bayer proviron

 

International nonproprietary name:

Bayer proviron

 

Dosage Form:

ointment for external use

Composition
in 1 g of ointment contains: Active ingredient : bayer proviron 50 mcg. Excipients: alpha-tocopherol 20 g, macrogol stearate 50 mg propylene glycol 100 mg Disodium edetate dihydrate 65 mg sodium dihydrogen phosphate dihydrate, 260 g paraffin liquid (containing about 10 rrsh alpha tocopherol) 50 mg, 26 mg water, white soft paraffin (about 10 rrsh contains alpha-tocopherol) to 1 g

Description: translucent ointment from white to white with a yellowish tinge.

 

Pharmacotherapeutic group:

treatment for psoriasis.

Pharmacological properties : Pharmacodynamics: bayer proviron is an analog of the natural active metabolite of vitamin D3. It stimulates morphological differentiation and inhibits proliferation of keratinocytes, which underlies its therapeutic effect for psoriasis. bayer proviron is an inhibitor of T lymphocyte activation caused by interleukin 1 Effect on the calcium metabolism of bayer proviron is 100 times weaker than calcitriol. 

Pharmacokinetics of

Transdermal Absorption of bayer proviron is from 1% to 5% of the dose. bayer proviron undergoes rapid biotransformation in the liver with the formation of pharmacologically inactive metabolites. The half-life is very short.

Indications for use
Psoriasis vulgaris (including in combination with acitretin, cyclosporine or corticosteroids).

Contraindications

 

  • Hypersensitivity to bayer proviron and any excipient of the drug;
  • Diseases associated with impaired calcium metabolism;
  • Children under 6 years of age.

 

Pregnancy and lactation
The safety of the drug during pregnancy and lactation has not been established. It is unknown whether bayer proviron in breast milk is released. Should be avoided during pregnancy and lactation.

Be wary – hypercalcemia, hypercalciuria, vitamin D hypervitaminosis, nephrolithiasis history, age over 65 years, acute renal and hepatic failure.

Dosage and administration:
Outwardly.

Adults
Apply a thin layer of ointment to the affected areas of skin 2 times a day. If necessary, the frequency of use of the drug can be reduced to 1 times per day. . The combined use of an ointment with acitretin or cyclosporin 2 times a day, effective and well tolerated
combined use of ointments with corticosteroids is performed according to the scheme, for example, cream -. In the morning, a corticosteroid -vecherom
maximum daily dose should not exceed 15 g, and the maximum weekly dose is not 100 g of a
therapeutic effect is usually observed after 1-2 weeks of treatment. The duration of treatment is not more than 6-8 weeks.

Children
in the age of over 12 years: apply ointment thin layer to affected areas of skin 2 times a day, the maximum dose per week should not exceed 75 g,
aged 6 to 12 years: apply ointment thin layer to affected areas of skin 2 times a day . The maximum dose per week, no more than 50 g.

Side effects
The data presented in accordance with the frequency of occurrence of the following:

Very often> 1/10
Most> 1/100 and <1/10
Uncommon> 1/1000 and <1/100
Rare> 1/10000 and <1/1000
Very rare <1/10000, including isolated cases

Violations of the immune system:
Very rare: allergic reactions, urticaria, angioedema,

Violations of the metabolic:
very rarely: hypercalcaemia, hypercalciuria;

Disorders of the skin and subcutaneous tissue disorders:
Common: skin irritation, rash (scaly, erythematous, maculo-papular, pustular, bullous), burning sensation, dryness and peeling of the skin, itching, erythema
Uncommon: exacerbation of psoriasis flow, eczema, contact dermatitis;
Very rare: reversible hyperpigmentation, reversible depigmentation of reversible development of photosensitivity, periorbital or facial edema.

Overdose
Use of the drug in doses higher than recommended may cause an increase in the concentration of calcium in the blood. In this case, treatment should cease.

Interaction with other drugs
Dayvoneks® ointment should not be used together with drugs for topical application containing salicylic acid.

Cautions
Do not apply ointment Dayvoneks® face. In order to avoid contact of the product with the skin of the face hands should be thoroughly washed after each application of ointment.

Appointment of patients younger than 18 years can only be short courses and on the skin surface, not exceeding 30% of the body surface.

Should not be applied to large surface lesions (more than 30% of the skin surface). Not recommended for use on large skin surfaces or in severe chronic psoriasis (due to higher absorption rate and increase the risk of hypercalcemia). If it becomes necessary to use in these forms of psoriasis, it requires careful monitoring of the concentration of calcium in the blood and urine.

Hypercalcemia may develop in excess of the maximum weekly dose of bayer proviron. In case of cancellation of the drug in the blood calcium concentration rapidly normalized.

In the case of a solution with the ointment should be taken into account that the total dose of bayer proviron should not exceed 5 mg per week (1 mL solution Dayvoneks® scalp Dayvoneks® corresponds to 1 g of ointment).

During treatment with Dayvoneks® doctors recommend patients to limit or avoid excessive exposure to either natural or artificial sunlight. Treatment can be combined with selective and PUVA – phototherapy, as well as with treatment with UV – light, if the doctor believes that the potential benefit outweighs the potential risk.

Effects on ability to drive and moving machinery
bayer proviron does not affect the ability to drive vehicles, machinery.

Product form
Ointment for external application of 0.005%.
As of 30 g or 100 g of ointment in an aluminum tube, coated on the inside with a protective membrane and a plastic screw cap having on the outside of the first opening Spike protective membrane; 1 tuba, along with instructions for use in a cardboard box.

Shelf life
2 years after opening the tube – 6 months.
Do not use beyond the expiration date printed on the package.

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