Ortho Tri-Cyclen (TriNessa, Mylan)

Introduction

ethinyl estradiol (estrogen) plus norgestimate (progestin)

Indications

• prevention of pregnancy
• treatment of acne in women > 15 years

Contraindications

pregnancy-category X

safety in lactation -

Dosage

ethinyl estradiol* (estrogen) 35 ug

norgestimate (progestin): 180 ug, 215 ug, 250 ug

* Ortho Tri-Cyclen Lo contains 25 ug of ethinyl estradiol

Pharmacokinetics

elimination: liver

Adverse effects

• common (> 10%)
  • headache, peripheral edema, bloating
• not common (1-10%)
  • breakthrough bleeding, amenorrhea, nausea, breast tenderness, breast enlargement, hypertension, weight gain, increased/decreased libido
• uncommon (< 1%)
  • alterations in mestrual flow, hypertension, breast tumors, thromboembolism, stroke, myocardial infarction, edema, depression, dizziness, anxiety, chloasma, melasma, rash, hyperglycemia, GI distress, increased serum triglycerides, increased LDL, cholestatic jaundice, increased susceptibility to Candida infection

• drug adverse effects of estrogens

Drug interactions

• barbiturates, carbamazepine, cyclosporine, troglitazone, griseofulvin, penicillins, phenytoin, rifampin, tetracyclines, troglitazone, protease inhibitors

• drug interaction(s) of beta-adrenergic receptor antagonists with oral contraceptives
• drug interaction(s) of NSAIDs with oral contraceptive

Mechanism of action

norgestimate:

• low affinity binding to sex-hormone binding globulin
• in combination with ethinyl estradiol may increase free testosterone

More general terms

• triphasic oral contraceptive
• ethinyl estradiol/norgestimate (Estarylla)

Components

• norgestimate