Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets)

Ovral-L Tablets
© Clearsky Pharmacy
Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) is
a combination hormone medication which is indicated
for use by females of reproductive potential to prevent
pregnancy. It is also used for the treatment of moderate
acne vulgaris in women greater than 14 years of age
who, have no known contraindications to oral
contraceptive therapy, desire contraception, and have
achieved menarche.

Ovral-L Tablets
Ovral-L Tablets are manufactured by
Wyeth, India, a division of Pfizer.
(Website: www.pfizerindia.com)

Levonorgestrel and Ethinyl Estradiol Tablets – Brand
Names
Ethinyl Estradiol and Levonorgestrel
tablets are available as Alesse,
Aviane, Ovral-L, Choice, Combee,
Loette, Enpresse, Lessina, Levlen,
Levlite, Levora, Lutera, Lybrel,
Microgynon 30, Nordette, Portia,
Sronyx, Tri-Levlen, Triphasil, Trivora,
Ovilow and Triquilar.

Active Ingredients
The active ingredients contained in
Ovral-L Contraceptive tablets are
Levonorgestrel and Ethinyl Estradiol.
Each Tablet contains 0.03 mg Ethinyl
Estradiol and 0.15 mg Levonorgestrel

Chemical Structure
The structure of Levonorgestrel is given
below:

Chemical Structure
The structure of Ethinyl Estradiol is given
below:

Uses of Ovral-L Tablets
Ovral-L is a combination of 2 hormones: an
estrogen (Ethinyl Estradiol) and a progestin
(Levonorgestrel) and is used to prevent
pregnancy.
It works mainly by preventing the release of an
egg (ovulation) during the menstrual cycle. It
also makes vaginal fluid thicker to help stop
sperm from reaching an egg (fertilization) and
changes the lining of the uterus (womb) to
prevent attachment of a fertilized egg. In case
a fertilized egg does not attach to the uterus, it
passes out of the body.

Uses of Ovral-L Tablets
This medicine is also used for treatment of
moderate acne vulgaris in women greater than
14 years of age who, have no known
contraindications to oral contraceptive therapy,
desire contraception, and have achieved
menarche.
Besides preventing pregnancy, birth control
pills could also make periods more regular,
decrease blood loss and painful periods and
decrease the risk of ovarian cysts .

Ovral-L Dosage
➢ The dosage of is one Ovral-L tablet daily for 21
consecutive days. Tablets should be taken exactly
as directed and at intervals not exceeding 24 hours.
➢During the first cycle of Ovral-L use, the patient
must be instructed to take one tablet daily,
beginning on day 1 of her menstrual cycle (the first
day of menstruation is day one). She should take
one tablet daily for 21 consecutive days, followed by
7 pill-free days. It is recommended that Ovral-L be
taken at the same time every day, preferably after
the evening meal or at bedtime.
The dosage of Ovral-L tablets (Ethinyl Estradiol
and tablets) is given below:

Ovral-L Dosage
➢ If Ovral-L is first administered later than the first day of the
menstrual cycle, it must not be considered effective as a
contraceptive until after the first 7 consecutive days of product
administration. The patient should use a non-hormonal
contraceptive as back-up during the first 7 days. The possibility of
ovulation and conception prior to initiation of this medicine must
also be considered.
➢The patient must begin her next and all subsequent 28-day
regimens of Ovral-L tablets on the same day of the week that she
began her first regimen, following the same schedule. She should
begin taking her tablets on the next day after the 7 pill-free days,
regardless of whether or not a menstrual period has occurred or is
still in progress. Any time a subsequent cycle of Ovral-L pills is
started later than the day following 7 pill-free days, the patient
should use another method of contraception until she has taken a
tablet daily for 7 consecutive days.
The dosage of Ovral-L (Ethinyl Estradiol and
Levonorgestrel Tablets) is given below:

Ethinyl Estradiol and Levonorgestrel Tablets
Dosage
➢Switching from another hormonal method of contraception:
When the patient is switching from a 21-day regimen of
tablets, she should wait 7 days after her last tablet before she
starts Ovral-L tablets.
➢When the patient is switching from a 28-day regimen of
tablets, she should start her first pack of Ovral-L on the day
after her last tablet. She should not wait any days between
packs.
➢ The patient may switch any day from a progestin-only pill
and should begin Ovral-L the next day.

Dosage
➢ If switching from an implant or injection, the patient
should start Ovral-L on the day of implant removal
or, if using an injection, the day the next injection
would be due. In switching from a progestin-only pill,
injection, or implant, the patient should be advised to
use a nonhormonal back-up method of birth control
for the first 7 days of tablet-taking.

Dosage
➢Withdrawal bleeding usually occurs within 3 days
following the last tablet.
➢In case spotting or breakthrough bleeding occurs
while taking Ovral-L pills, the patient should be
instructed to continue taking Ovral-L as instructed and
as per the regimen described above.
➢She should be instructed that this type of bleeding is
usually transient and without significance.
➢However, in case the bleeding is persistent or
prolonged, the patient is advised to consult her doctor
as soon as possible.

