ROZY DS DS Tablet
Drospirenone + Estradiol
0.5mg + 1.0mg
Square Pharmaceuticals Ltd.
| Pack size | 15's Pack |
|---|---|
| Unite Price | 24.00 BDT |
Indications
ROZY DS DS Tablet is used for:
Hormone replacement therapy (HRT),
Climacteric syndrome in postmenopausal women including vasomotor symptoms (such as hot flushes and sweating attacks), sleep disorders, depressed moods, nervousness and atrophic, urogenital conditions caused by deficient endogenous estrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure in women with an intact uterus, Prevention of postmenopausal osteoporosis
Adult Dose
Hormone Replacement Therapy
Oral
Tablet
1 tablet PO daily
Hepatic impairment
In women with mild or moderate hepatic impairment, DRSP is well tolerated. It is contraindicated in women with severe hepatic disease
Child Dose
Renal Dose
Renal Impairment
In women with mild or moderate renal impairment, a slight increase of Drug Resistant Streptococcus Pneumoniae exposure was observed but is not expected to be of clinical relevance. It is contraindicated in women with severe renal disease.
Administration
Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid irrespective of food intake. The tablets should preferably be taken at the same time every day.
For treatment of postmenopausal symptoms, the lowest effective dose should be used.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
Contra Indications
Hormone replacement therapy (HRT) should not be started in the presence of any of the conditions listed below. The product should be stopped immediately, if any of the conditions appear during HRT use.
Undiagnosed abnormal genital bleeding
Known or suspected cancer of the breast
Known or suspected premalignant conditions or malignancies, if sex steroid-influenced
The excess risk disappears within a few years after stopping HRT.
Endometrial cancer
Prolonged exposure to unopposed estrogens increases the risk of development of endometrial hyperplasia or carcinoma. The addition of DRSP opposes the development of endometrial hyperplasia caused by estrogens.
Liver tumors
In rare cases benign, and even more rarely, malignant liver tumors have been observed after the use of hormonal substances such as those contained in HRT products. In isolated cases, these tumors led to life-threatening intra-abdominal hemorrhage.
Precautions
Before initiating therapy, all conditions/risk factors mentioned below should be considered when determining the individual benefit/risk of treatment for the patient.
During HRT use, therapy should be discontinued immediately in case a contraindication is discovered, as well as in the following situations:
1. Migrainous or frequent and unusually severe headaches that occur for the first time or other symptoms that are possible prodromal of cerebrovascular occlusion.
2. Recurrence of cholestatic jaundice or cholestatic pruritus which occurred first during pregnancy or previous use of sex steroids.
3. Symptoms of a thrombotic event.
In the event of new onset or deterioration of the following conditions or risk factors, the individual benefit/risk analysis should be re-done, taking into consideration the possible necessity of discontinuing therapy.
The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increased risk may be greater than a simple cumulative risk of the factors. HRT should not be prescribed in case of a negative risk benefit assessment.
Pregnancy-Lactation
Pregnancy Category: contraindicated in pregnancy
Lactation: enters breast milk/not recommended
Interactions
Pharmacodynamic interaction with antihypertensive medications and non-steroidal anti-inflammatory drugs (NSAID)
Hypertensive women treated with this combination drugs and anti-hypertensive medications, e.g. ACE inhibitors, angiotensin II receptor antagonists, and hydrochlorothiazide may experience an additional decrease in blood pressure.
Combined use of this and NSAIDs or antihypertensive medications is unlikely to increase serum potassium. Concomitant use of these three types of medications together may cause a small increase in serum potassium, more pronounced in diabetic women.
Side Effects
Side effects of Drospirenone + Estradiol :
>10%
Breast pain (19%)
Upper respiratory infection (19%)
Abdominal pain (11%)
1-10%
Edema
Peripheral edema
Headache
Accidental injury, back pain, pain in extremity
Endometrial disorder
Leukorrhea
Vaginal hemorrhage
Abdominal enlargement
Flu syndrome
Sinusitis
Mode of Action
Estradiol: Endogenous estrogen; reduces the release of gonadotropin-releasing hormone from hypothalamus, reduces release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from pituitary gland; increases synthesis of DNA, RNA, and various proteins in target tissues. Estrogen replacement reduces elevated levels of estrogen and progesterone LH and FSH in postmenopausal women
Drospirenone: Progestin; spironolactone analog with antimineralocorticoid and antiandrogenic activity
Note
ROZY DS 0.5mg + 1.0mg DS Tablet generic name is Drospirenone + Estradiol. ROZY DS 0.5mg + 1.0mg DS Tablet is manufactured by Square Pharmaceuticals Ltd.ROZY DS is availble in all over Bangladesh.
Mes BD drug index information on ROZY DS DS Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.