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Deblitane
  • Professionals
  • FDA PI

Deblitane

Generic name:norethindrone
Dosage form: tablet
Drug classes:Contraceptives, Progestins

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

Rx Only

PHYSICIAN LABELING

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Deblitane Description

Deblitane (Norethindrone tablets, USP). Each yellow, biconvex, round tablet debossed with "K2" on one side contains 0.35 mg norethindrone. Inactive ingredients include polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, D&C Yellow No. 10 Aluminum Lake, lecithin (soya), FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized starch.

Therapeutic class = oral contraceptive.

USP Dissolution Test is Pending

Deblitane - Clinical Pharmacology

1. Mode of Action

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