® largely metabolized in the liver, and although its concentration in the blood at very low external use in patients with decompensated liver disease ointment used with caution.
Care must be taken when using Protopik® ointment in patients with extensive lesions of the skin, especially long courses, and children.
Dosage
0,001
Indications
Ointment Protopik® applied in a dosage of 0.03% and 0.1% in adults and only 0.03% for children 2 to 16 years for the treatment of atopic dermatitis (moderate and severe) in the event of resistance to other agents outer therapy or contraindications such.
Interaction with other drugs
Tacrolimus is not metabolised in the skin, which eliminates the risk of drug interactions in the skin, which can affect its metabolism.
Since systemic absorption of tacrolimus when used in the form of an ointment minimal interaction with CYP3A4 inhibitors (erythromycin, itraconazole, ketoconazole, diltiazem, etc.) With simultaneous application of ointment Protopik® unlikely but can not be completely ruled out in patients with extensive lesions, and / or erythroderma.
Influence ointment Protopik® on vaccine efficacy has not been studied. However, due to the potential risk of reduced efficiency, vaccination should be held prior to the application of an ointment or 14 days after the last use Protopik® ointment. In the case of a live attenuated vaccine, the period must be extended to 28 days, otherwise it should consider the use of alternative vaccines.
The ability to share applications ointments Protopik® with other external preparations, systemic corticosteroids and immunosuppressive agents has not been studied.
Overdose
When applied topically overdose were noted.
If ingested, it is necessary to take common action which include monitoring of vital body functions and the monitoring of the general state.
Stimulation of vomiting or gastric lavage is not recommended.
pharmachologic effect
Pharmacological group:
Anti-inflammatory agent for topical application.
Pharmacodynamics:
Tacrolimus refers to a group of calcineurin inhibitors. It binds to a specific cytoplasmic immunophilin protein (FKBP12), which is a cytosolic receptor for calcineurin (FK506). The result is a complex comprising tacrolimus, FKBP12, calcium, calmodulin, and calcineurin, resulting in the inhibition of calcineurin phosphatase activity. This makes it impossible dephosphorylation and translocation of nuclear factor of activated T-cells (NFAT), required for initiation of transcription of genes encoding key for production of a T cell immune response cytokine (IL-2 and interferon-gamma). Furthermore, tacrolimus inhibits the transcription of genes coding for the production of cytokines such as IL-3, IL-4, IL-5, granulocyte macrophage colony-stimulating factor (GMKSF) and tumor necrosis factor (TNF-alpha), which are involved in the early stages of T-lymphocyte activation. In addition, under the influence of tacrolimus is inhibited release of inflammatory mediators from mast cells, basophils and eosinophils, as well as decrease FceRI expression (high-affinity surface receptor for IgE) on Langerhans cells, which leads to a decrease in their activity of presentation of antigen and T-lymphocytes.
Tacrolimus ointment does not affect the synthesis of collagen and, thus, does not cause skin atrophy.
Pharmacokinetics:
Absorption. Tacrolimus absorption into the systemic circulation when topically applied is minimal. Most atopic dermatitis patients (adults and children) as in a single application, and at the repeated application of 0.03 and 0.1% tacrolimus ointment concentration in blood plasma was
Distribution in the body. Due to the fact that the systemic absorption of tacrolimus ointment low, high ability to bind plasma proteins (more than 98.8%) is regarded as clinically significant.
Metabolism. Tacrolimus is not metabolised in the skin. When injected into the systemic circulation tacrolimus largely metabolized in the liver by CYP3A4.
Withdrawal. When multiple local application of tacrolimus ointment half-life of 75 hours for adults and 65 hours for children.
Conditions of supply of pharmacies
On prescription.
side effects
The most common adverse reactions are skin irritation symptoms (burning sensation and itching, redness, pain, paraesthesia and rash) at the application site. As a rule, they are expressed moderately or slightly and tested during the first weeks after starting treatment.
Often found alcohol intolerance (facial flushing or skin irritation symptoms after drinking).
Patients applying ointment Protopik®, there is an increased risk of folliculitis, acne and herpes infection.
Frequency of occurrence adverse reactions are divided into very frequent (> 1/10), frequent (> 1/100, 1 / 1,000,
General disorders and local reactions
Very common: burning and itching at the application site.
Common: feeling of warmth, redness, pain, irritation, rash at the application site
infection
Common: herpes infection (herpes simplex face and lips, rash varitselliformnaya’s sarcoma).
Skin and subcutaneous tissue
Common: folliculitis, itching.
