Medroxyprogesterone Acetate

INDICATIONS & USAGE

MEDROXYPROGESTERONE ACETATE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

B. INFORMATION FOR PATIENTS

C. DRUG & OR LABORATORY TEST INTERACTIONS

D. CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

E. PREGNANCY

F. NURSING MOTHERS

G. PEDIATRIC USE

H. GERIATRIC USE

MEDROXYPROGESTERONE ACETATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

SPL PATIENT PACKAGE INSERT

• ●     Treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your health care provider about whether medroxyprogesterone acetate tablets are right for you.

• ●     Reduce your chances of getting cancer of the uterus. In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chances of getting cancer of the uterus.

• ●     Have undiagnosed vaginal bleeding

• ●     Currently have or have had certain cancers.

• ●     Had a stroke or heart attack in the past year

• ●     Currently have or have had blood clots

• ●     Currently have or have had liver problems

• ●     Think you may be pregnant

• ●     Are allergic to any of the ingredients in medroxyprogesterone acetate tablets

• ●     If you are breastfeeding. The hormone in medroxyprogesterone acetate tablets can pass into your breast milk.

• ●     About all of your medical problems. Your health care provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing); epilepsy (seizures); migraine headaches; endometriosis (severe pelvic pain); lupus; problems with your heart, liver, thyroid, or kidneys; or if you have high calcium levels in your blood.

• ●     About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how medroxyprogesterone acetate tablets work. Medroxyprogesterone acetate tablets may also affect how other medicines work.

• ●     If you are going to have surgery or will be on bed rest. If you are taking estrogen in addition to medroxyprogesterone acetate tablets, you may need to stop taking estrogen and medroxyprogesterone acetate tablets.

• ●     Breast tenderness

• ●     Breast milk secretion

• ●     Breakthrough bleeding

• ●     Spotting (minor vaginal bleeding)

• ●     Irregular periods

• ●     Amenorrhea (absence of menstrual periods)

• ●     Vaginal secretions

• ●     Headaches

• ●     Nervousness

• ●     Dizziness

• ●     Depression

• ●     Insomnia, sleepiness, fatigue

• ●     Premenstrual syndrome-like symptoms

• ●     Thrombophlebitis (inflamed veins)

• ●     Blood clot

• ●     Itching, hives, skin rash

• ●     Acne

• ●     Hair loss, hair growth

• ●     Abdominal discomfort

• ●     Nausea

• ●     Bloating

• ●     Fever

• ●     Increase in weight

• ●     Swelling

• ●     Changes in vision and sensitivity to contact lenses

• ●     Breast cancer

• ●     Cancer of the uterus

• ●     Stroke

• ●     Heart attack

• ●     Blood clots

• ●     Dementia

• ●     Gallbladder disease

• ●     Ovarian cancer

• ●     High blood pressure

• ●     Liver problems

• ●     High blood sugar

• ●     Enlargement of benign tumors of the uterus ("fibroids")

• ●     Breast lumps

• ●     Unusual vaginal bleeding

• ●     Dizziness and faintness

• ●     Changes in speech

• ●     Severe headaches

• ●     Chest pain

• ●     Shortness of breath

• ●     Pains in your legs

• ●     Changes in vision

• ●     Vomiting

• ●     Yellowing of the skin, eyes or nail beds

• ●     Headache

• ●     Breast pain

• ●     Irregular vaginal bleeding or spotting

• ●     Stomach/abdominal cramps, bloating

• ●     Nausea and vomiting

• ●     Hair loss

• ●     Fluid retention

• ●     Vaginal yeast infection

• ●     Talk with your health care provider regularly about whether you should continue taking medroxyprogesterone acetate tablets. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

• ●     See your health care provider right away if you get vaginal bleeding while taking medroxyprogesterone acetate tablets.

• ●     Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your health care provider tells you otherwise. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.

• ●     If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your health care provider for ways to lower your chance of getting heart disease.

• ●     Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

• ●     Do not take medroxyprogesterone acetate tablets for conditions for which it was not prescribed.

• ●     Do not give medroxyprogesterone acetate tablets to other people, even if they have the same symptoms you have. It may harm them.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION