Generic Name: Drospirenone + Ethinylestradiol

FORMULATION
Drospirenone, USP 3 mg
Ethinylestradiol 20mcg

INDICATION

Oral Contraceptive, with antimineralcorticoid and antiandrogenic effects also beneficial for women who experience hormone related fluid retention and the resulting symptoms.

Treatment of moderate acne vulgaris in women who elect to use oral contraception.

Treatment of symptoms of PMDD (Premenstrual Dysphoric Disorder) in women who elect to use oral contraception.

Method of Administration
Oral use

Dosage Regimen

How to take Drospirenone + Ethinylestradiol

Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be taken daily for 24 consecutive days followed by 4 treatment free days i.e., day 25 through 28. Withdrawal bleeding usually starts within 3 days following the last tablet.

How to start Drospirenone + Ethinylestradiol

No preceding hormonal contraceptive use (in the past month)

Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e., the first day of her menstrual bleeding). Starting on days 2–5 is allowed, but during the 1st cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

Changing from a combined hormonal contraceptive [combined oral contraceptive (COC)], vaginal ring or transdermal patch

The woman should start with drospirenone + ethinylestradiol preferably on the day after the last hormone-containing tablet of the previous COC, but at the latest on the day following the usual tablet-free or hormone-free interval of her previous COC.

In case a vaginal ring or transdermal patch has been used, the woman should start using drospirenone + ethinylestradiol preferably on the day of removal, but at the latest when the next application would have been due.

Changing from a progestogen-only method

(Minipill, Injection, Implant) or from a Progestogen-Releasing Intrauterine System (IUS))

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but in all these cases she should be advised to additionally use a barrier method for the first 7 days of tablet-taking.

Following first-trimester abortion

The woman may start immediately. When doing so, she does not need additional contraceptive measures.

Following delivery or second-trimester abortion

Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.

Management of missed tablets

If the user is less than 24 hrs late in taking a tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.

If she is more than 24 hrs late in taking a tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:

1. Tablet-taking must never be discontinued for longer than 7 days (please note the recommended tablet-free interval is 4 days). 
2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis. 

Accordingly the following advice can be given in daily practice:

Day 1–7

The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time.

In addition, a barrier method such as a condom should be used for the next 7 days.

If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.

The more tablets are missed and the closer they are to the tablet-free phase, the higher the risk of pregnancy.

Day 8–14

The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time.

Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions.

However, if this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.

Day 15–24

The risk of reduced reliability is imminent because of the forthcoming tablet-free phase.

However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented.

By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly.

If this is not the case, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well.

1. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. The next pack must be started right away, without the tablet-free interval.

The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding.

1. The woman may also be advised to discontinue taking tablets from the current pack. She should then have a tablet-free interval of up to 4 days, including the days she missed tablets, and subsequently continue with the next pack.

If the woman missed tablets and subsequently has no withdrawal bleed in the tablet-free phase, the possibility of a pregnancy should be considered.

CONTRAINDICATIONS

Combined oral contraceptives should not be used in the presence of any of the conditions listed below. Should any of these conditions appear for the first time during COC use, the product should be stopped immediately.

• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
• Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
• A high risk of venous or arterial thrombosis
• History of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Severe hepatic disease as long as liver function values have not returned to normal
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumors (benign or malignant)
• Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Hypersensitivity to drospirenone or ethinylestradiol or to any of the excipients

Manufactured by:
Sun Pharmaceutical Industries Limited
Baroda Highway, Halol, Gujarat,
389350, India
 
Imported by:
Sun Pharma Philippines, Inc.
17F Unit 3, Milestone @ Fifth Avenue, 5th Avenue,
Bonifacio Global City, Taguig City, Metro Manila,
Philippines

Distributed by:
DKT Health, Inc.
80 E. Rodriguez Jr. Avenue (C5),
Bagumbayan, Quezon City
1110 Philippines