NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE kit

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Mylan Pharmaceuticals Inc.

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The e

Prehľad produktov:

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets are available in blister packs each containing 28 tablets. The first five white to off white tablets each contain 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol; the next seven light purple tablets each contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol; the next nine purple tablets each contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol; and the last seven (brown) tablets each contain 75 mg ferrous fumarate. Carton of 3 tri-laminated aluminium pouches (NDC 0378-7303-53), Carton of 6 tri-laminated aluminium pouches (NDC 0378-7303-56) each pouch containing blister of 28 tablets. Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Store tablets in blister sleeve when not in use. Keep this and all medication out of the reach of children. REFERENCES AVAILABLE UPON REQUEST The brands listed are trademarks of their respective owners.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
MYLAN PHARMACEUTICALS INC.
----------
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS:
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR SIDE
EFFECTS FROM COMBINED 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
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, ARE
CONTRAINDICATED
IN WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS
FUMARATE
TABLETS
Each white to off white tablet contains 1 mg norethindrone acetate and
20 mcg ethinyl
estradiol; each light purple tablet contains 1 mg norethindrone
acetate and 30 mcg
ethinyl estradiol; each purple tablet contains 1 mg norethindrone
acetate and 35 mcg
ethinyl estradiol; each brown tablet contains 75 mg ferrous fumarate.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Norethindrone acetate and ethinyl estradiol tablets are graduated
estrophasic combined
oral contraceptive providing estrogen in a graduated sequence over a
21-day period
with a constant dose of progestogen.
Norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets provide
for 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 white to off white tablet contains 1 mg norethindrone acetate
[(17 alpha)- 17-
(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl
estr