Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets)

Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets)
© The Swiss Pharmacy

Yasmin (Drospirenone and Ethinyl Estradiol Tablets) is a
estrogen/progestin combined oral contraceptive indicated
for use by women to prevent pregnancy.
The decision to prescribe Yasmin should take into
consideration the individual woman's current risk factors,
particularly those for venous thromboembolism (VTE), and
how the risk of VTE with Yasmin compares with other
combined hormonal contraceptives (CHCs).

Yasmin Tablets are manufactured by Bayer AG, Berlin
Germany and marketed by Bayer Zydus Pharma Private Limited,
India in the strength of 3 mg of Drospirenone and 0.03 mg of
Ethinyl Estradiol.

Chemical Structure - Drospirenone

Chemical Structure - Ethinyl Estradiol

The active ingredients contained in Yasmin tablets are
Drospirenone and Ethinyl Estradiol.
Each Yasmin tablet contains 3 mg of Drospirenone and
0.03 mg of Ethinyl Estradiol.

Uses of Yasmin (Drospirenone 3mg & Ethinyl Estradiol 0.03mg) tablets:
Drospirenone and Ethinyl Estradiol combination (Yasmin Tablets) is
used to prevent pregnancy. It is a birth control pill that contains two
types of hormones, Ethinyl Estradiol and Drospirenone, and when
taken properly, prevents pregnancy. It works by stopping a woman's
egg from fully developing each month. The egg can no longer accept
a sperm and fertilization (pregnancy) is prevented.
It also makes vaginal fluid thicker to help prevent sperm from
reaching an egg (fertilization) and changes the lining of the uterus
(womb) to prevent attachment of a fertilized egg. If a fertilized egg
does not attach to the uterus, it passes out of the body.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html

Uses of Yasmin (Drospirenone 3mg & Ethinyl Estradiol 0.03mg) tablets:
Besides preventing pregnancy, birth control pills may make your
periods more regular, decrease blood loss and painful periods, and
decrease your risk of ovarian cysts.
This medicine is also used to treat premenstrual dysphoric disorder
(PMDD) and acne in women at least 14 years of age. PMDD is a severe
form of premenstrual syndrome (PMS). Patients with PMDD may have
severe emotional and physical symptoms 10 to 14 days before their
menstrual flow starts.

Recommended Adult Dosage
Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Should
be administered as given below:
Take one tablet by mouth at the same time every day.
The 21 yellow tablets, each containing 3 mg Drospirenone (DRSP) and
0.03 mg Ethinyl Estradiol (EE), should be taken first, one tablet a day
followed by seven tablet free days.
The failure rate may increase when pills are missed or taken
incorrectly.
To achieve maximum contraceptive effectiveness, Yasmin 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 Yasmin Tablets
Instruct the patient to begin taking Yasmin 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 Yasmin use, instruct the patient to take
one yellow Yasmin daily, beginning on Day 1 of her menstrual cycle. (The first
day of menstruation is Day 1.)
She should take one yellow Yasmin daily for 21 consecutive days, followed by
7 pill free days on Days 22 through 28.
If Yasmin is first taken later than the first day of the menstrual cycle, Yasmin
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 back-up during the first 7 days. The possibility of
ovulation and conception prior to initiation of medication should be
considered.

How to Start Yasmin Tablets
Sunday Start: During the first cycle of Yasmin use, instruct the patient
to take one yellow Yasmin daily, beginning on the first Sunday after
the onset of her menstrual period. She should take one yellow
Yasmin daily for 21 consecutive days, followed by 7 pill free days on
Days 22 through 28.
Yasmin 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 back-up during
the first 7 days. The possibility of ovulation and conception prior to
initiation of medication should be considered.

Yasmin Tablets – Missed Pill Instructions
If You Miss 1 Pill:
Take the tablet as soon as you remember. Take the next pill at your
regular time. This means you may take two pills in one day.
If You Miss 2 Pills In A Row In Week 1 Or Week 2 Of Your Pack: Take
two pills on the day you remember and two pills the next day.Then
take one pill a day until you finish the pack. You MUST use another
birth control method (such as condoms or spermicides) as a back-up
for 7 days after restarting your tablets.

If You Miss 2 Pills In A Row In Week 3 Or Week 4 Of Your Pack:
If you are a Day 1 Starter: Throw out the rest of the pill pack and start
a new pack that same day.
If you are a Sunday Starter: Keep taking one pill every day until
Sunday. On Sunday, throw out the rest of the pack and start a new
pack of pills that same day.
You could become pregnant if you have sex in the 7 days after you
restart your pills. You must use another birth control method (such as
a condom and spermicide) as a back-up for those 7 days.
You may not have your period this month but this is expected.
However, if you miss your period two months in a row, call your
healthcare provider because you might be pregnant.

