Overview
DESCRIPTION Tilia Fe is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets.
Mechanism of Action
CLINICAL PHARMACOLOGY ORAL CONTRACEPTION Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). In vitro and animal studies have shown that norethindrone combines high progestational activity with low intrinsic androgenicity. In humans, norethindrone acetate in combination with ethinyl estradiol does not counteract estrogen-induced increases in sex hormone binding globulin (SHBG).
Indications
- INDICATIONS AND USAGE Tilia Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION The tablet dispenser has been designed to make Tilia Fe dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets. Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen.
Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Cigarette smoking increases the risk of serious cardiovascular side effects from combined oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Tilia Fe, are contraindicated in women who are over 35 years of age and smoke.
Contraindications
- CONTRAINDICATIONS Combined oral contraceptives should not be used in women who currently have the following: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 • Have cerebrovascular disease • Have coronary artery disease • Have current or history of deep vein thrombosis or pulmonary embolism • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart • Have inherited or acquired hypercoagulopathies • Have uncontrolled hypertension or hypertension with vascular disease • Have headaches with focal neurological...
Side Effects
- ADVERSE REACTIONS Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 4). Three studies compared breast cancer risk between current or recent COC users (
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.