Rosen Plus0.03 mg+3 mg+0.415 mg

Rosen Plus is a combined hormonal oral contraceptive (drospirenone + ethinyl estradiol) with added levomefolate calcium (an active form of folate). It is indicated in reproductive-aged females for the following, classified by strength of evidence:

Established / Approved Uses

• Prevention of pregnancy in females who elect to use this product as their method of contraception.
• Increasing folate levels to reduce the risk of neural tube defects (NTDs) in a pregnancy conceived while taking Rosen Plus or shortly after discontinuation, in females who become pregnant while using or soon after stopping this product.

Guideline-Supported / Adjunct Uses (in females who have chosen oral contraception)

• Treatment of moderate acne vulgaris in females at least 14 years of age who have started menstruation, desire contraception, have no known contraindication to oral contraceptive use, and have reached menarche.
• Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females who choose to use an oral contraceptive as their method of contraception (not for use solely for PMDD without a contraceptive need).

Rosen Plus does not protect against sexually transmitted infections, including HIV.

Each active film-coated tablet of Drospirenone + Ethinyl Estradiol + Levomefolate contains:

• Drospirenone 3 mg (a synthetic progestin with antimineralocorticoid and antiandrogenic activity)
• Ethinyl estradiol 0.02 mg (20 mcg) (a synthetic estrogen)
• Levomefolate calcium 0.451 mg (equivalent to 0.4 mg folate)

A 28-day regimen typically consists of 24 active tablets containing all three components, followed by 4 non-hormonal tablets containing levomefolate calcium 0.451 mg alone.

Rosen Plus is a combined oral contraceptive (COC) that pairs an estrogen-progestin hormonal contraceptive with a folate supplement. Drospirenone is a spironolactone-derived progestin that also has mild antimineralocorticoid (potassium-sparing) and antiandrogenic properties. Ethinyl estradiol is a synthetic estrogen that works together with the progestin to suppress ovulation. Levomefolate calcium is the biologically active form of folate (vitamin B9), added to raise folate levels in women of reproductive age in case pregnancy occurs during use or soon after stopping.

Rosen Plus is intended for females of reproductive potential and is taken once daily, generally in a 28-day cyclic regimen.

Rosen Plus belongs to the therapeutic class of combined hormonal contraceptives (estrogen-progestin combination), further supplemented with a folate (vitamin B9) preparation. It falls under the broader category of female sex hormones used for fertility control.

Pharmacodynamics: Drospirenone + Ethinyl Estradiol + Levomefolate prevents pregnancy through combined mechanisms including inhibition of the hypothalamic-pituitary-ovarian axis (suppressing gonadotropin release and thereby ovulation), thickening of cervical mucus (impeding sperm penetration), and alteration of the endometrium (reducing the likelihood of implantation). Drospirenone additionally has antimineralocorticoid activity, which can increase serum potassium in at-risk individuals, and antiandrogenic activity.

Pharmacokinetics: Drospirenone and ethinyl estradiol are well absorbed orally, undergo hepatic metabolism (drospirenone partly via CYP3A4, though not solely dependent on it), and are eliminated with elimination half-lives of approximately 30 hours (drospirenone) and 24 hours (ethinyl estradiol) respectively. Levomefolate calcium is a folate salt that is absorbed and directly utilized as the active folate form without requiring enzymatic conversion, allowing it to raise blood folate levels effectively, including in individuals with reduced folate-converting enzyme activity.

Take Rosen Plus orally, once daily, at approximately the same time each day, with or without food, to help maintain consistent hormone levels and reduce breakthrough bleeding. Swallow the tablet whole. Take the tablets in the exact sequence indicated on the blister pack. Do not skip tablets or extend the tablet-free/folate-only interval without medical advice, as this may reduce contraceptive effectiveness.

Rosen Plus is associated with the following well-established, clinically significant interactions:

• Strong CYP3A4 inducers (e.g., rifampin, certain anticonvulsants such as phenytoin and carbamazepine, St. John's Wort) can decrease hormone levels and reduce contraceptive effectiveness; an alternative or back-up contraceptive method should be considered.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, certain macrolide antibiotics such as clarithromycin) may increase hormone exposure and side effects.
• Hepatitis C combination therapy containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir) is contraindicated with Rosen Plus due to risk of ALT elevations.
• Potassium-elevating drugs (ACE inhibitors, angiotensin II receptor blockers, potassium-sparing diuretics, NSAIDs, potassium supplements) can, in combination with the antimineralocorticoid activity of drospirenone, increase the risk of hyperkalemia; potassium monitoring is recommended in at-risk patients (see Precautions and Warnings).
• Lamotrigine: Rosen Plus can significantly decrease lamotrigine plasma concentrations, potentially reducing seizure control; dose adjustment of lamotrigine may be needed under physician supervision.

Common side effects of Rosen Plus (reported in roughly 2% or more of users) include:

• Headache/migraine
• Menstrual irregularities (breakthrough bleeding, spotting) or, less commonly, amenorrhea
• Nausea and/or vomiting
• Breast pain or tenderness
• Mood changes

Less common but serious effects can include hyperkalemia, venous or arterial thromboembolism (DVT, PE, stroke, myocardial infarction), gallbladder disease, hepatic adenoma, hypertension, and, rarely, allergic reactions. See Contraindications and Precautions and Warnings for details on serious risks and warning signs requiring prompt medical attention.

