LARIN 1/20- norethindrone acetate/ethinyl estradiol kit

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Inapatikana kutoka:

Northstar Rx LLC

INN (Jina la Kimataifa):

NORETHINDRONE ACETATE

Tungo:

NORETHINDRONE ACETATE 1 mg

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

LARIN™ 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Oral contraceptives are contraindicated in women who currently have the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease • 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

Bidhaa muhtasari:

LARIN™ 1/20 is available in dispensers (NDC 16714-408-01) each containing 21 pale yellow tablets. Each pale yellow, biconvex, round tablet debossed with “L2” on one side contains 1mg of norethindrone acetate and 20 mcg of ethinyl estradiol. LARIN™ 1/20 Tablets are available in the following configurations: Carton of 1 NDC 16714-408-02 Carton of 3 NDC 16714-408-03 Carton of 6 NDC 16714-408-04 Store at 20 ˚C to 25 ˚C (68 ˚F to 77 ˚F) [See USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LARIN 1/20 - NORETHINDRONE ACETATE/ETHINYL ESTRADIOL
NORTHSTAR RX LLC
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LARIN™ 1/20
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP
Rx only
Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl
estradiol.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including LARIN™ 1/20, are contraindicated in
women who are
over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
LARIN™ 1/20 is a progestogen-estrogen combination.
LARIN™ 1/20 provides a continuous dosage regimen consisting of 21
pale yellow oral
contraceptive tablets.
Each pale yellow tablet contains norethindrone acetate (17
alpha-ethinyl-19-
nortestosterone acetate), 1 mg; ethinyl estradiol (17
alpha-ethinyl-1,3,5(10)-estratriene-
3, 17 beta-diol), 20 mcg. Also contains polyvinyl alcohol, titanium
dioxide, talc,
macrogol/polyethylglycol 3350 NF, lecithin (soya), D&C Yellow No.10
Aluminum Lake,
FD&C Blue No.2 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose,
magnesium
stearate and pregelatinized corn starch.
The structural formulas are as follows:
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).
PHARMACOKINETICS
The pharmacokinetics of LARIN™ 1/20 have not been characterized;
however, the
following pharmacokinetic information regarding norethindrone acetate
and ethinyl
estradiol is taken from the literature.
ABSORPTION
Norethindrone acetate appears to be completely and rapidly
deacetylated to
norethindrone after oral