Lutera (levonorgestrel and ethinyl estradiol tablets)

Generic name: levonorgestrel and ethinyl estradiol · Brand names: Lutera

Quick facts

Drug class
Section
CLINICAL PHARMACOLOGY, Mode of Action
Source
Lutera label (Dr. Reddy's). Pharmacologic class (EPC): not checked.
Source text (exact source wording)
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
Rx or otc
Value
Rx only
Source
Lutera label
Forms and strengths
Value
28-tablet blister card: 21 orange active tablets each containing 0.10 mg of levonorgestrel and 0.02 mg of ethinyl estradiol; 7 white inert tablets. Active tablets: orange, round, debossed with "A3" on one side. Inert tablets: white, round, debossed with "P" on one side and "N" on the other side.
Source
Lutera label, DESCRIPTION and HOW SUPPLIED (NDC 55741-005-28; carton of 6 NDC 55741-005-06)
Generic available
Source
Lutera label
Common use one line
Used by females of reproductive potential to prevent pregnancy (label, INDICATIONS AND USAGE).

What it is used for

Lutera is a birth control pill used by females of reproductive potential to prevent pregnancy. Its effectiveness in women with a body mass index (BMI) over 35 kg/m2 has not been adequately evaluated.
Section
INDICATIONS AND USAGE
Source
Lutera label (Dr. Reddy's)
Source text (exact source wording)
Lutera is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Lutera in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated.

How it works

Combination birth control pills prevent pregnancy mainly by suppressing ovulation.
Section
CLINICAL PHARMACOLOGY, Mode of Action
Source
Lutera label
Source text (exact source wording)
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

Dosage: adults

Take one orange tablet every day for 21 days, then one white inert tablet every day for 7 days. Take it at the same time each day, at intervals not exceeding 24 hours. Start on the first Sunday after your period begins (use a nonhormonal back-up method for 7 days) or on Day 1 of your period (no back-up needed).
Section
DOSAGE AND ADMINISTRATION
Source
Lutera label
Start instructions
Sunday start: begin on the first Sunday after the onset of menstruation; use a nonhormonal back-up method for the first 7 days (until an orange tablet has been taken daily for 7 consecutive days). Day 1 start: begin during the first 24 hours of the period; no back-up contraception is necessary. (DOSAGE AND ADMINISTRATION, During The First Cycle Of Use)
Source text (exact source wording)
To achieve maximum contraceptive effectiveness, Lutera® (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Lutera is one orange tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Lutera tablets be taken at the same time each day.

Dosage: children

Safety and efficacy have been established in women of reproductive age and are expected to be the same for postpubertal adolescents under 16 and users 16 and older. It is not indicated before menarche.
Section
PRECAUTIONS, 14. Pediatric Use
Source
Lutera label
Source text (exact source wording)
Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated.

Dosage adjustments

Drug interaction caps
Lutera may lower lamotrigine levels, so the lamotrigine dose may need adjusting when Lutera is started or stopped. Lutera may raise thyroid-binding globulin, so TSH should be monitored in people also taking thyroid hormone.
Section
PRECAUTIONS, 9. Drug Interactions
Source
Lutera label
Source text (exact source wording)
Concomitant use of Lutera may decrease lamotrigine exposure, which may reduce efficacy of lamotrigine. Adjust lamotrigine dosage as recommended in its Prescribing Information based on Lutera initiation or discontinuation. Concomitant use of Lutera may increase thyroid-binding globulin concentration. Monitor thyroid-stimulating hormone (TSH) level and follow the recommendation for the thyroid hormone in accordance with its Prescribing Information.
Kidney
No formal studies have looked at the effect of kidney disease on how Lutera is handled by the body.
Section
CLINICAL PHARMACOLOGY, Renal insufficiency
Source
Lutera label
Source text (exact source wording)
No formal studies have evaluated the effect of renal disease on the disposition of Lutera.
Liver
No formal studies have looked at liver disease, but steroid hormones may be poorly metabolized in people with impaired liver function. The label lists hepatic adenomas or carcinomas, or active liver disease, as a contraindication.
Section
CLINICAL PHARMACOLOGY, Hepatic insufficiency
Source
Lutera label
Source text (exact source wording)
No formal studies have evaluated the effect of hepatic disease on the disposition of Lutera (levonorgestrel and ethinyl estradiol tablets USP). However, steroid hormones may be poorly metabolized in patients with impaired liver function.
Elderly
Not studied in women over 65 years of age and not indicated in this population.
Section
PRECAUTIONS, 15. Geriatric Use
Source
Lutera label
Source text (exact source wording)
Levonorgestrel and ethinyl estradiol tablets have not been studied in women over 65 years of age and is not indicated in this population.

