Dizuva Capsule
Estradiol Hemihydrate + Progesterone Micronized
1 mg+100 mg
Ziska Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 22.00 AED |
Indications
Dizuva Capsule is used for:
Vasomotor symptoms, due to menopause
Adult Dose
Oral
Vasomotor Symptoms
Indicated for women with a uterus for moderate-to-severe vasomotor symptoms related to menopause
1 capsule (1 mg/100 mg) each evening with food
Child Dose
Renal Dose
Administration
Oral Administration
Take each evening with food
Contra Indications
Undiagnosed abnormal genital bleeding
Breast cancer or a history of breast cancer
Estrogen-dependent neoplasia
Active DVT, PE, or history of these conditions
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions
Known anaphylactic reaction, angioedema, or hypersensitivity to Estradiol Hemihydrate + Progesterone Micronized
Hepatic impairment or disease
Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Precautions
Estrogen plus progestin therapy
Cardiovascular disorders and probable dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
Women’s Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of myocardial infarction (MI), stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT) in postmenopausal women (aged 50-79 yr) during 5.6 yr of treatment with daily PO conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) compared with placebo
WHI Memory Study, a substudy of the WHI study, reported an increased risk of developing probable dementia in postmenopausal women aged >65 yr during 4 yr of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, compared with placebo
Breast cancer
WHI demonstrated an increased risk of invasive breast cancer
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman
Estrogens increase the risk of gallbladder disease
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs
Monitor thyroid function in women on thyroid replacement hormone therapy
Pregnancy-Lactation
Not indicated for women who are premenopausal, pregnant, or lactating
Pregnancy
There are no data with use in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy
Lactation
Estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding females; this reduction can occur at any time but is less likely to occur once breast-feeding is well-established; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Estrogens and progestins are metabolized partially by CYP3A4
CYP3A4 inducers may reduce plasma estrogen/progestin concentration, possibly resulting in decreased therapeutic effect
CYP3A4 inhibitors may increase plasma concentrations of estrogen/progestin, possibly resulting increased adverse effects
Adverse Effects
Side effects of Estradiol Hemihydrate + Progesterone Micronized :
>10%
Breast tenderness (10.4%)
1-10%
Headache (3.4%)
Vaginal bleeding (3.4%)
Vaginal discharge (3.4%)
Pelvic pain (3.1%)
Mechanism of Action
Replaces 17 beta-estradiol and progesterone hormones
Estradiol: Estrogen replacement therapy; reduces the release of gonadotropin-releasing hormone from hypothalamus and luteinizing hormone and FSH from pituitary gland
Progesterone: Progestin replacement therapy; inhibits secretion of gonadotropins from pituitary gland; enhances cellular differentiation and generally opposes the actions of estrogens by decreasing estrogen receptor levels
Note
Dizuva 1 mg+100 mg Capsule manufactured by Ziska Pharmaceuticals Ltd.. Its generic name is Estradiol Hemihydrate + Progesterone Micronized. Dizuva is availble in Bangladesh.
Farmaco BD drug index information on Dizuva Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.