Ovral-21

Uses

Norgestrel in combination with ethinyl estradiol is used for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Ovral-21 is also used to associated treatment for these conditions: Abnormal Uterine Bleeding, Endometriosis, Hypermenorrhea, Menstrual Distress (Dysmenorrhea), Polycystic Ovarian Syndrome, Emergency Contraception, Oral Contraceptives

How Ovral-21 works

Norgestrel (and more specifically the active stereoisomer levonorgestrel) binds to the progesterone and estrogen receptors within the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like levonorgestrel will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. Loss of the LH surge inhibits ovulation and thereby prevents pregnancy.

Dosage

Ovral-21 dosage

0.075 mg at same time each day

Side Effects

Edema, Weakness, Anorexia, Amenorrhea, Breakthrough bleeding, Change in menstrual flow, Spotting

Precaution

• Documented hypersensitivity
• Active or history of breast cancer
• Thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding, uncontrolled hypertension, diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use, pregnancy, smoking >15 cigarettes/d) and >35 yo, history of migraine w/ aura
• Serum levels near baseline 24 hr after ingestion, so rigid adherence to dosing schedule is essential for efficacy
• DM, asthma, cardiac dysfunction, irregular menstrual bleeding patterns, bone mineral density changes, depression, epilepsy, migraine, renal dysfunction
• Risk of ectopic pregnancy is 0.5%

Pregnancy & Breastfeeding use

Pregnancy Category: X

Lactation: unsafe

Contraindication

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• Jaundice with prior oral contraceptive use, pregnancy, smoking >15 cigarettes/d) and >35 yo, history of migraine with aura
• Pregnancy or use as a diagnostic test for pregnancy

Storage Condition

Should be stored in cool and dry place

Innovators Monograph

You find simplified version here Ovral-21