Nikki

Nikki

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Oral Contraceptive

Nikki™ (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy.

1.3 Acne

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.

History

There is currently no drug history available for this drug.

Other Information

Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg provides an oral contraceptive regimen consisting of 24 pink, round, biconvex active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white to off-white inert film-coated tablets.

The inactive ingredients in the pink film-coated tablets are corn starch, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, pregelatinised starch, talc and titanium dioxide. The white to off-white inert film-coated tablets contain corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch and titanium dioxide.

Drospirenone (6R, 7R, 8R, 9S, 10R, 13S, 14S, 15S, 16S, 17S) - 1, 3', 4', 6, 6a, 7, 8, 9, 10, 11, 12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta [a] phenanthrene- 17, 2' (5H)- furan]-3, 5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Ethinyl estradiol (19-nor-17a-pregna 1, 3, 5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.

The structural formulas are as follows:

Fig-3

USP dissolution test is pending.

Nikki Manufacturers


  • Lupin Pharmaceuticals, Inc.
    Nikki ( Drospirenone And Ethinyl Estradiol ) Kit [Lupin Pharmaceuticals, Inc.]

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