Daivonex

Daivonex®

LEO Pharma founded in 1908, is an independent, research-based pharmaceutical company.LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. LEO Pharma has its own sales forces in 61 countries and employs around 4,800 employees worldwide. The company is headquartered in Denmark and is wholly owned by the LEO Foundation.

Daivonex is produced in Denmark which can be used in treating psoriasis vulgaris. On the one hand the high prevalence of this disease worldwide and on the other hand the efficacy of this ointment in relieving psoriasis, the significance of Daivonex is highlighted.

Daivonex ointment contains 50µg/g calcipotriol. Daivonex ointment is a smooth, white, preservative- free base.

Feature:

  • Topical formulation of the vitamin D derivative (calcipotriol)
  • Normalizing abnormal cell proliferation and differentiation in psoriatic skin.
  • Inducing differentiation and suppressing proliferation of skin cells (keratinocytes)
  • Reducing the inflammation due to the activity of immune system

 

  • Psoriasis vulgaris

Minor advers effects such as transient local irritation and, very rarely, facial dermatitis may occur.

Over- dosage: Excessive use(more than 100g Daivonex weekly) may cause elevated serum calcium, which rapidly subsides when the treatment is discontinued.

Hypersensitivity to any of the constituents.

Use in pregnant women and children: Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex in human pregnancy has not been established.

Daivonex ointment should be applied twice daily to the affected skin lesions. For some patients the maintenance therapy may be achieved with less frequent application.

What is the maximum size of skin areas that can be treated with Daivonex®? 

Clinical studies have demonstrated that calcipotriol does not cause hypercalcaemia when used as recommended with a weekly dose not exceeding 100 g.

Usually this will be enough to treat 15-20% of the body surface twice daily, but the usage differs a lot from person to person. It is therefore possible to treat patients with much larger lesions.

In some of our clinical trials 40-50% of the body surface has been covered with lesions. In very severe cases it is of course possible to start treatment on smaller lesions, e.g. on the legs, and when they have cleared proceed to the body. 

Can Daivonex® be mixed or diluted with other products? 

We do not recommend any kind of mixing or dilution of Daivonex®, primarily because the stability of the product is challenged every time. Daivonex® can be very instable under certain circumstances and the conversion velocity can be very high, especially if the adjusted pH value of Daivonex® is challenged with more acid products. Corticosteroid products are also acidic with a buffer system.

We have not investigated all the interactions that may be possible when Daivonex® is mixed with other products.

Can Daivonex® is mixed with salicylic acid? 

We would not recommend direct mixing of Daivonex® with salicylic acid or any other acidic products, because calcipotriol will be inactivated due to its low pH value.

Normally patients will not directly mix the formulations on the skin which would of course be comparable to mixing the formulations in the laboratory.

Patients may use Daivonex® in the morning and salicylic acid in the evening for the first 3-4 days or salicylic acid for 3-4 days followed by Daivonex® twice a day with no expected special risk of accelerated calcipotriol breakdown. Application of salicylic acid to the skin does not influence skin surface pH to any extent that could influence the stability of calcipotriol in its in vivo situation.

Can Daivonex® be used in the genital area? 

In general we do not recommend the use of Daivonex® in the genital area.
The German authorities in particular are greatly concerned about application of creams and ointments to the genital/anal area, as the base cream/ointment may compromise the use of condoms. This potential problem is not specifically related to Daivonex®.

As compromised condoms may contribute to unwanted pregnancy, spread of HIV infection etc. we are not in a position to recommend this particular use of our product.

آیا می توان از دایونکس در پسوریازیس flexural (معکوس) استفاده نمود؟

بله، می توان از دایونکس برای درمان این نوع پسوریازیس استفاده نمود اگرچه مصرف آن در این زمینه تأیید نشده است.چناچه از مطالعات بر می آید مصرف دو بار در روز دایونکس به مدت 6 هفته می تواند در بهبود این نوع پسوریازیس موثر واقع گردد؛ اگرچه سوختگی خفیف به عنوان عوارض جانبی این دارو گزارش شده است. اما در اکثر موارد هیچ اثر ناخواسته ای دیده نشده است.

لازم به ذکر است که پسوریازیس flexural (معکوس) در چین و چروکهای بدن نظیر کشاله ران و چروکهای زیر سینه به وجود می آید که در آن ضایعاتی به رنگ قرمز و با حاشیه مشخص تشکیل می شود. با وجودی که پوسته های نقره ای روی سطح ضایعات مشاهده نمی شوند ولی ممکن است در کناره های آن به وجود آیند. این نوع پسوریازیس ممکن است به صورت ثانویه و در اثر نوعی عفونت به وجود آید که در نتیجه تشخیص دقیق این بیماری را مشکل می کند. در صورتی که ضایعات به درمانهای ضدباکتریایی و یا ضد قارچی پاسخ مناسب ندهند احتمال وجود پسوریازیس تقویت می شود. آنچه در درمان این ضایعات اهمیت دارد این است که استفاده ازپمادهای موضعی بهتر از سایر روشهای درمانی در بهبود زخمها موثر است. "تار" و "دیترانول" باعث ایجاد سوزش در محل ضایعه شده و "استروئیدها" خطر آتروفی را افزایش می دهند. در نتیجه به نظر می رسد دایونکس بهترین انتخاب در این رابطه باشد.

Can Daivonex® be used in pregnant women? 


Although studies in experimental animals have not shown any teratogenic effect, the safety of Daivonex® (calcipotriol) for use during human pregnancy has not yet been established and therefore Daivonex® is not recommended in pregnant patients unless there is no safer alternative.

What is the shelf life of Daivonex® cream after opening the tube? 

The shelf life of Daivonex® cream is 2 years after the date of manufacturing, when stored at controlled room temperature (25oC or below). This is also the case after opening the tube.

Is psoriasis a blood disorder? 

Psoriasis is not a blood disorder. Psoriasis is a disorder of the immune system. It causes excessive reproduction of skin cells, thus resulting in skin thickening and scaling.

Is Daivonex® a complete control of psoriasis? 

If by complete control of psoriasis you mean a cure for the disease then the answer is NO. Since psoriasis is a genetically determined disease, currently there are no treatments to cure this disease. Daivonex® is used to control the symptoms of the disease during the flare-up phase but it can also be used during the maintenance period.

1-What happens if I overdose?

 

 

If you suspect an overdose, or if DAIVONEX Ointment (Calcipotriol) has been ingested, call an emergency room or poison control center near you. Symptoms of an overdose of DAIVONEX Ointment (Calcipotriol) include weakness, fatigue, drowsiness, dizziness, headache, decreased appetite, nausea, vomiting, and high levels of calcium in the blood.

2-What are the possible side effects of DAIVONEX Ointment (Calcipotriol)?

Calcipotriol has been shown in clinical trials to have an excellent safety profile. Reports of hypercalemia are rare.

3-What is Psoriasis?

Psoriasis is a long-term (chronic) skin problem that causes skin cells to grow too quickly, resulting in thick, white, silvery, or red patches of skin. Normally, skin cells grow gradually and flake off about every 4 weeks. New skin cells grow to replace the outer layers of the skin as they shed. But in psoriasis, new skin cells move rapidly to the surface of the skin in days rather than weeks. They build up and form thick patches called plaques (say "plax").
The patches range in size from small to large. They most often appear on the knees, elbows, scalp, hands, feet, or lower back. Psoriasis is most common in adults. But children and teens can get it too

4-What Causes Psoriasis?

Experts believe that psoriasis occurs when the immune system overreacts, causing inflammation and flaking of skin.
In some cases, psoriasis runs in families. Researchers are studying large families affected by psoriasis to find out how it is passed from parents to their children and what might trigger the condition.

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