Errin®(norethindrone tablets, USP 0.35 mg)

ERRIN - norethindrone tablet 
Barr Laboratories Inc.

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Errin®
(norethindrone tablets, USP 0.35 mg)

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

DESCRIPTION

Norethindrone Tablet 28 Day Regimen

Norethindrone is a white to creamy white, odorless, crystalline powder. It is stable in air. Practically insoluble in water; soluble in chloroform and in dioxane; sparingly soluble in alcohol; slightly soluble in ether. The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula is as follows:

Chemical Structure for norethindrone

Each yellow tablet contains 0.35 mg norethindrone, and has the following inactive ingredients: anhydrous lactose, corn starch, D&C yellow no. 10 aluminum lake, ethylcellulose aqueous dispersion, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

Meets USP Dissolution Test 2.

CLINICAL PHARMACOLOGY

1. Mode of Action

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. Pharmacokinetics

Serum 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. 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.

Table 1 Comparison of reversible contraceptive methods: Percent of women experiencing a contraceptive failure (pregnancy) during the first year of use.
*
Depending on method (calendar, ovulation, sympto-thermal, post ovulation).
Hatcher RA, Trussel J, Stewart F, Stewart GK, Kowal D, Guest F, Cates W, Pollcar M. Contraceptive Technology 1994-1996. New York, NY: Irvington Publishers. 1994.
Percent of women experiencing
a pregnancy within the first year of use
MethodAverage UsePerfect Use
No contraception8585
Spermicides216
Periodic abstinence201-9*
Withdrawal194
Cervical caps
Given birth3626
Never given birth189
Diaphragms186
Condoms
Female215
Male123
Pills3-
Progestin-only-0.5
Combined-0.1
IUDs
Progesterone21.5
Copper T 380A0.80.6
Injectables0.30.3
Implant0.090.09
Adapted with permission.

CONTRAINDICATIONS

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.

Norethindrone tablets do 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 provider 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 physician 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. Health providers 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 intraabdominal 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. General

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

2. Physical Examination and Follow Up

It 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 clinician.

3. Carbohydrate and Lipid Metabolism

Some 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 Interactions

The 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.

5. Interactions with Laboratory Tests

The following endocrine tests may be affected by progestin-only oral contraceptive use:

6. Carcinogenesis

See WARNINGS section.

7. Pregnancy

Many 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 Mothers

No adverse effects have been found on breast-feeding performance or on the health, growth or development of the infant. Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1 to 6% of the levels of maternal plasma.

9. Fertility Following Discontinuation

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

10. Headache

The 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 THE PATIENT

1. See Detailed Patient Labeling for detailed information.

2. Counseling Issues

The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:

ADVERSE REACTIONS

Adverse reactions reported with the use of POPs include:

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, norethindrone tablets 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

Errin® (norethindrone tablets, USP 0.35 mg) are packaged in cartons of six blister cards each containing 28 tablets. Each yellow, round, flat-faced, beveled-edge, unscored tablet is debossed with stylized b on one side and 344 on the other side.

(NDC 0555-0344-58)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

 REFERENCE

McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.

DETAILED PATIENT LABELING

Norethindrone Tablets, USP 0.35 mg

This product (like all oral contraceptives) is used to prevent pregnancy.It does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

DESCRIPTION

Norethindrone Tablet 28 Day Regimen

Each yellow tablet contains 0.35 mg norethindrone. Inactive ingredients include anhydrous lactose, corn starch, D&C yellow no. 10 aluminum lake, ethylcellulose aqueous dispersion, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

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 doctor or clinic.

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 Comparison of reversible contraceptive methods: Percent of women who become pregnant during the first year of use.
*
Depending on method (calendar, ovulation, sympto-thermal, post-ovulation method).
Hatcher RA, Trussel J, et al., Contraceptive Technology 1994-1996. New York, NY: Irvington Publishers, 1994.
Percent of women experiencing
a pregnancy within the first year of use
MethodAverage UsePerfect Use
No contraception8585
Spermicides216
Periodic abstinence201-9*
Withdrawal194
Cervical caps
Given birth3626
Never given birth189
Diaphragms186
Condoms
Female215
Male123
Pills3-
POPs-0.5
Combined pills-0.1
IUDs
Progesterone21.5
Copper T 380A0.80.6
Injectables0.30.3
Implant0.090.09
Adapted with permission.