Missed dose

Missing orange active pills can lower effectiveness, especially the first few or last few of a pack. If you miss 1 orange pill, take it as soon as you remember, take the next pill at your regular time (you may take 2 pills in 1 day), and use a nonhormonal back-up method for 7 days. If you miss 2 in a row in week 1 or 2, take 2 pills that day and 2 the next day, then 1 a day, with 7 days of back-up. If you miss 2 or more in a row later in the pack, the label gives separate Day 1 Starter and Sunday Starter instructions: throw out the rest of the pack and start a new one (Sunday Starters keep taking 1 pill a day until Sunday). Missed white reminder pills in week 4 are thrown away and you keep taking 1 pill a day. If unsure, use a back-up method and keep taking one pill each day until you reach your health-care provider.
Section
Brief Summary Patient Package Insert, WHAT TO DO IF YOU MISS PILLS
Source
Lutera label (Dr. Reddy's)
Source text (exact source wording)
Lutera may not be as effective if you miss orange "active" pills, and particularly if you miss the first few or the last few orange "active" pills in a pack. If you MISS 1 orange "active" pill: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. 2. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 2 orange "active" pills in a row in WEEK 1 OR WEEK 2 of your pack: 1. Take 2 pills on the day you remember and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 2 orange "active" pills in a row in THE 3rd WEEK: 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. 2. You may not have your period this month but this is expected However, if you miss your period 2 months in a row, call your health-care provider because you might be pregnant. 3. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days. If you MISS 3 OR MORE orange "active" pills in a row (during the first 3 weeks): 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you forget any of the 7 white "reminder" pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up nonhormonal birth-control method if you start your next pack on time.

Overdose

Overdose symptoms may include nausea, vomiting and drowsiness or fatigue, and withdrawal bleeding may occur. There is no specific antidote; treatment is directed to the symptoms. Call poison control at 1-800-222-1222.
Section
OVERDOSAGE
Source
Lutera label
Medlineplus text
In case of overdose, call the poison control helpline at 1-800-222-1222.
Source text (exact source wording)
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Storage

Store at 20° to 25°C (68° to 77°F); excursions to 15ºC to 30ºC (59ºF to 86ºF) are permitted.
Section
HOW SUPPLIED
Source
Lutera label (Dr. Reddy's; labeler-specific)
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP controlled room temperature].

Boxed warning

Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives. The risk increases with age, particularly over 35 years of age, and with the number of cigarettes smoked. Birth control pills like Lutera must not be used by women over 35 who smoke.
Section
WARNINGS (boxed warning heading in the label)
Source
Lutera label (Dr. Reddy's); same text repeated in the Patient Package Insert
Source text (exact source wording)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS. Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (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 Lutera, are contraindicated in women who are over 35 years of age and smoke.

Contraindications

Do not use in women with blood clot disorders or a history of them, stroke or coronary artery disease, certain heart valve or rhythm problems, inherited or acquired clotting disorders, prolonged immobilization after major surgery, diabetes with vascular involvement, migraine with aura or with focal neurological symptoms, migraine at age 35 years or older, uncontrolled high blood pressure, breast cancer or other hormone-sensitive cancer, undiagnosed abnormal vaginal bleeding, jaundice of pregnancy or with prior pill use, liver tumors or active liver disease, or while taking hepatitis C combinations containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Section
CONTRAINDICATIONS
Source
Lutera label
Source text (exact source wording)
Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders; A history of deep-vein thrombophlebitis or thromboembolic disorders; Cerebrovascular or coronary artery disease (current or past history); Valvular heart disease with thrombogenic complications; Thrombogenic rhythm disorders; Hereditary or acquired thrombophilias; Prolonged immobilization (especially with major surgery); Diabetes with vascular involvement; Headaches with focal neurological symptoms or migraine with aura; Women with migraine who are 35 years or older; Uncontrolled hypertension; Known or suspected carcinoma of the breast or personal history of breast cancer; Known or suspected estrogen-or progesterone sensitive malignancy; Undiagnosed abnormal vaginal bleeding; Cholestatic jaundice of pregnancy or jaundice with prior pill use; Hepatic adenomas or carcinomas, or active liver disease; Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations.

