PIRMELLA 1/35- norethindrone and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 0.035 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pirmella 1/35 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. 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. Source: Trussel J, Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily

Product summary:

Pirmella 1/35 is available in a wallet (NDC 68180-893-11) containing 28 tablets. Such three wallets are packaged in a carton (NDC 68180-893-13). The wallet contains 28 tablets, as follows: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PIRMELLA 1/35 - NORETHINDRONE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
PIRMELLA™ 1/35
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
1 MG/0.035 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
COMBINATION ORAL CONTRACEPTIVES
Pirmella™ 1/35 is a combination oral contraceptive containing the
progestational compound
norethindrone and the estrogenic compound ethinyl estradiol.
PIRMELLA 1/35:
Each peach tablet contains 1 mg of norethindrone and 0.035 mg of
ethinyl estradiol. Inactive ingredients
include FD&C Yellow No. 6, lactose anhydrous, magnesium stearate and
pregelatinized starch. Each
green tablet contains only inert ingredients, as follows: D&C Yellow
No. 10, FD&C Blue No. 2,
lactose monohydrate, magnesium stearate, microcrystalline cellulose
and pregelatinized starch.
The chemical name for norethindrone is
17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl
estradiol is 19-Nor-17α-pregna-1, 3,5(10)-trien-20-yne-3, 17-diol.
Their structural formulas are as
follows:
CLINICAL PHARMACOLOGY
COMBINATION ORAL CONTRACEPTIVES
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).
INDICATIONS AND USAGE
Pirmella 1/35 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.
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