Rozy0.5 mg+0.25 mg

Rozy is indicated for use in postmenopausal women as combined estrogen-progestin hormone replacement therapy (HRT). Evidence-based indications include:

• Established/approved use: Treatment of moderate to severe vasomotor symptoms (hot flashes, night sweats) associated with menopause.
• Established/approved use: Treatment of moderate to severe symptoms of vulvovaginal atrophy due to menopause (when systemic therapy is appropriate).
• Guideline-supported use: Endometrial protection in women with an intact uterus who are receiving estrogen therapy — the progestin component (drospirenone) opposes estrogen-induced endometrial proliferation, reducing the risk of endometrial hyperplasia/cancer.

Rozy is not indicated for contraception, and this hormone replacement therapy formulation should not be interchanged with contraceptive-labeled ethinylestradiol/drospirenone products, which are formulated and dosed for a different purpose.

Each tablet of Ethinylestradiol + Drospirenone [For hormone replacement therapy] contains a fixed-dose combination of:

• Ethinylestradiol — a synthetic estrogen that replaces the estrogen deficit occurring after menopause.
• Drospirenone — a synthetic progestin derived from spironolactone, possessing additional anti-mineralocorticoid (potassium-sparing) and anti-androgenic properties.

Rozy is a fixed-dose combination hormone product containing a synthetic estrogen (ethinylestradiol) and a progestin with anti-mineralocorticoid activity (drospirenone), formulated and labeled specifically for postmenopausal hormone replacement therapy rather than for contraception. Combining an estrogen with a progestin allows relief of menopausal symptoms while protecting the endometrium from unopposed estrogen stimulation.

Rozy belongs to the therapeutic class of Hormone Replacement Therapy (HRT) agents — specifically, a combined estrogen-progestin preparation used for management of menopausal symptoms.

Ethinylestradiol + Drospirenone [For hormone replacement therapy] combines two hormonal components:

• Ethinylestradiol binds to estrogen receptors, replenishing circulating estrogen levels after menopause. This relieves vasomotor symptoms (hot flashes, night sweats) and reverses atrophic changes in the urogenital epithelium.
• Drospirenone binds progesterone receptors, converting proliferative endometrium to secretory endometrium and opposing estrogen-driven endometrial hyperplasia. It also has anti-mineralocorticoid (aldosterone-antagonist) activity, which can promote mild natriuresis and potassium retention, and anti-androgenic activity.

Because of drospirenone's anti-mineralocorticoid effect, serum potassium should be monitored in patients at risk of hyperkalemia during the first treatment cycles of Ethinylestradiol + Drospirenone [For hormone replacement therapy].

Rozy is for oral use only. Swallow the tablet whole with water, at the same time each day to maintain steady hormone levels. It may be taken with or without food. Do not stop, start, or change the dose of Rozy without consulting a physician, and follow up regularly for re-evaluation of continued need for therapy.

Clinically significant interactions with Rozy include:

• Potassium-elevating drugs — ACE inhibitors, angiotensin receptor blockers (ARBs), potassium-sparing diuretics, potassium supplements, and NSAIDs used with Rozy can raise the risk of hyperkalemia because drospirenone has anti-mineralocorticoid activity; potassium levels should be checked during the first treatment cycle when these are combined.
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort) can lower ethinylestradiol and drospirenone concentrations, reducing efficacy of Rozy and potentially causing breakthrough bleeding.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) can raise hormone levels of Rozy, increasing the risk of adverse effects.

Common side effects of Rozy include headache, breast tenderness/pain, nausea, bloating, irregular or breakthrough vaginal bleeding/spotting (especially in early cycles), and mood changes.

Less common but serious effects include venous thromboembolism, stroke, myocardial infarction, gallbladder disease, and hyperkalemia (particularly in at-risk patients — see Contraindications and Interactions). Patients should seek prompt medical attention for chest pain, sudden shortness of breath, leg swelling/pain, sudden severe headache, or vision changes while taking Rozy.

Pregnancy: Rozy is not indicated for use during pregnancy and offers no benefit in this setting; it should be discontinued immediately if pregnancy is confirmed or suspected, and the patient should consult her physician promptly.

Lactation: Use of Rozy during breastfeeding is generally not recommended, as estrogen-containing hormone products can reduce milk quantity and quality, and small amounts of hormone may pass into breast milk. A physician should be consulted before use in breastfeeding women, and only used if the potential benefit clearly justifies the potential risk to the infant.

Before and during use of Rozy, physicians and patients should consider:

• Cardiovascular and thromboembolic risk: Combined estrogen-progestin therapy is associated with an increased risk of venous thromboembolism, stroke, and myocardial infarction, particularly with longer duration of use, in older women, and in smokers over age 35.
• Hyperkalemia risk: Because drospirenone has anti-mineralocorticoid activity, serum potassium should be monitored in the first treatment cycle in patients with renal, hepatic, or adrenal conditions, or those taking interacting potassium-elevating drugs (see Interactions).
• Breast and endometrial cancer risk: Long-term combined HRT use has been associated with a small increase in breast cancer risk; periodic breast and gynecologic examination is recommended.
• Gallbladder disease: Estrogen therapy increases the risk of gallbladder disease.
• Migraine with aura: Use with caution, as there may be an increased stroke risk; seek medical advice if new or worsening migraine with aura occurs.
• Dementia risk: In women aged 65 and older, combined HRT has been associated with an increased risk of probable dementia; it is not recommended for prevention of dementia or cardiovascular disease.
• Use the lowest effective dose of Rozy for the shortest duration needed to control symptoms (see Duration of Treatment).

Overdose of Rozy may cause nausea, vomiting, breast tenderness, dizziness, abdominal discomfort, and withdrawal bleeding in women. There is no specific antidote. In case of a suspected overdose, seek immediate medical attention or contact a poison control center; treatment is supportive and symptomatic and should be provided under medical supervision.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Renal impairment: Rozy is contraindicated in renal insufficiency due to hyperkalemia risk (see Contraindications).
• Hepatic impairment: Contraindicated in severe hepatic impairment or active liver disease; use with caution and physician supervision in mild impairment.
• Elderly (≥65 years): Not recommended for prevention of cardiovascular disease or dementia; increased risks of stroke, myocardial infarction, and dementia have been observed in this age group with combined HRT.
• Pediatric patients: Not indicated; safety and efficacy have not been established (see Pediatric Uses).

Rozy should be used at the lowest effective dose for the shortest duration consistent with treatment goals and individual risks and benefits. Physicians should re-evaluate the need for continued therapy at least annually, or sooner if new risk factors develop.

Ethinylestradiol + Drospirenone [For hormone replacement therapy] belongs to the drug classes: Estrogen-progestin combinations; Sex hormones and modulators of the genital system; Hormone replacement therapy agents.

Ethinylestradiol + Drospirenone [For hormone replacement therapy] works through two complementary mechanisms: ethinylestradiol, a synthetic estrogen, binds estrogen receptors to relieve menopausal vasomotor and urogenital symptoms, while drospirenone, a progestin with anti-mineralocorticoid and anti-androgenic activity, converts the endometrium to a secretory state and opposes unopposed-estrogen-induced endometrial hyperplasia.

Rozy is not indicated for use in pediatric patients. It has no role before menarche, and safety and efficacy in children and adolescents have not been established.