CHATEAL

CHATEAL — levonorgestrel and ethinyl estradiol
Afaxys Pharma, LLC

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.

Structure
(click image for full-size original)

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 — 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.

Method Perfect Use Typical Use
Levonorgestrel implants 0.05 0.05
Male sterilization 0.1 0.15
Female sterilization 0.5 0.5
Depo-Provera® (injectable progestogen) 0.3 0.3
Oral contraceptives 5
Combined 0.1 NA
Progestin only 0.5 NA
IUD
Progesterone 1.5 2.0
Copper T 380A 0.6 0.8
Condom (male) without spermicide 3 14
(Female) without spermicide 5 21
Cervical cap
Nulliparous women 9 20
Parous women 26 40
Vaginal sponge
Nulliparous women 9 20
Parous women 20 40
Diaphragm with spermicidal cream or jelly 6 20
Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26
Periodic abstinence (all methods) 1 to 9a 25
Withdrawal 4 19
No contraception (planned pregnancy) 85 85

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