Contraceptives, Oral (Combination Products)

Pronunciation: (kan-tra-SEP-tiv)Class: Hormone, Contraceptive

Trade Names:Apri- Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg

Trade Names:Aranelle- Tablets ethinyl estradiol 35 mcg/norethindrone 0.5 mg

Trade Names:Aviane- Tablets ethinyl estradiol 20 mcg/levonorgestrel 0.1 mg

Trade Names:Balziva- Tablets ethinyl estradiol 35 mcg/norethindrone 0.4 mg

Trade Names:Brevicon- Tablets ethinyl estradiol 35 mcg/norethindrone 0.5 mg

Trade Names:Caziant- Tablets Phase 1: desogestrel 0.1 mg/ethinyl estradiol 25 mcg. Phase 2: desogestrel 0.125 mg/ethinyl estradiol 25 mcg. Phase 3: desogestrel 0.15 mg/ethinyl estradiol 25 mcg.

Trade Names:Cryselle- Tablets ethinyl estradiol 30 mcg/norgestrel 0.3 mg

Trade Names:Cyclessa- Tablets Phase 1: desogestrel 0.1 mg/ethinyl estradiol 25 mcg. Phase 2: desogestrel 0.125 mg/ethinyl estradiol 25 mcg. Phase 3: desogestrel 0.15 mg/ethinyl estradiol 25 mcg.

Trade Names:Desogen- Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg

Trade Names:Enpresse-28- Tablets Phase 1: levonorgestrel 0.05 mg/ethinyl estradiol 30 mcg. Phase 2: levonorgestrel 0.075 mg/ethinyl estradiol 40 mcg. Phase 3: levonorgestrel 0.125 mg/ethinyl estradiol 30 mcg.

Trade Names:Estrostep Fe- Tablets Phase 1: norethindrone acetate 1 mg/ethinyl estradiol 20 mcg. Phase 2: norethindrone acetate 1 mg/ethinyl estradiol 30 mcg. Phase 3: norethindrone acetate 1 mg/ethinyl estradiol 35 mcg.

Trade Names:Femcon Fe- Tablets ethinyl estradiol 35 mcg/norethindrone acetate 0.4 mg

Trade Names:Jolessa- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Junel 21 Day 1.5/30- Tablets ethinyl estradiol 30 mcg/norethindrone acetate 1.5 mg

Trade Names:Junel 28 Day 1/20- Tablets ethinyl estradiol 20 mcg/norethindrone acetate 1 mg

Trade Names:Junel Fe 1/20- Tablets ethinyl estradiol 20 mcg/norethindrone acetate 1 mg

Trade Names:Junel Fe 1.5/30- Tablets ethinyl estradiol 30 mcg/norethindrone acetate 1.5 mg

Trade Names:Kariva- Tablets ethinyl estradiol 20 mcg (white tablets)/ethinyl estradiol 10 mcg (lt. blue tablets)/desogestrel 0.15 mg (white tablets only)

Trade Names:Kelnor- Tablets ethinyl estradiol 35 mcg/ethynodiol diacetate 1 mg

Trade Names:Leena- Tablets Phase 1: ethinyl estradiol 35 mcg/norethindrone 0.5 mg. Phase 2: ethinyl estradiol 35 mcg/norethindrone 1 mg.

Trade Names:Lessina- Tablets ethinyl estradiol 20 mcg/levonorgestrel 0.1 mg

Trade Names:Levora-28 0.15/30- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Loestrin 21 1/20- Tablets ethinyl estradiol 20 mcg/norethindrone acetate 1 mg

Trade Names:Loestrin 21 1.5/30- Tablets ethinyl estradiol 30 mcg/norethindrone acetate 1.5 mg

Trade Names:Loestrin Fe 1/20- Tablets ethinyl estradiol 20 mcg/norethindrone acetate 1 mg

Trade Names:Loestrin Fe 1.5/30- Tablets ethinyl estradiol 30 mcg/norethindrone acetate 1.5 mg

Trade Names:Lo/Ovral- Tablets ethinyl estradiol 30 mcg/norgestrel 0.3 mg

Trade Names:LoSeasonique- Tablets Phase 1: levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg. Phase 2: ethinyl estradiol 0.01 mg

