Ndac And Ee Tablets And Ferrous Fumarate Tablets

FDA Drug Information • Also known as: Tilia Fe

Brand Names: Tilia Fe
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

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.

Description

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. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each pale yellow tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium...

What Is Ndac And Ee Tablets And Ferrous Fumarate Tablets Used For?

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. Tilia Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfect Use 2 (1) (2) (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Symptothermal 6 2 Post-ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNG 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75% 9 . Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology : Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who...

Dosage and Administration

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. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Tilia Fe should be taken exactly as directed and at intervals not exceeding 24 hours. Tilia Fe provides a continuous administration regimen consisting of 21 active tablets (pale yellow, light yellow and light brown) and seven brown non-hormone containing tablets of ferrous fumarate. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no "off-tablet days." A. Sunday-Start Regimen: The patient begins taking the first pale yellow tablet from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first pale yellow is taken on the same day. The patient takes one active tablet daily for 21 days. The last light brown tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 active tablets, and without interruption, the patient takes one brown tablet daily for 7 days. Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday active tablet in the top row. Adhering to this regimen of one active tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday. B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self adhesive day label sticker that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one active tablet daily, beginning with the first active tablet in the top row. After the last active tablet (at the end of the third row) has been taken, the patient will then take the brown tablets...

Side Effects (Adverse Reactions)

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 (<6 months since last use) and never users of COCs (Figure 4). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

Thrombophlebitis

Arterial thromboembolism

Pulmonary embolism

Myocardial infarction

Cerebral hemorrhage

Cerebral thrombosis

Hypertension

Gallbladder disease

Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of combined oral contraceptives, although additional confirmatory studies are needed:

Mesenteric thrombosis

Retinal thrombosis The following adverse reactions have been reported in patients receiving combined oral contraceptives and are believed to be drug-related:

Nausea

Vomiting

Gastrointestinal symptoms (such as abdominal cramps and bloating)

Breakthrough bleeding

Spotting

Change in menstrual flow

Amenorrhea

Temporary infertility after discontinuation of treatment

Edema

Melasma which may persist

Breast changes: tenderness, enlargement, secretion

Change in weight (increase or decrease)

Change in cervical erosion and secretion

Diminution in lactation when given immediately postpartum

Cholestatic jaundice

Migraine

Rash (allergic)

Mental depression

Mood swings

Reduced tolerance to carbohydrates

Vaginal candidiasis

Change in corneal curvature (steepening)

Intolerance to contact lenses The following adverse reactions have been reported in users of combined oral contraceptives and the association has been neither confirmed nor refuted:

Pre-menstrual syndrome

Cataracts

Changes in appetite

Cystitis-like syndrome

Headache

Nervousness

Dizziness

Hirsutism

Loss of scalp hair

Erythema multiforme

Erythema nodosum

Hemorrhagic eruption

Vaginitis

Porphyria

Impaired renal function

Hemolytic uremic syndrome

Budd-Chiari syndrome

Acne

Changes in libido

Colitis fig4

Warnings and Precautions

WARNINGS The use of combined oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing combined oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used combined oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the combined oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among combined oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between combined oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods. 1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction An increased risk of myocardial infarction has been attributed to combined oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current combined oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30. Smoking in combination with combined oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Figure 3) among women who use combined oral contraceptives. Combined oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In...

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 symptoms, migraine headaches with aura, or over age 35 with any migraine headaches

Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or end-organ damage, or diabetes mellitus of > 20 years duration

Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive

Undiagnosed abnormal genital bleeding

Cholestatic jaundice of pregnancy or jaundice with prior pill use

Hepatic adenomas or carcinomas

Known or suspected pregnancy

Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

Overdosage

OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of combined oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

How Supplied

HOW SUPPLIED Tilia Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets and seven brown tablets in a blister card (NDC 75907-086-28) within a plastic dispenser. Each of the five pale yellow, biconvex, round tablets (debossed with "H2" on one side) contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol. The next seven light yellow, biconvex, round tablets (debossed with "H3" on one side) contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol. The next nine light brown, biconvex, round tablets (debossed with "H4" on one side) contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol. The last seven brown, biconvex, round tablets (debossed with "F" on one side and " N " on the other side) each contain 75 mg ferrous fumarate. Tilia Fe Tablets are available in the following configurations: Carton of 3 compacts NDC 75907-086-32 Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light. REFERENCES AVAILABLE UPON REQUEST

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.