Jencycla
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Questions & Answers
Side Effects & Adverse Reactions
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
Jencycla does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
1. Ectopic Pregnancy
The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.
2. Delayed Follicular Atresia/Ovarian Cysts
If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.
3. Irregular Genital Bleeding
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
4. Carcinoma of the Breast and Reproductive Organs
Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.
A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.
This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.
5. Hepatic Neoplasia
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
1. Indications
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
| |
% of Women Experiencing an Unintended Pregnancy within the First Year of Use |
% of Women Continuing Use at One Year3 |
|
| Method |
Typical Use 1 |
Perfect Use2 |
|
| Header$(1) |
(2) |
(3) |
(4) |
| Adapted from Hatcher et al, 1998, Ref. # 1. |
|||
| Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 |
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| Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10 |
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| Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. |
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| 1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. |
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| 2Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. |
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| 3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. |
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| 4The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. |
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| 5Foams, creams, gels, vaginal suppositories, and vaginal film. |
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| 6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. |
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| 7With spermicidal cream or jelly. |
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| 8Without spermicides. |
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| 9The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). |
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| 10However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. |
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| Chance4 |
85 |
85 |
|
| Spermicides5 |
26 |
6 |
40 |
| Periodic abstinence |
25 |
|
63 |
| Calendar |
|
9 |
|
| Ovulation Method |
|
3 |
|
| Sympto-Thermal6 |
|
2 |
|
| Post-Ovulation |
|
1 |
|
| Cap7 |
|
|
|
| Parous Women |
40 |
26 |
42 |
| Nulliparous Women |
20 |
9 |
56 |
| Sponge |
|
|
|
| Parous Women |
40 |
20 |
42 |
| Nulliparous Women |
20 |
9 |
56 |
| Diaphragm7 |
20 |
6 |
56 |
| Withdrawal |
19 |
4 |
|
| Condom8 |
|
|
|
| Female (Reality®) |
21 |
5 |
56 |
| Male |
14 |
3 |
61 |
| Pill |
5 |
|
71 |
| Progestin Only |
|
0.5 |
|
| Combined |
|
0.1 |
|
| IUD |
|
|
|
| Progesterone T |
2.0 |
1.5 |
81 |
| Copper T380A |
0.8 |
0.6 |
78 |
| LNg 20 |
0.1 |
0.1 |
81 |
| Depo-Provera® |
0.3 |
0.3 |
70 |
| Norplant® and |
0.05 |
0.05 |
88 |
| Norplant-2® |
|
|
|
| Female Sterilization |
0.5 |
0.5 |
100 |
| Male Sterilization |
0.15 |
0.10 |
100 |
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
History
There is currently no drug history available for this drug.
Other Information
Jencycla™ Tablets
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C yellow No. 10, FD&C blue No. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate.
The chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. It has a molecular formula of C20H26O2 and a molecular weight of 298.4. It has the following structural formula:
Jencycla meets USP Dissolution Test 2.
DESCRIPTIONJencycla™ Tablets
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C yellow No. 10, FD&C blue No. 1, lactose anhydrous, magnesium stearate, povidone and sodium starch glycolate.
The chemical name of norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. It has a molecular formula of C20H26O2 and a molecular weight of 298.4. It has the following structural formula:
Jencycla meets USP Dissolution Test 2.
Sources
Jencycla Manufacturers
-
Lupin Pharmaceuticals, Inc.
![Jencycla (Norethindrone) Tablet [Lupin Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Jencycla | Lupin Pharmaceuticals, Inc.
To achieve maximum contraceptive effectiveness, Jencycla must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See DETAILED PATIENT LABELING for detailed instruction.
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