Dosage & Administration
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Lo Loestrin FE Prescribing Information
Cigarette smoking increases the risk of serious cardiovascular events from combination 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 should not be used by women who are over 35 years of age and smoke [see Contraindications (4)].
Lo Loestrin® Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
2.1 How to Take Lo Loestrin Fe
To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Lo Loestrin Fe tablets may be administered without regard to meals [see Clinical Pharmacology (12.3)].
2.2 How to Start Lo Loestrin Fe
Instruct the patient to begin taking Lo Loestrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Loestrin Fe other than on the first day of her menstrual cycle.
For postpartum women who do not breastfeed or after a second trimester abortion, Lo Loestrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.
Lo Loestrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Loestrin Fe immediately, additional contraceptive measures are not needed.
2.3 Switching from another Hormonal Method of Contraception
If the patient is switching from a combination hormonal method such as:
○ Another pill
○ Vaginal ring
○ Patch
- Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Loestrin Fe.
- If she previously used a vaginal ring or transdermal patch, she should start using Lo Loestrin Fe on the day she would have resumed the previous product.
If the patient is switching from a progestin-only method such as a:
○ Progestin-only pill
○ Implant
○ Intrauterine system
○ Injection
- Instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill, or had her next injection or on the day of removal of her implant.
- If switching from an IUD, depending on the timing of removal, back-up contraception may be needed.
2.4 Missed Doses
Table 1: Instructions for Missed Lo Loestrin Fe Tablets in a Monthly Dosing Regimen
| Take the tablet as soon as possible, even if two tablets are taken in one day. Continue taking one tablet a day until the pack is finished. |
| Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking the remaining tablets, one tablet a day until the pack is finished. Use additional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. |
| Throw out the rest of the pack and start a new pack the same day. A withdrawal bleed may not occur. Use additional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. |
| Throw out the rest of the pack and start a new pack that same day. A withdrawal bleeding may not occur. Use additional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. |
| Throw out the tablet you missed. Start a new pack on the same day a new pack is usually started. |
2.5 Advice in Case of Gastrointestinal Disturbances
If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white pill), she should follow the instructions in Missed Doses [see Dosage and Administration (2.4)].
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister packs.
Each blister pack (28 tablets) contains in the following order:
- 24 blue, round (active) tablets imprinted with “WC” on one side and “421” on the other and each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol.
- 2 white, hexagonal (active) tablets imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol.
- 2 brown, round (non-hormonal placebo) tablets imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
8.1 Pregnancy
Risk Summary
There is no use for contraception in pregnancy; therefore, Lo Loestrin Fe should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (CHCs) before conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Data
Human Data
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy.
8.2 Lactation
Risk Summary
Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [See also Dosage and Administration (2.2).] The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lo Loestrin Fe and any potential adverse effects on the breastfed child from Lo Loestrin Fe or from the underlying maternal condition.
8.4 Pediatric Use
Safety and efficacy of Lo Loestrin Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
8.5 Geriatric Use
Lo Loestrin Fe has not been studied in postmenopausal women and is not indicated in this population.
8.6 Renal Impairment
The pharmacokinetics of Lo Loestrin Fe has not been studied in subjects with renal impairment.
8.7 Hepatic Impairment
No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of Lo Loestrin Fe. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.3)].
8.8 Body Mass Index
The safety and efficacy of Lo Loestrin Fe in women with a body mass index (BMI) >35 kg/m2 has not been evaluated [see Clinical Studies (14)].
Lo Loestrin Fe is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
• Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
• Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
• Have cerebrovascular disease [see Warnings and Precautions (5.1)]
• Have coronary artery disease [see Warnings and Precautions (5.1)]
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
• Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
• Have uncontrolled hypertension [see Warnings and Precautions (5.5)]
• Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)]
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8)] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.2)]
- Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.4)].