Warnings and precautions

Combined hormonal contraceptives increase the risk of heart attack, stroke, deep vein thrombosis and pulmonary embolism. The risk is greater with age 35 years and older, smoking, hypertension, dyslipidemia, diabetes or obesity. The VTE rate in COC users has been estimated at 3 to 9 cases per 10,000 woman-years. VTE risk is highest during the first year and when restarting after a break of four weeks or longer, returns to baseline approximately 3 months after stopping, and is increased during the first six weeks postpartum.
Heading
1. Thromboembolic Disorders and Other Vascular Problems
Section
WARNINGS 1
Source
Lutera label
Source text (exact source wording)
Use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk of these events with CHC use is greater in females with concomitant risk factors: age 35 years and older, smoking, hypertension, dyslipidemia, diabetes, or obesity. Use of CHCs also increases the risk of VTE, such as deep vein thrombosis and pulmonary embolism. The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of CHC use and when restarting hormonal contraception after a break of four weeks or longer. The risk of VTE returns to baseline approximately 3 months after CHC use is discontinued. The risk of VTE is increased during the first six weeks postpartum.
Heading
2. Malignant Neoplasms
Section
WARNINGS 2
Source
Lutera label
Source text (exact source wording)
Lutera is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer in some populations of women.
Benign liver adenomas are associated with oral contraceptive use and are rare in the United States; rupture can cause death through internal bleeding. Studies from Britain showed increased risk of liver cancer in long-term (more than 8 years) users.
Heading
3. Hepatic Neoplasia
Section
WARNINGS 3
Source
Lutera label
Source text (exact source wording)
Benign hepatic adenomas are associated with oral-contraceptive use, although the incidence of these benign tumors is rare in the United States. Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral-contraceptive users.
Liver enzyme (ALT) rises greater than 5 times the upper limit of normal, including some greater than 20 times, were more frequent in women using ethinyl estradiol medicines during treatment with that hepatitis C combination. Stop Lutera before starting it; Lutera can be restarted approximately 2 weeks after completing treatment.
Heading
4. Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment
Section
WARNINGS 4
Source
Lutera label
Source text (exact source wording)
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue Lutera prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Lutera can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
Retinal thrombosis that may cause partial or complete vision loss has been reported. Stop the pill for unexplained vision loss, bulging eyes, double vision, papilledema or retinal vascular lesions.
Heading
5. Ocular Lesions
Section
WARNINGS 5
Source
Lutera label
Source text (exact source wording)
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives that may lead to partial or complete loss of vision. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.
If two consecutive periods are missed, pregnancy should be ruled out. Stop the pill if pregnancy is confirmed.
Heading
6. Use Before or During Early Pregnancy
Section
WARNINGS 6
Source
Lutera label
Source text (exact source wording)
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. Oral-contraceptive use should be discontinued if pregnancy is confirmed.
May worsen existing gallbladder disease and may speed its development in women without symptoms.
Heading
7. Gallbladder Disease
Section
WARNINGS 7
Source
Lutera label
Source text (exact source wording)
Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women.
Can cause glucose intolerance in a significant percentage of users, so females with prediabetes or diabetes should be monitored carefully. A small proportion of women have persistent high triglycerides.
Heading
8. Carbohydrate and Lipid Metabolic Effects
Section
WARNINGS 8
Source
Lutera label
Source text (exact source wording)
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Carefully monitor females with prediabetes and diabetes who are using Lutera. Lutera may decrease glucose tolerance. A small proportion of women will have persistent hypertriglyceridemia while on the COCs.
Blood pressure should be monitored at routine visits and Lutera stopped if it rises significantly. Increases are more likely in older women with longer use.
Heading
9. Elevated Blood Pressure
Section
WARNINGS 9
Source
Lutera label
Source text (exact source wording)
For all females, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop Lutera if blood pressure rises significantly. An increase in blood pressure has been reported in females using CHCs, and this increase is more likely in older women with extended duration of use.
New, recurrent, persistent or severe headaches, or worsening migraine, require stopping the pill and evaluating the cause.
Heading
10. Headache
Section
WARNINGS 10
Source
Lutera label
Source text (exact source wording)
The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.
Unscheduled bleeding and spotting are sometimes seen, especially in the first three months. In the trial, the proportion with unscheduled bleeding or spotting per 28-day cycle decreased from 30.5% at Cycle 1 to 18.2% at Cycle 12.
Heading
11. Bleeding Irregularities
Section
WARNINGS 11
Source
Lutera label
Source text (exact source wording)
Unscheduled bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Based on subject diaries, the proportion of subjects reporting unscheduled bleeding or spotting per 28-day cycle decreased over time: 30.5% at Cycle 1 versus 18.2% at Cycle 12.
Estrogens may trigger or worsen angioedema in women with hereditary angioedema. Chloasma may occur; women with a history of it should avoid sun and ultraviolet exposure. TSH should be monitored in women also taking thyroid hormone replacement.
Heading
12-14. Hereditary angioedema, chloasma, binding globulins
Section
WARNINGS 12, 13, 14
Source
Lutera label
Source text (exact source wording)
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occur, especially in women with a history of chloasma gravidarum. Advise women with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while taking Lutera. Monitor thyroid-stimulating hormone (TSH) levels for females receiving Lutera and thyroid hormone replacement therapy concomitantly.
Vomiting or diarrhea can reduce hormone absorption. After an active tablet, do not take an extra one that day; continue the next day. If it lasts 48 hours or more, contact the provider and use back-up contraception until active tablets have been taken for 7 consecutive days after it resolves. The product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions in susceptible people. It does not protect against HIV or other sexually transmitted diseases.
Heading
Precautions: Vomiting or diarrhea; tartrazine; no STD protection
Section
PRECAUTIONS 1 and 8
Source
Lutera label
Source text (exact source wording)
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations. If a patient vomits or has diarrhea after taking an active tablet, instruct the patient to not take an additional active tablet on that day and to continue the regimen the next day as prescribed. In case of vomiting or diarrhea that continues for 48 hours or greater, instruct the patient to contact the health care provider and use back-up or alternative contraception until active tablets have been taken for 7 consecutive days after vomiting and diarrhea have resolved. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Monitor people with a history of depression and stop if it recurs to a serious degree. Contact-lens wearers with vision changes should see an eye doctor. Fluid retention may occur. Stop the medicine if jaundice develops.
Heading
Precautions: Depression, contact lenses, fluid retention, lipid disorders, liver function
Section
PRECAUTIONS 3-7
Source
Lutera label
Source text (exact source wording)
Monitor females with a history of depression and discontinue Lutera if depression recurs to a serious degree. Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Oral contraceptives may cause some degree of fluid retention. If jaundice develops in any woman receiving such drugs, the medication should be discontinued.

