LEVONEST- levonorgestrel and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar Rx LLC

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.05 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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 the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology : 17t h Revised Edition . NY, NY: Ardent Media, Inc., 1998 Levonest™ is contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein-thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Current diagnosis or history of breast cancer

Product summary:

LEVONEST™ Tablets (levonorgestrel and ethinyl estradiol tablets—triphasic regimen) are available in 28-tablet blister cards (NDC 16714-340-01). Each cycle contains 28 tablets as follows: • Six yellow tablets containing 0.05 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The yellow tablets are unscored, round in shape with "T1" debossed on one side. • Five green tablets containing 0.075 mg of levonorgestrel and 0.04 mg of ethinyl estradiol. The green tablets are unscored, round in shape with "T2" debossed on one side. • Ten light brown tablets containing 0.125 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The light brown tablets are unscored, round in shape with "T3" debossed on one side. • Seven white inert tablets. The white inert tablets are unscored, round in shape with "P" debossed on one side and "N " on the other side. LEVONEST™ Tablets are available in the following: Carton of 1 NDC 16714-340-02 Carton of 3 NDC 16714-340-03 Carton of 6 NDC 16714-340-04 Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] References available upon request. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 I 0105 Rev. 06/2023 Rev.B This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 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 less than 1.0% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3.0% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing 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 take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three 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: 1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessel in the heart (heart attack and angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. 2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped. The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health-care 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, may decrease oral-contraceptive effectiveness. There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more. In addition, 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. Taking the pill provides some important noncontraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus. Be sure to discuss any medical condition you may have with your health-care provider. Your health-care 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 health-care 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 health-care provider. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Novast Laboratories Ltd. Nantong, China 226009 I 0105 Rev. 06/2023 Rev.B This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. INTRODUCTION Any woman who considers using oral contraceptives (the birth-control pill or the pill) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health-care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health-care provider's advice with regard to regular check-ups while you are on the pill. Oral contraceptives or “birth-control pills” or “the pill” are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1.0% when used perfectly, without missing any pills. Typical failure rates are less than 3.0% per year. The chance of becoming pregnant increases with each missed pill during the menstrual cycle. In comparison, typical failure rates for other nonsurgical methods of birth control during first year of use are as follows: *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology : 17th Revised Edition . NY, NY: Ardent Media, Inc., 1998 WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have had any of the following conditions: Tell your health-care provider if you have ever had any of these conditions. Your health-care provider can recommend another method of birth control. You should not take the pill if you take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your health-care provider if you or any family member has ever had: Also, be sure to inf

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONEST - LEVONORGESTREL AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC
----------
LEVONEST™ (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP,
TRIPHASIC
REGIMEN)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each LEVONEST™ cycle of 28 tablets consists of three different drug
phases as follows:
Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of
levonorgestrel (d(-)-
13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a
totally synthetic
progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17
-pregna-1,3,5(10)-trien-20-
yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing
0.075 mg
levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised
of 10 light brown
tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl
estradiol; then
followed by 7 white inert tablets. The inactive ingredients present in
the yellow, green
and light brown tablets are lactose, magnesium stearate and
pregelatinized corn starch.
Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C
Yellow #6
Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/
polyethylene
glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each
green tablet also contains
FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2
Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000
NF, lecithin (soya),
talc, and polyvinyl alcohol. Each light brown tablet also contains
iron oxide yellow, iron
oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene
glycol 3350 NF,
lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white
tablet (7) contains the
following inactive ingredients: Titanium dioxide, polydextrose,
hypromellose, triacetin,
macrogol/polyethylene glycol 8000, lactose, magnesium stearate and
pregelatinized corn
starch.
CLINICAL PHARMACOLOGY
Mechanism of Action
Combination oral contraceptives prevent pregnancy primari