Amethia

What Is Amethia?

Amethia (ethinyl estradiol and levonorgestrel kit) is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.

What Are Side Effects of Amethia?

Side effects of Amethia include:

• irregular and/or heavy uterine bleeding,
• nausea,
• breast tenderness,
• headache,
• weight gain,
• mood changes, and
• acne

Dosage for Amethia

The dose of Amethia is one tablet by mouth at the same time every day. The dosage of Amethia tablets is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Amethia tablets must be taken exactly as directed and at intervals not exceeding 24 hours.

Amethia In Children

Safety and efficacy of Amethia tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 18 as for users 18 years and older. Use of Amethia tablets before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Amethia?

Amethia may interact with other medicines such as:

• barbiturates,
• bosentan,
• carbamazepine,
• felbamate,
• griseofulvin,
• oxcarbazepine,
• phenytoin,
• rifampin,
• St. John's wort,
• topiramate,
• HIV protease inhibitors,
• non-nucleoside reverse transcriptase inhibitors,
• antibiotics,
• ascorbic acid,
• acetaminophen,
• itraconazole,
• ketoconazole,
• lamotrigine, and
• HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Tell your doctor all medications and supplements you use.

Amethia During Pregnancy and Breastfeeding

Amethia is intended to prevent pregnancy and is not indicated for use during pregnancy. There is little or no increased risk of birth defects in women who inadvertently use combined oral contraceptive (COCs) during early pregnancy. Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Estrogen-containing COCs such as Amethia can reduce milk production in breastfeeding mothers. Nursing mothers are advised when possible to use other forms of contraception until they have weaned their children. Consult your doctor before breastfeeding.

Additional Information

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

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.

 

Amethia Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
• breast tenderness or swelling, nipple discharge;
• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge; or
• changes in your menstrual periods, decreased sex drive.

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 Amethia (Lvonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Tablets)

 

Amethia Professional Information

SIDE EFFECTS

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

• Serious cardiovascular events and smoking [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Vascular events [see WARNINGS AND PRECAUTIONS]
• Liver disease [see WARNINGS AND PRECAUTIONS]

Adverse reactions commonly reported by COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trial that evaluated the safety and efficacy of levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 1,006 took at least one dose of levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets.

Adverse Reactions Leading to Study Discontinuation: 16.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).

Common Treatment-Emergent Adverse Reactions (≥ 5% of women): irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).

Serious Adverse Reactions: migraine, cholecystitis, cholelithiasis, pancreatitis, abdominal pain, and major depressive disorder.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorders: hypersensitivity reaction

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis

Read the entire FDA prescribing information for Amethia (Lvonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Tablets)