NIKKI- drospirenone 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), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 0.02 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nikki™ (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and we

Product summary:

Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is available in a wallet (NDC 68180-886-11) packed in a pouch (NDC 68180-886-11). Such three pouches are packaged in a carton (NDC 68180-886-13). Each wallet pack (28 film-coated tablets) contains in the following order: 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

NIKKI - DROSPIRENONE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NIKKI SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NIKKI.
NIKKI™ (DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP), 3 MG/0.02
MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NIKKI (4).
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.5) 08/2017
INDICATIONS AND USAGE
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg
is an estrogen/progestin COC, indicated for use by
women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who
choose to use an oral contraceptive for
contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the
patient desires an oral contraceptive for birth control.
(1.3)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg
consists of 28 film-coated, round, biconvex tablets in
the following order (3):
24 pink tablets, each containing 3 mg drospirenone (DRSP) and 0.02 mg
ethinyl estradiol (EE)
4 white to off-white inert tablets
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavi