ENPRESSE- levonorgestrel and ethinyl estradiol kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Physicians Total Care, Inc.

DCI (Dénomination commune internationale):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.050 mg

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Oral contraceptives should not be used in women with any of the following conditions: - Thrombophlebitis or thromboembolic disorders. - A past history of deep-vein thrombophlebitis or thromboembolic disorders. - Cerebral-vascular or coronary-artery disease. - Known or suspected carcinoma of the breast. - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. - Undiagnosed abnormal genital bleeding. - Cholestatic jaundice of pregnancy or jaundice with prior pill use. - H

Descriptif du produit:

Enpresse™ 28 Tablets (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen), NDC 54868-4860-0, as 28 tablets in a blister pack/pouch. Each cycle contains 28 round tablets as follows: six pink, coated tablets marked "dp" and "510", each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol; five white, coated tablets marked "dp" and "511", each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; ten orange, coated tablets marked "dp" and "512", each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol and seven light-green inert tablets marked "dp" and "519".   References available upon request. Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. 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.  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: • smoke. • have high blood pressure, diabetes, high cholesterol. • have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors. You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels 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 not smoke. 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: 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 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, may decrease oral-contraceptive effectiveness. Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that pills may cause such cancers. 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 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. DETAILED PATIENT LABELING 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 healthcare 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 healthcare provider's advice with regard to regular check-ups while you are on the pill. EFFECTIVENESS OF ORAL CONTRACEPTIVES: 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 the first year of use are as follows: WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels 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 not smoke. 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: Or, if you have any of the following: Tell your healthcare provider if you have ever had any of these conditions. Your healthcare provider can recommend another method of birth control. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES : Tell your healthcare provider if you or any family member has ever had: Women with any of these conditions should be checked often by their healthcare provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or healthcare provider if you smoke or are on any medications. RISKS OF TAKING ORAL CONTRACEPTIVES : ESTIMATED RISK OF DEATH FROM A BIRTH-CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.   In the above table, the risk of death from any birth-control method is less than the risk of childbirth, except for oral-contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, except for those women over the age of 40, when the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ENPRESSE - LEVONORGESTREL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
ENPRESSE™ – 28 TABLETS
(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.
RX ONLY
REVISED OCTOBER 2003
31090460104
DESCRIPTION:
Each Enpresse™ cycle of 28 tablets consists of three different drug
phases as follows: Phase 1
comprised of 6 pink 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-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol); phase
2 comprised of 5 white tablets,
each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl
estradiol; and phase 3 comprised of 10
orange tablets, each containing 0.125 mg levonorgestrel and 0.030 mg
ethinyl estradiol; then followed
by 7 light-green inert tablets. The inactive ingredients present are
hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
and pregelatinized starch.
Coloring agents used are as follows: pink, 0.050mg/0.030mg tablets:
D&C Yellow No. 10 Aluminum
Lake and D&C Red No. 7 Calcium Lake; white, 0.075mg/0.040mg tablets:
none; orange,
0.125mg/0.030mg tablets: FD&C Yellow No. 6 Aluminum Lake, 38-42%; and
light-green, inert tablets:
D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and
FD&C Blue No. 1
Aluminum Lake.
LEVONORG ESTREL MW: 312.4 5 MF: C H O
ETHINYL ESTRADIOL MW: 296.4 1 MF: C
H
O
21
28
2
ETHINYL ESTRADIOL MW: 296.4 1 MF: C
H
O
CLINICAL PHARMACOLOGY:
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 the
endometrium (which reduce the likelihood
of implantation).
TABLE I: PERCENTA