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TRI-LEGEST Fe
Acne
Contraception
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Drug Name:

TRI-LEGEST Fe Rx

Generic Name and Formulations:
Norethindrone acetate 1mg, ethinyl estradiol 20mcg (5 tabs), norethindrone acetate 1mg, ethinyl estradiol 30mcg (7 tabs), norethindrone acetate 1mg, ethinyl estradiol 35mcg (9 tabs); inert+ (7 tabs); + contains ferrous fumarate 75mg.

Company:
Teva Pharmaceuticals

Therapeutic Use:

Indications for TRI-LEGEST Fe:

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.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarche: not recommended.

Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

Warnings/Precautions:

Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid rentention. Monitor blood pressure. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

Pharmacological Class:

Progestin + estrogen.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tri-Legest Fe prior to starting HCV regimen and restart 2wks after completion. Antagonized by rifampin, phenobarbital, phenytoin, carbamazepine, St. John's wort. Efficacy may be reduced by ampicillin, tetracycline, griseofulvin, phenylbutazone. May be potentiated by atorvastatin, acetaminophen, ascorbic acid. May potentiate cyclosporine, prednisolone, theophylline. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.

How Supplied:

Packs—5

Indications for TRI-LEGEST Fe:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarche: not recommended.

Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

Warnings/Precautions:

Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid rentention. Monitor blood pressure. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

Pharmacological Class:

Progestin + estrogen.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tri-Legest Fe prior to starting HCV regimen and restart 2wks after completion. Antagonized by rifampin, phenobarbital, phenytoin, carbamazepine, St. John's wort. Efficacy may be reduced by ampicillin, tetracycline, griseofulvin, phenylbutazone. May be potentiated by atorvastatin, acetaminophen, ascorbic acid. May potentiate cyclosporine, prednisolone, theophylline. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.

How Supplied:

Packs—5

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