Infrequent: acne.
Nervous system
Common: paresthesia, hyperesthesia.
Metabolism and nutrition characteristics
Common: Alcohol intolerance (facial flushing or skin irritation symptoms after drinking).
Over the entire period of observation of the drug have been reported isolated cases of rosacea, malignancy (skin and other types of lymphoma, skin cancer).
special instructions
Protopik® Ointment should not be used in patients with congenital or acquired immunodeficiencies or in patients who are taking immunosuppressive drugs.
During application of ointment Protopik® must minimize exposure to sunlight on the skin, solarium, treatment with UV rays B or A in combination with psoralen (PUVA-treatment).
Protopik® Ointment should not be used to treat the affected areas, which are considered to be potentially malignant or pre-malignant.
For 2 hours on the skin areas to which the ointment was applied Protopik® can not be used emollients.
Efficacy and safety of Protopik® ointment in the treatment of infected atopic dermatitis has not been evaluated. If there are signs of infection before prescribing ointments Protopik® necessary to conduct appropriate therapy. Application of ointments Protopik® may be associated with an increased risk of herpes infection. Where there is evidence of HSV infection should be individually weigh the benefits and risks of Protopic.
In the presence of lymphadenopathy is necessary to examine the patient before therapy and monitor it during application of ointment. If there is no apparent cause lymphadenopathy or when symptoms of acute infectious mononucleosis Protopik® necessary to stop applying ointments.
Ointments should be avoided entering the eyes and mucous membranes (in cases of accidental ointment must be removed and / or washed with water).
Do not wear ointment Protopik® under an occlusive dressing and wearing tight clothes airtight.
Just as with any other topical medication, patients should wash their hands after applying the ointment, except in cases where the ointment applied to the area of ​​hands for therapeutic purposes.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Adults and children over 2 years Protopik® ointment applied thinly to the affected areas of skin. The drug can be used on all body parts, including the face and neck, in the area of ​​skin folds. Do not apply medication to mucous membranes and for the occlusive dressing.
Use in children (2 years of age and older) and adolescents up to 16 years
Treatment should start with applying Protopik® 0.03% ointment twice a day. The duration of treatment under the scheme should not exceed three weeks. Subsequently application frequency is reduced to once a day, continuing the treatment until complete purification of lesions.
Use in adults and adolescents 16 years and older
The treatment should begin with the application Protopik® 0.1% ointment twice daily and continued until complete purification of lesions. As improvements can reduce the frequency of application of 0.1% ointment, or switch to the use of 0.03% Protopik® ointment. In the case of re-emergence of symptoms should resume treatment Protopik® 0.1% ointment twice a day. If you allow the clinical picture, it should attempt to reduce the frequency of use of the drug, or to use a lower dosage – 0.03% ointment Protopik®.
Use in the elderly (65 years and older)
Features of the application in elderly people are missing.
Usually improvement is seen within one week from the date of initiation of therapy.
If signs of improvement during therapy absent for two weeks, you should consider changing treatment strategies.
treatment of exacerbations
Ointment Protopik® can be used temporarily or permanently in a periodically repeated courses of therapy. Treatment of affected areas is carried out until complete disappearance of clinical manifestations of atopic dermatitis. As a rule, the improvement observed in the first week of treatment. If the symptoms are not improving within two weeks from the start of the use of ointments, other options should be considered for further treatment. Treatment should resume at the first signs of exacerbation of atopic dermatitis.
Prevention of exacerbations
For the prevention of relapse and increase the duration of remission in patients with frequent (more than 4 times per year) exacerbations of the disease in the history of maintenance therapy is recommended ointment Protopik®. Feasibility destination determined by the efficiency of maintenance therapy prior treatment according to standard scheme (2 times daily) for up to 6 weeks.
When maintenance therapy Protopik® ointment should be applied 2 times a week (e.g., Monday and Thursday) at the skin, usually strikes in exacerbations.
The time interval between application of the drug should be at least 2-3 days. In adults and adolescents 16 years and older used Protopik® 0.1% ointment, children (2 years and older) – 0.03% ointment Protopik®. When the manifestation of acute symptoms should go to normal therapy ointment Protopik® (see. Section “Treatment of exacerbations”).
After 12 months of maintenance therapy is necessary to evaluate the clinical dynamics and decide whether to continue prophylactic use Protopik® ointment. In children, to evaluate the clinical dynamics should temporarily stop the drug and then to consider the need to continue maintenance therapy.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Protopic

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