Pharmacist Pharma Levonorgestral Size: 12-1/8 x 13-1/2 Fold: 3-3/8 x 2 Type: 6 pt. Side A Rev 4/2013 Proof 1 4/18/13 JB
Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular
HIGHLIGHTS OF PRESCRIBING INFORMATION
taking Levonorgestrel Tablet should be evaluated for ectopic pregnancy. (5.1)
Levonorgestrel Tablet is not effective in terminating an existing pregnancy. (5.2)
These highlights do not include all the information needed to use Levonorgestrel Tablets safely
Effect on menses: Levonorgestrel Tablet may alter the next expected menses. If menses is delayed
and effectively. See full prescribing information for Levonorgestrel Tablets.
beyond 1 week, pregnancy should be considered. (5.3)
Levonorgestrel Tablet, 1.5 mg, for oral use
STI/HIV: Levonorgestrel Tablet does not protect against STI/HIV. (5.4)
Initial U.S. Approval: 1982
-------------------------------------------- ADVERSE REACTIONS ---------------------------------------------
≥10%) in clinical trials included heavier menstrual bleeding
Levonorgestrel
--------------------------------------------INDICATIONS AND USAGE ------------------------------------------
(31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness
Levonorgestrel Tablet is a progestin-only emergency contraceptive indicated for prevention of
pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or
available over the counter for women 17 years and older. Levonorgestrel Tablet is not intended for
www.fda.gov/medwatch
-------------------------------------------- DRUG INTERACTIONS--------------------------------------------
---------------------------------------- DOSAGE AND ADMINISTRATION -------------------------------------
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the
12 CLINICAL PHARMACOLOGY
One tablet taken orally as soon as possible within 72 hours after unprotected intercourse. Efficacy is
effectiveness of progestin-only pills. (7)
12.1 Mechanism of Action
better if the tablet is taken as soon as possible after unprotected intercourse. (2)
Emergency contraceptive pills are not effective if a woman is already pregnant. Levonorgestrel Tablet
----------------------------------------USE IN SPECIFIC POPULATIONS---------------------------------------
is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by
-------------------------------------- DOSAGE FORMS AND STRENGTHS -------------------------------------
Nursing Mothers: Small amounts of progestin pass into the breast milk of nursing women taking
altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the
progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant
endometrium). It is not effective once the process of implantation has begun.
--------------------------------------------- CONTRAINDICATIONS --------------------------------------------- 12.3 Pharmacokinetics
Levonorgestrel Tablet is not intended for use in premenarcheal (8.4) or postmenopausal females (8.5).
2 AAD4DWBlY1ypEQBQwVVV3BbyyEdQ IEJ=sw9gNmzNcAx0054A2CT bMO0Dxw8BA0QS
See 17 for PATIENT COUNSELING INFORMATION
Following a single dose administration of Levonorgestrel Tablet in 30 women under fasting conditions,
-------------------------------------- WARNINGS AND PRECAUTIONS ----------------------------------------
maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.
Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after
Revised: 04/2013
Table 2. Pharmacokinetic Parameter Values Following Single Dose Administration of Levonorgestrel
tablet to 30 Healthy Female Volunteers under Fasting Conditions
FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 9 DRUG ABUSE AND DEPENDENCE 4 CONTRAINDICATIONS 10 OVERDOSAGE 5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
AUCt = area under the drug concentration curve from time 0 to time of last determinable
13 NONCLINICAL TOXICOLOGY
inf = area under the drug concentration curve from time 0 to infinity
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following
7 DRUG INTERACTIONS
single oral administration of Levenorgestrel Tablet has not been evaluated.
8 USE IN SPECIFIC POPULATIONS PRINCIPAL DISPLAY PANEL- TRADE CARTON
The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is
* Sections or subsections omitted from the full prescribing information are not listed
about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a
FULL PRESCRIBING INFORMATION 6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plan B (2 doses of
Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates
1 INDICATIONS AND USAGE
0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from
and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and
Levonorgestrel Tablet, 1.5 mg is a progestin-only emergency contraceptive indicated for prevention
a population of uncertain size, it is not always possible to reliably estimate their frequency or establish
unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller
of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To
amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β hydroxylevonorgestrel. Levonorgestrel and its
obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may
Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and
differ among individuals by several-fold, and this may account in part for the wide variation observed
available over the counter for women 17 years and older. Levonorgestrel Tablet is not indicated for
in levonorgestrel concentrations among users.
