Professional Information — Portia B 992

Full FDA prescribing details for healthcare professionals.

Last updated · May 16, 2026Source: DailyMed ↗

On this page

Highlights of Prescribing InformationRevised: Mar 12, 2025

Stop levonorgestrel and ethinyl estradiol tablets if an arterial or venous thrombotic/thromboembolic event occurs.
Stop levonorgestrel and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.
Discontinue levonorgestrel and ethinyl estradiol tablets during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol tablets at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism.
Start levonorgestrel and ethinyl estradiol tablets no earlier than four weeks after delivery in females who are not breast-feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.
Before starting levonorgestrel and ethinyl estradiol tablets evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases (see CONTRAINDICATIONS ).

Arterial Events

COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.

Levonorgestrel and ethinyl estradiol tablets are contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS ). 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.

Venous Events

Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS ). While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). 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 use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.

Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.

Figure 1: Likelihood of Developing a VTE

Indications and Usage

Portia^® (levonorgestrel and ethinyl estradiol tablets USP) is indicated for use by females of reproductive potential to prevent pregnancy.

Dosage and Administration

1. How to Start and Take Portia ^®

Portia^® is dispensed in a blister card containing 28 tablets (see HOW SUPPLIED ). Portia^® may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

Table 3: Instructions for Administration of Portia®
Starting Portia^® in females with no current use of hormonal contraception	Day 1 start Take first tablet without regard to meals on the first day of menses Take subsequent tablets once daily at the same time each day Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet)
Sunday start Take first tablet without regard to meals on the first Sunday after the onset of menstrual period Take subsequent tablets once daily at the same time each day Use additional nonhormonal contraception for the first seven days of product use Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet)
Switching from another contraceptive method A COC	Start Portia^®: On the day when the new pack of the previous COC would have been started
Transdermal patch	On the day when next application would have been scheduled
Vaginal ring	On the day when next insertion would have been scheduled
Injection	On the day when next injection would have been scheduled
Intrauterine contraceptive	On the day of removal
Implant	On the day of removal

Starting Portia ^® after Abortion or Miscarriage

First-trimester

After a first-trimester abortion or miscarriage, Portia^® may be started immediately. An additional method of contraception is not needed if Portia^® is started immediately.
If Portia^® is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of Portia^®.

Second-trimester

Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Portia^® following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of Portia^® (see CONTRAINDICATIONS , WARNINGS (1) , PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING ).

Starting Portia ^® after Childbirth

Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Portia^® following the instructions in Table 3 for women not currently using hormonal contraception.
Portia^® is not recommended for use in lactating women (see PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING ).
If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Portia^® (see CONTRAINDICATIONS , WARNINGS (9) , PRECAUTIONS (6) and FDA-APPROVED PATIENT LABELING ).

2. Dosing Portia ^®

Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Portia^® as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.

3. Missed doses

Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.

Table 4: Instructions for Missed Portia® Tablets
If one active tablet is missed in Weeks 1, 2, or 3	Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
If two active tablets are missed in Week 1 or Week 2	Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3	Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.

4. Advice in Case of Gastrointestinal Disturbances

If vomiting occurs within 3 to 4 hours after taking Portia^®, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.

Contraindications

Portia^® (levonorgestrel and ethinyl estradiol tablets USP) is contraindicated in females 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 [see BOXED WARNING and WARNINGS (1) ].
Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ].
Have cerebrovascular disease [see WARNINGS (1) ].
Have coronary artery disease [see WARNINGS (1) ].
Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ].
Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ].
Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ].
Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7) ].
Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8) ].

Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive.
Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see WARNINGS (2) ].
Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS (5) ].
Undiagnosed abnormal uterine bleeding [see WARNINGS (9) ].

Adverse Reactions

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Serious cardiovascular adverse events [see BOXED WARNING and WARNINGS (1) ]
Vascular events [see WARNINGS (1) ]
Liver disease [see WARNINGS (2) ]
Hypertension [see WARNINGS (3) ]
Gallbladder disease [see WARNINGS (6) ]
Carbohydrate and lipid effects [see WARNINGS (7) ]
Headache [see WARNINGS (8) ]
Carcinoma of the cervix [see WARNINGS (11) ]

Adverse reactions reported by COC users and described elsewhere in the labeling are:

Bleeding irregularities and amenorrhea [see WARNINGS (9) ]
Mood changes, including depression [see WARNINGS (10) ]
Melasma/chloasma which may persist [see WARNINGS (14) ]
Edema/fluid retention [see PRECAUTIONS (2) ]
Diminution in lactation when given immediately postpartum [see PRECAUTIONS (7) ]

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 to 1.12 (Figure 2).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). 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 to 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 to 10 years of COC use.

Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

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.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

figure-2

Drug Interactions

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.

Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.

No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets.

4.1 Effects of Other Drugs on Combined Oral Contraceptives

Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs:

Table 1 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets.

Table 1: Significant Drug Interactions Involving Substances That Affect COCs
Metabolic Enzyme Inducers
Clinical effect	Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding.
Prevention or management	Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability.
Examples	Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort^a, and certain protease inhibitors (see separate section on protease inhibitors below).
Colesevelam
Clinical effect	Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC.
Prevention or management	Administer 4 or more hours apart to attenuate this drug interaction.
^aInduction potency of St. John’s wort may vary widely based on preparation.

Substances increasing the systemic exposure of COCs:

Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice,⁷or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs.

Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos) amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).

In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).

4.2 Effects of Combined Oral Contraceptives on Other Drugs

Table 2 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablets.

Table 2: Significant Drug Interaction Information for Drugs Co-Administered With COCs
Lamotrigine
Clinical effect	Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation. Decreased systemic exposure of lamotrigine may reduce seizure control.
Prevention or management	Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine.
Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy
Clinical effect	Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin (see Warnings , EFFECT ON BINDING GLOBULINS ).
Prevention or management	The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use (see Warnings , EFFECT ON BINDING GLOBULINS ).
Other Drugs
Clinical effect	Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole).
Prevention or management	The dosage of drugs that can be affected by this interaction may need to be increased. Consult the approved product labeling for the concomitantly used drug.

4.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation

Do not co-administer levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, [see Warnings (5) ], and glecaprevir/pibrentasvir due to potential for ALT elevations.

4.4 Effect on Laboratory Tests

The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Overdosage

There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.

Description

Portia ^® (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 pink active tablets, each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 30 mcg of ethinyl estradiol, USP, an estrogen, and 7 white inert tablets (without hormones).

The structural formulas for the active components are:

Levonorgestrel, USP
C₂₁H₂₈O₂ M.W. 312.45

Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-.

Ethinyl Estradiol, USP
C₂₀H₂₄O₂ M.W. 296.40

Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.

Each pink active tablet contains the following inactive ingredients: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The ingredients in the film-coating include FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.

Each white inert tablet contains the following inactive ingredients: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

Levonorgestrel Structure Ethinyl Estradiol Structure

Clinical Pharmacology

Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

How Supplied / Storage and Handling

Portia^® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58), each card containing 28 tablets:

21 Active Tablets:	Pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized b on one side and 992 on the other side.
7 Inert Tablets:	White, round, biconvex, unscored inert tablets, debossed with stylized b on one side and 208 on the other side.

Store at 20º to 25°C (68° to 77º F) (See USP Controlled Room Temperature).

Keep this and all medications out of the reach of children.

Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. H 3/2025

Sources

RxCUI: 751890

NDC: 5559020

Last fetched: May 16, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.