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Lo Loestrin Fe

Generic Name: Norethindrone Acetate and Ethinyl Estradiol Tablets/Ethinyl Estradiol Tablets/Ferrous Fumarate Tablets
Drug Category: Estrogen/Progestin COC
Litigation Alert Level: High
This drug has been approved for use by females over the age of 18 years old and under the age of 45 years old for a maximum duration of year.

Approved Uses

Indicated for use by women to prevent pregnancy.

The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

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.

Stop Lo Loestrin Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

Hepatic adenomas are associated with COC use.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users.

Do not prescribe Lo Loestrin Fe to women who are known to have the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: smoke, if over age 35, have deep vein thrombosis or pulmonary embolism, now or in the past, have cerebrovascular disease, have coronary artery disease, have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation), have inherited or acquired hypercoagulopathies, have uncontrolled hypertension, have diabetes mellitus with vascular disease, have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past 
  • Liver tumors, benign or malignant, or liver disease
  • Undiagnosed abnormal uterine bleeding 
  • Pregnancy, because there is no reason to use COCs during pregnancy
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

If feasible, stop Lo Loestrin Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Women with a history of depression should be carefully observed and Lo Loestrin Fe discontinued if depression recurs to a serious degree.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

Carefully monitor prediabetic and diabetic women who are taking Lo Loestrin Fe. COCs may decrease glucose tolerance in a dose-related fashion.

If a woman taking Lo Loestrin Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Lo Loestrin Fe if indicated. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.

There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort and topiramate.

Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors.

Do not co-administer Lo Loestrin Fe with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.

COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of
conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid binding globulin increase with use of COCs.

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.

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.

Estrogen-containing OCs can reduce milk production in breastfeeding mothers. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

GoToSource

Off-label Uses

• Acne. GoToSource

• Anti-aging, low libido and sexual dysfunction. GoToSource

• Uterine fibroids. GoToSource

• Endometriosis. GoToSource

• Heavy menstrual bleeding. GoToSource

Adverse Events

Migraines and ischemic stroke. GoToSource

Venous thromboembolism (including pulmonary embolism and deep venous thrombosis) and hypertension (high blood pressure). GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Depression. GoToSource

Increased risk of gallbladder disease. GoToSource

Erythema nodosum (skin inflammation). GoToSource

Litigation

Lawsuits filed for blood clots.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024