LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

LUPIN LIMITED

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel 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. In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stew

Product summary:

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg are available in Extended-Cycle Wallets, each containing a 13-week supply of tablets: 84 pink tablets each containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl Estradiol, and 7 white to off white inert tablets. Active pink tablets are round biconvex film coated tablets, debossed with "LU" on one side and "U21" on the other side. The inert tablets are white to off white tablets with "LU" on one side and "U22" on the other side. They are supplied as follows: Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg are available in Extended-Cycle Wallets of 91 tablets which is packed in a pouch (NDC 68180-843-11). Such three pouches are packed in a carton (NDC 68180-843-13). Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature] Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA July 5, 2013                                                                                                     ID # 233829 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg Rx only Brief Summary Patient Package Insert This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Oral contraceptives, also known as "birth control pills" or "the pill", are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximately 1.0% per year (1 pregnancy per 100 women per year of use). The typical failure rate of pill users is approximately 5% per year when women who miss pills are included. For the majority of women, oral contraceptives can be taken safely. But for some women oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you: You should not take the pill if you are pregnant. Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women. Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke. Most side effects of the pill are not serious. The most common are nausea, vomiting, bleeding or spotting between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. Some of these side effects, especially nausea and vomiting, may subside within the first 3 months of use. The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill. The symptoms associated with these serious side effects are discussed in the detailed patient information leaflet. Notify your healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, and herbal preparations containing St. John’s Wort (hypericum perforatum) may decrease oral contraceptive effectiveness. Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It maybe that women taking the pill were examined more often, so that breast cancer was more likely to be detected. You should have regular breast examinations by a healthcare provider and examine your own breasts monthly. Tell your healthcare provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormone-sensitive tumor. Some studies have found an increase in the incidence of cancer or precancerous lesions of the cervix in women who use the pill. However, this finding may be related to factors other than the use of the pill. Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your healthcare provider. When you take levonorgestrel and ethinyl estradiol tablets, which has a 91-day treatment cycle, you should expect to have 4 menstrual periods per year (bleeding when you are taking the 7 white pills). However, you also should expect to have more bleeding or spotting between your menstrual periods than if you were taking an oral contraceptive with a 28-day treatment cycle. During the first levonorgestrel and ethinyl estradiol tablets treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting (bleeding when you are taking pink pills). This bleeding or spotting tends to decrease during later cycles. Do not stop levonorgestrel and ethinyl estradiol tablets because of the bleeding. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider. You should consider the possibility that you are pregnant if you miss your menstrual period (no bleeding on the days that you are taking white tablets). Since scheduled menstrual periods are less frequent when you are taking levonorgestrel and ethinyl estradiol tablets, notify your healthcare provider that you have missed your period and are taking levonorgestrel and ethinyl estradiol tablets. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking levonorgestrel and ethinyl estradiol tablets if it is determined that you are pregnant. IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS 1. BE SURE TO READ THESE DIRECTIONS: 2. THE RIGHT WAY TO TAKE LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS IS TO TAKE ONE PILL EVERYDAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3. MANY WOMEN MAY FEEL SICK TO THEIR STOMACH DURING THEFIRST FEW WEEKS OF TAKING PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider. 4. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING DURING THE FIRST FEW MONTHS OF TAKING LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS. Do not stop taking your pills even if you are having irregular bleeding. If the bleeding lasts for more than 7 consecutive days, talk to your healthcare provider. 5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 6. IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN LIMITED
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LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.15 MG /0.03 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV-INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle
oral contraceptive consisting of
84 pink active tablets each containing 0.15 mg of levonorgestrel, a
synthetic progestogen and 0.03 mg
of ethinyl estradiol, and 7 white inert tablets (without hormones).
The chemical formula of levonorgestrel USP is 18,
19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-
hydroxy-, (17α)-, (-)-, and the chemical formula of ethinyl estradiol
USP is 19-Norpregna-1, 3, 5(10)-
trien-20-yne-3, 17-diol, (17α)-. The structural formulas are as
follows:
Each pink active tablet contains the following inactive ingredients:
croscarmellose sodium, FD & C
Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, povidone and titanium dioxide. Each
white inert tablet contains the
following inactive ingredients: croscarmellose sodium, lactose
monohydrate, magnesium stearate and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
MODE OF ACTION
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and changes in
the endometrium (which reduce the
likelihood of implantation).
PHARMACOKINETICS
_ABSORPTION_
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl estradiol tablets
in humans has been conducted. However, literature indicates that
levonorgestrel is rapidly and
completely absorbed after oral administration (bioavailability nearly
100%) and is not subject to first-
pass metabolism. Ethinyl estradiol is rapid