Estradiol Transdermal System

Active substance:

Content

Pharmacological groups

Nosological classification (ICD-10)

Description of the dosage form

The oval-shaped patch (about 4.5 cm by 3.3 cm, which corresponds to 12.5 cm 2), consisting of a transparent carrier film with a transparent homogeneous matrix containing the active substance.

The oval-shaped patch (about 6.3 cm by 4.7 cm, which corresponds to 25 cm 2), consisting of a transparent carrier film with a transparent homogeneous matrix containing the active substance.

pharmachologic effect

Pharmacokinetics

Estradiol is released from the patch (50 µg daily) and transdermally enters the bloodstream at a constant rate, maintaining a given level of hormone in the plasma.

Indications drug Klimara ®

Hormone replacement therapy for disorders caused by natural or surgical menopause (only in case of non-cancer diseases): vasomotor symptoms (flushes of heat, sweating), sleep disorders, atrophic processes.

Prevention of postmenopausal osteoporosis.

Contraindications

Hypersensitivity, breast tumors, endometriosis, liver tumors, sex steroid hormone-dependent tumors, vaginal bleeding of unknown etiology, thromboembolic processes (thrombophlebitis, thrombosis), pregnancy, breast-feeding.

Use during pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects

Information on the incidence of adverse events in the application of Klimara ® (MedDRA – Medical Dictionary of Regulatory Activity) is reflected below. The information is based on data from clinical studies. The most frequent adverse reactions reported during clinical trials were skin irritation at the site of application and pain in the breast (>ten%). Local symptoms at the site of application are mostly mild and include redness, itching, burning, and vesicle formation.

On the part of the gastrointestinal tract: often (≥1 / 100 and ® can neither be refuted nor proved.

Congenital hereditary genetic diseases: worsening of symptoms of concomitant porphyria.

On the part of the digestive tract: vomiting.

On the part of the liver: cholestatic jaundice.

Mental disorders: change in libido.

Reproductive system, mammary glands: change in the size of uterine leiomyoma, changes in cervical secretion in volume.

Skin and subcutaneous tissues: chloasma or melasma, which can persist after discontinuation of the drug, allergic contact dermatitis, post-inflammatory itching, generalized exanthema.

In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema (see “Special Instructions”).

Dosage and administration

Treatment of symptoms of menopausal syndrome. Treatment begins with the lowest dose of Klimara® plaster. If necessary, you can use a more highly dosed patch. After dose adjustment, the lowest effective dosage of the patch should be used to alleviate the symptoms.

Prevention of osteoporosis. Treatment to prevent postmenopausal bone loss should be started immediately after menopause. Long-term treatment based on an individual approach is recommended. Treatment should be carried out either continuously or cyclically.

When switching from long-term continuous or cyclic therapy: treatment should begin the day after the end of the previous treatment regimen. Estrogen-only therapy is used if the woman has had a hysterectomy. In women with an intact uterus, a progestogen should be added to treatment with Klimara ® for 10–14 days every month. When using a patch that releases more than 50 μg of the hormone / day, no protective effect on the endometrium was detected by adding progestogens.

Estradiol Transdermal System

The patch should be attached weekly in continuous mode, each used patch must be removed after 7 days, after which the fresh patch is attached to another place. Patches may also be recommended for cyclical treatment. In this case, the patch is attached weekly for 3 consecutive weeks, followed by a 7-day interval without attaching the patch until the next course of treatment.

Menstrual-like bleeding normally develops 2–3 days after stopping gestagens.

Estradiol Transdermal System

The method of attaching the patch. After removing the protective film, Klimara® adhesive tape is attached to the clean, dry skin area along the spine or buttocks with an adhesive side. Klimara ® should not be attached in the area of ​​the mammary glands or close to them. The area chosen to fix the patch should not be greasy, damaged or irritated, you should also avoid the waist,

Late replacement or loss of plaster. If the patch is peeled off before the end of the 7-day course of treatment, you can try to glue it again. If necessary, you can glue the new patch on the remaining days of the 7-day interval of application.

If the patient has forgotten to change the patch in time, the replacement should be made as soon as possible after establishing the fact of the pass. A new patch should be used after the end of the normal 7-day treatment period.

Precautionary measures

Before use, it is necessary to conduct a complete general medical and gynecological examination (including examination of the mammary glands, cytology of the cervical smear), exclusion of pregnancy. Do not put a plaster on the area of ​​the mammary glands or waist. If the patch is applied correctly, then you can take a bath or shower, but you need to consider that in hot water the patch can peel off. You must inform your doctor about the presence of diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, minor chorea, heart failure, disorders of the liver or kidneys, migraine, and the simultaneous reception of barbiturates, phenylbutazone, hydantoin , rifampicin, the appearance of irregular bleeding or unusually heavy bleeding between the use of the drug, discomfort in the epigastric region.

In the course of treatment, it should be borne in mind that prolonged use of estrogens only in menopause can lead to endometrial hyperplasia and increase the risk of endometrial cancer. To reduce the risk of endometrial cancer, additional progestogen is needed (usually within 10–12 days per month), which leads to the transition of the uterine mucosa to the secretory phase with its rejection and subsequent menstrual-like bleeding after stopping the introduction of progestogen.

Release form

Patch – transdermal therapeutic system 3.9 mg / 12.5 2; 7.8 mg / 25 2. In the package of the contour boxless 1 pc. In a carton box 4 packs.

Estradiol Transdermal System

Manufacturer

Bayer Weimar GmbH & Co. KG, Germany.

RU owner: Bayer Pharma AG, Germany.

Additional information can be obtained at the following address: 107113, Moscow, 3rd Rybinskaya Str., 18,

Tel .: +7 (495) 231 12 00 Fax: + (495) 231 12 02.

Pharmacy sales terms

Storage conditions drug Klimara ®

Keep out of the reach of children.

Expiration date of the drug Klimara ®

Do not use after the expiration date printed on the package.

Like this post? Please share to your friends:
Leave a Reply