Trozimed-B Davipharm ointment treatment for normal psoriasis (30g)

Dosage form Box x 30g
Specifications Betamethasone, Calcipotriol

Ingredient

Composition information	Content
Betamethasone	15mg
Calcipotriol	1.5mg

Uses

Indications

Medicines used to treat normal psoriasis in adults over the age of 18.

Pharmacokinus

Pharmacological group: Other psoriasis treatments used on the spot, Calcipotriol form combined.

ATC code: D05AX52.

Calcipotriol

Calcipotriol is a synthetic derivative of vitamin D3, which treats psoriasis. The exact mechanism of acting for psoriasis of Calcipotriol has not been fully understood, however, in vitro evidence shows that the drug stimulates the differentiation and inhibition of proliferation of many cells including horny cells. This effect is approximately equivalent to natural vitamin D but shows that the efficiency of using calcium of calcium is less natural vitamin D up to 100 to 200 times.

betamethason

Similar to local corticosteroids, Betamethason Dipropionate has anti -inflammatory, itching, vasoconstrictor and immunosuppressive effects, but has no treatment effect of the disease. By icy, the effect may increase due to increased medication through horny cells, but the unwanted effect will also increase. In general, the anti -inflammatory mechanism of local steroids has not been well understood.

pharmacokinetic

absorption

The whole body absorption of calcification and betamethasone from the form of ointment combined with two active ingredients less than 1% of the dose (2.5 g) after applying to normal skin (625 cm) for 12 hours. Applying the drug on the psoriasis and closed skin area can increase the absorption of local corticosteroids. The percentage of drugs absorbed by skin is about 24%.

Calcipotriol and betamethason dipropionate levels are below the quantitative level at all 34 patients treating the whole body psoriasis and the scalp for 4 to 8 weeks with both gel and ointment containing two active ingredients. The concentration of a metabolites of calcableriol and a metabolic substance of betamethasone is at a quantitative level in some patients.

Distribution

The drug is linked to protein about 64%. Research in mice shows that Calcipotriol and Betamethasone are the highest distributed in the kidneys and liver.

Metabolism

After absorbing, both active ingredients - Calcipotriol and betamethasone - are metabolized quickly and completely. Betamethason is metabolized mainly in the liver, partly in the kidneys in the form of esters sulfate and glucuronid.

Elimination

The half -life of two active ingredients in plasma after using intravenously is about 5-6 hours. Due to the amount of drugs kept in the skin, the drug after applying is deducted from day by day.

Calcipotriol is excreted mainly in feces (rats and small pigs) and betamethason excreted mainly through the kidneys (rats and rats).

Before taking Trozimed-B Davipharm ointment treatment for normal psoriasis (30g)

How to use

trozimed B is used on the skin. Do not take or put the drug into the body.

Apply only drugs on sick skin.

Always wash your hands before applying the drug.

Avoid taking medication under the tape because it increases the absorption of corticosteroids into your body.

Avoid using medication on wide skin, mucous membranes or skin folds (groin, armpits, under the breast) because it can increase the absorption of drugs.

Do not apply medicine on the face or genitals because these skin areas are very sensitive to the drug.

Do not mix trozimed b with other drugs.

You can squeeze the pills directly on the psoriasis skin or squeeze the pills to clean your fingers first and apply it to the psoriasis area. You should apply a thick layer of medication and then rub gently to cover the psoriasis area until the drug is absorbed.

Unless you use the medication to treat psoriasis on your hands, always wash your hands after applying the drug. This will prevent the drug accidentally involved in other parts of the body. You do not need to worry if the drug is sticking to the normal skin near the psoriasis area, however, you should wipe off if the topical is spread too wide.

For optimal treatment effect, you should not wash the place to apply or bath immediately after taking the drug.

After applying the drug, avoid the skin in contact with greasy fabrics (such as silk fabric).

You should keep your skin moisture enough, especially after bathing. If you use a moisturizer, wait for the cream to absorb before taking the medication.

Avoid excessive contact with natural sunlight, light or optical therapy.

Most patients will see clear results after 2 weeks of treatment, even though psoriasis is not over.

Dosage

Adults: Apply the drug to the sick area once a day.

recommend the time for each treatment is 4 weeks. There have been cases of using Calcipotriol Betamethason multiple repeated periods up to 52 weeks. Continuing to treat or start treatment after 4 weeks if necessary, should only continue treatment after careful review of the patient's condition and are performed under the close supervision of health workers.

When using preparations containing Calcipotriol, the total amount of drugs containing Calcipotriol maximum daily should not exceed 15 g. The area of topical skin does not exceed 30% of the body surface area.