Pregnancy and breastfeeding

Section
PRECAUTIONS 12. Pregnancy; 13. Lactation
Source
Lutera label
Medlineplus text
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
Source text (exact source wording)
Pregnancy, Risk Summary: There is no use for contraception in pregnancy; therefore, Lutera 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 COCs before conception or during early pregnancy. Lactation: Contraceptive hormones and metabolites are present in human milk. CHCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for Lutera and any potential adverse effects on the breast-fed child from Lutera or from the underlying maternal condition.

Side effects

Common
The label says common side effects of combined hormonal birth control pills are headache, abdominal pain, nausea, bleeding between periods, vaginal yeast infection and pain, acne and vaginitis. No percentages are given.
Threshold
none stated in label; this is a class statement for oral CHCs, and the label has no placebo-controlled incidence table
Section
ADVERSE REACTIONS
Source
Lutera label
Source text (exact source wording)
Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
Less common
Other reported reactions include contact lens intolerance, steepening of corneal curvature, bloating, vomiting, edema, fluid retention, cholestatic jaundice, change in libido, mood changes, amenorrhea, breast tenderness, pain or enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding, acne, melasma, Budd-Chiari syndrome and aggravation of varicose veins.
Section
ADVERSE REACTIONS
Source
Lutera label
Source text (exact source wording)
Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature. Gastrointestinal disorders: Abdominal bloating, vomiting. General disorders and administration site conditions: Edema, fluid retention. Hepatobiliary disorders: Cholestatic jaundice. Pyschiatric disorders: Change in libido, mood changes. Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding. Skin and subcutaneous tissue disorders: Acne, melasma. Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins.
Serious
Label: oral contraceptives are associated with increased risk of blood clots and other vascular problems (including heart attack and cerebral hemorrhage), cancers of the reproductive organs and breasts, liver tumors, eye lesions, gallbladder disease, carbohydrate and lipid effects, high blood pressure and headache including migraine. MedlinePlus: stop and call your doctor right away for yellowing of the skin or eyes, abdominal pain or tenderness, a breast lump, or unusual bleeding including menstrual bleeding that is unusually heavy or lasts longer than 7 days in a row.
Section
ADVERSE REACTIONS
Source
Lutera label
Medlineplus text
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking ethinyl estradiol and levonorgestrel oral contraceptives and call your doctor immediately or get emergency medical treatment: yellowing of the skin or eyes; pain or tenderness in the abdomen; a lump in your breast; unusual bleeding, including menstrual bleeding that is unusually heavy or that lasts for longer than 7 days in a row
Medlineplus source
https://medlineplus.gov/druginfo/meds/a625049.html
Source text (exact source wording)
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

Interactions

Drugs
Do not take Lutera with these hepatitis C drug combinations because of possible ALT (liver enzyme) elevations.
Name
Hepatitis C combinations with ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)
Section
CONTRAINDICATIONS; PRECAUTIONS 9
Source text (exact source wording)
Do not co-administer Lutera with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.
Some medicines can make the pill less effective, which could cause pregnancy or breakthrough bleeding. Examples listed: rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin and modafinil. A back-up nonhormonal method should be considered.
Name
Drugs that increase metabolism of contraceptive steroids (antibiotics, anticonvulsants, others)
Section
PRECAUTIONS 9
Source text (exact source wording)
Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil. In such cases a back-up nonhormonal method of birth control should be considered.
Anti-HIV protease inhibitors can change estrogen and progestin levels and may affect the safety and effectiveness of the pill. Providers should check the label of the individual HIV drug.
Name
Anti-HIV protease inhibitors
Section
PRECAUTIONS 9
Source text (exact source wording)
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
Atorvastatin raises ethinyl estradiol exposure (AUC) by approximately 20%. Ascorbic acid and acetaminophen increase its bioavailability. CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole and troleandomycin may increase hormone levels, and troleandomycin may increase the risk of intrahepatic cholestasis.
Name
Drugs that raise ethinyl estradiol levels
Section
PRECAUTIONS 9
Source text (exact source wording)
Co-administration of atorvastatin and certain oral contraceptives containing ethinyl estradiol increases AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen increase the bioavailability of ethinyl estradiol. CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels. Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.
Oral contraceptives have been reported to raise levels of cyclosporin, prednisolone and other corticosteroids, and theophylline, and to lower acetaminophen levels and increase clearance of temazepam, salicylic acid, morphine and clofibric acid. Lutera may decrease lamotrigine exposure, so the lamotrigine dose may need adjusting.
Name
Drugs whose levels are changed by oral contraceptives
Section
PRECAUTIONS 9
Source text (exact source wording)
Increased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation (particularly glucuronidation), have been noted when these drugs were administered with oral contraceptives. Concomitant use of Lutera may decrease lamotrigine exposure, which may reduce efficacy of lamotrigine. Adjust lamotrigine dosage as recommended in its Prescribing Information based on Lutera initiation or discontinuation.
Monitor TSH in people also taking thyroid hormone.
Name
Thyroid hormone replacement
Section
WARNINGS 14; PRECAUTIONS 9
Source text (exact source wording)
Concomitant use of Lutera may increase thyroid-binding globulin concentration. Monitor thyroid-stimulating hormone (TSH) level and follow the recommendation for the thyroid hormone in accordance with its Prescribing Information.
Food and alcohol
Continue your normal diet unless your doctor says otherwise. The label has no food or alcohol interaction statement.
Name
Diet
Section
What special dietary instructions should I follow? (MedlinePlus)
Source text (exact source wording)
Unless your doctor tells you otherwise, continue your normal diet.
Other
St. John's Wort may reduce the effectiveness of the pill and may cause breakthrough bleeding.
Name
St. John's Wort
Section
PRECAUTIONS 9
Source text (exact source wording)
Herbal products containing St. John's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Oral contraceptives can affect some hormone and liver tests and blood components; tell the lab you take them.
Name
Laboratory tests
Section
PRECAUTIONS 10
Source text (exact source wording)
Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives.