General Disorders and Administration Site Conditions 2 DOSAGE AND ADMINISTRATION
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted
Take Levonorgestrel Tablet orally as soon as possible within 72 hours after unprotected intercourse
in feces, mostly as glucuronide conjugates.
or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as
possible after unprotected intercourse. Levonorgestrel Tablet can be used at any time during the
Specific Populations Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating
This product is not intended for use in the premenarcheal population, and pharmacokinetic data are
7 DRUG INTERACTIONS
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may
3 DOSAGE FORMS AND STRENGTHS
decrease the plasma concentrations of progestins, and may decrease the effectiveness of
The Levonorgestrel Tablet is supplied as a white to off-white, round, flat tablets containing 1.5 mg of
This product is not intended for use in postmenopausal women, and pharmacokinetic data are not
progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of
levonorgestrel and debossed with “NL 620” on one side and plain on the other side.
4 CONTRAINDICATIONS
Levonorgestrel Tablet is contraindicated for use in the case of known or suspected pregnancy.
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher
5 WARNINGS AND PRECAUTIONS
pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of
5.1 Ectopic Pregnancy
emergency contraception). There was a non-statistically significant increased rate of pregnancy
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of
among Chinese women in the Levonorgestrel Tablet trial. The reason for this apparent increase in the
pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
pregnancy rate with emergency contraceptives in Chinese women is unknown [see USE IN SPECIFIC
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive
method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in
women who become pregnant or complain of lower abdominal pain after taking Levonorgestrel
No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of
Tablet. A follow-up physical or pelvic examination is recommended if there is any doubt concerning
the general health or pregnancy status of any woman after taking Levonorgestrel Tablet.
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in
some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse
5.2 Existing Pregnancy
No formal studies were conducted to evaluate the effect of renal disease on the disposition of
Levonorgestrel tablet is not effective in terminating an existing pregnancy.
Consult the labeling of all concurrently used drugs to obtain further information about interactions
5.3 Effects on Menses Drug-Drug Interactions
with progestin-only pills or the potential for enzyme alterations.
Some women may experience spotting a few days after taking Levonorgestrel Tablet. Menstrual
No formal drug-drug interaction studies were conducted with Levonorgestrel Tablet [see DRUG
bleeding patterns are often irregular among women using progestin-only oral contraceptives and
8 USE IN SPECIFIC POPULATIONS
women using levonorgestrel for postcoital and emergency contraception.
8.1 Pregnancy 13 NONCLINICAL TOXICOLOGY
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of
Many studies have found no harmful effects on fetal development associated with long-term use of
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
contraceptive doses of oral progestins. The few studies of infant growth and development that have
Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins.
been conducted with progestin-only pills have not demonstrated significant adverse effects.
5.4 STI/HIV
There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years
Levonorgestrel Tablet does not protect against HIV infection (AIDS) or other sexually transmitted
8.3 Nursing Mothers
at approximately 5 mg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for
In general, no adverse effects of progestin-only pills have been found on breastfeeding performance
10 years at up to 250 mg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5
or on the health, growth, or development of the infant. However, isolated post-marketing cases of
mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. 5.5 Physical Examination and Follow-up
decreased milk production have been reported. Small amounts of progestins pass into the breast milk
A physical examination is not required prior to prescribing Levonorgestrel Tablet. A follow-up physical
of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable
or pelvic examination is recommended if there is any doubt concerning the general health or
Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro
pregnancy status of any woman after taking Levonorgestrel Tablet.
mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an
8.4 Pediatric Use 5.6 Fertility Following Discontinuation
Safety and efficacy of progestin-only pills for long-term contraception have been established in
A rapid return of fertility is likely following treatment with Levonorgestrel Tablet for emergency
Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel
women of reproductive age. Safety and efficacy are expected to be the same for postpubertal
contraception; therefore, routine contraception should be continued or initiated as soon as possible
adolescents less than 17 years and for users 17 years and older. Use of Levonorgestrel Tablet
following use of Levonorgestrel Tablet to ensure ongoing prevention of pregnancy.
emergency contraception before menarche is not indicated.
14 CLINICAL STUDIES 6 ADVERSE REACTIONS
A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy
6.1 Clinical Trials Experience 8.5 Geriatric Use
and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
This product is not intended for use in postmenopausal women.
in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese,
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of
34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age
another drug and may not reflect the rates observed in clinical practice.
