Ovral L (Levonorgestrel and Ethinyl Estradiol Tablets)

Ovral L (Levonorgestrel and Ethinyl Estradiol Tablets)
© The Swiss Pharmacy

Ovral L (Levonorgestrel And Ethinyl Estradiol Tablets) is
used for the prevention of pregnancy in women who
decide to use oral contraceptives as a method of
contraception.
Ethinyl Estradiol and Levonorgestrel is a combination birth
control pill containing female hormones that prevent
ovulation (the release of an egg from an ovary). Ovral L
also causes changes in your cervical mucus and uterine
lining, making it harder for sperm to reach the uterus and
harder for a fertilized egg to attach to the uterus.

Ovral L Tablets are manufactured
by Wyeth Limited (a division of
Pfizer), India in the strength of 150
µg of Levonorgestrel I.P. and 30 µg of
Ethinyl Estradiol.

Chemical Structure - Levonorgestrel

Chemical Structure - Ethinyl Estradiol

The active ingredients contained in Ovral L
tablets are Levonorgestrel And Ethinyl
Estradiol.
Each Ovral L tablet contains 150 µg of
Levonorgestrel I.P. and 30 µg of Ethinyl
Estradiol.

Uses of Ovral L tablets:
Ovral L (Levonorgestrel and Ethinyl Estradiol Tablets) is used
to prevent pregnancy.
Ethinyl Estradiol And Levonorgestrel is a combination birth
control pill containing female hormones that prevent ovulation
(the release of an egg from an ovary). Ovral L also causes
changes in your cervical mucus and uterine lining, making it
harder for sperm to reach the uterus and harder for a fertilized
egg to attach to the uterus.
It is also used to treat moderate acne in women 14 years of age
and older who are able to use birth control pills, desire birth
control and have achieved menarche (first menstrual period).

Uses of Ovral L tablets:
In a 1-year controlled clinical trial, 4 pregnancies occurred in
women 18 to 35 years of age during 809 completed 91-day
cycles of Levonorgestrel and Ethinyl Estradiol tablets during
which no backup contraception was utilized.
This represents an overall use-efficacy (typical user efficacy)
Pregnancy rate of 1.98 per 100 women-years of use.

Recommended Adult Dosage
The dose of
Ovral L (Levonorgestrel and Ethinyl Estradiol Tablets) is
detailed below:
Your pill pack contains 21 pills with active medication. Take one
active pill (with hormones) once daily for 21 days in a row. Since
Ovral L is a product with 21 tablets, do not take any tablets for 7
days unless otherwise directed by your doctor. You should have
your period during the fourth week of the cycle. After you have
gone 7 days without taking an active tablet, start a new pack the
next day whether or not you have your period. If you do not get
your period, consult your doctor.

During The First Cycle Of Use
The possibility of ovulation and conception prior to initiation of medication should
be considered. The patient should be instructed to begin taking Ovral L on either
the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of
menstruation (Day 1 Start).
Sunday Start: The patient is instructed to begin taking Ovral L on the first Sunday
after the onset of menstruation. If menstruation begins on a Sunday, the first tablet
is taken that day. One tablet should be taken daily for 21 consecutive days,
followed by 7 days without taking any tablet. Withdrawal bleeding should usually
occur within 3 days following discontinuation of tablets and may not have finished
before the next pack is started.
During the first cycle, contraceptive reliance should not be placed on Ovral L until
an tablet has been taken daily for 7 consecutive days, and a nonhormonal backup
method of birth control should be used during those 7 days.

Day 1 Start: During the first cycle of medication, the patient is instructed
to begin taking Ovral L during the first 24 hours of her period (day one
of her menstrual cycle). One tablet should be taken daily for 21
consecutive days, followed by 7 days without taking any tablet.
Withdrawal bleeding should usually occur within 3 days following
discontinuation of tablets and may not have finished before the next pack
is started.
If medication is begun on day one of the menstrual cycle, no backup
contraception is necessary. If Ovral L tablets are started later than day
one of the first menstrual cycle or postpartum, contraceptive reliance
should not be placed on Ovral L tablets until after the first 7 consecutive
days of administration, and a nonhormonal backup method of birth
control should be used during those 7 days.

Contraindications
➔
Ovral L is contraindicated in patients with a known hypersensitivity to
Levonorgestrel, Ethinyl Estradiol or any component of the tablet.
➔
Thrombophlebitis or thromboembolic disorders
➔
A history of deep-vein thrombophlebitis or thromboembolic disorders
➔
Cerebrovascular or coronary artery disease (current or past history)
➔
Valvular heart disease with thrombogenic complications
➔
Thrombogenic rhythm disorders
➔
Hereditary or acquired thrombophilias
➔
Major surgery with prolonged immobilization
➔
Diabetes with vascular involvement

Contraindications
➔
Headaches with focal neurological symptoms
➔
Uncontrolled hypertension
➔
Known or suspected carcinoma of the breast or personal history of breast cancer
➔
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
➔
Undiagnosed abnormal genital bleeding
➔
Cholestatic jaundice of pregnancy or jaundice with prior pill use
➔
Hepatic adenomas or carcinomas, or active liver disease
➔
Known or suspected pregnancy
➔
Women who are receiving Hepatitis C drug combinations containing Ombitasvir /
Paritaprevir / Ritonavir, with or without Dasabuvir, due to the potential for alanine
aminotransferase (ALT) elevations

Storage Instructions
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
Cigarette smoking increases the risk of serious cardiovascular side effects from oral
contraceptive use. This risk increases with age and with the extent of smoking (in
epidemiologic studies, 15 or more cigarettes per day was associated with a
significantly increased risk) and is quite marked in women over 35 years of age.
Women who use oral contraceptives should be strongly advised not to smoke.
Discontinue Medication at the Earliest Manifestation of the following:
A.Thromboembolic and cardiovascular disorders, such as thrombophlebitis,
pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric
ischemia, mesenteric thrombosis and retinal thrombosis.
B. Conditions that predispose to venous stasis and to vascular thrombosis (e.g.
immobilization after accidents or confinement to bed during long-term illness).
Other non-hormonal methods of contraception should be used until regular
activities are resumed.

Warnings
Discontinue Medication at the Earliest Manifestation of the following:
C. Visual defects - partial or complete
D. Papilledema or ophthalmic vascular lesions
E. Severe headache of unknown etiology, or worsening of pre-existing migraine headache
F.Increase in epileptic seizures.
A meta-analysis from 54 epidemiological studies reported that there is a slightly increased
relative risk (RR=1.24) of having breast cancer diagnosed in women who are currently
using COCs compared to never-users. The increased risk gradually disappears during the
course of the 10 years after cessation of COC use. These studies do not provide evidence
for causation.
The most important risk factor for cervical cancer is persistent human papillomavirus
infection. Some epidemiological studies have indicated that long-term use of COCs may
further contribute to this increased risk but there continues to be controversy about the
extent to which this finding is attributable to confounding effects, e.g., cervical screening
and sexual behaviour including use of barrier contraceptives.

Warnings
Levonorgestrel and Ethinyl Estradiol tablets are contraindicated in patients
with a history of or actual benign or malignant liver tumours.
Hepatocellular carcinoma may be associated with COC use. The risk
appears to increase with duration of COC use. However, the attributable
risk (the excess incidence) of liver cancer in OC users is extremely small.
Glucose intolerance has been reported in COC users. Current low-dose
COCs exert minimal impact on glucose metabolism. Diabetic patients, or
those with a family history of diabetes, should be observed closely to
detect any worsening of carbohydrate metabolism.
A small proportion of women will have adverse lipid changes while taking
oral contraceptives. Nonhormonal contraception should be considered in
women with uncontrolled dyslipidemias.

Warnings
Published epidemiological studies indicate a possible association of COC use and the
development of Crohn’s disease and ulcerative colitis, although this has not been firmly
established
Vomiting and/or diarrhea may reduce absorption of oral contraceptives resulting in
decreased serum concentration and therefore may reduce contraceptive efficacy.
Physicians should advise the patients of the need for a back-up contraceptive method in the
case of such gastrointestinal symptoms.
Persistent irregular vaginal bleeding requires assessment to exclude underlying pathology.
Patients with fibroids (leiomyomata) should be carefully observed. Sudden enlargement,
pain, or tenderness requires discontinuation of the use of COCs.
Use of COCs is associated with an increased risk of venous and arterial thrombotic and
thromboembolic events.

Warnings
Epidemiological studies have shown that the incidence of venous thromboembolism (VTE)
in users of oral contraceptives with low estrogen content (less than 50 mcg Ethinyl
Estradiol) ranges from about 20 to 40 cases per 100,000 women-years; this risk estimate
varies according to the progestogen. This compares with 5 to 10 cases per 100,000 women-
years for non-users.
Other generalized risk factors for venous thromboembolism include but are not limited to a
personal history, a family history, severe obesity and systemic lupus erythematosus.
The use of COCs increases the risk of arterial thrombotic and thromboembolic events.
Reported events include myocardial infarction and cerebrovascular events (ischemic and
hemorrhagic stroke, transient ischemic attack).
Levonorgestrel and Ethinyl Estradiol tablets are contraindicated in patients with active liver
disease or abnormal liver function testing. Acute or chronic disturbances of liver function
necessitate the discontinuation of COC use until markers of liver function return to normal.

