Apisolvat skin cream 0.05% apimed reduces symptoms of inflammation and itching skin diseases (10g)

Dosage form Box
Specifications Clobetasol Propionat
Ingredient Apimed Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Clobetasol Propionat	2.5mg

Uses

Indications

Apisolvat skin cream 0.05% indicated in the following cases:

Apisolvat is a highly valid corticosteroid corticosteroids that are indicated for adults, the elderly and children over 1 year of age to reduce the symptoms of inflammatory and itching of skin diseases that respond to steroids, including:

Psoriasis (except for spreading arrays).

persistent dermatitis. at Group 1 (the strongest effect).

ATC code: Dozado1

Local corticosteroids act as anti -inflammatory substances through many mechanisms inhibiting late -phase allergic reactions include reducing mast cell density, dynamic reduction and active leukocytes, reducing cytokin production from lymphocytes, mono cells, mast cells and eosinophilia, and inhibition of arachidonic acid metabolism.

Local corticosteroids have anti -inflammatory, anti -itching and vasoconstriction properties.

Dynamic pharmacokinetics

absorption

Local corticosteroids can be absorbed throughout the normal healthy skin. Local corticosteroid absorption level depends on many factors, including excipients and intactness of the epidermal fence.

With kin, inflammation or other skin diseases can also increase the absorption of skin.

In a study, the average peak concentration Clobetasol propionat in plasma is 0.63 nanogram/ ml reached eight hours after the second dose (after the first 13 hours) 30 g of 0.05% Clobetasol Propionate ointment on normal skin of normal people.

After applying the second dose of 30 g Clobetasol propionate cream 0.05%, the average peak concentration in plasma is slightly higher than the type of ointment and achieved after 10 hours.

In another study, the peak concentration of plasma is approximately 2.3 nanogram/ ml and 4.6 Nanogram ml achieved in patients with candles and eczema for 3 hours after applying a single dose of 25 g of Clobetasol Propionate ointment 0.05%.

distribution

The use of the criteria that are learned to evaluate the body exposure of local corticosteroids is necessary because the circulatory concentration is lower than the concentration that can detect the drug.

transformation

When absorbed through the skin, topical corticosteroids undergo a pharmacokinetic process like corticosteroids used systemic. The drug is metabolized mainly in the liver.

Elimination

Local corticosteroids are eliminated through the kidneys. In addition, some of their corticosteroids and specialized substances are eliminated through bile.

Before taking Apisolvat skin cream 0.05% apimed reduces symptoms of inflammation and itching skin diseases (10g)

How to use

topical drugs.

Handling drugs after use: Do not destroy the drug by throwing the drug in domestic waste or water sources, asking the pharmacist how to destroy the drug to ensure no environmental impact. Dosage

adults, elderly people and children over 1 year old

Apply a thin layer and gently rub just enough to completely cover the infected skin 1-2 times daily until the condition is improved, then reduce the number of use or switch to lower -effective drug treatment. After each application, keep the drug sufficiently absorbed into the skin before applying the skin to soften the skin.

can repeat short treatments with apisolvat to control outbreaks.

For resistant lesions, especially when increased horns, if necessary, the effect of apisolvat can be increased by sealing with a polythen film. Usually just overnight bandage is enough to meet the desire. After that, usually just applying the medicine without a tightness still maintains improvement.

If the condition worsens or does not improve within 2-4 weeks, should re-evaluate treatment and diagnosis.

Do not extend the treatment time for more than 4 weeks. If necessary treatment continues, the drug should be used lower. The maximum dose is no more than 50 g/ week.

Once the disease is controlled, it is advisable to stop treating with apisolvat gradually and continue to be maintained with a skin softening. Previous skin diseases may relapse when stopping apisolvat suddenly.

Persistent skin disease is difficult to treat, patients often recur:

When an exacerbation has been effectively treated with local corticosteroids continuously, should consider using interrupt doses (once a day, twice a week, not equal to closed). This has shown reducing the frequency of recurrence.

Continue to apply drugs in the skin that has been sick or may recur. This process should be combined with daily skin softening. The condition, benefits and risks of treatment continue to be periodic.

Children

Children under 1 year of age: contraindicated use of apisolvat.

Children from 1 - 12 years old: It is not recommended to use Apisolvat, only used when necessary and must have a close supervision of a doctor. In case of treatment, do not take more than 5 days and should re -evaluate weekly. Do not cover.

Children often suffer from unwanted and more intimate effects when taking local corticosteroids, so they often require shorter treatment time and use lower effects than adults.

Apply to the face

Do not treat more than 5 days. Do not cover.

Elderly

There is no difference in response to the treatment between elderly and young patients.

If the body absorption occurs, the elimination of drugs in the elderly may be slower due to the frequency of impaired liver or kidney function in this group of patients. Therefore, the minimum amount of drugs should be used in the shortest treatment period to achieve the desired clinical effect.

People with liver and kidney failure

In the case of systemic absorption (when applying the drug on a large scale for a long time), liver failure, the kidneys may slow down the metabolism and elimination process of the drug, which increases the risk of systemic toxicity.

Therefore should use the minimum amount of drugs in the shortest treatment period to achieve the desired clinical effect.

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?

Symptoms:

Apisolvat on the spot can absorb a sufficient amount to cause systemic effect.

Acute overdose does not occur, however, in case of chronic overdose or abuse of drugs, the manifestations of increased cortisol may occur.

Management:

In case of overdose, Apisolvat should be stopped gradually by reducing the number of medication or replacement with a lower validity of corticosteroids due to the risk of glucocorticosteroid deficiency.

More intensive controls should be based on clinical indications or recommendations of the National Poison Control Center, if any.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Stop taking the drug and contact the doctor, pharmacist or go to the hospital immediately if the drug users have the following symptoms:

Skin rash and swelling.

Common, ADR> 1/100:

Itchy, skin pain/skin burns.

Skin atrophy, stretch marks, capillary dilatation.

Very rare, ADR opportunistic infections. Reducing endogenous cortisol levels, bald, broken hair.

To avoid adrenal insufficiency, when used for a long time and apply on a large scale (high doses), it is necessary to assess adrenal function because it may be inhibited the hypothalamus, pituitary, adrenal (HPA axis), by stimulating solutions by ACTH, the method of determining cortisol in plasma and free cortisol in urine.

If there is signs of adrenal insufficiency, try to stop the drug, must reduce the number of applied times, or replace it with a lower activity glucocorticoid. When stopping the drug, the HPA axis function often recovers quickly and completely, but if there is a shortage of glucocorticoid, it must be supplemented by taking corticosteroids.

Warnings

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

Contraindicated

Apisolvat skin cream 0.05% contraindicated in the following cases:

Sensitive people with Clobetasol propionat, with other corticosteroids or any ingredients of the drug. Inflammation.

Be cautious when using

Be cautious when using apisolvat in patients with a history of hypersensitivity with corticosteroids or any excipients of the drug.

local hypersensitivity reactions may be similar to the symptoms of treatment.

Expression of Cortisol (Cushing syndrome) and axial inhibitor in the anomalous pituitary (HPA), leading to glucocorticosteroid deficiency, may occur in some patients due to increased body absorption of steroid body. If one of the above manifestations is detected, stop taking the drug gradually by reducing the number of applied or replaced by corticosteroids.

Sudden stopping drugs can lead to glucocorticosteroid deficiency (see unwanted effects).

Apisolvat skin cream contains:

propylene glycol can cause skin irritation.

The factors that increase the body effect include:

The effect and formula of the local steroid.

The exposure time for the drug. face.

Children:

Children under 12 years of age should avoid local corticosteroids, because they can inhibit the adrenal glands.

Children can absorb partially partially used corticosteroids than adults and therefore are more likely to experience unwanted body effects. This is because children have immature skin barriers and surface area ratio compared to higher weight than adults.

Children are prone to skin atrophy when using topical corticosteroids. If you need to use apisolvat for children, it is recommended to limit treatment in just a few days and check weekly.

The risk of an infection due to icy: warm, moist conditions at the folds of the skin or when the skin is covered, it facilitates the infection. Need to clean the skin before bandaging.

Be cautious when using topical corticosteroids when treating psoriasis because there are some recurrence, tolerance, risk of pustules of pustules and increase body to toxicity due to damaged skin barriers. If used to treat psoriasis, it is important to monitor patients carefully.

Should use appropriate antibiotics when inflammatory lesions are being treated with infection. When the infection spreads, it is necessary to stop local corticosteroids and use appropriate antibiotics.

Local corticosteroids are sometimes used to treat dermatitis around chronic ulcer.

However, this use may increase hypersensitivity reactions and the risk of local infections.

Do not apply medicine on the face because the skin this area is prone to atrophy. If used on the face, the treatment should be limited to just a few days.

If applying the drug to the eyelids, it is necessary to be cautious so that the drug does not enter the eye because the contact many times can lead to cataracts and glaucoma.

Pregnant or breastfeeding women

Pregnant women:

Data on the use of apisolvat in pregnant women is limited. Using topical corticosteroids on pregnant animals can cause abnormalities for fetal development. The relationship of this finding with people has not been established. Apisolvat should only be used for women during pregnancy if the benefits are superior to the risk. Should use the least amount of drugs in the shortest treatment period.

breastfeeding women:

Local corticosteroid safe use when breastfeeding has not been set. Only Apisolvat should only be considered during breastfeeding if the benefits are superior to the risk.

If used during breastfeeding, do not apply medicine to the breast to prevent children from swallowing the drug.

The ability to drive and operate machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Medicinal interaction

simultaneously used with CYP3A4 inhibitors (for example, ritonavir and iTraconazole) have shown inhibitors of corticosteroid metabolism, leading to increased body exposure. Clinically related interaction level depends on the dose, sugar of corticosteroids and the effect of CYP3A4 inhibitors.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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