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher
of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were
Levonorgestrel Tablet was studied in a randomized, double-blinded multicenter clinical trial. In this
pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of
involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg
study, all women who had received at least one dose of study medication were included in the safety
emergency contraception). There was a non-statistically significant increased rate of pregnancy
of levonorgestrel was administered to women allocated into group 1. Two doses of 0.75 mg
analysis: 1,379 women in the Levonorgestrel Tablet group, and 1,377 women in the Plan B group (2
among Chinese women in the Levonorgestrel Tablet trial. The reason for this apparent increase in the
levonorgestrel 12 hours apart (Plan B) were administered to women in group 2. In the Levonorgestrel
doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Levonorgestrel
pregnancy rate with emergency contraceptives in Chinese women is unknown.
Tablet, 1.5 mg group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20
Tablet was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian
pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was
8.7 Hepatic Impairment
or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Levonorgestrel
calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. Among
No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of
Tablet group and 1.4% in Plan B group were lost to follow-up.
women receiving Levonorgestrel Tablet, 1.5 mg 84% of expected pregnancies were prevented and
among those women taking Plan B, 79% of expected pregnancies were prevented. The expected
The most common adverse events (>10%) in the clinical trial for women receiving Levonorgestrel
pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with
8.8 Renal Impairment
Tablet included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%),
No formal studies were conducted to evaluate the effect of renal disease on the disposition of
fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4%
Emergency contraceptives are not as effective as routine contraception since their failure rate, while low
9 DRUG ABUSE AND DEPENDENCE
Table 1. Adverse Events in > 4% of Women, by % Frequency
based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE
Levonorgestrel is not a controlled substance. There is no information about dependence associated
Most Common Adverse Events (MedDRA) Levonorgestrel tablet N = 1359 (%)
In the clinical study, bleeding disturbances were the most common adverse event reported after
10 OVERDOSAGE
taking the levonorgestrel-containing regimens. More than half of the women had menses within two
There are no data on overdosage of Levonorgestrel Tablet, although the common adverse event of
days of the expected time; however, 31% of women experienced change in their bleeding pattern
nausea and associated vomiting may be anticipated.
during the study period; 4.5% of women had menses more than 7 days after the expected time. 11 DESCRIPTION 16 HOW SUPPLIED/STORAGE AND HANDLING
Levonorgestrel Tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel
Levonorgestrel Tablet, 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is a white
[18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)-(-)-], a totally synthetic
to off-white, round, flat, debossed with “NL 620” on one side and plain on the other side containing
progestogen. The inactive ingredients are colloidal silicon dioxide, pregelatinized starch, lactose
monohydrate, magnesium stearate, and talc.
NDC 63704-009-01 (1 tablet unit of use package)
Pharmacist Pharma Levonorgestral Size: 12-1/8 x 13-1/2 Fold: 3-3/8 x 2 Type: 6 pt. Side B Rev 4/2013 Proof 1 4/18/13 JB
Store Levonorgestrel Tablet at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Tablet, the better it works. Levonorgestrel Tablet should be
• If you vomit within 2 hours of taking the medication, call a
17 PATIENT COUNSELING INFORMATION
taken as soon as possible within 72 hours (3 days) after
healthcare professional to find out if you should repeat the
17.1 Information for Patients
• Take Levonorgestrel Tablets as soon as possible and not more than 72 hours after unprotected
intercourse or a known or suspected contraceptive failure.
How effective is Levonorgestrel Tablet?
Prescription only for women younger than age 17. If you are
• If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to
The sooner you take Levonorgestrel Tablet, the better it will
younger than age 17, see a healthcare professional.
work. Take Levonorgestrel Tablet as soon as possible after
• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking
What should I do if I have questions about Levonorgestrel
unprotected sex. If it is taken as soon as possible within 72
Levonorgestrel Tablet, in order to be evaluated for an ectopic pregnancy.
hours (3 days) after unprotected sex, it will significantly
• After taking Levonorgestrel Tablet, consider the possibility of pregnancy if your period is delayed
If you have questions or need more information about this
more than one week beyond the date you expected your period.
decrease the chance that you will get pregnant. Seven out of
product, call 1-800-224-4606, visit our website at
• Do not use Levonorgestrel Tablet as routine contraception.
every 8 women who would have gotten pregnant will not
www.ecpill.com, or ask a healthcare professional.
• Levonorgestrel Tablet is not effective in terminating an existing pregnancy.
Other information
• Levonorgestrel Tablet does not protect against HIV-infection (AIDS) and other sexually transmitted
How will I know if Levonorgestrel Tablet worked?
Tablet is enclosed in a blister seal. Do not use if the blister
Most women will have their next menstrual period at the
seal is broken.
