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Basic Drug Info
Drug Name:Kelnor 1/35
Manufacturer:BARR LABORATORIES, INC.
Other Info:MANUFACTURED BYBARR LABORATORIES, INC.POMONA, NY 10970Revised MAY 2006BR-9064



Clinical Trials:


Indications and Usage

Kelnor™ 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective.

Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates.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. 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, in press.1 % of Women Experiencing anUnintended Pregnancywithin the First Year of Use% of Women Continuing Useat One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.  Method (1)Typical UseAmong 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.(2)Perfect UseAmong 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.(3)(4) ChanceThe 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.8585 SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640 Periodic abstinence 2563 Calendar 9 Ovulation method 3 Sympto-thermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2 Post-ovulation 1 Withdrawal 194 CapWith spermicidal cream or jelly. Parous women 402642 Nulliparous women 20956 Sponge Parous women 402042 Nulliparous women 20956 Diaphragm20656 CondomWithout spermicides. Female (Reality) 21556 Male 14361 Pill 571 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.01.581 Copper T 380A 0.80.678 LNg 20 0.10.181 Injection (Depo-Provera) 0.30.370 Implant (Norplant and Norplant-2)0.050.0588 Female sterilization 0.50.5100 Male sterilization 0.150.10100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The 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).  Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, 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. 
Contraindications
Oral contraceptives should not be used in women who have the following conditions:Thrombophlebitis or thromboembolic disordersA past history of deep vein thrombophlebitis or thromboembolic disordersCerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditionsKnown or suspected carcinoma of the breast, or a history of this conditionKnown or suspected carcinoma of the female reproductive organs or suspected estrogen-dependent neoplasia, or a history of these conditionsUndiagnosed abnormal genital bleedingHistory of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive usePast or present, benign or malignant liver tumorsKnown or suspected pregnancy
Thrombophlebitis -- Inflammation of a vein associated with a blood clot (THROMBUS).

Deep thrombophlebitis --

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Vascular Diseases -- Pathological processes involving any of the BLOOD VESSELS in the cardiac or peripheral circulation. They include diseases of ARTERIES; VEINS; and rest of the vasculature system in the body.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Obstructive Jaundice -- JAUNDICE, the condition with yellowish staining of the skin and mucous membranes, that is due to impaired BILE flow in the BILIARY TRACT, such as INTRAHEPATIC CHOLESTASIS, or EXTRAHEPATIC CHOLESTASIS.

Icterus -- A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction.

Warnings

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.

This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.

Women who use oral contraceptives should be strongly advised not to smoke.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.