Rosen Star Tablet 0.02 mg+3 mg+0.415 mg

Uses

Oral Contraceptive: This is indicated for use by women to prevent pregnancy.Premenstrual Dysphoric Disorder (PMDD): This contraceptive preparation is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose ... Read more

Rosen Star Tablet 0.02 mg+3 mg+0.415 mg is also used to associated treatment for these conditions: Abnormal Uterine Bleeding, Acne Vulgaris, Endometriosis, Hypermenorrhea, Idiopathic Hirsutism, Menstrual Distress (Dysmenorrhea), Menstrual Irregularities, Osteoporotic Fractures, Pregnant State, Premenstrual Dysphoric Disorder, Vasomotor Symptoms Associated With Menopause, Vulvovaginal Atrophy, Hypoestrogenism, Folate supplementation therapy, Hormone Replacement Therapy, Oral ContraceptivesMenopausal Osteoporosis, Mild to Moderate Acne, Premenstrual Dysphoric Disorder ( PMDD), Moderate Acne vulgaris, Moderate, severe, Vasomotor Symptoms caused by Menopause, Contraception, Folate supplementation therapy

How Rosen Star Tablet 0.02 mg+3 mg+0.415 mg works

Drospirenone and ethinyl estradiol in combination suppress the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH), preventing ovulation. Other changes induced by this drug which may aid in the prevention of pregnancy include alterations in cervical mucus consistency, hindering sperm movement, and lowering the chance of embryo implantation.

Drospirenone is an analog of the diuretic spironolactone, which exerts anti-mineralocorticoid activity, blocking aldosterone receptors, which increases sodium and water excretion. Studies in animals have demonstrated that drospirenone administration leads to antiandrogenic activity. This activity helps to oppose the effects of naturally occurring androgens, inhibiting the binding of dihydrotestosterone (DHT) to its receptor, and preventing androgen synthesis in the ovaries, helping to treat acne and hirsutism. Drospirenone may also decrease the level of edema in sebaceous follicle during the second half of the menstrual cycle, when acne often appears.

Ethinylestradiol is a synthetic estrogenic compound. Use of estrogens have a number of effects on the body including reduced bone density. Combined oral contraceptives suppress ovulation by suppressing gonadotrophic hormone, thickening cervical mucus to prevent the travel of sperm, and preventing changes in the endometrium required for implantation of a fertilized egg. Ethinylestradiol decreases luteinizing hormone, decreasing vascularity in the endometrium. It also increases sex hormone binding globulin.

Dosage

Rosen Star Tablet 0.02 mg+3 mg+0.415 mg dosage

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%)

Toxicity

The oral LD50 of drospirenone in rats is >2000 mg/kg.

Overdose information An overdose of drospirenone, like other oral contraceptives, may lead to cause nausea or withdrawal bleeding. For drospirenone in particular, as an analog of spironolactone, may affect the levels of serum sodium and potassium. Their concentrations should be monitored in cases of overdose in addition to monitoring from metabolic acidosis and hyperkalemia, which may also result.

Female patients experiencing and overdose may present with withdrawal bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Overdose should be treated with symptomatic and supportive care including monitoring for potassium concentrations, sodium concentrations, and signs of metabolic acidosis.

Precaution

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.

Interaction

Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Volume of Distribution

The volume of distribution of drospirenone is estimated to be 4 L/kg, according to the FDA label for Yaz. Prescribing information from a combination of estradiol and drospirenone estimates the volume of distribution to range from 3.7- 4.2 L/kg.

A 30µg oral dose has an apparent volume of distribution of 625.3±228.7L and a 1.2mg topical dose has an apparent volume of distribution of 11745.3±15934.8L.

Elimination Route

The absolute bioavailability of drospirenone is approximately 76% due to first-pass effects. The maximum plasma concentration of drospirenone occurs within 1 to 2 hours after oral administration and is estimated to range between 60 and 87 ng/mL. A European prescribing monograph for the combination product of estradiol and drospirenone indicates that drospirenone is both completely and rapidly absorbed. It reports a Cmax of 21.9 ng/ml, achieved approximately 1-hour post-administration. The absolute bioavailability is reported to range between 76 to 85%.

A 30µg oral dose of ethinylestradiol reaches a C_max of 74.1±35.6pg/mL, with a T_max of 1.5±0.5h, and an AUC of 487.4±166.6pg*h/mL. A 1.2mg dose delivered via a patch reaches a C_max of 28.8±10.3pg/mL, with a T_max of 86±31h, and an AUC of3895±1423pg*h/mL.

Half Life

The serum half-life of drospirenone is estimated to be 30 hours. The half-life of drospirenone metabolite excretion in the urine and feces is approximately 40 hours.

A 30µg oral dose has a half life of 8.4±4.8h and a 1.2mg topical dose has a half life of 27.7±34.2h.

Clearance

Drospirenone is rapidly cleared, typically within 2-3 days of administration of the last active tablet. The rate of clearance of drospirenone calculated in the serum ranges from 1.2-1.5 ml/min/kg, however, this value can vary by up to 25% according to the patient.

Ethinylestradiol has an intravenous clearance of 16.47L/h, and an estimated renal clearance of approximately 2.1L/h. A 30µg oral dose has a clearance of 58.0±19.8L/h and a 1.2mg topical dose has a clearance of 303.5±100.5L/h.

Elimination Route

Various metabolites of drospirenone are measured in the urine and feces. Drospirenone elimination from the body is almost after 10 days post-administration when negligible amounts of drospirenone are found unchanged in both the urine and feces. Between 38% to 47% of the metabolites are identified as glucuronide and sulfate conjugates in the urine. In the feces, approximately 17% to 20% of identifiable metabolites are found to be excreted as glucuronides and sulfates.

Ethinylestradiol is 59.2% eliminated in the urine and bile, while 2-3% is eliminated in the feces. Over 90% of ethinylestradiol is eliminated as the unchanged parent drug.

Pregnancy & Breastfeeding use

Nursing mothers: Not recommended; can decrease milk production.

Contraindication

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

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Innovators Monograph

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