• For women younger than age 17 years, Levonorgestrel Tablet is available only by prescription.
expected time or within a week of the expected time. If your
menstrual period is delayed beyond 1 week, you may be
Store at room temperature 20–25°C (68–77°F).
pregnant. You should get a pregnancy test and follow up with
You may report side effects to FDA at 1-800-FDA-1088. Active ingredient: Levonorgestrel 1.5 mg What if I am already pregnant and use Levonorgestrel Medication Guide Inactive ingredients: colloidal silicon dioxide, pregelatinized
starch, magnesium stearate, talc, and lactose monohydrate
There is no medical evidence that Levonorgestrel Tablet
would harm a developing baby. If you take Levonorgestrel
Protect yourself in more ways than one!
Tablet (accidentally) after you are already pregnant or it does
If you are sexually active, but you are not ready for a
Important information about Levonorgestrel Tablets,
not work and you become pregnant, it is not likely to cause
pregnancy, it is important to use regular pregnancy protection.
Birth Control and Sexually Transmitted Diseases
any harm to you or your pregnancy. The pregnancy will
There are many types of birth control. Whichever type you
continue. Levonorgestrel Tablet will not work if you are
For additional information intended for healthcare
choose, it is important to use your regular birth control
professionals, please see enclosed Product Information for
method as directed. This ensures that you have effective
What should I do if my menstrual period is delayed beyond
protection against pregnancy every time you have sex. 1 week and I have severe lower stomach (abdominal) What is Levonorgestrel Tablet?
But things do not always go as planned. For example, if you
Levonorgestrel Tablet is emergency contraception that helps
were using a condom and it broke or slipped, or if you did
If you have severe lower stomach (abdominal) pain about 3 to
prevent pregnancy after birth control failure or unprotected
not use your regular birth control as you should have, or if
5 weeks after taking Levonorgestrel Tablet, you may have a
sex. It is a backup method of preventing pregnancy and is
you did not use any birth control, Levonorgestrel Tablet may
pregnancy outside the uterus, which is called a tubal
work for you. Levonorgestrel Tablet is an emergency
pregnancy. A tubal pregnancy requires immediate medical
contraceptive that helps prevent pregnancy after unprotected
Levonorgestrel Tablet can reduce your chance of pregnancy
treatment, so you should see a healthcare professional right
sex or when your birth control fails or is not used correctly.
after unprotected sex (if your regular birth control was used
incorrectly or fails, or if you have had sex without birth
Remember, Levonorgestrel Tablet is only for emergency
Can I use Levonorgestrel Tablet for regular birth control?
control). For example, if you were using a condom and it
pregnancy prevention. There are many other products that
No. Levonorgestrel Tablet should not be used for regular
broke or slipped, if you did not use your regular birth control
work for regular birth control that are available by
birth control. It is an emergency or backup method to be
as you should have, or if you did not use any birth control,
used if your regular birth control fails or is used incorrectly
Levonorgestrel Tablet may work for you.
or if you have sex without birth control. You should protect
There is also another form of protection to think about when
What Levonorgestrel Tablet is not.
yourself against STDs and pregnancy every time you have
you have sex: protection against sexually transmitted diseases
Levonorgestrel Tablet will not work if you are already
sex. If you have unprotected sex again after taking
(STDs). Some common STDs are HIV/AIDS, chlamydia, genital
pregnant and will not affect an existing pregnancy.
Levonorgestrel Tablet, it will not help protect you from
herpes, gonorrhea, hepatitis, human papilloma virus (HPV),
Levonorgestrel Tablet should not be used as regular birth
genital warts, syphilis, and trichomonas. Some of these STDs
control. It is important to have another reliable source of
can be very serious and can lead to infertility (inability to have
How often can I use Levonorgestrel Tablet?
birth control that is right for you. Levonorgestrel Tablet will
a baby), problems during pregnancy, chronic illness, and even
Levonorgestrel Tablet is meant for emergency protection
not protect you from HIV infection (the virus that causes
only, and is not designed to be used frequently. If you find
AIDS) and other sexually transmitted diseases.
that you need to use emergency contraception often, talk to
All sexually active women are at risk of catching STDs
When is the appropriate time to use Levonorgestrel
your healthcare professional and learn about methods of
because they may not know that their partner has an STD
birth control and STD prevention that are right for you.
(the partner himself may not know). If your partner uses a
You can use Levonorgestrel Tablet after you have had latex condom correctly each and every time you have sex Will I experience any side effects from Levonorgestrel
unprotected sex in the last 72 hours (3 days), and you do not
with him, this will help reduce, but not eliminate, the chance that you will catch an STD.
