LOW-OGESTREL- norgestrel and ethinyl estradiol kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

NORGESTREL (UNII: 3J8Q1747Z2) (NORGESTREL - UNII:3J8Q1747Z2), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ESTRADIOL - UNII:4TI98Z838E)

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

NORGESTREL

Složení:

NORGESTREL 0.3 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Low-Ogestrel® (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is 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 I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 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 should not be used in women who have the following conditions: - Thrombophlebitis or thromboembolic disorders Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the

Přehled produktů:

Low-Ogestrel® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg)   NDC 54868-4850-0 : Each white tablet is unscored, round in shape, with 847 debossed on one side and WATSON on the other side, and contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol. Low-Ogestrel® is packaged in cartons of dispensers. Each tablet dispenser contains 21 white (active) tablets and 7 peach (inert) tablets. Inert tablets are unscored, round in shape with WATSON debossed on one side and P1 on the other side. STORAGE: Store at controlled room temperature 15°C to 25°C (59°F to 77°F). Keep this and all medications out of the reach of children.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LOW-OGESTREL - NORGESTREL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTIVE AGENTS
DESCRIPTION
_LOW-OGESTREL _
Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg)
provide an oral
contraceptive regimen consisting of 21 white tablets followed by 7
peach tablets.
Each white tablet, for oral administration contains 0.3 mg of
norgestrel and 0.03 mg ethinyl estradiol and
the following inactive ingredients: croscarmellose sodium, lactose,
magnesium stearate,
microcrystalline cellulose, and povidone.
Each inactive peach tablet, for oral administration, in the 28 day
regimen contains the following inactive
ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose
monohydrate, magnesium stearate,
and microcrystalline cellulose.
Norgestrel is a totally synthetic progestogen, insoluble in water,
freely soluble in chloroform,
sparingly soluble in alcohol with the chemical name
(±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-
4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in
water, soluble in alcohol, in
chloroform, in ether, in vegetable oils, and in solutions of fixed
alkali hydroxides with the chemical
name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their
structural formulae follow:
Therapeutic class: Oral contraceptive.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotrophins.
Although the primary
mechanism of this action is inhibition of ovulation, other alterations
include changes in the cer-vical
mucus (which increase the difficulty of sperm entry into the uterus)
and the endometrium (which may
reduce the likelihood of implantation).
INDICATIONS AND USAGE
Low-Ogestrel
(norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is
indicated for the
prevention of pregnancy in women who elect to use this product as a
method of contraception.
Oral contraceptives are highly effe