Dermovate Cream Cream GSK skin treatment, psoriasis, dermatitis, flat lichen (15g)

Dosage form Tube
Specifications Clobetasol Propionat

Ingredient

Composition information	Content
Clobetasol Propionat	0.05%

Uses

Indications

Dermovate Cream is a very highly valid corticosteroid corticosteroid for adults, elderly people and children over 12 years of age to reduce the symptoms of inflammatory and itching of skin diseases responding to steroids.

These diseases include:

Psoriasis (except for widespread array);

persistent dermatitis;

Lichen flat;

Lupus red rash;

Other skin diseases do not respond satisfactorily with lower steroids.

Pharmacokology

topical corticosteroids with anti -inflammatory, anti -itching and vasoconstriction properties.

Mechanism of action

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

pharmacokinetic

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. Taces, inflammation and/or other skin diseases may also increase the absorption through the skin.

In a study, the average peak concentration Clobetasol propionate in plasma is 0.63 nanogram/ml reached eight hours after the second dose (after the first dose of 13 hours) 30g of Clobetasol propionate ointment 0.05% on the healthy skin of normal people. After applying the second 30g clobetasol propionate, 0.05%cream, the average peak concentration in plasma is slightly higher than the 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 psoriasis and eczema for 3 hours after applying a single dose of 25g of clobetasol propionate ointment 0.05%.

Distribution

The use of pharmacological criteria to evaluate the body's systemic exposure is necessary because the circulating concentration is lower than the concentration that can detect the drug.

Metabolism

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 corticosteroids and their metabolites are eliminated through the bile.

Before taking Dermovate Cream Cream GSK skin treatment, psoriasis, dermatitis, flat lichen (15g)

How to use

Dermovate cream is especially suitable for wet or leaky skin surfaces.

Dosage

Dermovate Cream in adults, elderly people and children over 12 years old

Apply a thin layer and gently rub just enough to fully cover the infected skin 1 or 2 times a day until 4 weeks 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 to Dermovate to control outbreaks.

In cases of hardship, especially when there is increased horny horn, if necessary, it is possible to enhance the effects of Dermovate by irritating the treatment area with polythene film.

Normally, just overnight bandage is enough to meet the desire. After that, usually just applying the medicine without sealing still maintains improvement.

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

Do not last for more than 4 weeks. If necessary treatment continues, the drug should be used lower effect.

Maximum dose per week does not exceed 50g/week.

Dever Dermovate Cream in the treatment of atopic dermatitis (eczema).

Once the disease is controlled, it is advisable to stop treating with Dermovate Cream gradually and continue to maintain with a skin softening drug.

Previous skin diseases may recur when discontinued dermovate suddenly.

Dermovate dose in the treatment of persistent skin diseases is difficult to treat, patients often relapse.

When an exacerbation has been effectively treated with local corticosteroids continuously, should consider using interrupt doses (once a day, twice a week, no echo). 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.

Dermovate Cream in children

Contraindicated using Dermovate for children under 12 years old.

Children often suffer from unwanted and more body effects when taking local corticosteroids and generally requires shorter treatment time with lower effects than adults.

Be careful when using Dermovate to ensure the minimum amount of drugs and still have treatment.

Dermovate Cream in the elderly

Clinical studies do not show a difference in response to the treatment between elderly and young patients. If the whole body absorption occurs, the elimination of drugs in the elderly may be slower due to the frequency of liver or kidney impairment in this group of patients. Therefore, the amount of drugs should be used in the shortest treatment period to achieve the desired clinical effect.

Dermovate Cream in patients with liver/kidney failure

In the case of body absorption (when applying the drug on a large scale for a long time), liver/kidney failure may slow down the metabolism and elimination process of the drug, which increases the risk of systemic toxicity. Therefore, the minimum amount of drugs should be used in the shortest treatment period to achieve the desired clinical effect.

What to do when more than 1 dose?

Dermovate overdose symptoms

Dermovate used on the spot can be absorbed in 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 (see unwanted effects).

Extract Dermovate overdose

In case of overdose, Dermovate should be stopped gradually by reducing the number of drugs or replacement with a lower effect 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.

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. Do not drink twice as prescribed.

Side Effects

The unwanted effects of the drug (ADRS) are listed below according to the classification of the Meddra body system and the frequency. The frequency is determined as follows: Very popular (> 1/10), popular (> 1/100 and 1/1,000 and 1/10,000 and

after -sales data

Infections and parasites

Very rare: opportunistic infections.

immune system disorders

Very rare: Hypersensitivity to the spot.

Endocrine disorders

Very rare: Inhibiting the hypothalamus - Pituitary gland - adrenal gland (HPA axis). endogenous cortisol, bald, broken hair.

Skin and tissue disorders

common: itching, skin pain/skin burns on the spot. Fish.

Very rare: Pain/Applying medicine.

Notify the doctor with 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

Contraindicated treatment with Dermovate in the following cases:

Unreasonable skin infections;

Rosacea red acne disease;

Acne;

Itching but no inflammation;

Itching around the anus and genital area;

Dermatitis around the mouth;

Hypersensitivity to the drug;

virus infection;

Fungal infection;

Psoriasis psoriasis spread;

Contraindicated using Dermovate in skin diseases in children under 12 years old, including dermatitis.

Be cautious when using

Caution when using Dermovate in patients with a history of hypersensitivity with corticosteroids or any excipients of the drug. Hypersensitivity reactions (see unwanted effects) may be similar to the symptoms of the disease being treated.

Expression of Cortisol (Cushing syndrome) and reversible inhibition of the anomalous pituitary (HPA), leading to glucocorticosteroid deficiency, can occur in some patients due to increased body absorption of steroids. If one of the above manifestations is found, stop taking the drug gradually by reducing the number of applied or replaced by corticosteroids. Sudden stopping of the drug can lead to glucocorticosteroid deficiency (see unwanted effects).

Risk factors that increase the body effect include:

Effect and formula of local steroids;

Time exposure to drugs;

Apply medicine on a large scale;

Apply on the icing skin (for example, folded or bandaged skin (in children's diapers that can be acting as when closed bandages));

Increase the horny classification;

Apply on skin thin skin;

Apply on torn skin or other cases when the barrier protects the skin damaged;

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

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

Risk of echoing infection

Warm, moist conditions at skin folds or when the skin is covered, it facilitates the infection. Need to clean the skin before bandaging.

Psoriasis treatment

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

Infections attached

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

Chronic ulceration in the foot

Local corticosteroids are sometimes used to treat dermatitis around chronic ulcer. However, this use may increase the hypersensitivity reactions and the risk of local infections.

Apply medicine on the face

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.

Apply medicine on eyelids

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

The ability to drive and operate machinery

There has been no research to evaluate the effect of Dermovate on the ability to drive and operate machinery. No adverse effects on these activities are mentioned in the unwanted effects of Dermovate used on the spot.

Pregnancy or lactation

Reproductive ability

There is no data that assesses the effects of local corticosteroids on human fertility. Clobetasol subcutaneously mice does not affect mating; However, fertility decreases at the highest doses (see preclinical safety data).

Pregnancy

Data use of Dermovate on pregnant women is limited.

Local corticosteroid use on pregnant animals can cause abnormalities for fetal development (see clinical safety data).

The relationship of this finding with people has not been established. Only consider using Dermovate during pregnancy if the expected benefits for the mother outstanding risk to the fetus. Should use the least amount of drugs in the shortest treatment period.

Breastfeeding period

Local corticosteroid safe use when breastfeeding has not been set up.

It is still unknown whether using topical corticosteroids can lead to enough body absorption to the amount of drug excretion in breast milk can be detected or not.

should only consider using Dermovate during breastfeeding if the expected benefits for the mother outstanding risk for children.

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

Medicinal interaction

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

Storage

Storage below 30 ° C.

Expiry date: 24 months from the date of production.

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