NECON norethindrone and mestranol

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Saadav alates:

Watson Pharma, Inc.

INN (Rahvusvaheline Nimetus):

NORETHINDRONE

Koostis:

NORETHINDRONE 1 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

New Drug Application

Toote omadused

NECON- NORETHINDRONE AND MESTRANOL
WATSON PHARMA, INC.
----------
NECON 1/50
(NORETHINDRONE AND MESTRANOL TABLETS USP, 1 MG/0.05 MG)
REVISED: JUNE 2007
IN-5377/S
RX ONLY
PHYSICIAN LABELING
ORAL CONTRACEPTIVE AGENTS
DESCRIPTION
_NECON 1/50 _Tablets provide a continuous oral contraceptive regimen
consisting of 21 white tablets
containing norethindrone 1 mg and mestranol 0.05 mg and 7 orange
tablets containing inert ingredients.
Norethindrone is a potent progestational agent with the chemical name
17-Hydroxy-19-Nor-17α-pregn-
4-en-20-yn-3-one. Mestranol is an estrogen with the chemical name
3-Methoxy-19-nor-17α-pregna-
1,3,5(10)-trien-20-yn-17-ol. Their structural formulae follow:
The white Necon 1/50 tablets contain the following inactive
ingredients: lactose, magnesium stearate,
povidone, and starch.
The inactive orange tablets contain the following ingredients: FD&C
Yellow No. 6, lactose,
microcrystalline cellulose, and magnesium stearate.
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 cervical
mucus (which increase the difficulty of sperm entry into the uterus)
and the endometrium (which may
reduce the likelihood of implantation).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to use this
product as a method of contraception.
Oral contraceptive products such as Necon 1/50, which contain 50 mcg
of estrogen, should not be
used unless medically indicated.
Oral contraceptives are highly effective. Table l lists the typical
accidental pregnancy rates for users
®
_®_
®
®
1
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.
TABLE L: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNAN