Usual Adult Dose for Contraception

1 tablet orally once a day

Comments: To be taken at the same time each day.

Usual Adult Dose for Postmenopausal Symptoms

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of vasomotor symptoms due to menopause; the manufacturer product information should be consulted.

Use: For the treatment of moderate to severe vasomotor symptoms due to menopause

Usual Adult Dose for Acne

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Use: For the treatment of moderate acne vulgaris in females with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Usual Adult Dose for Prevention of Osteoporosis

1 tablet orally once a day

Comments:

• Not all preparations are indicated for the prevention of postmenopausal osteoporosis; the manufacturer product information should be consulted.
• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

Use: For the prevention of postmenopausal osteoporosis

Usual Pediatric Dose for Contraception

1 tablet orally once a day

Comments: To be taken at the same time each day.

Usual Pediatric Dose for Acne

15 years or older: 1 tablet orally once a day

Comments:

• Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.
• Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months

Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Renal Dose Adjustments

Use with caution; discontinue if blood pressure rises significantly

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Elderly patients: Not indicated in postmenopausal women.

Changing from another oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have started; some manufacturers recommend starting this drug on the day she would have taken her next pill; she should not continue taking the tablets from the previous birth control pack

Changing from a transdermal patch: Start on the day when the next application would have been scheduled.

Changing from a vaginal ring: Start on the day when the next insertion would have been scheduled.

Changing from an injectable formulation: Start on the day when the next injection would have been scheduled

Changing from an intrauterine system (IUS) contraceptive:

• Start on the day of the removal of the IUS
• If the IUS is not removed on the first day of the menstrual cycle, additional nonhormonal contraceptives (e.g., condoms and spermicide) is needed for the first 7 days of the first cycle pack.

Changing from an implant: Start on the day when the implant is removed.

Following a first trimester abortion or miscarriage:

• May be started immediately; an additional method of contraception is not required if started immediately.
• If not started within 5 days after termination of pregnancy, an additional nonhormonal method of contraception (e.g., condoms and spermicide) is to be used for the first 7 days of the first cycle pack.

Following a second trimester abortion or miscarriage:

• Do not start until 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.
• Follow the instructions for Sunday start or Day 1 start as indicated and use additional non-hormonal contraception (e.g., condoms and spermicide) for the first 7 days of the patient's first cycle pack.

Following childbirth:

• For postpartum women who do not choose to breastfeed, may be started no earlier than 4 weeks postpartum; backup nonhormonal contraception is recommended for the first 7 days
• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
• Follow the instructions for women not currently using hormonal contraception.
• Not recommended for use in lactating women
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use.

Precautions

US BOXED WARNINGS: Combination Oral Contraceptive (COC)

• CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR ADVERSE EFFECTS: Cigarette smoking increases the risk of serious cardiovascular events from 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.

US BOXED WARNINGS: Hormone Replacement Therapy - Postmenopausal Osteoporosis:

• CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA: Estrogen plus progestin therapy should not be used for prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years) during 5.6 years of treatment with conjugated estrogens (CE; 0.625 mg/day) combined with medroxyprogesterone acetate (MPA; 2.5 mg/day), relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years or older during 4 years of treatment with daily CE combined with MPA (0.625 mg/2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
• BREAST CANCER: Increased risk of invasive breast cancer demonstrated by WHI estrogen plus progestin substudy. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
• ENDOMETRIAL CANCER: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding

CONTRAINDICATIONS:
A high risk of arterial or venous thrombotic disease, including:

• Women over 35 years who smoke
• Deep vein thrombosis or pulmonary embolism, now or in the past
• Cerebrovascular disease
• Coronary artery disease
• Thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Inherited or acquired hypercoagulopathies
• Uncontrolled hypertension
• Diabetes mellitus with vascular disease
• Headaches with focal neurological symptoms or migraine headaches with or without aura if over age 35
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Major surgery with prolonged immobilization
• Breast cancer or other estrogen or progestin-sensitive cancer, now or in the past
• Liver tumors, benign or malignant, or liver disease; cholestatic jaundice of pregnancy or jaundice with prior pill use
• Undiagnosed abnormal uterine bleeding
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
• Hypersensitivity to the active components or to any of the ingredients

Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• For maximum effectiveness, this drug must be taken exactly as directed and at intervals not exceeding 24 hours.
• Tablets should be taken at the same time each day.
• If it is a chewable tablet, the patient should drink 8 ounces of water immediately after chewing and swallowing the tablet.
• If severe vomiting or diarrhea occurs, absorption may not be complete and additional contraceptive measures should be taken; if vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet.
• If the patient has not adhered to the prescribed regimen, consider the possibility of pregnancy at the time of the first missed period and discontinue this drug if pregnancy is confirmed.
• If the patient has adhered to the prescribed regimen and misses 2 consecutive periods, rule out pregnancy.
• Some manufacturers only advise patients to start on the first day of their menstrual cycle; if it is not started on the first day of the menstrual cycle, advise the patient to use a nonhormonal contraceptive backup method for the first 7 days of pill use.
• The manufacturer product information should be consulted for information regarding specific preparations.

Sunday Start:

• Take the first active pill on the Sunday after the onset of menstruation, even if the patient is still bleeding; if menstruation begins on a Sunday, start the pack the same day.
• A backup form of birth control (e.g., condoms) should be used from the Sunday the pills are started to the next Sunday (7 days) for the first cycle.
• Take all subsequent pills once a day at the same time each day and begin all subsequent packs on the same day of the week (i.e., Sunday).

Day 1 Start:

• Take the first active pill during the first 24 hours of starting the period.
• Take all subsequent pills once a day at the same time each day.
• A backup method of birth control will not be necessary with the Day 1 start.

Missed Pills:

• If 1 active pill is missed, take it as soon as it is remembered and the next pill at the regular time (2 pills in 1 day); a backup birth control method is not necessary
• If 2 active pills are missed in a row on week 1 or week 2 of the pack, take 2 pills on the day they are remembered and 2 pills the next day, then 1 pill each day until the pack is finished; a form of back-up birth control is necessary for the next 7 days
• If 2 active pills are missed in a row on Week 3, or 3 or more pills are missed in a row, the rest of the pill pack should be thrown out and a new pack started the same day for Day 1 starters; for Sunday starters, keep taking 1 pill every day until Sunday, then on Sunday, throw out the rest of the pack and start a new pack of pills the same day; back-up birth control is necessary for the next 7 days

Storage Requirements:

• Protect from light.

General:

• The efficacy of Lo Loestrin(R) Fe has not been studied in women with a body mass index (BMI) of greater than 35 kg/m2.
• Noncontraceptive health benefits related to oral contraceptives include: increased menstrual cycle regularity, decreased blood loss, decreased incidence of iron-deficiency anemia, decreased incidence of dysmenorrhea, decreased incidence of functional ovarian cysts, decreased incidence of ectopic pregnancies, Decreased incidence of fibroadenomas and fibrocystic disease of the breast, decreased incidence of acute pelvic inflammatory disease, decreased incidence of endometrial cancer, and decreased incidence of ovarian cancer.

Monitoring:

• Cardiovascular: Regularly monitor blood pressure throughout therapy.
• General: A complete medical history and physical examination should occur prior to initiation or reinstitution of this drug.
• Women using this drug should have a yearly visit with a healthcare provider for a blood pressure check and other indicated healthcare.

Patient Advice:

• This drug does not protect against HIV infection, AIDS, and other sexually transmitted diseases.
• The patient information leaflet should be consulted for further information.