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Tilia Fe Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—5
Manufacturer
Tilia Fe Indications
Indications
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.
Tilia Fe Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Premenarche: not recommended.
Tilia Fe Contraindications
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.
Tilia Fe Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Tilia Fe Warnings/Precautions
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.
Tilia Fe Pharmacokinetics
See Literature
Tilia Fe Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tilia 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).
Tilia Fe Adverse Reactions
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.
Tilia Fe Clinical Trials
See Literature
Tilia Fe Note
Not Applicable
Tilia Fe Patient Counseling
See Literature
Tilia Fe Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—5
Manufacturer
Tilia Fe Indications
Indications
Oral contraception.
Tilia Fe Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Premenarche: not recommended.
Tilia Fe Contraindications
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.
Tilia Fe Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Tilia Fe Warnings/Precautions
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.
Tilia Fe Pharmacokinetics
See Literature
Tilia Fe Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tilia 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).
Tilia Fe Adverse Reactions
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.
Tilia Fe Clinical Trials
See Literature
Tilia Fe Note
Not Applicable
Tilia Fe Patient Counseling
See Literature
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