NDC 68180-877 Jencycla

Norethindrone

NDC Product Code 68180-877

NDC CODE: 68180-877

Proprietary Name: Jencycla What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Norethindrone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent pregnancy. It is often referred to as the mini-pill because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also stops the release of an egg (ovulation) in about half of a woman's menstrual cycles. While the mini-pill is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
  • This medication is used to prevent pregnancy. It is often referred to as the mini-pill because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also stops the release of an egg (ovulation) in about half of a woman's menstrual cycles. While the mini-pill is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Product Characteristics

Color(s):
GREEN (C48329 - GREEN)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
LU;O23
Score: 1

NDC Code Structure

NDC 68180-877-13

Package Description: 1 BLISTER PACK in 1 CARTON > 28 TABLET in 1 BLISTER PACK (68180-877-11)

NDC 68180-877-73

Package Description: 1 BLISTER PACK in 1 CARTON > 28 TABLET in 1 BLISTER PACK (68180-877-71)

NDC Product Information

Jencycla with NDC 68180-877 is a a human prescription drug product labeled by Lupin Pharmaceuticals, Inc.. The generic name of Jencycla is norethindrone. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Lupin Pharmaceuticals, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Jencycla Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NORETHINDRONE .35 mg/1
  • NORETHINDRONE .35 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • POVIDONE (UNII: FZ989GH94E)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lupin Pharmaceuticals, Inc.
Labeler Code: 68180
FDA Application Number: ANDA091323 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-08-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-30-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Norethindrone

Norethindrone is pronounced as (nor eth in' drone)

Why is norethindrone medication prescribed?
Norethindrone is used to treat endometriosis, a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy...
[Read More]
Progestin-Only Oral Contraceptives

Progestin-Only Oral Contraceptives is pronounced as (pro jes' tin)
Why is progestin-only oral contraceptives medication prescribed?
Progestin-only oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) a...
[Read More]

* Please review the disclaimer below.

Jencycla Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx OnlyPatients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAJune  2016                                                                               ID#: 246811

DETAILED PATIENT LABELINGJencycla™(norethindrone tablets USP, 0.35 mg)Rx OnlyThis product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

  • Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.HOW DO POPs WORK?POPs can prevent pregnancy in different ways including:They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg.They prevent ovulation (release of the egg from the ovary) in about half of the cycles.They also affect other hormones, the fallopian tubes and the lining of the uterus.YOU SHOULD NOT TAKE POPsIf there is any chance you may be pregnant.If you have breast cancer.If you have bleeding between your periods that has not been diagnosed.If you are taking certain drugs for epilepsy (seizures) or for TB, or medicine for pulmonary hypertension or certain herbal products. (See "Using POPs with Other Medicines " below.)If you are hypersensitive, or allergic, to any component of this product.If you have liver tumors, either benign or cancerous.If you have acute liver disease.RISKS OF TAKING POPsCigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.WARNING:If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.Ectopic PregnancyAn ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.Ovarian CystsThese cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.Cancer Of The Reproductive Organs And BreastsSome studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this 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.Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.Liver TumorsIn rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.Diabetic WomenDiabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your healthcare professional may monitor you more closely under these conditions.

  • SEXUALLY TRANSMITTED DISEASES (STDs) WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.SIDE EFFECTS Irregular Bleeding:The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding.Other Side Effects:Less common side effects include headaches, tender breasts, nausea, vomiting, dizziness, and fatigue. Depression, nervousness, leg pain, vaginal discharge, fluid retention, allergic reactions, jaundice or a yellowing of the skin or eyeballs, loss of scalp hair, rash/itchy rash, weight gain, acne and extra hair on your face and body have been reported, but are rare.If you are concerned about any of these side effects, check with your healthcare professional.USING POPs WITH OTHER MEDICINESBefore taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking.These medicines can make POPs less effective:Medicines for seizures such as:Phenytoin (Dilantin®)Carbamazepine (Tegretol®)Phenobarbital Medicine for TB:Rifampin (Rifampicin)Medicine for pulmonary hypertension such as: Bosentan (Tracleer®)Herbal products such as: St. John's WortBefore you begin taking any new medicines be sure your healthcare professional knows you are taking a progestin-only birth control pill.

