Description
Release form
Tablet set
Packing
21 pcs
Pharmacological action
DIVINA – combined hormonal drug
Pharmacodynamics
Estradiol valerate is an ester of natural estrogen – estradiol. The pharmacological effects of estradiol are via specific estrogen receptors in target tissues. By binding to specific receptors, estrogens, among other effects, stimulate endometrial growth and promote the development of secondary sexual characteristics.
Medroxyprogesterone Acetate is a derivative of the natural progesterone -17-alpha-hydroxy-6-methylprogesterone. Medroxyprogesterone acetate binds to progestin-specific receptors and acts on the endometrium, transferring it from the proliferative to the secretory phase.
Estradiol stimulates endometrial growth while increasing the risk of endometrial hyperplasia and cancer. Medroxyprogesterone acetate is added to treatment to counteract this effect.
Pharmacokinetics
After ingestion of estradiol, valerate is absorbed from the gastrointestinal tract (GIT) and hydrolyzed to estradiol with esterases in the liver and small intestine wall. The maximum concentration of estradiol in plasma is reached after 4-6 hours. Circulating estradiol binds to plasma proteins, mainly globulin, sex hormone binding, and serum albumin.
Metabolites are excreted in the urine in the form of glucuronide and sulfate conjugates. A small portion of the dose is excreted with feces.
After ingestion of one tablet of the drug Divisek, the maximum concentration of medroxyprogesterone acetate in the blood plasma is reached within 1-2 hours.
Medroxyprogesterone acetate binds to plasma proteins by more than 90% (mainly with albumin). When administered orally, the half-life of medroxyprogesterone acetate is 24-48 hours. Medroxyprogesterone acetate is extensively metabolized in the liver by hydroxylation and conjugation.
Medroxyprogesterone Acetate is excreted in urine and bile.
Indications
Hormone replacement therapy (HRT) for symptoms of estrogen and progesterone deficiency.
Pregnancy and lactation
Divina is contraindicated in pregnancy and lactation
Composition
1 white tablet contains:
Active ingredient: estradiol valerate 2 mg
Supplement lactose monohydrate starch corn corn gelatin magnesium stearate talc collidone K25 indigo carmine (E132), purified water.
1 blue tablet contains:
Active ingredients: estradiol valerate 2 mg medroxyprogesterone acetate 10 mg
Excipients: lactose monohydrate starch corn gelatin magnesium stearate talcum collydone K25 indigo carmine (E132), water.
Dosage and Administration
Inside. 1 tablet per day (preferably in the evening) for 21 days, followed by a 7-day break, during which menstrual bleeding occurs, and then again start taking.
For the first 11 days, white tablets containing only estrogen are taken, then for 10 days blue tablets containing a combination of estrogen and progesterone are taken. You can start taking the drug at any time if the normal menstrual cycle has stopped or if it is irregular, and also on the 5th day after the onset of menstruation.
Menstrual bleeding begins within a week free of Divina. In the menopause, differences in the duration of the menstrual cycle may be noted. Bleeding may begin while taking the blue pill (in this case, the dose should be stopped immediately, and after stopping the bleeding, white pill may be resumed).
If you miss a pill, you should take it no later than 12 hours and then take the drug as usual.
Side effects of
From the nervous system: headache, mood changes, including anxious and depressed mood, dizziness, migraine, sleep disorders.
From the digestive system: nausea, abdominal pain, dyspepsia, vomiting, flatulence, cholecystitis, gallstone disease, diarrhea, or constipation.
From the cardiovascular system: increased blood pressure, rarely – thrombosis, a feeling of palpitations.
From the endocrine system: alopecia, hirsutism, engorgement of the mammary glands, enlargement of myomatous nodes.
Allergic reactions: rash, itching, erythema multiforme exudative, erythema nodosum.
Other: uterine bleeding, vaginal candidiasis, body weight fluctuations, peripheral edema, changes in libido, muscle cramps in the lower extremities, visual impairment, increased plasma liver transaminases (ALT and ACT), alkaline phosphatase, gamma-glutamyl transferase, lupus syndrome .
Drug Interaction
Estrogenic effect of the drug Femoston at the same time as drugs that are inducers of microsomal enzymes (barbiturates, phenytoin, carbamazepine, oxcarbazepam) herbal preparations containing Hypericum perforatum.
The estrogenic effect of the drug Femoston can be enhanced with the simultaneous administration of microsomal liver enzyme inhibitors (ritonavir, nelfinavir). The interaction of dydrogesterone with other drugs is unknown.
The patient should be informed by the physician of the medicines she is taking during HRT or taken prior to prescribing Femoston. pPro4633 dprew46 pfro46 pectrocycline means, griseofulvin).
The estrogenic effect of Divine can be increased when administered concurrently with drugs that inhibit microsomal oxidation (ketoconazole, cyclosporine).
Storage Conditions
At temperatures from 15 to 25 ° C in original packaging out of the reach of children.
Deystvuyushtee substance stradiol
Prescription conditions from
pharmacies Prescription
dosage form
tablets
Prescribing
Prescribing
For women in postmenopausal women For adults in prescribing a doctor
Orion Corporation, Finland