Rx Item-Chateal 0.15 0.03 Tab 48X28 By Afaxys

CHATEAL � levonorgestrel and ethinyl estradiol
Afaxys Inc.

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.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

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-17? -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
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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.

Rx Item-Chateal 0.15 0.03 Tab 48X28 By A
Item No.: RX461954 NDC No.50102013048 UPC No.:350102130484 NDC No. 50102-0130-48 UPC/GTIN No. 3-50102-13048-4 MPN No. 13048 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.

Chateal 0.15 0.03 Tab 48X28 By Afaxys
BRAND: CHATEAL NDC: 50102-0130-48,50102013048 UPC: 3-50102-13048-4,350102130484 Afaxys Inc

LEVONORGESTREL-ETHIN ESTR
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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