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 LIMITED

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 indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Do not prescribe Nikki to women who are known to have the following: - Renal impairment - Adrenal insufficiency - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:           о Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1) ]           о Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1) ]           о Have cerebrovascular disease [se

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 LIMITED
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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
Warnings and Precautions, Hyperkalemia (5.2) 5/2015
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 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)
WARNINGS AND PRECAUTIONS
Vascular risks : Stop Nikki if a thrombotic event occurs. Stop at
least 4 weeks before and through 2 weeks after major
surgery. Start no earlier than 4 weeks after delivery, in women who
are not breastfeeding. (5.1)
COCs containing DRSP