Dosing and uses of Ovrette (norgestrel)
Adult dosage forms and strengths
No longer available in Us
Contraception
0.075 mg PO qDay, at same time each day
Pediatric dosage forms and strengths
Not applicable
Ovrette (norgestrel) adverse (side) effects
>10%
Edema
Weakness
Anorexia
Amenorrhea
Breakthrough bleeding
Change in menstrual flow
Spotting
Frequency not defined
Deep vein thrombosis
Thrombophlebitis
Depression
Dizziness
Headache
Nervousness
Somnolence
Breast tenderness
Galactorrhea
Abdominal pain
Nausea
Vomiting
Change in weight
Cholestatic jaundice
Warnings
Contraindications
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 w/ aura
Pregnancy or use as a diagnostic test for pregnancy
Cautions
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 and lactation
Pregnancy category: X
Lactation: unsafe
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ovrette (norgestrel)
Peak Plasma Time: 2 hr
Metabolism: liver
Metabolites: sulfate and glucuronide metabolites (inactive)
Mechanism of action
Progestin; inhibits secretion of gonadotropins from pituitary gland; prevents ovulation in half of users, thickens cervical mucus to inhibit sperm penetration
