DASETTA 1/35- norethindrone and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Northstar Rx LLC

INN (International Name):

NORETHINDRONE

Composition:

NORETHINDRONE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DASETTA™ 1/35 Tablets 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 1 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, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Adapted from Hatcher et al, 1998, Ref. #1. 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 highly effective, temporary method of contraception.1 0 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 other 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 percents becoming pregnant 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 percent who 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 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 1 0 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 six months of age. DASETTA ™ 1/35 has not been studied for and is not indicated for use in emergency contraception. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Known thrombophilic conditions - Cerebral vascular or coronary artery disease (current or history) - Valvular heart disease with complications - Persistent blood pressure values of 160 mm Hg systolic or 100 mg Hg diastolic96 - Diabetes with vascular involvement - Headaches with focal neurological symptoms - Major surgery with prolonged immobilization - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive - 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 - Acute or chronic hepatocellular disease with abnormal liver function - Hepatic adenomas or carcinomas - Known or suspected pregnancy - Hypersensitivity to any component of this product - 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)

Product summary:

DASETTA™ 1/35 Tablets are available in a compact blister card (NDC 16714-348-01) containing 28 tablets, as follows: 21 orange, biconvex round tablets with "D3" debossed on one side (1 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 white, biconvex round tablets with "P" debossed on one side and the "N " on the other side containing inert ingredients. DASETTA™ 1/35 Tablets are available in the following: Carton of 1                                                      NDC 16714-348-02 Carton of 3                                                      NDC 16714-348-03 Carton of 6                                                      NDC 16714-348-04 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DASETTA 1/35- NORETHINDRONE AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC
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DASETTA 1/35
WARING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL CONTRACEPTIVE USE. THIS RISK INCREASES WITH AGE,
PARTICULARLY IN WOMEN OVER 35 YEARS OF AGE, AND WITH THE NUMBER OF
CIGARETTES SMOKED. FOR THIS REASON, COMBINATION ORAL CONTRACEPTIVES,
INCLUDING DASETTA 1/35, SHOULD NOT BE USED BY WOMEN WHO ARE OVER
35 YEARS OF AGE AND SMOKE.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
COMBINED ORAL CONTRACEPTIVES
The following product is a combined oral contraceptive containing the
progestational
compound norethindrone and the estrogenic compound ethinyl estradiol.
Each orange tablet contains 1 mg of norethindrone and 0.035 mg of
ethinyl estradiol.
Inactive ingredients include: titanium dioxide, polyvinyl alcohol,
talc, macrogol/PEG 3350
NF, lecithin (soya), FD&C Yellow #6 Aluminum Lake, FD&C Yellow #5
Aluminum Lake,
FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, lactose
monohydrate,
magnesium stearate and pregelatinized starch. Each white tablet
contains only inert
ingredients, as follows: Titanium dioxide, polydextrose, hypromellose,
triacetin,
macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate
and
pregelatinized corn starch.
The chemical name for norethindrone is
17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-
one, and for ethinyl estradiol is
19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Their structural formulas are as follows:
CLINICAL PHARMACOLOGY
COMBINED ORAL CONTRACEPTIVES
Combined 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
DASETT