Storage Instructions
Ovral-L (Ethinyl Estradiol and
Levonorgestrel Tablets) has 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
Vascular risks: Stop Ovral-L (Ethinyl
Estradiol and Levonorgestrel Tablets) if a
thrombotic event occurs. Stop Ovral-L at
least 4 weeks before and through 2 weeks
after major surgery. Start Ovral-L no earlier
than 4 weeks after delivery, in women who
are not breastfeeding.
Liver disease: Discontinue Ovral-L if jaundice
occurs.
High blood pressure: Do not prescribe Ovral-
L for women with uncontrolled hypertension
or hypertension with vascular disease.

Warnings
Carbohydrate and lipid metabolic effects:
Monitor prediabetic and diabetic women
undergoing therapy with Ovral-L tablets.
Consider an alternate contraceptive method for
women with uncontrolled dyslipidemias.
Headache: Evaluate significant change in
headaches and discontinue Ovral-L if indicated.
Uterine bleeding: Evaluate irregular bleeding or
amenorrhea.
Women who currently have or have had breast
cancer should not use Combined Oral
Contraceptives because breast cancer may be
hormonally sensitive.

Warnings
Discontinue Ovral-L before starting therapy with the
combination drug regimen Ombitasvir/Paritaprevir/Ritonavir,
with or without Dasabuvir. Ovral-L can be restarted
approximately 2 weeks following completion of treatment
with the Hepatitis C combination drug regimen. This is
because of the risk of Liver Enzyme Elevations with
Concomitant Hepatitis C Treatment.
Studies suggest a small increased relative risk of developing
gallbladder disease among Combined Oral Contraceptive
users.
Unscheduled (breakthrough) bleeding and spotting
sometimes occur in patients on COCs, especially during the
first 3 months of use. If bleeding persists, check for causes
such as pregnancy or malignancy. If pathology and
pregnancy are excluded, bleeding irregularities may resolve
over time or with a change to a different COC product.

Ovral-L Tablets
Contraindications
Ovral-L is contraindicated in patients with a
hypersensitivity to Levonorgestrel, Ethinyl Estradiol or
any other component of this medication.
Ovral-L must not be administered to women who are
known to have the following: Smoke, if over age 35, 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, Renal impairment, Adrenal
insufficiency, Undiagnosed abnormal uterine bleeding ,
have hypercoagulopathies , have uncontrolled
hypertension, have diabetes with vascular disease, have
headaches with focal neurological symptoms or have
migraine headaches with or without aura if over age 35.

Ovral-L Tablets
Contraindications
The other contraindications are Breast
cancer or other estrogen- or progestin-
sensitive cancer, now or in the past ,Liver
tumors, benign or malignant, or liver disease,
Pregnancy, because there is no reason to
use Oral Contraceptives during pregnancy
Use of Ovral-L is also contraindicated with
Hepatitis C drug combinations containing
Ombitasvir / Paritaprevir / Ritonavir, with or
without Dasabuvir, due to the potential for
ALT elevations.

Ovral-L Side Effects
➢The most frequent Ethinyl Estradiol and
Levonorgestrel Tablets (Ovral-L) side effects in
5% or more of women during clinical trials were:
headaches (33%); irregular and/or heavy uterine
bleeding (13%), dysmenorrhea (11%), nausea
and/or vomiting (11%), back pain (8%).
➢Other side effects include: vulvovaginal
candidiasis, breakthrough bleeding, decreased
glucose tolerance, increased blood pressure,
migraine, spotty menstruation, vaginitis,
dizziness, abdominal cramps, abdominal
distention, acne vulgaris, breast tension and
breast changes.

Ovral-L Overdose
There have been no reports of serious ill
effects from Ovral-L (Ethinyl Estradiol and
Levonorgestrel Tablets) overdose,
including ingestion by children.
Overdosage may cause withdrawal
bleeding in females and nausea.
Symptoms of oral contraceptive
overdosage in adults and children may
include nausea, vomiting, and drowsiness /
fatigue; withdrawal bleeding may occur in
females.

Ethinyl Estradiol and Levonorgestrel
Tablets During Pregnancy
Ethinyl Estradiol and Levonorgestrel Tablets (Ovral-L)
has been classified by the US FDA as Pregnancy
Category X.
Ovral-L is contraindicated in Pregnancy, because there
is no reason to use COCs during pregnancy.
There is little or no increased risk of birth defects in
women who inadvertently use COCs during early
pregnancy. Small amounts of oral-contraceptive steroids
and/or metabolites have been identified in the milk of
nursing mothers, and a few adverse effects on the child
have been reported, including jaundice and breast
enlargement.
When possible, advise the nursing mother to use other
forms of contraception until she has weaned her child.

Ovral-L Tablets
For more details on
Ovral-L Tablets click here
Ovral-L (Ethinyl Estradiol and
Levonorgestrel Tablets) by Wyeth, a
division of Pfizer Limited, India.

Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets)

Similar to Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) (20)

More from Clearsky Pharmacy

More from Clearsky Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets)