Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets)

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Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets)

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

Active Ingredients
The active ingredients present in
Ovral-L tablets are
Levonorgestrel and Ethinyl
Estradiol.
Each Ovral-L Contraceptive
Tablets contains 150 mcg of
Levonorgestrel and 30 mcg of
Ethinyl Estradiol.

Chemical Structure
The structure of Levonorgestrel is given below:

Chemical Structure
The structure of Ethinyl Estradiol is given below:

Ovral-L Tablets are manufactured by Pfizer Limited, India.
(Website: https://www.pfizerindia.com/ )
URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html

Levonorgestrel and Ethinyl Estradiol Tablets – Brand Names
Levonorgestrel and Ethinyl Estradiol tablets
are available under various Drug trade names
that include 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.

Uses of Ovral-L Tablets
Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets
or LNG/EE Tablets) is a combination of Levonorgestrel, a progestin,
and Ethinyl Estradiol, an estrogen, indicated for use by females of
reproductive potential to prevent pregnancy. It contains 2 hormones: a
progestin and an estrogen. 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 for treatment of moderate acne vulgaris in
women 14 years of age or more who, have no known contraindications
to oral contraceptive therapy, desire contraception, and have achieved
menarche.

Ovral-L Dosage
The dosage of Ovral-L tablets (Generic Levonorgestrel
and Ethinyl Estradiol tablets) is given below:
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. The next pack should start 7
days after the last active tablet was taken. The patient should
be told to start taking Ovral-L on Day 1 of menstruation.
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.

Ovral-L Dosage
The dosage of Ovral-L tablets (Generic Levonorgestrel and Ethinyl Estradiol tablets)
is given below:
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.
If switching from an implant or injection, the patient must 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 must be advised to
use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.
Withdrawal bleeding should usually occur within 3 days following discontinuation of pink
tablets and may not have finished before the next pack is started.
If spotting or breakthrough bleeding occur, the patient is instructed to continue on the
same regimen. This type of bleeding is usually transient and without significance;
however, if the bleeding is persistent or prolonged, the patient is advised to consult her
physician.

Missed Dose Instructions
The following instructions are an alternative for the management of
missed tablets:
If one active tablet is missed, it should be taken as soon as it is
remembered. Subsequent tablets should be taken at the usual
time.
If two consecutive active tablets are missed during week 1 or week
2, two tablets should be taken on both the day remembered and
the following day. Subsequent tablets should be taken at the usual
time. A non-hormonal back-up method of birth control must be
used for the next 7 days.

Missed Dose Instructions
If two consecutive active tablets are missed during week
3 or if three or more consecutive active tablets are
missed during weeks 1-3, the following apply:
Day 1 starters should discard any tablets remaining in
the current pack and start a new pack the same day.

Advice In Case Of Vomiting And/ Or Diarrhea
If vomiting or diarrhea occurs within 4 hours after
tablet taking, absorption may be incomplete. Use of
tablets from a back-up pack is required, as outlined
below.
Refer to recommendations for management of missed
dose.

Ovral-L Tablets Contraindications
Ovral-L tablets are contraindicated in persons with a hypersensitivity (allergy)
to Ethinyl Estradiol, Levonorgestrel or any of the other ingredients of this
medicine. Combination oral contraceptives should not be used in women with
any of the following conditions:
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
Headaches with focal neurological symptoms
Uncontrolled hypertension

Ovral-L Tablets Contraindications
Combination oral contraceptives should not be used in women with
any of the following conditions:
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

Storage Instructions
Ovral-L Tablets (Generic
Levonorgestrel 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
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 and is quite marked in women over
35 years of age. Women who use oral contraceptives should be
strongly advised not to smoke.
Vascular Events: Stop Combined oral contraceptives (COCs) such
as Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) if an
arterial or deep venous thrombotic event occurs. Although use of
COCs increases the risk of venous thromboembolism, pregnancy
increases the risk of venous thromboembolism as much or more
than the use of COCs.

Warnings
Carcinoma of the Breast and Cervix: Women who currently have or have had
breast cancer should not use COCs because breast cancer may be
hormonally sensitive.
Liver Disease: Stop using COCs if jaundice develops. Steroid hormones may
be poorly metabolized in patients with impaired liver function.
Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment:
During clinical trials with the Hepatitis C combination drug regimen that
contains Obmitasvir / Paritaprevir / Ritonavir, with or without Dasabuvir, ALT
elevations greater than 5 times the upper limit of normal (ULN), including
some cases greater than 20 times the ULN, were significantly more frequent
in women using Ethinyl Estradiol-containing medications, such as COCs.
Discontinue Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) prior to
starting therapy with the combination medicine regimen.

Warnings
High Blood Pressure: For women with well-controlled hypertension, monitor blood
pressure and stop COCs if blood pressure rises significantly. Women with uncontrolled
hypertension or hypertension with vascular disease should not use COCs
Gallbladder Disease: Studies suggest a small increased relative risk of developing
gallbladder disease among COC users.
Carbohydrate and Lipid Metabolic Effects:Carefully monitor prediabetic and diabetic
women who are taking COCs. COCs may decrease glucose tolerance in a dose-related
fashion.
Headache:If a woman taking Combined oral contraceptives develops new headaches
that are recurrent, persistent, or severe, evaluate the cause as well as significant
change in headaches and discontinue COCs if indicated.
Bleeding Irregularities: Unscheduled (breakthrough) bleeding and spotting sometimes
occur in patients on Combined oral contraceptives, 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 Combined oral contraceptive medicine.

Warnings
Interference with Laboratory Tests: The use of Combined oral
contraceptives could change the results of some laboratory
tests, such as coagulation factors, lipids, glucose tolerance, and
binding proteins.
Monitoring: A woman who is taking Combined oral
contraceptives should have a yearly visit with her healthcare
provider for a blood pressure check and for other indicated
healthcare.
Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Ovral-L Tablets Side Effects
Common Side effects of Levonorgestrel and Ethinyl Estradiol
Tablets (Ovral-L ) 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.

Overdose
There have been no reports of serious adverse effects from overdose,
including ingestion by children. Overdosage may cause withdrawal
bleeding in females and nausea.
There is no specific antidote for Ovral-L overdosage and further
treatment of overdose, if necessary, is directed to the symptoms.

Ovral-L Tablets During Pregnancy
Levonorgestrel and Ethinyl Estradiol Tablets (Ovral-L) is
classified by the US FDA as Pregnancy Category X. There is
little or no increased risk of birth defects in women who
inadvertently use Combined oral contraceptives 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 Combined oral contraceptives prior to
conception or during early pregnancy.

Ovral-L Tablets (Generic Levonorgestrel and Ethinyl
Estradiol Tablets) is manufactured by Pfizer Limited,
India.

Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets)

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