Trade Names:Low-Ogestrel-28- Tablets ethinyl estradiol 30 mcg/norgestrel 0.3 mg

Trade Names:Lutera- Tablets ethinyl estradiol 20 mcg/levonorgestrel 0.1 mg

Trade Names:Lybrel- Tablets ethinyl estradiol 20 mcg/levonorgestrel 90 mcg

Trade Names:Microgestin Fe 1/20- Tablets ethinyl estradiol 20 mcg/norethindrone acetate 1 mg

Trade Names:Microgestin Fe 1.5/30- Tablets ethinyl estradiol 30 mcg/norethindrone acetate 1.5 mg

Trade Names:Mircette- Tablets Phase 1: desogestrel 0.15 mg/ethinyl estradiol 0.02 mg. Phase 2: ethinyl estradiol 0.01 mg.

Trade Names:Modicon- Tablets ethinyl estradiol 35 mcg/norethindrone 0.5 mg

Trade Names:Mononessa- Tablets ethinyl estradiol 35 mcg/norgestimate 0.25 mg

Trade Names:Necon 0.5/35- Tablets ethinyl estradiol 35 mcg/norethindrone 0.5 mg

Trade Names:Necon 1/35- Tablets ethinyl estradiol 35 mcg/norethindrone 1 mg

Trade Names:Necon 1/50- Tablets mestranol 50 mcg/norethindrone 1 mg

Trade Names:Necon 10/11- Tablets Phase 1: norethindrone 0.5 mg/ethinyl estradiol 35 mcg. Phase 2: norethindrone 1 mg/ethinyl estradiol 35 mcg.

Trade Names:Nordette- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Norinyl 1 + 35- Tablets ethinyl estradiol 35 mcg/norethindrone 1 mg

Trade Names:Norinyl 1 + 50- Tablets mestranol 50 mcg/norethindrone 1 mg

Trade Names:Nortrel 0.5/35- Tablets ethinyl estradiol 35 mcg/norethindrone 0.5mg

Trade Names:Nortrel 1/35- Tablets ethinyl estradiol 35 mcg/norethindrone 1 mg

Trade Names:Ocella- Tablets ethinyl estradiol 30 mcg/drospirenone 3 mg

Trade Names:Ogestrel-28 0.5/50- Tablets ethinyl estradiol 50 mcg/norgestrel 0.5 mg

Trade Names:Ortho-Cept- Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg

Trade Names:Ortho-Cyclen- Tablets ethinyl estradiol 35 mcg/norgestimate 0.25 mg

Trade Names:Ortho-Novum 1/35- Tablets ethinyl estradiol 35 mcg/norethindrone 1 mg

Trade Names:Ortho-Novum 1/50- Tablets mestranol 50 mcg/norethindrone 1 mg

Trade Names:Ortho-Novum 7/7/7- Tablets Phase 1: norethindrone 0.5 mg/ethinyl estradiol 35 mcg. Phase 2: norethindrone 0.75 mg/ethinyl estradiol 35 mcg. Phase 3: norethindrone 1 mg/ethinyl estradiol 35 mcg.

Trade Names:Ortho Tri-Cyclen- Tablets Phase 1: norgestimate 0.18 mg/ethinyl estradiol 35 mcg. Phase 2: norgestimate 0.215 mg/ethinyl estradiol 35 mcg. Phase 3: norgestimate 0.25 mg/ethinyl estradiol 35 mcg.

Trade Names:Ortho Tri-Cyclen Lo- Tablets Phase 1: norgestimate 0.18 mg/ethinyl estradiol 25 mcg. Phase 2: norgestimate 0.215 mg/ethinyl estradiol 25 mcg. Phase 3: norgestimate 0.25 mg/ethinyl estradiol 25 mcg.

Trade Names:Ovcon-35- Tablets ethinyl estradiol 35 mcg/norethindrone 0.4 mg

Trade Names:Ovcon-50- Tablets ethinyl estradiol 50 mcg/norethindrone 1 mg

Trade Names:Portia-28- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Quasense- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Reclipsen- Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg

Trade Names:Seasonale- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Seasonique- Tablets ethinyl estradiol 30 mcg/levonorgestrel 0.15 mg

Trade Names:Solia- Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg

Trade Names:Sronyx- Tablets ethinyl estradiol 20 mcg/levonorgestrel 0.1 mg.

Trade Names:Tri-Legest 21- Tablets Phase 1: norethindrone acetate 1 mg/ethinyl estradiol 20 mcg. Phase 2: norethindrone acetate 1 mg/ethinyl estradiol 30 mcg. Phase 3: norethindrone acetate 1 mg/ethinyl estradiol 35 mcg.

Trade Names:Tri-Legest Fe 28- Tablets Phase 1: norethindrone acetate 1 mg/ethinyl estradiol 20 mcg. Phase 2: norethindrone acetate 1 mg/ethinyl estradiol 30 mcg. Phase 3: norethindrone acetate 1 mg/ethinyl estradiol 35 mcg.

Trade Names:Tri-Lo-Sprintec- Tablets Phase 1: norgestimate 0.18 mg/ethinyl estradiol 25 mcg. Phase 2: norgestimate 0.215 mg/ethinyl estradiol 25 mcg. Phase 3: norgestimate 0.25 mg/ethinyl estradiol 25 mcg.

Trade Names:Tri-Norinyl- Tablets Phase 1: norethindrone 0.5 mg/ethinyl estradiol 35 mcg. Phase 2: norethindrone 1 mg/ethinyl estradiol 35 mcg. Phase 3: norethindrone 0.5 mg/ethinyl estradiol 35 mcg.

Trade Names:Tri-Previfem- Tablets Phase 1: norgestimate 0.18 mg/ethinyl estradiol 35 mcg. Phase 2: norgestimate 0.215 mg/ethinyl estradiol 35 mcg. Phase 3: norgestimate 0.25 mg/ethinyl estradiol 35 mcg.

Trade Names:Tri-Sprintec- Tablets Phase 1: norgestimate 0.18 mg/ethinyl estradiol 25 mcg. Phase 2: norgestimate 0.215 mg/ethinyl estradiol 35 mcg. Phase 3: norgestimate 0.25 mg/ethinyl estradiol 35 mcg.

Trade Names:Trivora-28- Tablets Phase 1: levonorgestrel 0.05 mg/ethinyl estradiol 30 mcg. Phase 2: levonorgestrel 0.075 mg/ethinyl estradiol 40 mcg. Phase 3: levonorgestrel 0.125 mg/ethinyl estradiol 30 mcg.

Trade Names:Velivet- Tablets Phase 1: desogestrel 0.1 mg/ethinyl estradiol 25 mcg. Phase 2: desogestrel 0.125 mg/ethinyl estradiol 25 mcg. Phase 3: desogestrel 0.15 mg/ethinyl estradiol 24 mcg.

Trade Names:Yasmin- Tablets ethinyl estradiol 30 mcg/drospirenone 3 mg

Trade Names:Yaz- Tablets ethinyl estradiol 0.02 mg/drospirenone 3 mg

Trade Names:Zenchent- Tablets ethinyl estradiol 35 mcg/norethindrone 0.4 mg.

Trade Names:Zovia 1/35E- Tablets ethinyl estradiol 35 mcg/ethynodiol diacetate 1 mg

Trade Names:Zovia 1/50E- Tablets ethinyl estradiol 50 mcg/ethynodiol diacetate 1 mg

Alesse 21 (Canada)Alesse 28 (Canada)Brevicon 0.5/35 (Canada)Brevicon 1/35 (Canada)Cyclen (Canada)Estalis (Canada)Estalis-Sequi (Canada)Estracomb (Canada)Linessa 21 (Canada)Linessa 28 (Canada)Marvelon (Canada)Min-Ovral 21 (Canada)Min-Ovral 28 (Canada)Ortho-0.5/35 (Canada)Ortho-1/35 (Canada)Ortho-7/7/7 (Canada)Ovral 21 (Canada)Select 1/35 (Canada)Synphasic (Canada)Tri-Cyclen (Canada)Tri-Cyclen Lo (Canada)Triphasil 21 (Canada)Triphasil 28 (Canada)Triquilar 21 (Canada)Triquilar 28 (Canada)

Pharmacology

Inhibits ovulation by suppressing gonadotropins, follicle-stimulating hormone, and luteinizing hormone.