If You Miss 3 Or More Pills In A Row During Any Week:
If you are a Day 1 Starter: Throw out the rest of the pill pack and start
a new pack that same day.
If you are a Sunday Starter: Keep taking 1 pill every day until Sunday.
On Sunday, throw out the rest of the pack and start a new pack of
pills that same day.
You could become pregnant if you have sex in the 7 days after you
restart your pills. You must use another birth control method (such as
condoms and spermicides) as a back-up for those 7 days.
You may not have your period this month but this is expected.
However, if you miss your period two months in a row, call your
healthcare provider because you might be pregnant.

Contraindications
➔
Yasmin is contraindicated in patients with a known hypersensitivity to
Drospirenone, Ethinyl Estradiol or any component of the tablet.
➔
Renal impairment
➔
Adrenal insufficiency
➔
A high risk of arterial or venous thrombotic diseases
➔
Have cerebrovascular disease
➔
Have coronary artery disease
➔
Have thrombogenic valvular or thrombogenic rhythm diseases of the
heart (for example, subacute bacterial endocarditis with valvular
disease, or atrial fibrillation).

Contraindications
➔
Have inherited or acquired hypercoagulopathies
➔
Have uncontrolled hypertension
➔
Have diabetes mellitus with vascular disease
➔
Have headaches with focal neurological symptoms or have migraine headaches with or
without aura if over age 35.
➔
Undiagnosed abnormal uterine bleeding
➔
Breast cancer or other estrogen- or progestin-sensitive cancer
➔
Liver tumors or liver disease
➔
Pregnancy, because there is no reason to use COCs during pregnancy
➔
Co-administration with Hepatitis C drug combinations Containing Ombitasvir,
Paritaprevir / Ritonavir, with or without Dasabuvir due to the potential for ALT elevations

Storage Instructions
Yasmin Tablets (Drospirenone and Ethinyl Estradiol
Tablets) ) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Women over 35 years old who smoke should not use Drospirenone
and Ethinyl Estradiol tablets (Yasmin tablets).
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral contraceptive (COC) use.
Vascular risks: Stop Drospirenone and Ethinyl Estradiol tablets 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.

Warnings
Before initiating Drospirenone and Ethinyl Estradiol tablets 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 anti-mineralocorticoid 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 drospirenone and Ethinyl Estradiol tablets if
jaundice occurs.

Warnings
High blood pressure: Do not prescribe Drospirenone and Ethinyl
Estradiol tablets for women with uncontrolled hypertension or
hypertension with vascular disease.
Carbohydrate and lipid metabolic effects: Monitor prediabetic and
diabetic women taking Drospirenone and Ethinyl Estradiol tablets.
Consider an alternate contraceptive method for women with
uncontrolled dyslipidemia.
Headache: Evaluate significant change in headaches and discontinue
Drospirenone and Ethinyl Estradiol tablets if indicated.
Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Possible Side Effects
Most common Drospirenone and Ethinyl Estradiol (Yasmin
tablets) side effects with an incidence rate of greater than or
equal to 2% are premenstrual syndrome (13.2%), headache
/migraine (10.7%), breast pain/tenderness/discomfort (8.3%),
nausea/vomiting (4.5%), abdominal
pain/tenderness/discomfort (2.3%), mood changes (2.3%).
Serious side effects associated with the use of COCs are:
Serious cardiovascular events and stroke Vascular events and
Liver disease.

Possible Side Effects
The following side effects have been identified during post-approval use
of Yasmin.
Vascular disorders: Venous and arterial thromboembolic events (including
pulmonary emboli, deep vein thrombosis, intracardiac thrombosis,
intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein
occlusion, myocardial infarction and stroke), hypertension
Hepatobiliary disorders: Gallbladder disease
Immune system disorders: Hypersensitivity
Metabolism and nutrition disorders: Hyperkalemia
Skin and subcutaneous tissue disorders: Chloasma

Yasmin Tablets Overdosage
There have been no reports of serious ill effects from Drospirenone
and Ethinyl Estradiol (Yasmin tablets) overdose, including ingestion by
children. Overdosage may cause withdrawal bleeding in females and
nausea.
Drospirenone is a spironolactone analogue which has anti-
mineralocorticoid properties. Serum concentration of potassium and
sodium, and evidence of metabolic acidosis, should be monitored in
cases of overdose.

Yasmin Tablets During Pregnancy
Drospirenone and Ethinyl Estradiol Tablets (Yasmin Tablets) have
been classified by the US FDA as Pregnancy Category X.
Estrogens and progestins should not be used during pregnancy. There
is little or no increased risk of birth defects in women who inadvertently
use COCs during early pregnancy. Epidemiologic studies and meta-
analyses have not found an increased risk of genital or non-genital birth
defects (including cardiac anomalies and limb-reduction defects)
following exposure to low dose COCs prior to conception or during early
pregnancy.
The administration of COCs to induce withdrawal bleeding should not
be used as a test for pregnancy. COCs should not be used during
pregnancy to treat threatened or habitual abortion

Yasmin Tablets (Drospirenone and Ethinyl Estradiol
Tablets) are manufactured by Bayer AG, Berlin, Germany
and marketed by Bayer Zydus Pharma Private Limited,
India.

Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets)

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