Rosen Star Tablet
Ethinylestradiol + Drospirenone + Levomefolate Calcium
0.02mg + 3mg + 0.451mg
Incepta Pharmaceuticals Ltd.
| Pack size | 28's Pack |
|---|---|
| Unite Price | 14.85 BDT |
Indications
Rosen Star Tablet is used for:
Indicated for use by women to,
Prevent pregnancy (contraception),
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception.
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control.
Raise folate levels in women who choose to use an oral contraceptive for contraception.
Adult Dose
Adult
Tablet
Contraception:
1 active tablet PO qDay for 24 days, then 1 inert tablet (levomefolate calcium) PO qDay for 4 days
Premenstrual Dysphoric Disorder (PMDD):
Symptoms of Premenstrual Dysphoric Disorder, but only if oral contraceptive is chosen as method of birth control, 1 active tablet PO qDay for 24 days, then 1 inert tablet ( levomefolate calcium) PO qDay for 4 days
Moderate Acne Vulgaris
Indicated for moderate acne in women, but only if oral contraceptive is chosen as method of birth control
1 active tablet PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days
Hepatic impairment: Contraindicated
Child Dose
Renal Dose
Renal impairment: Contraindicated
Administration
1. If you have decided to take this for contraception, wait for your next menstruation begins.
2. From the first day of your menstruation, start taking the first orange tablet from the left corner of the top row (with arrow mark) of your tablet pack.
3. Continue taking one orange tablet each day along the arrow mark.
4. After taking 21 orange tablets for 21 days, then continue taking one light orange non-hormonal tablet every day from the last row in the pack for next 7 days.
5. It is most likely that your menstruation will start while taking the light orange tablets. Do not discontinue taking the light orange tablets. Taking of the light orange tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.
6. After completing the seven light orange tablets, start taking orange tablets from another pack and continue taking the tablet as long as you don't want to be pregnant.
Contra Indications
This tablet should not be used in pregnancy, renal impairment, adrenal insufficiency, high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen-or progestin-sensitive cancer (exists or in the past), liver tumor (benign or malignant) or liver disease, use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir.
Precautions
Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely. Venous thromboembolism (VTE) manifesting as deep venous thrombosis and/or pulmonary embolism may occur during the use of all COCs.
In a clinical study it has been found that after the use of drospirenon containing COCs cause the prevalence of VTE & ATE may be upto 9.8 for 10,000 women/ year.
Folate Supplementation
The U.S. Preventive Services Task Force recommends that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily. Consider other folate supplementation that a woman may be taking before prescribing this.
Lactation: When possible, advise the nursing mother to use other forms of contraception until she has weaned her child.
Pregnancy-Lactation
Pregnancy category: X
Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)
Interactions
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.
Side Effects
Side effects of Ethinylestradiol + Drospirenone + Levomefolate Calcium :
10%
Premenstrual syndrome (13.2%)
Migraine/headache (10.7%)
1-10%
Breast pain/discomfort/tenderness (8.3%)
Menstrual irregularities (4.7%)
Nausea/vomiting (4.5%)
Abdominal pain/discomfort/tenderness (2.3%)
Mood changes, including affect lability, depression, alteration of mood, mood swings, and irritability (2.3%)
Frequency Not Defined
Irregular uterine bleeding
Venous/arterial thromboembolic events, including DVT, PE, stroke, MI, intracardiac thrombosis, sagittal sinus thrombosis, intracranial venous sinus thrombosis, retinal vein thrombosis
Hypertension
Hypersensitivity
Hyperkalemia
Chloasma
Gallbladder disease
Toxic skin eruption
Uterine leiomyoma
Mode of Action
Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components inhibit ovulation by suppressing gonadotropin release. Secondary mechanism includes changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens.
Levomefolate Calcium is a metabolite of vitamin B9. Rosen 28 plus Plus is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
Note
Rosen Star 0.02mg + 3mg + 0.451mg Tablet generic name is Ethinylestradiol + Drospirenone + Levomefolate Calcium. Rosen Star 0.02mg + 3mg + 0.451mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Rosen Star is availble in all over Bangladesh.
Mes BD drug index information on Rosen Star Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.