PIRMELLA 7/7/7- norethindrone and ethinyl estradiol kit 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 7/7/7 and Pirmella 1/35 Tablets are 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 1 lists the typical accidental pregnancy rates for users of combined 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. Pirmella 7/7/7 and Pirmella 1/35 have not been studied for and are not indicated for use in emergency contraception. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic dis

Product summary:

Pirmella 7/7/7 Tablets are available in a wallet (NDC 68180-892-11) containing 28 tablets. Such three wallets are packaged in a carton (NDC 68180-892-13). The wallet contains 28 tablets, as follows: Pirmella 1/35 Tablets are 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 7/7/7 - NORETHINDRONE AND ETHINYL ESTRADIOL
PIRMELLA 1/35 - NORETHINDRONE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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PIRMELLA™ 7/7/7 AND PIRMELLA™ 1/35 TABLETS
PIRMELLA™ 7/7/7 TABLETS
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
0.5 MG/0.035 MG, 0.75 MG/0.035 MG AND 1 MG/0.035 MG
AND
PIRMELLA™ 1/35 TABLETS
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
1 MG/0.035 MG
RX ONLY
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral
contraceptive use. This risk increases with age, particularly in women
over 35 years of age, and
with the number of cigarettes smoked. For this reason, combination
oral contraceptives, including
Pirmella, should not be used by women who are over 35 years of age and
smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
COMBINED ORAL CONTRACEPTIVES
Each of the following products is a combined oral contraceptive
containing the progestational
compound norethindrone and the estrogenic compound ethinyl estradiol.
PIRMELLA™7/7/7 TABLETS:
Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of
ethinyl estradiol. Inactive
ingredients include lactose anhydrous, magnesium stearate and
pregelatinized starch. Each light peach
tablet contains 0.75 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 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.
PIRMELLA™1/35 TABLETS:
Each peach tablet contains 1 mg of norethindrone and 0.