MICROGESTIN 1.5/30- norethindrone acetate/ethinyl estradiol kit

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mayne Pharma Inc.

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Microgestin 1.5/30 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 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, 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 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 ● Known or suspected carcinoma of the breast ● 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 ● Hepatic

Toote kokkuvõte:

Microgestin 1.5/30 is available in dispensers (NDC 51862-872-01) each containing 21 yellow tablets. Each yellow, biconvex, round tablet debossed with "L3" on one side contains 1.5mg of norethindrone acetate and 30 mcg of ethinyl estradiol. Microgestin 1.5/30 Tablets are available in the following configurations: Carton of 1 NDC 51862-872-02 Carton of 3 NDC 51862-872-03 Carton of 6 NDC 51862-872-06 Store at 20 ˚C ~ 25 ˚C (68 ˚F~77 ˚F) [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MICROGESTIN 1.5/30 - NORETHINDRONE ACETATE/ETHINYL ESTRADIOL
MAYNE PHARMA INC.
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MICROGESTIN® 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
Rx only
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
Cigarette smoking increases the risk of serious cardiovascular side
effects from
oral contraceptive use. This risk increases with age and with heavy
smoking (15 or
more cigarettes per day) and is quite marked in women over 35 years of
age.
Women who use oral contraceptives should be strongly advised not to
smoke.
DESCRIPTION
Microgestin 1.5/30 is a progestogen-estrogen combination.
Microgestin 1.5/30 provides a continuous dosage regimen consisting of
21 yellow oral
contraceptive tablets.
Each yellow tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone
acetate), 1.5 mg; ethinyl estradiol (17
alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol),
30mcg. Also contains polyvinyl alcohol, titanium dioxide, talc,
macrogol/polyethylglycol
3350 NF, lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum
Lake, D&C Yellow
No.10 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 Microgestin 1.5/30 has 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 administration, since the disposition of
norethin