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Ortho Tri-Cyclen (TriNessa, Mylan)
ethinyl estradiol (estrogen) plus norgestimate (progestin)
Indications:
1) prevention of pregnancy
2) 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 [3]
Pharmacokinetics: elimination: liver
Adverse effects:
1) common (> 10%)
- headache, peripheral edema, bloating
2) not common (1-10%)
- breakthrough bleeding, amenorrhea, nausea, breast tenderness, breast enlargement, hypertension, weight gain, increased/decreased libido
3) 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 interactions:
- barbiturates, carbamazepine, cyclosporine, troglitazone, griseofulvin, penicillins, phenytoin, rifampin, tetracyclines, troglitazone, protease inhibitors
Mechanism of action: norgestimate:
1) low affinity binding to sex-hormone binding globulin
2) in combination with ethinyl estradiol may increase free testosterone
Interactions
drug adverse effects of estrogens
General
triphasic oral contraceptive
ethinyl estradiol/norgestimate (Estarylla)
References
- The Pharmacological Basis of Therapeutics, 9th ed.
Gilman et al, eds. Permagon Press/McGraw Hill, 1996
- Kaiser Permanente Northern California Regional Drug
Formulary, 1998
- Prescriber's Letter 9(10):56 2002
Components
norgestimate