Norgestimate
in ORTHO TRI-CYCLEN
What it isProgestin with low androgenic activity, used in combined oral contraceptives.
Why this oneIts low androgenicity is why it is chosen for acne, and it carries an acne indication.
What limits itCombined use brings VTE risk, higher with smoking and over 35. Efficacy depends on daily adherence.
FDA-approved for
- contraception with ethinyl estradiol
- acne vulgaris
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Contraception | Females of reproductive potential | 1 active tablet QD | 1 tablet QD (21 active + 7 inactive per 28-day cycle) |
Renal Undefined
Hepatic Contraindicated in liver disease or hepatic tumors
Instructions
- Take 1 tablet by mouth at the same time daily, in blister-pack order
- Do not skip or delay tablets
- Day 1 or Sunday start; with Sunday start use backup contraception for first 7 days
- Start next pack the day after finishing prior pack
Contraindications
- High risk of arterial/venous thrombosis (DVT/PE, thrombophilia, cerebrovascular or coronary artery disease, thrombogenic valvular/rhythm disease)
- Women >35 years who smoke
- Uncontrolled hypertension
- Diabetes mellitus with vascular disease
- Headache with focal neurological symptoms, migraine with aura, or any migraine if >35
- Liver tumors (benign/malignant) or liver disease
- Undiagnosed abnormal uterine bleeding
- Pregnancy
- Current or history of breast cancer or other estrogen/progesterone-sensitive cancer
Cautions
- Stop if thrombotic event; stop ≥4 wk before and 2 wk after major surgery
- Discontinue if jaundice occurs
- Monitor BP; may worsen glucose/lipid control
- Evaluate new or worsening headache
- Irregular bleeding/amenorrhea
Adverse reactions
- Irregular uterine bleeding
- Nausea
- Breast tenderness
- Headache/migraine
- Abdominal pain
- Mood changes (depression, mood altered)
Pregnancy Contraindicated in pregnancy; no increased birth-defect risk with inadvertent early exposure.
Lactation Not recommended; can decrease milk production. Small amounts of steroids present in milk.
⚠ BOXED WARNING
- Cigarette smoking and serious cardiovascular events over age 35
Cost, est. cash$10–$300/month
Generic entry2002
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityVenous thromboembolism and hormone-related adverse effects; estrogen also lowers lamotrigine exposure.
Active metabolites
Mechanism of action: Norgestimate ballicule
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