  • HOW TO TAKE POPsIMPORTANT POINTS TO REMEMBERPOPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don’t wish to become pregnant, be certain to use another birth control method.If you are not sure about how to take POPs, ask your healthcare professional.STARTING POPsIt’s best to take your first POP on the first day of your menstrual period.If you decide to take your first POP on another day, use a backup method (such as a condom and/or a spermicide) every time you have sex during the next 48 hours.If you have had a miscarriage or an abortion, you can start POPs the next day.Find:         •     Where on the pack to start taking pills,          •     In what order to take the pills (follow the arrows), and          •     The week numbers as shown in the picture below:IF YOU ARE LATE OR MISS TAKING YOUR POPsIf you are more than 3 hours late or you miss one or more POPs:1) TAKE a missed pill as soon as you remember that you missed it,2) THEN go back to taking POPs at your regular time,3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.IF YOU ARE BREASTFEEDINGIf you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery.If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery.IF YOU ARE SWITCHING PILLSIf you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected.If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished.If you switch to another brand of POPs, start the new brand anytime.If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery.PREGNANCY WHILE ON THE PILLIf you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don’t need when you are pregnant.You should get a pregnancy test:If your period is late and you took one or more pills late or missed taking them and had sex without a backup method.Anytime it has been more than 45 days since the beginning of your last period.WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.BREASTFEEDINGIf you are breastfeeding, POPs will not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.OVERDOSENo serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.OTHER QUESTIONS OR CONCERNSIf you have any questions or concerns, check with your healthcare professional. You can also ask for the more detailed "Professional Labeling" written for doctors and other healthcare professionals.HOW TO STORE YOUR POPsStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children.Jencycla™ is a trademark of Lupin Pharmaceuticals, Inc.The other brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAJune 2016                                                                                                        ID#: 246812

Description

Jencycla™ TabletsEach 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.

Jencycla™ TabletsEach 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.

Clinical Pharmacology

1.           Mode of ActionJencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.2.           PharmacokineticsSerum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

Indications And Usage

1.           IndicationsProgestin-only oral contraceptives are indicated for the prevention of pregnancy.2.           EfficacyIf 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.Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.% of Women Experiencing anUnintended Pregnancy within theFirst Year of Use% of WomenContinuing Use atOne Year3MethodTypical Use 1Perfect Use2Header$(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%.9Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10Source: 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, 1998.1Among 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.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.3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.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.5Foams, creams, gels, vaginal suppositories, and vaginal film.6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7With spermicidal cream or jelly.8Without spermicides.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).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.Chance48585Spermicides526640Periodic abstinence2563     Calendar9     Ovulation Method3     Sympto-Thermal62     Post-Ovulation1Cap7     Parous Women402642     Nulliparous Women20956SpongeParous Women402042     Nulliparous Women20956Diaphragm720656Withdrawal194Condom8     Female (Reality®)21556     Male14361Pill571Progestin Only0.5Combined0.1IUDProgesterone T2.01.581     Copper T380A0.80.678     LNg 200.10.181Depo-Provera®0.30.370Norplant® and0.050.0588Norplant-2®Female Sterilization0.50.5100Male Sterilization0.150.10100Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.

Contraindications

  • Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:Known or suspected pregnancyKnown or suspected carcinoma of the breastUndiagnosed abnormal genital bleedingHypersensitivity to any component of this productBenign or malignant liver tumorsAcute liver disease

Warnings

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 PregnancyThe 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 CystsIf 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 BleedingIrregular 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 OrgansSome 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 NeoplasiaBenign 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.