Special subjects

Patients with liver kidney failure

Safety and effectiveness of drugs in patients with severe renal impairment or severe liver dysfunction has not been evaluated. Therefore, it is recommended not to use drugs for these patients.

Children and teenagers (under 18 years old)

Safety and effectiveness of drugs in children under 18 years of age has not been set. So do not use drugs in children under 18 years old.

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?

Clinical signs of hypercalcemia include: Multi, anorexia, nausea, vomiting, constipation, reducing muscle tone, depression, confusion and coma.

Monitor serum calcium concentration 1 time/ week until calcium concentration is normal.

Located use of local corticosteroids can inhibit the hypothalamus - pituitary - adrenal glands, which impair the secondary adrenal glands recovering. In this case, patients should be treated symptoms.

Cases of chronic poisoning, slowly stopped.

There is a report on a patient with wide skin psoriasis that has appeared cushing syndrome after abuse of the drug (240 g of drugs per week, equivalent to 34 g/day for 5 months), and scales should be pustules after sudden treatment.

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

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

When using Trozimed B often has unwanted effects (ADR) such as:

Common, 1/100 ≤ ADR

Skin and subcutaneous tissue: Peeling skin, itching.

Infection and parasitic infection: Skin infections (including bacterial, fungal and viral skin infections), folliculitis

The whole body and place of use: Change the skin pigmentation at the top of the drug, pain at the place of topical (burning burns including pain at the top of the drug).

Infection and parasitic infection: pimples.

Children

In a study conducted in 33 children from 12 to 17 years old, psoriasis treatment regularly with Calcipotriol/ Betamethason ointment within the next 4 weeks of the maximum dose of 56 g/ week. There is no other unwanted effect that is reported and does not see the effects related to systemic corticosteroids. However, it is impossible to make a firm conclusion about the safety of this combination ointment in children and adolescents.

The undesirable effects below are thought to be related to the corresponding pharmacological group of calcable and betamethason:

Calcipotriol

Unwanted effects include the reaction at the position of topical, itching, skin irritation, burning and tingling, dry skin, rash, rash, dermatitis, eczema, psoriasis severe, dermatitis around the mouth, sensitive and sensitive reactions (including rare angi and facial edema).

Systemic effects are very rare: hypercalcemia or hypercalcium.

betamethason (in the form of dipropionate)

Unwanted effects on the spot may be encountered after applying the drug, especially when used for prolonged use, including skin atrophy, capillary dilatation, stretch marks, folliculitis, hair, dermatitis around the mouth, contact dermatitis, pigmentation and acne.

When treating psoriasis with corticosteroids may be at risk of pustular psoriasis.

The whole body effect is rare by corticosteroids in adults, but may be serious. Inhibiting adrenal shells, infections, hypercalcemia, cataracts, affecting blood sugar control in patients with diabetes may occur, especially when prolonged treatment.

The whole body reaction is more common when taking the drug on a wide skin, the skin under the pressed bandage (plastic, skin folds) and for prolonged treatment.

The drug can cause other unwanted effects. It is necessary to closely monitor and recommend the patient to notify the doctor with unwanted effects when using the drug.

Notify the physician the 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

Trozimed B drugs are contraindicated in the following cases:

Hypersensitivity Calcipotriol, betamethason or with other corticosteroids or with any ingredients of the drug. Herpes or chickenpox), Fungal or bacterial skin infections, parasites infection, skin related to tuberculosis, dermatitis around the mouth, skin atrophy, stretch marks, thin skin veins, fish scales, regular individual acne, red acne, red face, ulcers and wounds.

Precautions when using

Effects on endocrine systems

The drug contains strong active corticosteroids (group III), avoiding simultaneous use with other steroids.

Unwanted effects related to the treatment of whole corticosteroids such as adrenal inhibition or impact on metabolic control in diabetes can also occur when treated with corticostiiod on the spot due to corticosteroid body absorption.

Avoid applying the drug to the wide skin, damaged, or applied to the mucosa, mucous membranes or folding skin because it can increase the absorption of corticosteroids.

In a study in patients with wide psoriasis on the scalp and body, when using high doses of Calcipotrol/Betamethason gel (scalp) and ointment (topical) shows 5 out of 32 patients who have reduced cortisol response limits with adrenal hormone (ACTH) after 4 weeks of treatment.

The effect on calcium metabolism

Due to the drug containing a calcium, hypercalcemia may occur if it exceeds the maximum amount of calcipotriol (15 g) and quickly recovers when stopping treatment. The risk of hypercalcemia decreases when adhering to the recommended dose. The area of the skin error is not exceeded 30% of the body surface area.

Unwanted effect on the spot

The drug contains strongly active corticosteriod (group III) should be avoided with other corticosteroids on the same skin area. Facial skin and genitals are very sensitive to corticosteriod, therefore, do not use drugs on these skin areas. Patients must be instructed to use the drug properly to avoid applying the drug or unintentionally sticking the medicine on the face, mouth and eyes.

Advise patients to wash their hands after applying the drug and avoid unintentionally sticking to other parts of the body, especially on the face. Only external used; Do not use eyes, drink or use in the vagina.

Calcipotriol -containing drugs can cause damage and non -related skin irritation.

Skin infections simultaneously

Treatment should be treated with appropriate antibiotic therapy in the event of a secondary infection, stop treatment with corticosteroids if the infection is worse.

Stop treatment

Treatment of psoriasis with local corticosteroids may have a risk of pustules of pustules or regression effects when stopping treatment. Therefore, it is necessary to continue closely monitoring after stopping the drug. Avoid stopping the drug suddenly.

prolonged treatment

Prolonged medication increases the risk of unwanted effects of topical and body corticosteroids. Treatment should be discontinued if there are cases of unwanted effects involving prolonged use of corticosteroids.

Unresed treatment

Inexperienced in using Calcipotriol/ Betamethasone combination in the treatment of Guttate compressive scales.

Combination and exposure treatment of UV rays

Experience in taking drugs on scalp is limited.

Calcipotriol/betamethason ointment treats body psoriasis lesions that have been used in combination with Calcipotriol/Betamethason gel for psoriasis lesions on the scalp, however, experience using Calcipotriol/Betamethasone with psoriasis treatments on the same place in the same area for psoriasis Limitations.

Recommend patients to avoid or limit skin exposure in natural or artificial sunlight. Only use Calcipotriol treated on the spot along with UV emission when the doctor and the patient consider the benefits superior to the risk.

Warning related to excipients

The drug contains propylene glycol can cause skin irritation, polysorbat 80 can cause allergies.

Because the drug contains propylene glycol, do not use drugs for open wounds or skin lesions with large area (such as burns) without notice to a doctor or pharmacist.

Use drugs for women during pregnancy and lactation

Pregnant women

Animal research on glucocorticoids shows that there is a reproductive toxicity, but in some epidemiological studies (resulting from less than 300 pregnant women), there is no birth defect in children born from mothers treated with corticosteroid during pregnancy.

Unknown risks. Calcipotriol has passed the placenta, but there is no controlled, adequate studies in pregnant women. Calcipotriol used skin is absorbed a little into the body but is not considered to change the balance of the lip cocoma.

There has been a weight loss in newborns when the mother uses a prolonged corticosteroid, because of the ability to inhibit the adrenal shell in the newborn baby because the mother uses a prolonged corticosteroid, so when prescribing the prescription, it is necessary to consider the benefits and risks in children.

breastfeeding women

It is unclear whether Calcipotriol is secreted into breast milk.

Calcipotriol distribution in the body is predicted similar to other vitamins. Using calcipotriol in a short time on a small surface does not lead to body absorption and has not seen an impact on breastfed babies. In other cases, breastfeeding is not recommended while using calcipotriol.

betamethason is distributed into breast milk but in the treatment dose often does not cause unwanted effects to breastfeed.

Be careful when taking Calcipotriol/Betamethason ointment for women who are in breast -feeding, recommend that patients should not breastfeed while taking the drug.

Patients need to be instructed not to apply medicine on breasts when breastfeeding.

fertility

Studies on Calcipotriol or Betamethason Dipropionate mice do not see a decline in fertility in both men and women.

The effect of drugs on driving and operating machinery

trozimed B has no effect or negligible effect on driving and operating machinery.

Medicinal interaction

Calcipotriol/betamethason combination

No drug interactive studies have been conducted with Calcipotriol Betamethason combination.

Calcipotriol

When taking the drug simultaneously with ultraviolet light treatment, it is necessary to apply the drug at least 2 hours before or after ultraviolet rays to avoid reducing the effects of ultraviolet rays as well as Calcipotriol.

Simultaneous use of calcification and salicylic acid that can lead to loss of effect of calcableriol.

Not used simultaneously with calcium supplements or vitamin D or drugs that enhance the body of calcium.

No experience in coordination with other psoriasis drugs on the same skin area at the same time.

Storage

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

Other drugs

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