Patient tips

Label patient information
Take one pill every day at the same time. Missing pills, including starting a pack late, can lead to pregnancy. Spotting, light bleeding or nausea in the first 1 to 3 packs is common; do not stop for nausea, and check with your provider if it does not go away. Vomiting within 4 hours of a pill is treated like a missed pill. Diarrhea or some medicines, including some antibiotics, can make pills work less well; use a nonhormonal back-up until you check with your provider. Do not skip pills when spotting, bleeding or nauseated, or when you rarely have sex.
Section
Brief Summary Patient Package Insert, HOW TO TAKE LUTERA; WHAT TO DO DURING THE MONTH
Source text (exact source wording)
THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking Lutera. The problem will usually go away. If it doesn't go away, check with your health-care provider. IF YOU HAVE VOMITING (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up nonhormonal method (such as condoms or spermicide) until you check with your health-care provider. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.
Medlineplus
Keep taking the pill as directed even with spotting, upset stomach or if you think pregnancy is unlikely, and do not stop without talking to your doctor. Vomiting or diarrhea may make it work less well, so contact your doctor. Get a complete physical exam every year including blood pressure, breast and pelvic exams and a Pap test. See an eye doctor for vision or contact lens changes. If you have had skin color changes before, avoid real or artificial sunlight.
Section
How should this medicine be used? / What special precautions should I follow? / What other information should I know?
Source
MedlinePlus https://medlineplus.gov/druginfo/meds/a625049.html (generic page for ethinyl estradiol and levonorgestrel oral contraceptives, not specific to Lutera)
Source text (exact source wording)
Continue to take them as directed even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor. If you vomit or have diarrhea while you are taking ethinyl estradiol and levonorgestrel oral contraceptive, it may not work as well. If this happens, contact your doctor about what to do. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. If you notice changes in vision or ability to wear your lenses while taking oral contraceptives, see an eye doctor. If you have experienced changes in your skin color during pregnancy or while you were taking oral contraceptives in the past, you should avoid exposure to real or artificial sunlight while you are taking oral contraceptives.

Alternatives

Openfda pharm class epc
not checked
Note
No recommendation made.

Frequently asked questions

Question
What is Lutera used for?
Answer
Lutera is a birth control pill used by females of reproductive potential to prevent pregnancy. Its effectiveness in women with a BMI over 35 kg/m2 has not been adequately evaluated.
Source section
INDICATIONS AND USAGE
Source
Lutera label
Question
How do I take Lutera?
Answer
Take one orange tablet daily for 21 consecutive days, then one white inert tablet daily for 7 consecutive days, at the same time each day and at intervals not exceeding 24 hours.
Source section
DOSAGE AND ADMINISTRATION
Source
Lutera label
Question
What should I do if I miss a pill?
Answer
If you miss 1 orange active pill, take it as soon as you remember, take the next pill at your regular time, and use a nonhormonal back-up method for 7 days. The instructions differ if you miss 2 or more; follow the pack leaflet and call your provider if unsure.
Source section
WHAT TO DO IF YOU MISS PILLS
Source
Lutera label
Question
What are the common side effects?
Answer
The label lists headache, abdominal pain, nausea, bleeding between periods, vaginal yeast infection and pain, acne and vaginitis as common with oral combination hormonal contraceptives. No percentages are given.
Source section
ADVERSE REACTIONS
Source
Lutera label
Question
Can I take Lutera if I smoke?
Answer
Not if you are over 35 years of age and smoke. Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives, and the risk increases with age and with the number of cigarettes smoked.
Source section
Boxed warning
Source
Lutera label
Question
Do other medicines affect Lutera?
Answer
Yes. Rifampin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, topiramate, griseofulvin, modafinil and others may reduce effectiveness, as may St. John's Wort. Do not take it with hepatitis C combinations containing ombitasvir/paritaprevir/ritonavir. Ask your provider about back-up contraception.
Source section
PRECAUTIONS 9. Drug Interactions
Source
Lutera label
Question
Does Lutera protect against sexually transmitted diseases?
Answer
No. The label says oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.
Source section
PRECAUTIONS 1. General
Source
Lutera label
Question
Is Lutera safe during pregnancy or breastfeeding?
Source section
PRECAUTIONS 12 and 13
Source
Lutera label

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug