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All price changes →Rozy DS
Rx1 mg+0.5 mg • Tablet
More from Rozy DS
Other strengths and forms by Square Pharmaceuticals PLC, Pabna
Indications & Uses
Rozy DS is indicated for:
Pharmacology
Drospirenone and estradiol combines 173-estradiol, which is chemically and biologically identical to endogenous human E2, with the synthetic progestogen, DRSP. The 173-estradiol provides hormone replacement during and after the climacteric. DRSP helps control bleeding and opposes the endometrial hyperplasia that estrogens can cause.
Effects of estradiol: When the ovaries stop working, estrogen and progesterone production falls. This leads to the menopausal syndrome, which shows up as vasomotor and organic symptoms. Hormone replacement therapy is indicated to remove these complaints. Of all the physiological estrogens, E2 is the most potent and has the highest affinity for the estrogen receptor. The estrogen target organs include, in particular, the uterus, hypothalamus, pituitary, vagina, breast and bones (osteoclasts).
Other effects of estrogens include lower insulin and blood glucose concentrations, local vasoactive effects mediated by receptors, and receptor-independent effects on vascular smooth muscle. Estrogen receptors have been found in the heart and coronary arteries. In certain cases of hypercholesterolemia, taking natural estrogens by mouth is an advantage, because it gives the greatest beneficial metabolic effects of the liver on lipids.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
How to start
Women who don't take estrogens, or who are changing from a continuous combination product, can start treatment at any time. Women changing from a continuous sequential or cyclic HRT should finish their current cycle of therapy before they begin Drospirenone + Estradiol.
Dosage
Take one tablet daily.
Missed tablets
If a tablet is forgotten, take it as soon as possible. If more than 24 hours have passed, there is no need to take an extra tablet. If several tablets are forgotten, bleeding may occur.
Side Effects
The most commonly reported adverse drug reactions (ADRs) with Ethinylestradiol & Drospirenone are breast pain, bleeding from the female genital tract, and pains in the stomach and abdomen. These occur in more than 6% of users. Bleeding irregularities usually settle as treatment continues, and bleeding becomes less frequent the longer treatment goes on. The serious adverse reactions are arterial and venous thromboembolic events, as well as breast cancer.
Cautions & Contraindications
Warnings & Precautions
Before starting Drospirenone + Estradiol, all the conditions and risk factors below should be considered, so the benefit and risk of treatment can be decided for each patient. If a contraindication is discovered during HRT use, stop the therapy immediately. Stop it immediately in these situations too: Migrainous or frequent and unusually severe headaches that occur for the first time, or other symptoms that may be early signs of cerebrovascular occlusion. Cholestatic jaundice or cholestatic pruritus that comes back, having first occurred during pregnancy or earlier use of sex steroids. Symptoms of a thrombotic event. If any of the following conditions or risk factors appears for the first time or gets worse, the benefit/risk analysis for that patient should be done again, and the possible need to stop therapy should be taken into account. Women who have a combination of risk factors, or one risk factor that is especially severe, may face a higher combined risk of thrombosis. This risk may be greater than the factors would give if simply added together. HRT should not be prescribed when the risk benefit assessment is negative. Venous thromboembolism Both randomized-controlled studies and epidemiological studies suggest a higher relative risk of venous thromboembolism (VTE), that is deep venous thrombosis or pulmonary embolism. So the benefit and risk should be weighed carefully with the patient when HRT is prescribed to a woman who has a risk factor for VIE. The generally recognized risk factors for VTE are a personal history, a family history and severe obesity. (VTE in a direct relative at a relatively early age may point to a genetic disposition.) The risk of VTE also rises with age. There is no agreement on whether varicose veins play a role in VTE. The risk of VTE may go up for a time with prolonged immobilization, major elective or post-traumatic surgery, or major trauma. Depending on the nature of the event and how long the immobilization lasts, a temporary stop to HRT should be considered.
Contraindications
Drospirenone + Estradiol, like any hormone replacement therapy (HRT), should not be started if any of these conditions is present: undiagnosed abnormal genital bleeding, known or suspected cancer of the breast, or known or suspected premalignant conditions or malignancies, if sex steroid-influenced. If any of them appear during HRT use, the product should be stopped immediately. The excess risk disappears within a few years after stopping HRT. HRT increases the density of mammographic images, and in some cases this may adversely affect the radiological detection of breast cancer. Endometrial cancer Prolonged exposure to unopposed estrogens increases the risk of developing endometrial hyperplasia or carcinoma. The addition of DRSP opposes the endometrial hyperplasia that estrogens cause. Liver tumors Benign liver tumors have been seen in rare cases, and malignant ones even more rarely, after the use of hormonal substances such as those in HRT products. In isolated cases, these tumors led to life-threatening intra-abdominal hemorrhage.
Pregnancy & Breastfeeding
Ethinylestradiol & Drospirenone must not be used during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Ethinylestradiol & Drospirenone, she should stop the treatment immediately. Small amounts of DRSP pass into the breast milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Children and adolescents: Drospirenone + Estradiol is not indicated for use in children and adolescents.
Geriatric patients: There are no data suggesting that the dose needs to be adjusted in elderly patients.
Patients with hepatic impairment: In women with mild or moderate hepatic impairment, DRSP is well tolerated. This medicine is contraindicated in women with severe hepatic disease.
Patients with renal impairment: In women with mild or moderate renal impairment, DRSP exposure was seen to rise slightly, but this is not expected to be of clinical relevance. This medicine is contraindicated in women with severe renal disease.
Overdose
Acute toxicity studies show that no acute toxicity risk is expected, even if someone accidentally takes a multiple of the therapeutic dose of Drospirenone + Estradiol. In clinical studies, up to 100 mg of DRSP was well tolerated, and so were estrogen/progestogen preparations containing 4 mg E2.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Drospirenone + Estradiol below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Rozy DS 1 mg+0.5 mg
What is Rozy DS 1 mg+0.5 mg Tablet?
Rozy DS 1 mg+0.5 mg Tablet is a medicine that contains Drospirenone + Estradiol. It is made by Square Pharmaceuticals PLC, Pabna. It belongs to the Drugs for menopausal symptoms: Hormone replacement therapy group of medicines.
What is Rozy DS used for?
Rozy DS is used for: Osteoporosis.
What are the side effects of Rozy DS?
The most commonly reported adverse drug reactions (ADRs) with Ethinylestradiol & Drospirenone are breast pain, bleeding from the female genital tract, and pains in the stomach and abdomen. These occur in more than 6% of users.
Can I take Rozy DS during pregnancy or while breastfeeding?
Ethinylestradiol & Drospirenone must not be used during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Ethinylestradiol & Drospirenone, she should stop the treatment immediately. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Rozy DS?
Acute toxicity studies show that no acute toxicity risk is expected, even if someone accidentally takes a multiple of the therapeutic dose of Drospirenone + Estradiol. In clinical studies, up to 100 mg of DRSP was well tolerated, and so were estrogen/progestogen preparations containing 4 mg E2. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Rozy DS?
Store Drospirenone + Estradiol below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Rozy DS?
Some medicines can interact with Drospirenone + Estradiol, for example: Carbamazepine, Rifampicin, Oxcarbazepine, Cimetidine, Griseofulvin, Topiramate. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Rozy DS is already among the lowest-priced brands of Drospirenone + Estradiol at this strength.
Do I need a prescription for Rozy DS?
Rozy DS is a prescription (Rx) medicine. Take it as your doctor advises.