Afirmelle

Afirmelle (levonorgestrel and ethinyl estradiol tablets) is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Afirmelle is available in generic form. Common side effects of Afirmelle include:

• include acne,
• missed menstrual periods,
• breast changes (tenderness, pain, enlargement, nipple discharge),
• problems with contact lenses,
• dizziness,
• bloating,
• abdominal pain,
• cramps,
• excess hair growth,
• changes in sex drive,
• freckles or darkening of facial skin,
• changes in menstrual flow,
• mood changes,
• depression,
• nausea,
• nervousness,
• rash (allergic),
• loss of scalp hair,
• spotting,
• vaginal infection including yeast infection,
• vomiting, or weight changes.

. Cigarette smoking increases the risk of serious cardiovascular side effects from use of oral contraceptives such as Afirmelle. Women who use oral contraceptives including Afirmelle are strongly advised not to smoke.

To achieve maximum contraceptive effectiveness, Afirmelle must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Afirmelle is one white tablet daily for 21 consecutive days, followed by one green inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Afirmelle tablets be taken at the same time each day. Afirmelle may interact with:

• antibiotics,
• anticonvulsants,
• rifampin,
• ifabutin,
• barbiturates,
• primidone,
• phenylbutazone,
• phenytoin,
• dexamethasone,
• carbamazepine,
• felbamate,
• oxcarbazepine,
• topiramate,
• griseofulvin,
• modafinil,
• anti-HIV protease inhibitors,
• St. John's wort,
• ascorbic acid,
• acetaminophen,
• indinavir,
• itraconazole,
• ketoconazole,
• fluconazole,
• troleandomycin,
• cyclosporine,
• prednisolone and other corticosteroids,
• theophylline,
• temazepam,
• salicylic acid,
• morphine,
• clofibric acid,
• and HCV drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).

Tell your doctor all medications and supplements you use. Afirmelle is not recommended for use during pregnancy. Small amounts of Afirmelle pass into breast milk and may cause adverse reactions in nursing infants. Breastfeeding while using Afirmelle is not recommended.

Our Afirmelle (levonorgestrel and ethinyl estradiol tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Afirmelle Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• nausea, vomiting (especially when you first start taking this medicine);
• breast tenderness;
• breakthrough bleeding;
• acne, darkening of facial skin;
• weight gain; or
• problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Afirmelle (Levonorgestrel and Ethinyl Estradiol Tablets)

 

Afirmelle Professional Information

SIDE EFFECTS

An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) 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.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

Acne
Amenorrhea
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
Breast changes: tenderness, pain, enlargement, secretion
Budd-Chiari syndrome
Cervical erosion and secretion, change in
Cholestatic jaundice
Chorea, exacerbation of
Colitis
Contact lenses, intolerance to
Corneal curvature (steepening), change in
Dizziness
Edema/fluid retention
Erythema multiforme
Erythema nodosum
Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
Hirsutism
Infertility after discontinuation of treatment, temporary
Lactation, diminution in, when given immediately postpartum
Libido, change in
Melasma/chloasma which may persist
Menstrual flow, change in
Mood changes, including depression
Nausea
Nervousness
Pancreatitis
Porphyria, exacerbation of
Rash (allergic)
Scalp hair, loss of
Serum folate levels, decrease in
Spotting
Systemic lupus erythematosus, exacerbation of
Unscheduled bleeding
Vaginitis, including candidiasis
Varicose veins, aggravation of
Vomiting
Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts
Cystitis-like syndrome
Dysmenorrhea
Hemolytic uremic syndrome
Hemorrhagic eruption
Optic neuritis, which may lead to partial or complete loss of vision
Premenstrual syndrome
Renal function, impaired

Read the entire FDA prescribing information for Afirmelle (Levonorgestrel and Ethinyl Estradiol Tablets)