NORGESTIMATE AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Glenmark Generics Inc., USA

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.25 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgestimate and ethinyl estradiol tablets USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table II 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, the IUD, and the Norplant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Method Typical Use§ Perfect Use¶ Norgestimate and ethinyl estradiol tablets USP have not been studied for and are not indicated for use in emergency contraception. In clinical trials with norgestimate and ethinyl estradiol tablets, 1,651 subjects completed 24,272 cycles and the overall use-efficacy (typical user efficacy) pregnancy rate was approximately 1 pregnancy per 100 women-years. This rate includes patients who d

Product summary:

Norgestimate and ethinyl estradiol tablets USP 0.25 mg/0.035 mg are packaged in a carton (NDC 68462-309-29) of 3 blister packs each containing 28 tablets as follows: 21 blue tablets containing 0.25 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP which are round, flat faced beveled edged, uncoated tablets debossed with ‘A7’ on one side. 7 light green tablets containing inert ingredients which are round, flat faced beveled edged, uncoated tablets debossed with ‘A2’on one side. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Rx only

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
Glenmark Generics Inc., USA
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DETAILED PATIENT LABELING
Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg
PLEASE NOTE: This labeling is revised from time to time as important
new medical information
becomes available. Therefore, please review this labeling carefully.
This product (like all oral contraceptives) does not protect against
HIV infection (AIDS) and other
sexually transmitted diseases.
Norgestimate and Ethinyl Estradiol Tablets USP Regimen
Each blue tablet contains 0.25 mg norgestimate USP and 0.035 mg
ethinyl estradiol USP. Each light
green tablet contains inert ingredients.
INTRODUCTION
Any woman who considers using oral contraceptives (the birth control
pill or the pill) should understand
the benefits and risks of using this form of birth control. This
patient labeling will give you much of the
information you will need to make this decision and will also help you
determine if you are at risk of
developing any of the serious side effects of the pill. It will tell
you how to use the pill properly so that it
will be as effective as possible. However, this labeling is not a
replacement for a careful discussion
between you and your healthcare professional. You should discuss the
information provided in this
labeling with him or her, both when you first start taking the pill
and during your revisits. You should also
follow your healthcare professional’s advice with regard to regular
check-ups while you are on the pill.
EFFECTIVENESS OF ORAL CONTRACEPTIVES FOR
CONTRACEPTION
Oral contraceptives or "birth control pills" or "the pill" are used to
prevent pregnancy and are more
effective than most other non-surgical methods of birth control. When
they are taken correctly without
missing any pills, the chance of becoming pregnant is approximately 1%
per year (1 pregnancy per 100
women per year of use). Typical failure rates, including women who do
not always take the pill correctly,
are approximately 5% per year (5

Summary of Product characteristics

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
GLENMARK GENERICS INC., USA
----------
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP, 0.25 MG/0.035 MG
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
The following product is a combination oral contraceptive containing
the progestational compound
norgestimate USP and the estrogenic compound ethinyl estradiol USP.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP:
Each blue tablet contains 0.25 mg of the progestational compound,
norgestimate USP (18,19-Dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and
0.035 mg of the estrogenic
compound, ethinyl estradiol USP
(19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive
ingredients include lactose monohydrate, povidone, FD&C Blue No.
2-5625, colloidal silicon dioxide,
talc, magnesium stearate, and pregelatinized starch.
Each light green tablet contains only inert ingredients, as follows:
D&C Yellow No. 10, FD&C Blue
No. 2-5625, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, pregelatinized starch
and talc.
NORGESTIMATE USP
ETHINYL ESTRADIOL USP
CLINICAL PHARMACOLOGY
ORAL CONTRACEPTION
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).
Receptor binding studies, as well as studies in animals and humans,
have shown that norgestimate and
17-deacetyl norgestimate, the major serum metabolite, combine high
progestational activity with minimal
intrinsic androgenicity
. Norgestimate, in combination with ethinyl estradiol, does not
counteract
the estrogen-induced increases in sex hormone binding globulin (SHBG),
resulting in lower serum
testosterone
.
PHARMACOKINETICS
Absorption
Norg