Low-Ogestrel

LOW-OGESTREL- norgestrel and ethinyl estradiol
RPK Pharmaceuticals, Inc.

Revised: October 2018

PHYSICIAN LABELING

Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ORAL CONTRACEPTIVE AGENTS DESCRIPTION

Low-Ogestrel® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets.

Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:

Norgestrel Chemical StructureEthinyl estradiol Chemical Structure
NORGESTREL
C21 H28 O2
MW 312.45
ETHINYL ESTRADIOL
C20 H24 O2
MW 296.41

Therapeutic class: Oral contraceptive.

CLINICAL PHARMACOLOGY

Combination oral contraceptives act by suppression of gonadotrophins. 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 may reduce the likelihood of implantation).

INDICATIONS AND USAGE

Low-Ogestrel® (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is 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.1 The efficacy of these contraceptive methods, except sterilization, 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 A CONTRACEPTIVE METHOD
Method Perfect use Average use
NA- not available
Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Medi, Inc., 1998
*
Depending on method (calender, ovulation symptothermal, post-ovulation)
Levonorgestrel implants 0.05 0.05
Male sterilization 0.10 0.15
Female sterilization 0.50 0.50
Depo-Provera® (injectable progestogen) 0.30 0.30
Oral contraceptives 5
Combined 0.10 NA
Progestin only 0.50 NA
IUD
Progesterone 1.50 2.00
Copper T 380A 0.60 0.80
Condom (male) without spermicide 3 14
(female) without spermicide 5 21
Cervical cap
Never given birth 9 20
Given birth 26 40
Vaginal sponge
Never given birth 9 20
Given birth 20 40
Diaphragm with spermicidal cream or jelly 6 20
Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26
Periodic abstinence (all methods) 1-9* 25
Withdrawal 4 19
No contraception (planned pregnancy) 85 85

CONTRAINDICATIONS

Oral contraceptives should not be used in women who have 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
  • Hepatic adenomas, carcinomas or benign liver tumors
  • Known or suspected pregnancy
  • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
Cigarette smoking increases the risk of serious cardiovascular side effects 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 be strongly advised not to smoke.

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