NORLYDA- norethindrone kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Available from:

Amneal Pharmaceuticals NY LLC

INN (International Name):

NORETHINDRONE

Composition:

NORETHINDRONE 0.35 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.   Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy.   2.   Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method (1) Typical Use1 (2) Perfect Use2 (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal6 2 Post-Ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Condom8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUDs Progesterone T 2 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Levonorgestrel Implants (Norplant® ) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell, J, Contraceptive Efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1.   Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. 2.   Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3.   Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4.   The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5.   Foams, creams, gels, vaginal suppositories, and vaginal film. 6.   Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7.   With spermicidal cream or jelly. 8.   Without spermicides. 9.   The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: - Known or suspected pregnancy - Known or suspected carcinoma of the breast - Undiagnosed abnormal genital bleeding - Hypersensitivity to any component of this product - Benign or malignant liver tumors - Acute liver disease

Product summary:

NORLYDA (norethindrone tablets, USP) 0.35 mg are white, round, biconvex film-coated tablets, debossed with “01 ” on one side and are supplied as follows: NDC 69238-1583-6                Blister Pack of 28 Tablets STORAGE Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2016-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORLYDA- NORETHINDRONE
AMNEAL PHARMACEUTICALS NY LLC
----------
NORLYDA™
(NORETHINDRONE TABLETS, USP) 0.35 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST
TRANSMISSION OF HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES
(STDS)
SUCH AS CHLAMYDIA, GENITAL HERPES, GENITAL WARTS, GONORRHEA, HEPATITIS
B, AND
SYPHILIS.
DESCRIPTION
Each white NORLYDA (norethindrone tablet, USP) provides a continuous
oral
contraceptive regimen of 0.35 mg norethindrone, USP daily, and the
inactive ingredients
include hydrogenated cottonseed oil, hydroxypropyl cellulose,
hypromellose, lactose
monohydrate, magnesium stearate, povidone, pregelatinized starch,
talc, and titanium
dioxide.
Norethindrone, USP is a white to creamy white, odorless, crystalline
powder practically
insoluble in water; soluble in chloroform and in dioxane; sparingly
soluble in alcohol;
slightly soluble in ether.
The chemical name for norethindrone is
17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-
one. The structural formula follows:
norethindrone
Therapeutic class = oral contraceptive.
CLINICAL PHARMACOLOGY
1. MODE OF ACTION. NORLYDA progestin-only oral contraceptives prevent
conception
by suppressing ovulation in approximately half of users, thickening
the cervical mucus
to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks,
slowing the
movement of the ovum through the fallopian tubes, and altering the
endometrium.
2. PHARMACOKINETICS.
ABSORPTION: Norethindrone is rapidly absorbed with maximum plasma
concentrations occurring within 1 to 2 hours after norethindrone
tablets administration
(see TABLE 1). Norethindrone appears to be completely absorbed
following oral
administration; however, it is subject to first pass metabolism
resulting in an absolute
bioavailability of approximately 65%.
FIGURE 1: MEAN ± SD NORETHINDRONE PLASMA CONCENTRATIONS FOLLOWING
NORETHINDRONE ADMINISTRATION.
Peak plasma concentrations occur approximately 1 hour after
administration (mean
T
1.2 hours). The mean (SD) C
was 4816.8 (1532.6)