Precautions

  • 1.         GeneralPatients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.2.         Physical Examination and Follow upIt is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.3.         Carbohydrate and Lipid MetabolismSome users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3 , LDL, or VLDL.4.         Drug InteractionsThe effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.Herbal products containing St. John's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding. Concurrent use of bosentan and norethindrone containing products may result in decreased concentrations of these contraceptive hormones thereby increasing the risk of unintended pregnancy and unscheduled bleeding.5.          Interactions with Laboratory TestsThe following endocrine tests may be affected by progestin-only oral contraceptive use:Sex hormone-binding globulin (SHBG) concentrations may be decreased.Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).6.         Carcinogenesis See WARNINGS .7.         PregnancyMany studies have found no 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 have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.8.          Nursing MothersIn general, no adverse effects 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, resulting in detectable steroid levels in infant plasma.9.          Pediatric UseSafety and efficacy of Jencycla tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.10.        Fertility Following DiscontinuationThe limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.11.        HeadacheThe onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.

Information For Patients

  • 1. See "DETAILED PATIENT LABELING " for detailed information.2. Counseling issuesThe following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:The necessity of taking pills at the same time every day, including throughout all bleeding episodes.The need to use a backup method such as condom and spermicide for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

Adverse Reactions

  • Adverse reactions reported with the use of POPs include:Menstrual irregularity is the most frequently reported side effect.Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal DisordersVomiting, abdominal pain General Disorders and Administration Site ConditionsFatigue, edema Psychiatric DisordersDepression, nervousnessMusculoskeletal and Connective Tissue DisordersPain in extremityReproductive System and Breast DisordersGenital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped Immune System Disorders Anaphylactic/anaphylactoid reaction, hypersensitivity Hepatobiliary Disorders Hepatitis, jaundice cholestatic Skin and Subcutaneous Tissue DisordersAlopecia, rash, rash pruritic

Overdosage

There have been no reports of serious ill effects from overdosage, including ingestion by children.

Dosage And Administration

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.

How Supplied

Jencycla Tablets containing 0.35 mg of norethindrone, green colored, round, flat face, beveled edge tablets, debossed with "O23" on one side and "LU" on the other side.Jencycla Tablets are available in a wallet (NDC 68180-877-11) containing 28 tablets. Such three wallets are packaged in a carton (NDC 68180-877-13). STORAGE: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep out of reach of children.

References

1.   McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994. 2.   Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006;44(3):113-118. 3.   Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3. 4.   Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6):1250-1258. 5.   Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539-579. 6.   Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611-21. 7.   2008 USPC Official:12/1/08-4/30/09, USP Monographs: Norethindrone Tablets (page 1 of 5). Jencycla™ is a trademark of Lupin Pharmaceuticals, Inc.The other brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Introduction

This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your healthcare professional.Progestin-only pills are often called "POPs" or "the minipill." POPs have less progestin than the combined birth control pill (or "the pill") which contains both an estrogen and a progestin.

How Effective Are Pops?

About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 "typical" POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods.Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.% of Women Experiencing anUnintended Pregnancy within theFirst Year of Use% of WomenContinuing Use atOne Year3MethodTypical Use 1Perfect Use2Header$(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%.9Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10Source: 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, 1998.1Among 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.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.3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.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.5Foams, creams, gels, vaginal suppositories, and vaginal film.6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7With spermicidal cream or jelly.8Without spermicides.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).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.Chance48585Spermicides526640Periodic abstinence2563     Calendar9     Ovulation Method3     Sympto-Thermal62     Post-Ovulation1Cap7     Parous Women402642     Nulliparous Women20956Sponge     Parous Women402042     Nulliparous Women20956Diaphragm720656Withdrawal194Condom8     Female (Reality®)21556     Male14361Pill571     Progestin Only0.5     Combined0.1IUD     Progesterone T2.01.581     Copper T380A0.80.678     LNg 200.10.181Depo-Provera®0.30.370Norplant® and0.050.0588Norplant-2®Female Sterilization0.50.5100Male Sterilization0.150.10100

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