LUNELLE

Drug Name: LUNELLE

LUNELLE DESCRIPTION:
ESTRADIOL/MEDROXYPROGESTERONE SUSPENSION - INJECTION (ess-truh-DYE-all/meh-DROX-ee-pro-JESS-tur-own)

COMMON LUNELLE BRAND NAME(S):
Lunelle

LUNELLE SIDE EFFECTS:
Irregular vaginal bleeding (e.g., decreased, breakthrough, prolonged bleeding), weight gain, headache, nausea, acne, or breast tenderness may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: stomach pain, swelling, mental/mood disorders, dizziness. Tell your doctor immediately if any of these unlikely, but serious side effects occur: vision problems, increased urination, weight loss, vaginal changes (e.g., infection, cervical changes). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: leg pain, chest pain, trouble breathing, severe headache, one-sided weakness; yellowing of the eyes and skin. An allergic reaction to LUNELLE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE LUNELLE:
LUNELLE: Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist. Shake the vial well before each dose. Inject LUNELLE into a muscle (IM) once monthly within the first 5 days of your menstrual period; or as directed by your doctor. Additional doses may be given between day 28 and day 30 (from the start of your menstrual cycle); do not use bleeding episodes to determine the injection schedule for LUNELLE. If it has been 33 days or longer since your last dose, inform your doctor promptly before receiving your next dose. A pregnancy test and an alternate form of birth control (e.g., diaphragm, condoms) should be used until the results of the pregnancy test are obtained. Do not use LUNELLE if it is within 4 weeks following childbirth (if not breast-feeding) or 6 weeks following childbirth if you are breast-feeding. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

LUNELLE WARNING:
Smoking cigarettes while using LUNELLE increases your chance of having heart problems. Do not smoke while using LUNELLE. The risk of heart problems increases with age (women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

LUNELLE USES:
This combination medication is used to prevent pregnancy. Using LUNELLE does not protect you or your partner against HIV or other sexually transmitted diseases.

LUNELLE PRECAUTIONS:
Tell your doctor your medical history, especially of: tobacco (smoking) use; blood circulation problems (e.g., blood clots in the legs); stroke, heart disease; abnormal vaginal bleeding not diagnosed by your doctor; liver disease, cancer, high blood pressure; diabetes, headache problems (e.g., migraines); gallbladder disease; high cholesterol or triglyceride levels in your blood (e.g., blood lipids); eye problems or if you wear contact lenses; epilepsy, depression, any allergies. LUNELLE must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. LUNELLE passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

LUNELLE DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription medication you may use, especially: aminoglutethimide, anti-seizure medication (e.g., carbamazepine, phenobarbital, phenytoin), other hormones (e.g., estrogen, progesterone), antibiotics, rifampin, ascorbic acid (vitamin C), acetaminophen, St John's Wort, cyclosporine, prednisolone, theophylline, aspirin, anti-anxiety drugs (e.g., diazepam), morphine, clofibric acid. LUNELLE may interfere with certain laboratory tests (e.g., folic acid, proteins, thyroid hormones). Do not start or stop any medicine without doctor or pharmacist approval.

LUNELLE OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea or vomiting.

LUNELLE NOTES:
Do not share LUNELLE with others. Laboratory and/or medical tests may be performed to monitor your progress. Make sure laboratory personnel and your doctors know you use LUNELLE.

MISSED LUNELLE DOSE:
If you miss a dose, consult your doctor or pharmacist to establish a new dosing schedule.

LUNELLE STORAGE:
Store at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage in temperatures 59 to 86 degrees F (15 and 30 degrees C) is permitted.