| MICRONOR

09:59 EDT 20th September 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, and povidone.

ORTHO MICRONOR 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.

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.

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

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.

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%. ¶Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception. 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.

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 an
Unintended Pregnancy within the
First Year of Use
% of Women
Continuing Use at
One Year*
Method
(1)
Typical Use †
(2)
Perfect Use‡
(3)
(4)
Chance# 85 85
SpermicidesÞ 26 6 40
Periodic abstinence 25
63
  Calendar
9
  Ovulation Method
3
  Sympto-Thermalß
2
  Post-Ovulation
1
Capà


  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge


  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragmà 20 6 56
Withdrawal 19 4
Condomè


  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 Norplant-2® 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100

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

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

ORTHO MICRONOR 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.

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.

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.

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.

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.

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.

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

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 healthcare professional.

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, HDL , LDL, or VLDL.

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.

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

See WARNINGS section.

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.

In 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.

Safety and efficacy of ORTHO MICRONOR 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.

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

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

Adverse reactions reported with the use of POPs include:

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

To achieve maximum contraceptive effectiveness, ORTHO MICRONOR 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.

ORTHO MICRONOR (0.35 mg norethindrone) Tablets are available in a DIALPAK Tablet Dispenser

(NDC 54868-4369-0) containing 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides.

STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

Keep out of reach of children.

Relabeling of "Additional" barcode label by: Physicians Total Care, Inc.Tulsa, OK       74146

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

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.

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.

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.

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.

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 ORTHO MICRONOR Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include corn starch, D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate 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 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.

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.¶

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.

ORTHO MICRONOR 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:

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 healthcare professional 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.

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 Tumors

In 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 Women

Diabetic 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 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 healthcare professional.

USING POPs WITH OTHER MEDICINES

Before 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:

Medicine for TB:

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

HOW TO TAKE POPs

PREGNANCY WHILE ON THE PILL

If 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:

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.

BREASTFEEDING

If you are breastfeeding, POPs will not affect the quality or amount of your breastmilk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.

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 yourhealthcare professional. You can also ask for the more detailed "Professional Labeling" written for doctors and other healthcare professionals.

HOW TO STORE YOUR POPs

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

Rx only

Keep out of reach of children.

ORTHO-McNEILPHARMACEUTICAL, INC.

Raritan, New Jersey 08869

©OMP 1998

PRINTED IN U.S.A.ISSUED June, 2008635-50-894

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 an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year*
Method
(1)
Typical Use †
(2)
Perfect Use‡
(3)

(4)
Chance# 85 85
SpermicidesÞ 26 6 40
Periodic abstinence 25
63
  Calendar
9
  Ovulation Method
3
  Sympto-Thermalß
2
  Post-Ovulation
1
Capà


  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge


  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragmà 20 6 56
Withdrawal 19 4
Condomè


  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 Norplant-2® 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
IMPORTANT POINTS TO REMEMBER
STARTING POPs
IF YOU ARE LATE OR MISS TAKING YOUR POPs
IF YOU ARE BREASTFEEDING
IF YOU ARE SWITCHING PILLS

If you are late or you miss taking your POPs:

Important points to remember:

1. Place the refill in the VERIDATE so that the V notch in the refill is at the top of the dispenser (see drawing). Press the refill down so that it fits firmly under all nibs.

2. The first time you use these pills, take your first pill on the first day of your menstrual period.

3. Choose a pill that corresponds with the day of the week on which you are taking the first pill.

4. Continue taking one pill daily, clockwise, until no pills remain in the outer circle. It is important that you take your pills at the same time every day.

5. The next day, take a pill from the inner circle that corresponds with the day of the week it happens to be. Take a pill each day until all seven are taken.

6. After you have taken all 28 pills, insert a new refill in the veridate and begin taking your pills again the next day. Be sure the calendar day on the package corresponds with the actual day.

ORTHO-MCNEIL PHARMACEUTICAL, INC.

Raritan, New Jersey 08869

©OMP 2001

PRINTED IN U.S.A.Issued June 2008651-50-895-X

IMAGE image02.jpg
INSTRUCTIONS FOR USE
VERIDATE® Tablet Dispenser-28's

MICRONOR (0.35 mg norethindrone) Tablets

NDC 54868-4369-0

Manufacturer

Physicians Total Care, Inc.

Active Ingredients

Source

Clinical Trials [0 Results]

None

PubMed Articles [0 Results]

None

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