HOW DO POPS WORK?

POPs can prevent pregnancy in different ways including:

YOU SHOULD NOT TAKE POPS

RISKS OF TAKING POPS

Cigarette 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 doctor or clinic immediately.

Ectopic Pregnancy

An 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 Cysts

These 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 Breasts

Some 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.

An analysis of 54 studies reports that women who are currently using combined oral contraceptives or have used them in the past 10 years are at a slightly increased risk of having breast cancer diagnosed although the additional cancers tend to be localized to the breast. There is no evidence of an increased risk of having breast cancer diagnosed 10 or more years after stopping 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 Tumors

In rare cases, 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 Women

Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.

SEXUALLY TRANSMITTED DISEASES (STDs)

WARNING: POPs do not protect against getting or giving someone HIV (AIDS) orany 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 and dizziness. 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 doctor or clinic.

USING POPS WITH OTHER MEDICINES

Before taking a POP, inform your healthcare provider 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:

Medicine for TB:

Before you begin taking any new medicines be sure your doctor or clinic knows you are taking a progestin-only birth control pill.

HOW TO TAKE POPS

IMPORTANT POINTS TO REMEMBER

STARTING POPS

IF YOU ARE LATE OR MISS TAKING YOUR 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 back-up method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.

IF YOU ARE BREAST-FEEDING

IF YOU ARE SWITCHING PILLS

PREGNANCY WHILE ON THE PILL

If you think you are pregnant, contact your physician. 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:

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.

BREAST-FEEDING

If you are breast-feeding, POPs will not affect the quality or amount of your breast-milk or the health of your nursing baby.

OVERDOSE

 No 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 CONCERNS

If you have any questions or concerns, check with your doctor or clinic. You can also ask for the more detailed “Professional Labeling” written for doctors and other healthcare providers.

HOW TO STORE YOUR POPS

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

INSTRUCTIONS TO PATIENTS

How to Use the Errin® Tablets Blister Card

1. The first time you use these pills, take your first pill on the first day of your menstrual period. Pick the Days of the Week Sticker that starts the first day of your period. When you have picked the right sticker, throw away the others and place the sticker on the blister card over the pre-printed days of the week and make sure it lines up with the pills.

2. Your blister package consists of three parts, the foil pouch, wallet, and a blister card containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. All 28 pills are “active” birth control pills. Refer to the sample of the blister card below:

Sample of the blister card

3. To remove a pill, push down on the pill with your thumb and forefinger so that the pill releases through the back of the blister card. Each day, take one pill. Always go from left to right along the row. Each new row will begin on the same day of the week.

4. Take one pill every day for 28 days, whether bleeding or not, until you have taken all the pills. It is important that you take your pill at the same time every day.

5. After you have taken all 28 pills, begin taking your pills again the next day. Be sure that the calendar day on your new package corresponds with the actual day.

BARR LABORATORIES, INC.

POMONA, NY 10970

Revised DECEMBER 2008

BR-344

PRINCIPAL DISPLAY PANEL

Errin (norethindrone tablets, USP) 0.35 mg Foil Pouch Label

Errin® (norethindrone tablets, USP) 0.35 mg Label Text

NDC 0555-0344-58

Errin®

(norethindrone

tablets, USP)

0.35 mg

Each yellow tablet contains 0.35 mg norethindrone.

28 DAY REGIMEN

Rx only

THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES)

IS INTENDED TO PREVENT PREGNANCY. IT DOES

NOT PROTECT AGAINST HIV INFECTION (AIDS) AND

OTHER SEXUALLY TRANSMITTED DISEASES.

barr Laboratories, Inc.

SHAPING WOMEN'S HEALTH

Barr Laboratories, Inc.


ERRIN 
norethindrone   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0555-0344
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE0.35 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
STARCH, CORN 
D&C YELLOW NO. 10 
ALUMINUM OXIDE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
Product Characteristics
ColorYELLOWScore no score
ShapeROUNDSize6mm
FlavorImprint Code b;344
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10555-0344-586 BLISTER PACK In 1 BOXcontains a BLISTER PACK
128 TABLET In 1 BLISTER PACKThis package is contained within the BOX (0555-0344-58)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07622501/31/2011

Labeler - Barr Laboratories Inc. (802716563)
Revised: 01/2011Barr Laboratories Inc.