Rx Item-Norethindrone 0.35Mg Tab 3X28 By Lupin Pharma

NORETHINDRONE- norethindrone tablet
Glenmark Generics Inc.,USA

Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

Each tablet contains 0.35 mg norethindrone USP. Inactive ingredients include colloidal silicon dioxide, corn starch, D&C Yellow No. 10, ethyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, methylene chloride, isopropyl alcohol and talc.


CLINICAL PHARMACOLOGY

1. Mode of Action


Norethindrone progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes and altering the endometrium.

2. Pharmacokinetics
Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

INDICATIONS AND USAGE

1. Indications
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

2. Efficacy
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

RX ITEM-Norethindrone 0.35Mg Tab 3X28 By
NDC 68180-0876-13 UPC/GTIN No.3-68180-87613-7 Mfg.Part No.87613

Norethindrone 0.35Mg Tab 3X28 By Lupin P
BRAND: NORETHINDRONE NDC: 68180-0876-13,68180087613 UPC: 3-68180-87613-7,368180876137

NORETHINDRONE ORAL TABLET
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