LARIN FE 1/20- norethindrone acetate/ethinyl estradiol and ferrous fumarate kit

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Northstar Rx LLC

INN (nume internaţional):

NORETHINDRONE ACETATE

Compoziție:

NORETHINDRONE ACETATE 1 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

LARIN™ Fe 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. *The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. **This term represents "typical" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ***N/A--Data not availab

Rezumat produs:

LARIN™ Fe 1/20 is available in dispensers (NDC 16714-406-01) each containing 21 pale yellow tablets and 7 brown tablets. Each pale yellow, biconvex, round tablet debossed with "L2" on one side contains 1mg of norethindrone acetate and 20 mcg of ethinyl estradiol. Each brown, biconvex, round tablet debossed with "F" on one side and "N " on the other side contains 75 mg ferrous fumarate. LARIN™ Fe 1/20 Tablets are available in the following configurations: Carton of 1 NDC 16714-406-02 Carton of 3 NDC 16714-406-03 Carton of 6 NDC 16714-406-04 Store at 20 ˚ C to 25˚ C (68˚ F to 77 ˚ F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LARIN FE 1/20- NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS
FUMARATE
NORTHSTAR RX LLC
----------
LARIN™ FE 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION.
Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl
estradiol. Each brown tablet contains 75 mg ferrous fumarate.
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™ Fe 1/20, are contraindicated in
women who
are over 35 years of age and smoke _(see CONTRAINDICATIONS and
WARNINGS)._
DESCRIPTION
LARIN™ Fe 1/20 is a progestogen-estrogen combination.
LARIN™ Fe 1/20 provides a continuous dosage regimen consisting of 21
oral
contraceptive tablets and seven ferrous fumarate tablets. The ferrous
fumarate tablets
are present to facilitate ease of drug administration via a 28-day
regimen, are non-
hormonal, and do not serve any therapeutic purpose.
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:
Each brown placebo tablet contains ferrous fumarate, polyvinyl
alcohol, talc,
macrogol/polyethyleneglycol 3350 NF, lecithin (soya), iron oxide
black, iron oxide yellow,
microcrystalline cellulose, hydroxypropyl cellulose, magnesium
stearate and
crospovidone.
The ferrous fumarate tablets do not serve any therapeutic purpose.