Rosen 28(Ethinylestradiol & Drospirenone)

Therapeutic Group: Contraceptive

Presentation

Rosen 28 : Each Rosen 28 package contains 28 tablets. Among these 21 tablets are light yellow in color and each contains Ethinylestradiol 0.030 mg & Drospirenone 3 mg . Each of 7 white colored tablets is placebo tablet.

Description

Rosen 28 contains two active ingredients, Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of Rosen 28 inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of Rosen 28 as a contraceptive, include 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. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoproteinHDL. 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.

Indications

Prevention of pregnancy

Dosage & Administration

How to Take Rosen 28
To achieve maximum contraceptive effectiveness, Rosen 28 must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.
1. If you have decided to take Rosen 28 for contraception, wait for your next menstruation begins.
2. From the first day of your menstruation, start taking the first light yellow tablet from the left corner of the top row (with arrow mark) of your Rosen 28 tablet pack.
3. Continue taking one light yellow tablet each day along the arrow mark.
4. After taking 21 light yellow tablets for 21 days, then continue taking one white placebo 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 white tablets. Do not discontinue taking the white tablets. Taking of the white 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 white tablets, start taking light yellow tablets from another Rosen 28 pack and continue taking the tablet as long as you don\’t want to be pregnant.
Management of Missed Tablets
If you forgot to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception while you are taking the tablets & until your next menstruation.
If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.
How to Delay a Period
To delay a period you should continue with another new pack of Rosen 28 just after finishing the light yellow active tablet of the present pack (that is no need to take white placebo tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day white inactive tablet interval.
Advice in Case of Vomiting
If vomiting occurs within 4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack after vomiting.
Paediatric Use
Rosen 28 is only indicated after menarche. There is no data suggesting the need for a dosage adjustment.
Use in the Elderly
Rosen 28 is not indicated after menopause.

Side Effects

Different types of tablet suit different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, nausea or inter-menstrual bleeding. If taken regularly, such types of side-effects normally go away after 2-3 months. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.
After starting one brand of oral contraceptive tablets, if you feel any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, yellow skin or a rise in blood pressure take advice from your doctor or contact the nearest family planning centre.

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.

Use in Pregnancy & Lactation

Use During Pregnancy :
The administration of Rosen 28 is contraindicated during pregnancy. Pregnancy must be excluded before starting Rosen 28. If pregnancy occurs during use of Rosen 28, the preparation must be withdrawn immediately.
Oral contraceptives have not been shown to have any deleterious effects on the foetus or to increase the incidence of miscarriage in women who discontinue their use prior to conception. However, in women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.
Use during Lactation :
Oestrogen-containing oral contraceptives given in the postpartum period may interfere with lactation. There may be a decrease in the quantity and a change in the composition of the breast milk. Furthermore, small amounts of contraceptive steroids and/or metabolites have been identified in the milk of mothers receiving them. A few adverse effects have been reported, including jaundice and breast enlargement. The use of oestrogen-containing oral contraceptives should be deferred until the infant has been completely weaned.

Drug Interaction

Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively.Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates.
Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives.
During concomitant use of Rosen 28 & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal back-up method of contraception to be used in addition to the regular intake of Rosen 28.

Over Dose

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Storage

Store in a cool and dry place. Keep away from light & out of reach of children.

Commercial Pack

Rosen 28 : Each blister contains 21 light yellow tablets (each containing Ethinylestradiol 0.030 mg & Drospirenone 3 mg) and 7 white color placebo tablet.