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Sharobel
  • Professionals
  • FDA PI

Sharobel

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

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

Rx Only

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

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.

Sharobel Description

Sharobel Tablets.

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), hydromellose, lactose monohydrate, magnesium stearate, and pregelatinized starch.

Meets USP Dissolution Test 3.

Sharobel - Clinical Pharmacology

1. Mode of Action

Sharobel 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 leve...