Ethinylestradiol/levonorgestrel

What is Ethinylestradiol/levonorgestrel?

• Ethinylestradiol/levonorgestrel is a combined birth control pill made up of ethinylestradiol, an estrogen and levonorgestrel a progestin.

Ethinylestradiol

Ethinylestradiol

What are the uses of this medicine?

• Ethinylestradiol/levonorgestrel are used for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

How does this medicine work?

• Combination oral contraceptives act by suppression of gonadotropins.
• Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation).

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Uncontrolled hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any component of this product

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• acetaminophen (APAP, Tylenol)
• antibiotics such as ampicillin (Principen), clarithromycin (Biaxin),erythromycin (E.E.S., E-Mycin, Erythrocin), isoniazid (INH, Nydrazid), metronidazole (Flagyl),minocycline (Dynacin, Minocin), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), tetracycline (Sumycin), and troleandomycin (TAO) (not available in the U.S.)
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• antifungals such as griseofulvin (Fulvicin, Grifulvin, Grisactin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral) atorvastatin (Lipitor)
• clofibrate (Atromid-S)
• cyclosporine (Neoral, Sandimmune)
• bosentan (Tracleer)
• cimetidine (Tagamet)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• diltiazem (Cardizem, Dilacor, Tiazac)
• fluoxetine (Prozac, Sarafem, in Symbyax)
• HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir)
• medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trilepta), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), primidone (Mysoline), and topiramate (Topamax)
• modafinil (Provigil)
• morphine (Kadian, MS Contin, MSIR, others)
• nefazodone
• rifampin (Rimactane, in Rifadin, in Rifater)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone)
• temazepam (Restoril)
• theophylline (Theobid, Theo-Dur)
• thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid)
• verapamil (Calan, Covera, Isoptin, Verelan)
• vitamin C
• zafirlukast (Accolate)

Is this medicine FDA approved?

• Ethinylestradiol/levonorgestrel has been approved for medical use in the United States at least since 1982.

How should this medicine be used?

Recommended dosage:

• The dosage of levonorgestrel and ethinyl estradiol tablets is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets.
• To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
• Ideally, the tablets should be taken at the same time of the day on each day of active treatment.

Administration:

• Oral contraceptives come in packets of 21, 28, or 91 tablets to take by mouth once a day, every day or almost every day of a regular cycle.
• To avoid nausea, take oral contraceptives with food or milk.
• Take your oral contraceptive at the same time every day.
• If you have a 91-day tablet packet, take 1 tablet daily for 91 days. Your packet will contain three trays of tablets. Start with the first tablet on the first tray and continue taking 1 tablet every day in the order specified on the packet until you have taken all of the tablets on all of the trays. The last set of tablets are a different color. These tablets may contain an inactive ingredient, or they may contain a very low dose of estrogen. Start your new packet the day after you take your 91st tablet.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet

This medicine is available in fallowing brand namesː

• Alesse

What side effects can this medication cause?

The most common side effects of this medicine include:

• Nausea
• Vomiting
• Gastrointestinal symptoms (such as abdominal cramps and bloating)
• Breakthrough bleeding
• Spotting
• Change in menstrual flow
• Amenorrhea
• Temporary infertility after discontinuation of treatment
• Edema/fluid retention
• Melasma/chloasma which may persist
• Breast changes: tenderness, enlargement, and secretion
• Change in weight or appetite (increase or decrease)
• Change in cervical ectropion and secretion
• Possible diminution in lactation when given immediately postpartum
• Cholestatic jaundice
• Migraine headache
• Rash (allergic)
• Mood changes, including depression
• Vaginitis, including candidiasis
• Change in corneal curvature (steepening)
• Intolerance to contact lenses
• 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

Serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGSsection):

• Thrombophlebitis
• Arterial thromboembolism
• Pulmonary embolism
• Myocardial infarction
• Cerebral hemorrhage
• Cerebral thrombosis
• Hypertension
• Gallbladder disease
• Hepatic adenomas or benign liver tumors

What special precautions should I follow?

• Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
• A periodic history and physical examination are appropriate for all women, including women using oral contraceptives.
• Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives.
• Oral contraceptives may cause some degree of fluid retention.
• Women with a history of depression should be carefully observed and the drug discontinued 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.
• 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.
• Women with significant hypertension should not be started on hormonal contraceptive. An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use.
• Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.
• 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.
• An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.
• Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is a hormone sensitive tumor.
• Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, and withdrawal bleeding

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Ethinylestradiol/levonorgestrel are contraindicated during pregnancy.

Can this medicine be used in children?

• Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age.
• Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

Active ingredient: ETHINYL ESTRADIOL LEVONORGESTREL

Inactive ingredients:

• Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Each white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Who manufactures and distributes this medicine?

Manufactured for:

• Lupin Pharmaceuticals, Inc.
• Baltimore, Maryland
• United States

Manufactured by:

• Lupin Limited
• Pithampur (M.P.)
• INDIA

What should I know about storage and disposal of this medication?

• Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F).

• Dailymed label info on Ethinylestradiol/levonorgestrel
• FDA Ethinylestradiol/levonorgestrel

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