Levonorgestrel 1.5 MG Oral Tablet
DRUG INTERACTIONS
7 Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills.
Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St.
John’s wort topiramate Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of coadministration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills.
(7)
OVERDOSAGE
10 There are no data on overdosage of levonorgestrel tablet, although the common adverse event of nausea and associated vomiting may be anticipated.
DESCRIPTION
11 Next Choice One DoseTM contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)-(-)-], a totally synthetic progestogen.
The inactive ingredients present are colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, povidone.
Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas: chemical structure of levonorgestrel
CLINICAL STUDIES
14 A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception.
Subjects were enrolled at 15 sites in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese).
2,381 healthy women with a mean age of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups.
A single dose of 1.5 mg of levonorgestrel (levonorgestrel tablet) was administered to women allocated into group 1.
Two doses of 0.75 mg levonorgestrel 12 hours apart (levonorgestrel tablets) were administered to women in group 2.
In the levonorgestrel tablet group, 16 pregnancies occurred in 1,198 women and in the levonorgestrel tablets group, 20 pregnancies occurred in 1,183 women.
The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle.
Among women receiving levonorgestrel tablet, 84% of expected pregnancies were prevented and among those women taking levonorgestrel tablets, 79% of expected pregnancies were prevented.
The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with levonorgestrel tablet.
Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE ( 1 )].
In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens.
More than half of the women had menses within two days of the expected time; however, 31% of women experienced change in their bleeding pattern during the study period; 4.5% of women had menses more than 7 days after the expected time.
GERIATRIC USE
8.5 Geriatric Use This product is not intended for use in postmenopausal women.
DOSAGE FORMS AND STRENGTHS
3 The Next Choice One DoseTM tablet is supplied as a peach, round tablet containing 1.5 mg of levonorgestrel and is embossed with 287 on one side and WATSON on the other side.
1.5 mg tablet (3)
MECHANISM OF ACTION
12.1 Mechanism of Action Emergency contraceptive pills are not effective if a woman is already pregnant.
Levonorgestrel is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova).
In addition, it may inhibit implantation (by altering the endometrium).
It is not effective once the process of implantation has begun.
INDICATIONS AND USAGE
1 Next Choice One DoseTM is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
Next Choice One Dose TM is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Next Choice One DoseTM is not indicated for routine use as a contraceptive.
(1) Next Choice One DoseTM is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
Next Choice One Dose TM is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Next Choice One DoseTM is not intended for routine use as a contraceptive.
(1)
PEDIATRIC USE
8.4 Pediatric Use Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age.
Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older.
Use of Next Choice One DoseTM emergency contraception before menarche is not indicated.
PREGNANCY
8.1 Pregnancy Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins.
The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.
NUSRING MOTHERS
8.3 Nursing Mothers In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant.
However, isolated post-marketing cases of decreased milk production have been reported.
Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.
WARNING AND CAUTIONS
5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Next Choice One DoseTM tablet should be evaluated for ectopic pregnancy.
(5.1) Next Choice One DoseTM tablet is not effective in terminating an existing pregnancy.
(5.2) Effect on menses: Next Choice One DoseTM tablet may alter the next expected menses.
If menses is delayed beyond 1 week, pregnancy should be considered.
(5.3) STI/HIV: Next Choice One DoseTM tablet does not protect against STI/HIV.
(5.4) Contains FD&C Yellow #6 as a color additive.
5.1 Ectopic Pregnancy Ectopic pregnancies account for approximately 2% of all reported pregnancies.
Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
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 Next Choice One DoseTM.
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 Next Choice One DoseTM.
5.2 Existing Pregnancy Next Choice One DoseTM is not effective in terminating an existing pregnancy.
5.3 Effect on Menses Some women may experience spotting a few days after taking Next Choice One DoseTM.
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.
5.4 STI/HIV Next Choice One DoseTM does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
5.5 Physical Examination and Follow-up A physical examination is not required prior to prescribing Next Choice One DoseTM.
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 Next Choice One DoseTM.
5.6 Fertility Following Discontinuation A rapid return of fertility is likely following treatment with Next Choice One DoseTM for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Next Choice One DoseTM to ensure ongoing prevention of pregnancy.
5.7 Presence of FD&C Yellow #6 Next Choice One DoseTM contains FD&C Yellow #6 as a color additive.
INFORMATION FOR PATIENTS
17 PATIENT COUNSELING INFORMATION 17.1 Information for Patients Take Next Choice One DoseTM as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.
Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Next Choice One DoseTM, in order to be evaluated for an ectopic pregnancy.
After taking Next Choice One DoseTM, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
Do not use Next Choice One DoseTM as routine contraception.
Next Choice One DoseTM is not effective in terminating an existing pregnancy.
Next Choice One DoseTM does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
For women younger than age 17 years, Next Choice One DoseTM is available only by prescription.
Next Choice One DoseTM tablets contain FD&C Yellow #6 as a color additive.
Manufactured by: Watson Laboratories, Inc.
Corona, CA 92880 USA Distributed by: Watson Pharma, Inc.
Parsippany, NJ 07054 USA Phone: 1-866-9WATSON (1-866-992-8766) www.mynextchoiceonedose.com Revised: October 2012 205050-1
DOSAGE AND ADMINISTRATION
2 Take Next Choice One DoseTM tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse.
Next Choice One DoseTM tablet can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.
One tablet taken orally as soon as possible within 72 hours after unprotected intercourse.
Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse.
(2)