When used as directed, Levonorgestrel Tablet is safe for
Levonorgestrel Tablet can be used as a backup or emergency
women. Some women will have mild, temporary side effects,
No other birth control methods will effectively protect you
method to regular birth control if, for example,
such as menstrual changes, nausea, lower stomach
from STDs. The female condom may give you some STD
• Your regular birth control method was used incorrectly or
(abdominal) pain, tiredness, headache, dizziness, breast pain
protection, but it is not as effective as a male latex condom.
failed (your partner’s condom broke or slipped)
and vomiting. These are similar to the side effects that some
For more information on STDs, call the Centers for Disease
• You made a mistake with your regular method
women have when taking regular birth control pills. Some
Control and Prevention (CDC) AIDS/STD Hotline. The CDC
• You did not use any birth control method
women taking Levonorgestrel Tablet will have menstrual
phone numbers are 1-800-342-AIDS (2437) for English,
changes such as spotting or bleeding before their next
When is it not appropriate to use Levonorgestrel Tablet?
1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing
period. Some women may have a heavier or lighter next
• Levonorgestrel Tablet should not be used as a regular birth
period, or a period that is early or late. If your period is more
control method. It does not work as well as most other
Be sure to protect yourself against pregnancy and STDs by
than a week late, you should get a pregnancy test.
forms of birth control when they are used consistently and
using some form of birth control plus a latex condom. Of
What warnings should I know about when using
correctly. Levonorgestrel Tablet is a backup or emergency
course, not having sex is the most effective way to prevent
Levonorgestrel Tablet? Levonorgestrel Tablet does not protect against AIDS virus
• Levonorgestrel Tablet should not be used if you are already
Levonorgestrel Tablet is used to prevent pregnancy after
(HIV) or other sexually transmitted diseases (STDs).
• Levonorgestrel Tablet should not be used if you are allergic to
Do not use:
levonorgestrel or any other ingredients in Levonorgestrel
Levonorgestrel Tablet should not be used for regular birth
• If you are already pregnant (because it will not work)
control, if you are already pregnant (because it will not
• If you are allergic to levonogestrel or any of the ingredients
• Levonorgestrel Tablet does not protect against HIV (the
work), or if you are allergic to levonorgestrel or any of the
virus that causes AIDS) or other sexually transmitted
ingredients in Levonorgestrel Tablet.
diseases (STDs). The best ways to protect yourself against
The sooner you take Levonorgestrel Tablet the better it will When using this product, you may have:
getting HIV or other STDs are to use a latex condom
correctly with every sexual act or not to have sex at all.
Levonorgestrel Tablet does not protect against the AIDS How does Levonorgestrel Tablet work? virus (HIV) or other sexually transmitted diseases (STDs)
Levonorgestrel Tablet is one pill with levonorgestrel, a hormone
Common side effects associated with the use of
that has been used in many birth control pills for over 35 years.
Levonorgestrel Tablet include menstrual changes, nausea,
Levonorgestrel Tablet contains a higher dose of levonorgestrel
lower stomach (abdominal) pain, tiredness, headache,
than birth control pills, but works in a similar way to prevent
pregnancy. It works mainly by stopping the release of an egg
from the ovary. It is possible that Levonorgestrel Tablet may
Keep out of reach of children.
also work by preventing fertilization of an egg (the uniting of
In case of overdose, get medical help or contact a Poison
sperm with the egg) or by preventing attachment
Control Center right away at 1-800-222-1222.
(implantation) to the uterus (womb). What are the directions for using Levonorgestrel Tablet? How can I get the best results from Levonorgestrel Women 17 years of age and older:
• Take Levonorgestrel Tablet as soon as possible within 72
You have only a few days to try to prevent pregnancy after
unprotected sex. The sooner you take Levonorgestrel
SEE SPOT RUN: OBESITY DOESN’T HAVE system uses both visual cues and palpation of specific TO BE PERMANENT areas (the ribcage, waist, and dorsal spinous processes) to estimate subcutaneous and abdominal fat Debra L. Zoran, DVM, PhD, Diplomate ACVIM accumulation relative to superficial muscles. This technique is highly precise (repeatable), but not Texas A&M University, College S
2012 Express Scripts National Preferred Preventive Drug List Prescription Drugs: You Make the Choices, We Make it Easy Preventive Prescription Drugs: A Good Choice Prescription drugs that can help keep you from developing a health condition are cal ed preventive prescription drugs. They can help you maintain your quality of life and avoid expensive treatment, helping to reduce your ov