Indications and Usage

Prevention of pregnancy.

Estrostep Fe , Ortho Tri-Cyclen , Yaz

Treatment of moderate acne vulgaris in females 15 yr of age and older ( Yaz , 14 yr of age and older).

Yaz

Treatment of symptoms of premenstrual dysphoric disorder (PMDD).

Contraindications

Thrombophlebitis or thromboembolic disorders; history of deep vein thrombophlebitis or thromboembolic disorders; cerebral vascular or coronary artery disease (current or history of); valvular heart disease with thrombogenic complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast or history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy, jaundice of pregnancy, or jaundice with prior hormonal contraceptive use; benign or malignant hepatic tumors or active liver disease; known or suspected pregnancy; heavy smoking (15 or more cigarettes/day) and older than 35 yr of age; renal insufficiency, adrenal insufficiency ( Ocella only); hypersensitivity to any component of the product.

Dosage and Administration

Prevention of PregnancyAdults Sunday-start packaging

PO 1 tablet daily beginning on first Sunday after menstruation begins. If menstruation begins on Sunday, take first tablet on that day.

21-day regimen

PO 1 tablet daily for 21 days, beginning on day 5 of cycle. Take no tablets for 7 days; then start new course of 21-day regimen.

28-day regimen

PO 1 tablet daily.

AcneAdults and Children 15 yr of age and older

PO Timing of initiation of dosing follows the guidelines for use as an oral contraceptive.

General Advice

May be given with or without food.

Storage/Stability

Store at 59° to 86° F (see package insert).

Drug Interactions

ACE inhibitors, aldosterone antagonists, angiotensin II receptor antagonists, heparin, NSAIDs, potassium-sparing diuretics

Use with caution with products containing drospirenone.

Acetaminophen, ascorbic acid

May increase ethinyl estradiol plasma concentrations.

Acetaminophen, lamotrigine

Concentration may be decreased, reducing the therapeutic effect.

Atorvastatin

Ethinyl estradiol and norethindrone AUC may be increased approximately 20% and 30%, respectively.

Azole antifungal agents (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazine, penicillins, phenylbutazone, rifampin, St. John's wort, tetracyclines, topiramate

Decreased effectiveness of hormonal contraceptives. Use additional form of birth control during concomitant therapy.

Benzodiazepines, caffeine, corticosteroids, cyclosporine, metoprolol, selegiline, theophylline, tricyclic antidepressants

Effects may be increased by hormonal contraceptives, increasing the risk of toxicity.

Clofibric acid, morphine, temazepam, salicylic acid

Coadministration may result in decreased Cl of these drugs.

Protease inhibitors

Plasma concentrations of estrogen and progestin may be increased or decreased.

Thyroid hormones (eg, levothyroxine)

Serum free thyroxine concentrations may be decreased, increasing serum thyrotropin concentrations and the need for thyroid hormone.

Laboratory Test Interactions

May cause increases in prothrombin and factors VII, VIII, IX, and X; norepinephrine-induced platelet aggregability; thyroid-binding globulin (TBG), leading to increased circulating total thyroid hormone as measured by protein-bound iodine, T4 by column or by radioimmunoassay; binding proteins; sex hormone–binding globulins; and triglycerides. May cause decrease in antithrombin 3; free T3 resin uptake, reflecting elevated TBG; glucose tolerance; and serum folate levels.

Adverse Reactions

Cardiovascular

Hypertension, MI.

CNS

Appetite changes, cerebral hemorrhage, cerebral thrombosis, dizziness, headache, libido changes, mental depression, migraine, nervousness; asthenia, emotional lability (postmarketing).

Dermatologic

Acne, erythema multiforme, erythema nodosum, hemorrhagic eruption, hirsutism, loss of scalp hair, melasma/chloasma, rash, skin disorder (postmarketing).

EENT

Cataracts, contact lens intolerance, optic neuritis, retinal thrombosis, steepening of corneal curvature; pharyngitis, rhinitis, sore throat (postmarketing).

GI

Abdominal cramps, bloating, colitis, mesenteric thrombosis, nausea, pancreatitis, vomiting; diarrhea, dyspepsia, gastroenteritis, tooth disorder (postmarketing).

Genitourinary

Accidental injury; amenorrhea; breakthrough bleeding; breast enlargement, secretion, and tenderness; breast pain; change in cervical erosion and cervical secretion; change in menstrual flow; cystitis-like syndrome; diminished lactation; dysmenorrhea; hemolytic uremic syndrome; intermenstrual bleeding; leukorrhea; menorrhagia; menstrual disorder; renal artery thrombosis; renal function impairment; spotting; suspicious Pap smear; temporary infertility after discontinuation; vaginal candidiasis; vaginitis; UTI, vaginal moniliasis (postmarketing).

Hematologic

Arterial thromboembolism; thrombophlebitis; thrombosis.

Hepatic

Budd-Chiari syndrome; cholestatic jaundice; gallbladder disease; hepatocellular carcinoma; liver tumors.

Hypersensitivity

Anaphylactic/anaphylactoid reactions including angioedema; severe reactions with respiratory and circulatory symptoms; urticaria; allergic reaction (postmarketing).

Metabolic-Nutritional

Porphyria, reduced carbohydrate tolerance, weight change; hyperlipidemia (postmarketing).

Musculoskeletal

Arthralgia, back pain, pain in extremities (postmarketing).

Respiratory

Pulmonary embolism; bronchitis, increased cough, sinusitis, upper respiratory tract infection (postmarketing).

Miscellaneous

Aggravation of varicose veins, edema, exacerbation of systemic lupus erythematosus, premenstrual syndrome; accidental injury, enlarged abdomen, fever, flu-syndrome, infection, moniliasis, pain, pelvic pain (postmarketing).

Precautions

Warnings

Smoking

Cigarette smoking increases the risk of serious CV adverse reactions. The risk increases with age (older than 35 yr of age) and heavy smoking (at least 15 cigarettes/day). Women using oral contraceptives should not smoke.

Monitor

Monitor blood glucose in diabetic patients. Check potassium during first treatment cycle in patients receiving products with drospirenone who are predisposed to hyperkalemia. Monitor BP in patients with hypertension. If requested and deemed appropriate, physical examination should include reference to BP, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed persistent or recurrent abnormal vaginal bleeding, measures should be conducted to rule out malignancy and other pathology. Closely monitor women with a strong family history of breast cancer or who have breast nodules.

Pregnancy

Category X .

Lactation

Excreted in breast milk.

Children

Use not indicated before menarche.

Elderly

Use not indicated in women older than 65 yr of age.

Hepatic Function

Estrogens may be poorly metabolized in patients with impaired liver function. Discontinue use if jaundice develops.

Bleeding irregularities

If other causes, including nonhormonal causes, pregnancy, or malignancy, cannot be ruled out, consider a change to another formulation.

Carbohydrate and lipid metabolism

Glucose intolerance may occur. More than 75 mcg of estrogens cause hyperinsulinism, while lower doses cause less glucose intolerance. Progestogens increase insulin secretion and cause insulin resistance. In nondiabetic women, oral contraceptives do not appear to affect fasting blood glucose.

Carcinoma of reproductive organs and breasts

Risk of breast cancer may be slightly increased but decreases over time after oral contraception discontinuation, and the increased risk disappears by 10 yr after cessation of use.

CV disease

Use with caution in women with CV disease risk factors. Increased risk of MI has been attributed to oral contraceptive use, primarily in smokers or women with other underlying risk factors for coronary artery disease (eg, hypertension, obesity, diabetes). Increased risk of thrombotic disease associated with oral contraceptive use is well established. The risk reverses after use is stopped.

Cerebrovascular disease

Increase in the relative and attributable risk of cerebrovascular events (eg, thrombotic and hemorrhagic strokes) has been reported. The risk is greatest among women who are older than 35 yr of age and smoke.

Depression

Carefully observe women with a history of depression and discontinue the drug if depression recurs to a serious degree.

Ectopic pregnancy

Ectopic and intrauterine pregnancy may occur in contraceptive failure.

Fluid retention

Since estrogen and estrogen/progestin may cause fluid retention, use with caution in patients whose condition may be influenced by fluid retention (eg, cardiac dysfunction, renal function impairment).

Headache

Onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of hormonal contraception and evaluation of the cause.

Hepatic neoplasm

Benign hepatic adenomas, which may cause death through intra-abdominal hemorrhage, have been associated with hormonal contraceptive use.

Hyperkalemia

Some of these products contain drospirenone, which has antimineralcorticoid. Do not use products with drospirenone in patients with conditions that predispose them to hyperkalemia (renal insufficiency, hepatic dysfunction, and adrenal insufficiency).

Hypertension

Increase in BP in women taking hormonal contraceptives appears to be related to the increasing dose of progestogens. Encourage women with a history of hypertension to use other means of contraception.

Lipid disorders

Some progestogens may elevate LDL levels and interfere with control of hyperlipidemia.

Vascular disease

A positive association has been seen between amount of estrogen and progestogen in hormonal contraceptives and risk of vascular disease. Many progestational agents have been reported to decrease HDL, which is associated with an increased incidence of ischemic heart disease.

Visual abnormalities

Retinal vascular thrombosis may occur, leading to loss of vision, sudden onset of proptosis, diplopia, or migraine.

Overdosage

Symptoms

Abdominal pain, breast tenderness, dizziness, drowsiness/fatigue, nausea, vomiting, withdrawal bleeding.

Patient Information

Advise women to use additional method of birth control until after first week of administration in initial cycle.
Advise women what to do if dose is missed: (1) if missed 1, take when remembered or take 2 the next day; (2) if missed 2, take 2 on 2 consecutive days; (3) if missed at least 3, stop pills; (4) use alternative form of birth control in all cases.
Estrostep Fe and Tri-Legest Fe : Advise women what to do if 1 or more active tablets is missed: If 1 tablet is missed: take as soon as remembered, take next dose at regular time. If 2 consecutive active tablets are missed during wk 1 or 2: take 2 tablets as soon as remembered, take 2 tablets the next day, and use another birth control method for 7 days following the missed tablets. If 2 consecutive active tablets are missed during week 3: Sunday-start regimen: Take 1 tablet daily until Sunday, discard remaining tablets, start new pack of tablets immediately (Sunday); use another birth control method for 7 days following the missed tablets. Day-1 start regimen: Discard remaining tablets, start new pack of tablets that same day; use another birth control method for 7 days following the missed tablets. Three or more consecutive active tablets are missed: Sunday-start regimen: Take 1 tablet until Sunday, discard remaining tablets, start new pack of tablets immediately (Sunday); use another birth control method for 7 days following the missed tablets. Day-1 start regimen: Discard remaining tablets, start new pack of tablets that same day; use another birth control method for 7 days following the missed tablets.
Advise women to take daily multivitamin.
Encourage women who smoke to stop. CV dysfunction and thromboembolic disease have been associated with use of oral contraceptives in patients who smoke.
Advise women that hormonal contraceptives may change the fit of rigid contact lenses.
Advise women to wait at least 3 mo after discontinuing oral contraceptives before trying to become pregnant.
Caution women that antibiotics may decrease effectiveness of oral contraceptives and to use a nonhormonal form of contraception while taking antibiotics and for 7 days after stopping antibiotics.
Instruct women to report symptoms of blood clots (eg, numbness, pain, shortness of breath, visual disturbances).
Teach women routine breast self-examination technique.
Warn women that adverse reactions such as nausea and breakthrough bleeding are common at first.
Advise women that this product does not protect against HIV (AIDS) infection or other STDs.
Advise women to have annual history and physical examinations.
Instruct women to immediately contact health care provider if they experience change in mood; coughing of blood; breast lumps; crushing chest pain or heaviness in the chest; difficulty sleeping; dizziness or fainting; disturbances of vision or speech; fatigue; jaundice or a yellowing of the skin or eyeballs, frequently accompanied by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements; lack of energy; pain in the calf; severe pain or tenderness in the stomach area; sharp chest pain; sudden partial or complete loss of vision; sudden, severe headache or vomiting; sudden shortness of breath; weakness or numbness in an arm or leg; weakness.