Gel Xamiol Leo on the spot of scalp psoriasis (15g)

Dosage form Tube x 15g
Specifications Calcipotriol, betamethasone dipropionate

Ingredient

Thành phần cho 1g

Composition information	Content
Calcipotriol	50mcg
Betamethasone dipropionate	0.5mg

Uses

indications

Xamiol Gel is indicated in the following cases:

Local treatment scalp psoriasis in adults. Psalchic psoriasis treatment is not in mild to medium skin in adults.

Pharmacokic

Calcipotriol is the same substance as vitamin D, reducing the differentiation and inhibition of horn cell proliferation.

Like local corticosteroids, in addition to treating basic conditions, Betamethasone dipropionate has anti -inflammatory, anti -itching, vasoconstriction and immunosuppressant.

Dynamic pharmacokinetics

Apply the drug to psoriasis lesions and cover by clothes that can increase the absorption of topical corticosteroids.

In studies on the ability to tolerate rabbits on the rabbit, Xamiol Gel causes skin to stimulate mild to moderate and light, airy irritation in the eye.

Before taking Gel Xamiol Leo on the spot of scalp psoriasis (15g)

How to use

Apply Xamiol Gel to the infected area on the scalp once a day. A treatment is 4 weeks. It is necessary to monitor medical monitoring if the treatment of Xamiol Gel repeats.

Dosage

recommended treatment time is 4 weeks for the scalp area and 8 weeks with the "not scalp" area. If necessary to continue treating or starting the treatment after this time, the treatment should be continued after medical examination and under regular medical supervision.

When using cigarette products containing calcoriol, the maximum daily dose must not exceed 15g. The surface area of the body is treated with products containing Calcipotriol should not exceed 30%.

If used for scalp

All damaged scalp areas can be treated with Xamiol® Gel. Usually an amount from 1g to 4g per day is enough for treatment in the scalp (4g equivalent to a teaspoon).

Special subjects

Hepatic and kidney failure

Safety and effectiveness of Xamiol® Gel in patients with kidney failure or severe liver failure has not been evaluated.

Children

Safety and effectiveness of Xamiol® Gel in children under 18 have not been set up. The current available data in children aged 12 to 17 has been presented in the unwanted effect and pharmacological properties, but does not make recommendations about the dose.

What to do when overdose? Symptoms of hypercalcemia include diabetes, constipation, muscle weakness, confusion and coma. Using local corticosteroids can inhibit the pituitary -adrenal function, causing reduced secondary adrenal glands that can often be reversed. Symptomatic treatment should be treated in these cases.

In cases of chronic poisoning, corticosteroid treatment should be stopped slowly.

What to do when forgetting 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

The frequency assessment of harmful reactions is based on analytical data obtained from clinical studies including safety studies after circulation and spontaneous reports. The most common harmful reaction is reported during the treatment process.

The harmful reactions listed by Meddra Soc and the personal harmful reactions are listed starting from the most frequent frequency reported. In each frequency group, the harmful reaction is presented in the order of severe decreasing levels.

Very popular (≥ 1/10)

Popular (≥ 1/100 to

Not popular (≥ 1/1000 to

Rare (≥ 1/10,000 to

Very rare ( Infections and parasites infection 1/1,000 sensitive 1/10 itchy

psoriasis

Dermatitis

Redders

Ban **

Acne

Skin burning sensation

Skin irritation

Dry skin

rare
≥ 1/10,000 to

***

** Types of rash reactions such as Hong Ban and pustules have been reported
*** Pain of pain where drugs include burning at the place of use.

Here are harmful reactions related to the pharmacology classification of calcificationriol and betamethason, respectively:

Calcipotriol

Harmful reactions include reactions in the topical area, itching, skin stimulation, burning sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis are severe, sensitive to light and hypersensitivity reactions including very rare cases such as endothelial and face edema.

Very rarely occur in the body's effects after local drugs causing blood calcium hypercalcemia and hypercalcium.

Betamethason (Dang Dipropionate)

There may be local reactions after use, especially when used for prolonged use, including skin atrophy, capillary dilatation, floating, folliculitis, hair, dermatitis around the mouth, contact dermatitis, pigmentation and glue formation.

When treating psoriasis with local corticosteroids, the risk of pustules may occur. The systemic reactions of local corticosteroid use are rare in adults but may be heavy. Adenocortical inhibitors may occur, the head, infection and glaucoma, especially after long -term treatment. Systemic reactions often occur when the topical area is covered (plastic, skin fold), when applying the drug on a large scale and long -term treatment.

Children

No observations of new harmful effects and new harmful reactions in 109 teenagers aged 12-17 are treated with scalp psoriasis with Xamiol® Gel for 8 weeks. However, due to the sample size of the study, it is not possible to make a strong conclusion about the safety of Xamiol® Gel in adolescents compared to adults.

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

Xamiol Gel contraindicated in the following cases:

Hypersensitivity to the active ingredients or excipients of the drug.

Xamiol Gel is contraindicated for people with calcium metabolic disorders because the drug contains calcableriol.

Due to the ingredient containing corticosteroids, the anti -gel is contraindicated in the following cases: Virus skin lesions (such as herpes or varicella), fungi or bacterial skin infections, parasites infection, skin manifestation of tuberculosis or syphilis, dermatitis around the mouth, skin atrophy, crispy crispy skin, fish scales, ovary, ulcers and wounds.

Contraindicated to use Xamiol Gel in drop -shaped, red psoriasis, pumping, pustulent psoriasis.

Contraindicated to use Xamiol Gel for patients with impaired renal function or severe liver dysfunction.

Be cautious when using

Xamiol Gel contains a strong group III steroid, so avoid using another steroid on the scalp.

Due to the composition of Calcipotriol containing Calcipotriol, there may be hypercalcemia if the maximum overdose is used for maximum overdose (100 g).

Avoid applying more than 30% of the body surface area. Avoid applying to damaged skin, on the mucosa or skin folds due to increased body corticosteroid absorption. Facial skin and genitalia are very sensitive to corticosteroids. Corticosteroids should only be weaker for these areas. It can be seen that the harmful reaction on the spot is not common (such as stimulating eyes or face skin) when the drug falls into the face or eye and eye conjunctiva.

Need to be treated with anti -bacterial drugs if the lesions turn into secondary infection.

There may be a risk of pustules of pustules or harmful effects when stopping psoriasis treatment with local corticosteroids.

may increase the risk of unwanted effects of body corticosteroids and localities when taking the drug for a long time.

When treated with Xamiol Gel, physicians should advise patients to limit or avoid excessive contact with natural or artificial light.

Xamiol Gel contains Butylated Hydroxytoluene (E321) that can cause local skin reactions (such as contact dermatitis) or eye and mucous irritation.

Children: It is not recommended to use Xamiol Gel for children under 18 years of age due to lack of data on safety and efficiency.

The ability to drive and operate machinery

Xamiol Gel does not affect the ability to drive and operate machinery.

Pregnancy

Pregnant women

There is no adequate data on Xamiol® Gel for pregnant women. Animal studies using glucocorticoids have shown maternity toxicity, but some studies on epidemiology (less than 300 pregnant women) not only indicate congenital abnormalities in infants whose mothers use corticosteroids during pregnancy. Not necessarily risk on human.

Therefore, Xamiol® Gel should only be used during pregnancy when the benefits are out of risk.

Reproduction

Rats on mice using Calcipotriol or Betamethason Oral have been shown not to reduce the fertility of male and female.

Breastfeeding period

Betamethasone passes through breast milk but is not clear about harmful muscle effects on infants with treatment dose. There is no data on Calcipotriol excretion in breast milk. Be careful when prescribing Xamiol® Gel for breastfeeding women. Need to guide patients not to use Xamiol® Gel into the breast when breastfeeding.

Drug interaction

has not conducted research on drug interaction.

Storage

Do not freeze. Keep the jar in the carton box to avoid contact with light.

Storage below 30 ° C.

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