Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)

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:

RPK Pharmaceuticals, Inc.

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. NA - not available a 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. Combination 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. Thrombogenic valvulopathies

Product summary:

Chateal (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) are available in a carton of 3 packages, each package contains 28 tablets: 21 Active Tablets: White to off-white, round, unscored tablets debossed with 209 on one side and plain on the other side. 7 Inert Tablets: Green, round, unscored tablets debossed with 274 on one side and plain on the other side. Package (NDC-50102-130-10) Carton (NDC-50102-130-03) containing 3 Packages Store at 20° to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. References available upon request.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHATEAL - LEVONORGESTREL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
----------
CHATEAL® (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15
MG/0.03 MG)
Rx only
CHATEAL
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
21 white to off-white levonorgestrel and ethinyl estradiol tablets ,
each containing 0.15 mg of
levonorgestrel, (d(-)-13
beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally
synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17α
-pregna-1,3,5 (10)-trien-20-yne-
3,17-diol), and 7 green inert tablets. The inactive ingredients for
white to off-white active tablets are
Lactose monohydrate, Polacrilin Potassium, Magnesium Stearate. The
inactive ingredients for green
inert tablets are Lactose monohydrate, Polacrilin Potassium, Magnesium
Stearate, yellow oxide of iron
and FD&C Blue No.1 Aluminium lake.
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).
INDICATIONS AND USAGE
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.
®
TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY
DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
NA - n