Rosen Plus
Rx0.03 mg+3 mg+0.415 mg • Tablet
Indications & Uses
Rosen Plus is indicated for:
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 Take this contraceptive pill: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, this contraceptive pill must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.How to Start this contraceptive pill: Instruct the patient to begin taking this contraceptive pill either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).Day 1 Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. If this contraceptive pill is first taken later than the first day of the menstrual cycle, this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.Sunday Start: During the first cycle of this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. this contraceptive pill can be taken without regard to meals. this contraceptive pill should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as backup during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.The patient should begin her next and all subsequent 28-day regimens of this contraceptive pill on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of this contraceptive pill is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink contraceptive pill daily for seven consecutive days.When switching from a different birth control pill: When switching from another birth control pill, this contraceptive pill should be started on the same day that a new pack of the previous oral contraceptive would have been started.
Side Effects
The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)
Cautions & Contraindications
Warnings & Precautions
Vascular risks: Stop this contraceptive pill if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating this contraceptive pill in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.Liver disease: Discontinue this contraceptive pill if jaundice occurs.High blood pressure: Do not prescribe this contraceptive pill for women with uncontrolled hypertension or hypertension with vascular disease.Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this contraceptive pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.Headache: Evaluate significant change in headaches and discontinue this contraceptive pill if indicated.Uterine bleeding: Evaluate irregular bleeding or amenorrhea.
Contraindications
Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases Undiagnosed abnormal uterine bleeding Breast cancer or other estrogen- or progestin-sensitive cancer Liver tumors or liver disease Pregnancy