Warnings
During clinical trials with patients treated for HCV infections with the combination of ombitasvir,
paritaprevir, ritonavir and dasabuvir with or without ribavirin, it was found that transaminase (ALT)
elevations higher than 5 times the upper limit of normal (ULN) were significantly more frequent in
women using ethinyl estradiol-containing medications such as COCs. Therefore Ovral L tablets are
contraindicated in hepatitis C patients during treatment with these drugs.
For women with symptomatic gall bladder disease, consideration should be given to whether the
benefits of COCs outweigh the risks. COC use these patients may worsen existing disease.
Patients who have had jaundice, should be given oral contraceptives only with great care and under
close observation.
Hepatic nodules (adenoma and focal nodular hyperplasia) have been reported, particularly in long-
term users of oral contraceptives. Although these lesions are extremely rare, they have caused fatal
intra-abdominal hemorrhage and should be considered in women presenting with an abdominal mass,
acute abdominal pain, or evidence of intra-abdominal bleeding.
Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with
hereditary angioedema.

Warnings
The onset or exacerbation of migraine or the development of headache of a new pattern that is
recurrent, persistent or severe, requires discontinuation of COCs and evaluation of the cause. Women
with migraine headaches who take oral contraceptives may be at increased risk of stroke.
Patients who are pregnant or are taking COCs, may experience corneal edema that may cause visual
disturbances and changes in tolerance to contact lenses, especially of the rigid type. Soft contact lenses
usually do not cause disturbances.
There is an increased risk of thromboembolic complications in COC users after major surgery. If
feasible, COCs should be discontinued and an alternative method substituted at least one month prior
to major elective surgery and during periods of prolonged immobilization. COC use should not be
resumed for at least two weeks after major elective surgery, and only after the first menstrual period
has occurred following hospital discharge.
Patients with a history of emotional disturbances, especially the depressive type, may be more prone to
have a recurrence of depression while taking COCs. Women with a history of depression who use
COCs should be carefully observed and the drug discontinued if depression recurs to a serious degree.
Hormonal contraceptives may cause some degree of fluid retention.

Possible Side Effects
An increased risk of the following serious adverse reactions has been
associated with the use of oral contraceptives: Thrombophlebitis,
Arterial thromboembolism, Pulmonary embolism, Myocardial
infarction, Cerebral hemorrhage, Cerebral thrombosis,
Hypertension, Gallbladder disease, Hepatic adenomas or benign liver
tumors
There is evidence of an association between the following conditions and
the use of oral contraceptives: Mesenteric thrombosis, Retinal
thrombosis

Possible Side Effects
The following side effects have been reported in patients receiving oral contraceptives
and are believed to be drug related: Nausea, Vomiting, Gastrointestinal symptoms
(such as abdominal cramps and bloating), Breakthrough bleeding, Spotting, Change in
menstrual flow, Amenorrhea, Temporary infertility after discontinuation of treatment,
Edema/fluid retention, Melasma/chloasma which may persist, Breast changes:
tenderness, enlargement, and secretion, Change in weight or appetite (increase or
decrease), Change in cervical ectropion and secretion, Possible diminution in lactation
when given immediately postpartum, Cholestatic jaundice, Migraine headache, Rash
(allergic), Mood changes, including depression, Vaginitis, including candidiasis, Change
in corneal curvature (steepening), Intolerance to contact lenses, Decrease in serum
folate levels, Exacerbation of systemic lupus erythematosus, Exacerbation of porphyria,
Exacerbation of chorea, Aggravation of varicose veins, Anaphylactic / anaphylactoid
reactions, including urticaria, angioedema, and severe reactions with respiratory and
circulatory symptoms

Overdosage
Symptoms of COC 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.

Ovral L Tablets During Pregnancy
Levonorgestrel and Ethinyl Estradiol Tablets (Ovral L Tablets) has been
classified by the US FDA as Pregnancy Category X.
Extensive epidemiological studies have revealed no increased risk of birth
defects in infants born to women who have used oral contraceptives prior
to pregnancy.
Studies also do not suggest a teratogenic effect, particularly in so far as
cardiac anomalies and limb-reduction defects are concerned, when taken
inadvertently during early pregnancy.

Ovral L Tablets are manufactured by Wyeth
Limited (a division of Pfizer), India.
For More details Click Here

Ovral L (Levonorgestrel and Ethinyl Estradiol Tablets)

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