Pregnancy: Rosen Plus is contraindicated in known or suspected pregnancy, as there is no indication for its use during pregnancy. If pregnancy is confirmed while taking this medicine, discontinue immediately and consult a physician. Although folate supplementation in this product is intended to reduce neural-tube-defect risk if conception occurs on therapy, the hormonal components themselves are not intended for use during an established pregnancy; use only under medical guidance if any pregnancy exposure has occurred.

Lactation: Combined hormonal contraceptives such as Rosen Plus can reduce the quantity and quality of breast milk and are generally not recommended until breastfeeding is well established or has been discontinued. Small amounts of drospirenone pass into breast milk. Nursing mothers who wish to use hormonal contraception should discuss non-estrogen-containing alternatives with their physician, and use Rosen Plus only if the benefits clearly outweigh the potential risk to the breastfed infant.

Before and during use of Rosen Plus, the following warnings apply:

• Thromboembolic risk: Combined hormonal contraceptives, including drospirenone-containing products, increase the risk of serious blood clots (DVT, PE, stroke, MI). Some epidemiologic studies suggest drospirenone-containing products may carry a higher VTE risk than levonorgestrel-containing products; discuss individual risk factors with a physician. Discontinue immediately if a thrombotic event is suspected.
• Hyperkalemia: Due to the antimineralocorticoid activity of drospirenone, Rosen Plus can increase serum potassium. Use caution and consider potassium monitoring in patients with renal, hepatic, or adrenal impairment, or those on other potassium-elevating medications.
• Cardiovascular risk: Risk of stroke and myocardial infarction increases with age, smoking, hypertension, diabetes, obesity, and other cardiovascular risk factors; discontinue if new severe headache, visual disturbance, or signs of stroke/MI occur.
• Hepatic effects: Discontinue if jaundice develops; use caution in patients with liver disease.
• Blood pressure: Monitor blood pressure periodically; discontinue if a significant, sustained increase occurs.
• Irregular bleeding: Evaluate persistent or unexplained irregular vaginal bleeding.
• Mood changes: Monitor for new or worsening depressive symptoms.

See Contraindications for conditions in which Rosen Plus must not be used at all.

There are no reports of serious harm from acute overdose of Rosen Plus. Overdose may cause nausea, vomiting, or withdrawal-type vaginal bleeding in females. Because of the drospirenone component, there is a theoretical risk of hyperkalemia and mild metabolic acidosis with significant overdose, particularly in patients with renal impairment or those taking other potassium-elevating drugs.

If an overdose is suspected, seek immediate medical attention or contact a poison control center right away. Do not attempt specific home treatment; management should be supportive and supervised by a healthcare professional, who may check serum electrolytes (including potassium) as clinically indicated.

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

Renal impairment: Use with caution; drospirenone's antimineralocorticoid activity can increase serum potassium, so Rosen Plus should be avoided or used with close potassium monitoring in patients with renal insufficiency.

Hepatic impairment: Contraindicated in active liver disease, hepatic tumors, or significant hepatic impairment (see Contraindications).

Adrenal insufficiency: Contraindicated, due to risk of hyperkalemia from drospirenone's antimineralocorticoid effect.

Obesity: Contraceptive effectiveness may be reduced in women with a higher body mass index; discuss alternative or additional contraceptive methods with a physician.

Smokers over age 35: Contraindicated due to significantly increased cardiovascular risk (see Contraindications).

Elderly/postmenopausal females: Not indicated; Rosen Plus is intended for reproductive-aged females only.

Pediatric/adolescent use: See Pediatric Uses.

Rosen Plus may be used continuously, cycle after cycle, for as long as pregnancy prevention (or the relevant approved indication) is desired and no contraindication develops. Periodic medical review (at least annually, and sooner if new risk factors or symptoms arise) is recommended to reassess the ongoing appropriateness of therapy, blood pressure, and overall risk profile.

Drospirenone + Ethinyl Estradiol + Levomefolate belongs to the following drug classes:

• Combined hormonal contraceptives (estrogen + progestin)
• Progestin: drospirenone (a spironolactone-derived progestin)
• Estrogen: ethinyl estradiol
• Vitamin/folate supplement: levomefolate calcium (active folate)

Drospirenone + Ethinyl Estradiol + Levomefolate works primarily by suppressing the hypothalamic-pituitary-ovarian axis, which inhibits gonadotropin (LH/FSH) release and thereby prevents ovulation. It also thickens cervical mucus to impede sperm transport and alters the endometrial lining to make implantation less likely. The levomefolate calcium component supplies the biologically active form of folate directly, raising red-blood-cell and plasma folate levels without needing enzymatic conversion, which helps reduce the risk of neural tube defects should pregnancy occur during or shortly after use.

X (legacy FDA pregnancy category historically applied to combined hormonal contraceptives, reflecting that use during known or suspected pregnancy is contraindicated)

Rosen Plus is not indicated before menarche. For the acne indication, safety and effectiveness have been established in females at least 14 years of age who have started menstruation, desire contraception, and have no contraindication to oral contraceptive use; it should be prescribed only after menarche has occurred. Safety and efficacy for contraception or PMDD in adolescents younger than the approved acne age threshold, or in premenarcheal females for any indication, have not been established, and Rosen Plus is not intended for use in that population.