Rosen Gold0.02 mg+3 mg

Rosen Gold is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who choose to use this method of contraception.

Established/FDA-approved use

• Prevention of pregnancy in women of reproductive age who elect to use oral contraception (the sole approved indication for this bracketed formulation of Rosen Gold).

Guideline-supported non-contraceptive benefits (not the primary approved indication of this product, but recognized effects of combined oral contraceptives containing drospirenone)

• Some women using Rosen Gold experience improvement in acne and reduction in menstrual blood loss/cycle regularity as a secondary effect of ovulation suppression, though Rosen Gold is not indicated as a first-line treatment for acne or heavy menstrual bleeding on its own.

Rosen Gold is not indicated for use as a treatment for cancer, as an emergency contraceptive after unprotected intercourse, or for use by men.

Each film-coated tablet of Ethinylestradiol + Drospirenone [For oral contraception] contains:

• Drospirenone 3 mg (a synthetic progestin with antimineralocorticoid and antiandrogenic activity)
• Ethinylestradiol 0.02 mg or 0.03 mg (a synthetic estrogen), depending on the specific pack strength

Inactive/placebo tablets (hormone-free) may be included in some 28-day pack presentations to help maintain the daily dosing habit.

Rosen Gold is a combined hormonal oral contraceptive tablet containing two active hormonal components: ethinylestradiol, a synthetic estrogen, and drospirenone, a synthetic progestin derived from spironolactone that also has antimineralocorticoid (aldosterone-antagonist) and antiandrogenic properties.

Rosen Gold is taken as a fixed-dose combination, typically in a 21-active-tablet or 24-active/4-placebo-tablet cycle pack, and is used specifically to prevent pregnancy.

Rosen Gold belongs to the therapeutic class of combined hormonal oral contraceptives (estrogen-progestin combinations).

Mechanism of action

Ethinylestradiol + Drospirenone [For oral contraception] prevents pregnancy primarily through suppression of gonadotropins (follicle-stimulating hormone and luteinizing hormone), which inhibits ovulation. Additional contraceptive effects include changes in the cervical mucus that increase resistance to sperm penetration and changes in the endometrium that reduce the likelihood of implantation.

Pharmacokinetics

Drospirenone is rapidly and almost completely absorbed after oral administration, with peak plasma concentration reached within 1-2 hours; it is metabolized in the liver (not via cytochrome P450 as the major pathway) and has a plasma half-life of approximately 30 hours. Drospirenone also has antimineralocorticoid activity, which can raise serum potassium in susceptible individuals. Ethinylestradiol is well absorbed, undergoes significant first-pass conjugation, and is metabolized mainly by CYP3A4.

Rosen Gold is for oral use only. Swallow the tablet whole with water, at the same time each day, in the order indicated on the blister pack. Do not skip the placebo/inactive tablets in a 28-day pack, as they help maintain the daily pill-taking habit.

Clinically significant drug interactions

• Potassium-elevating drugs (ACE inhibitors, angiotensin receptor blockers, potassium-sparing diuretics such as spironolactone, and NSAIDs taken chronically): co-administration with Rosen Gold can increase serum potassium because drospirenone has antimineralocorticoid activity; potassium monitoring during the first treatment cycle is recommended in patients on these agents.
• Strong CYP3A4 inducers (e.g., rifampin, certain anticonvulsants such as phenytoin, carbamazepine, and topiramate, and St. John's Wort): may reduce the contraceptive efficacy of Rosen Gold by increasing ethinylestradiol metabolism; a back-up contraceptive method is advised during and for a period after co-administration.
• CYP3A4 inhibitors (e.g., certain azole antifungals, protease inhibitors): may increase hormone levels from Rosen Gold and the risk of associated adverse effects.
• Hepatitis C combination antiviral regimens containing ombitasvir/paritaprevir/ritonavir: co-administration with Rosen Gold can cause ALT elevations and is not recommended.

Always inform your physician of all medications, supplements, and herbal products being taken before starting Rosen Gold.

Common side effects

• Nausea and vomiting
• Headache
• Breast tenderness or pain
• Irregular menstrual bleeding or spotting, particularly in the first few cycles
• Mood changes
• Weight change

Serious side effects

• Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Arterial thromboembolism (stroke, myocardial infarction) - risk increased with smoking and age over 35 (see Precautions and Warnings)
• Hyperkalemia, particularly in women with risk factors (see Interactions and Precautions)
• Hypertension
• Gallbladder disease
• Hepatic adenoma (rare)

Seek immediate medical attention for signs of blood clots (leg swelling/pain, chest pain, shortness of breath, sudden severe headache, vision changes, or weakness on one side of the body) while using Rosen Gold.

Pregnancy

Rosen Gold is contraindicated in pregnancy. There is no indication for the use of combined oral contraceptives during pregnancy, and Rosen Gold should be discontinued immediately if pregnancy is confirmed or suspected. Consult a physician promptly if pregnancy occurs while using Rosen Gold.

Lactation

Combined hormonal contraceptives such as Rosen Gold can reduce milk quantity and quality and are generally not recommended until breastfeeding is well established, and caution is advised throughout lactation. A progestin-only contraceptive method is generally preferred during breastfeeding. Use Rosen Gold during lactation only if clearly needed and after consulting a physician, who can weigh the benefits against the potential effect on milk supply and infant exposure.

Boxed Warning: Cigarette smoking and cardiovascular risk

Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive use, including Rosen Gold. This risk increases with age, particularly in women over 35 years, and with the number of cigarettes smoked. Women who use Rosen Gold should be strongly advised not to smoke.

Other precautions

• Hyperkalemia risk: Because drospirenone has antimineralocorticoid activity, Rosen Gold should be used with caution, and potassium monitoring considered, in women with conditions predisposing to hyperkalemia or who are taking medications that increase potassium (see Interactions).
• Thromboembolic risk: Use of Rosen Gold increases the risk of venous and arterial thromboembolic events; risk factors such as obesity, prolonged immobilization, family history, and older age should be assessed before and during use.
• Blood pressure: Blood pressure should be monitored periodically during use of Rosen Gold, as it can cause or worsen hypertension.
• Liver function: Rosen Gold should be discontinued if jaundice develops.
• Rosen Gold does not protect against sexually transmitted infections, including HIV.

No serious harmful effects have been reported from acute overdose of Rosen Gold, and overdose may cause nausea, vomiting, or withdrawal bleeding in females. There is no specific antidote. If an overdose of Rosen Gold is suspected, seek immediate medical attention or contact a poison control center; treatment should be symptomatic and supportive as directed by a healthcare professional.

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

Pediatric use

Rosen Gold is indicated only after menarche (onset of menstruation) in females who require contraception; safety and efficacy of Rosen Gold have not been established in premenarchal females, as this product is not intended for use prior to menarche.

Use in older reproductive-age women

The risk of serious cardiovascular events from Rosen Gold increases with age, particularly after age 35, especially in smokers. Rosen Gold is generally not recommended for women over 35 who smoke.

Renal impairment

Rosen Gold is contraindicated in significant renal impairment due to the risk of hyperkalemia from drospirenone's antimineralocorticoid effect (see Contraindications).

Hepatic impairment

Rosen Gold is contraindicated in active liver disease or hepatic tumors (see Contraindications).

Use in men

Rosen Gold is not indicated for use in men.

Rosen Gold may be used continuously, cycle after cycle, for as long as contraception is desired and no contraindications develop, subject to periodic medical review (including blood pressure checks). There is no fixed maximum duration of use; the decision to continue Rosen Gold should be reassessed periodically with a physician, particularly as risk factors such as age and smoking status change over time.

Ethinylestradiol + Drospirenone [For oral contraception] belongs to the drug classes: combined oral contraceptive; estrogen-progestin combination. Its progestin component, drospirenone, is a spironolactone-derived progestin with antimineralocorticoid and antiandrogenic activity.

Ethinylestradiol + Drospirenone [For oral contraception] works mainly by suppressing the hypothalamic-pituitary-ovarian axis (inhibiting FSH and LH release), which prevents ovulation. It also thickens cervical mucus to impede sperm transport and alters the endometrial lining to reduce the likelihood of implantation, together preventing pregnancy.

Rosen Gold may be prescribed for contraception in adolescent females who have started menstruating (post-menarche) and require pregnancy prevention. Safety and efficacy of Rosen Gold have not been established in premenarchal patients, and Rosen Gold is not indicated for this population. Use in adolescents should follow the same dosing as in adult women, with attention to counseling on adherence, missed doses, and the smoking-related cardiovascular warning.