Rosen Star pill - 0.02mg

Tablet

Pack Size : 28 Tablet x 1 Strip

Generics : Ethinylestradiol + Drospirenone + Levomefolate Calcium

Manufacturer : Incepta Pharmaceuticals Ltd.

Best Price * TK 415.80

* Delivery will be done in Dhaka city only.

Alternative Product

More Information About - Rosen Star pill - 0.02mg

Description

Generic Name

Ethinylestradiol + Drospirenone + Levomefolate Calcium

Precaution

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.

Indication

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.

Contra Indication

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.

Dose

N/A

Side Effect

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

Pregnancy Category

Name : X

Description

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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.

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.

Pregnancy Category Note

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)

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

N/A

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.

Disclaimer

The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.