Norgestimate and Ethinyl Estradiol (Triphasic)
Brand Names: Tri-Cyclen, TriSprintec, Trinessa
Generic Available
Common Dosage Forms:
Tablets (Ortho Tri-Cyclen): Each white tablet contains norgestimate 0.18 mg, ethinyl estradiol 35 mcg. Each light blue tablet contains norgestimate 0.215 mg, ethinyl estradiol 35 mcg. Each blue tablet contains norgestimate 0.25 mg, ethinyl estradiol 35 mcg.
28-day Dialpak includes 7 green inert tablets.
FDA Indications/Dosages:
For the prevention of pregnancy: Take one tablet daily for 28 days, beginning on the fifth day of the cycle. Day one of cycle is the first day of menstrual bleeding. Use a second method of birth control during the first 3 weeks of oral contraceptive use. Patients should visit their physician yearly for an examination.
For the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Dosage is the same as for prevention of pregnancy.
Pharmacology/Pharmacokinetics: Suppression of luteinizing hormone (LH) and follicle stimulation hormone (FSH) result in the inhibition of ovulation. Thickening of the cervical mucous (inhibiting sperm penetration) and alteration of the endometrium (which inhibits implantation) might also contribute to the effectiveness of oral contraceptives.
Drug Interactions: Broad spectrum antibiotics (ampicillin, amoxicillin, metronidazole, tetracycline) may alter the absorption of estrogens. Barbiturates and hydantoins may increase the metabolism of estrogens. Pharmacological effects may be decreased when used with rifampin. St John’s Wort may induce hepatic enzymes and p-glycoprotein transporter and may reduce the effectiveness of oral contraceptives.
Contraindications/Precautions: Contraindicated in women known or suspected: thromboembolic disorders, breast carcinomas or estrogen-dependent neoplasia, pregnancy, undiagnosed genital bleeding, benign or malignant liver tumors developed during oral contraceptive use (past or present), and cerebral vascular or cardiovascular disease (past or present). Use may cause mental depression, fluid retention, and depressed serum folate levels. Pregnancy Category X.
Adverse Effects: Abdominal cramping, acne, anorexia, nausea, vomiting, edema, unusual tiredness of weakness, and CARDIOVASCULAR or THROMBOEMBOLIC disorders.
Patient Consultation:
Store in a cool, dry place away from sunlight and children.
Oral contraceptives are intended to prevent pregnancy. The do not protect against sexually transmitted infections, including HIV (AIDS) infection.
Consult a physician if the above side effects are severe or persistent.
Breakthrough bleeding may occur during the first three months, notify a physician if it continues.
If 1 tablet is missed at any time during therapy, take it as soon as possible or take 2 tablets the next day and then continue regular cycle. If 2 tablets are missed, take 2 tablets daily for two days then continue normal schedule. If 3 tablets are missed, stop taking medication and begin new packet 7 days following the last dose.
Use a second method of birth control during the first 3 weeks of oral contraceptive use and during treatment with a broad-spectrum antibiotic.
