Chemical Name

medroxyprogesterone

 

Ingredients

Active Ingredients: medroxyprogesterone

 

Non-Active Ingredients: 

Injection: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, water for injection.

Tablets: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, and talc. The 2.5mg tablet contains FD&C Yellow No. 6.

 

Indications

Provera is indicated for the prevention of pregnancy in women. It is an oral and intrevenus contraceptive. Medroxyprogesterone is used to treat other conditions as well, such as absent or irregular menstrual periods, or abnormal uterine bleeding. Medroxyprogesterone can be used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.

Medroxyprogesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

 

How It Works

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods.

 

Tablets (2.5mg, 5mg, 10mg)

The recommended dose of Provera is s one tablet daily for 21 consecutive days per menstrual cycle according to prescribed schedule. Tablets are then discontinued for seven days (three weeks on, one week off). Withdrawal bleeding usually will occur within three days following discontinuation. Consult your doctor about the recommended strength tablets that are right for you.

 

Injection (150mg, 1ml)

Depro Provera injections are a proven method of birth control, and are particularly affective as one injection lasts for three months.

Precautions

Provera is contraindicated in people who have a hypersensitivity to the ingredients in Provera, a history of a stroke or blood clot, serious circulation problems, diabetes, hormone-related cancer, breast cancer, uterine cancer, unusual vaginal bleeding, liver disease, liver cancer, severe risky high blood pressure, severe migraine headaches, a heart valve disorder, abnormal levels of lips in the blood, surgery, obesity, or a history of jaundice caused by birth control pills.

 

Speak to a doctor if you have the following conditions: High blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack, high cholesterol or if you are overweight, history of depression, gallbladder disease, diabetes, seizures or epilepsy, a history of irregular menstrual cycles, a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

 

Contraceptive reliance should not be placed on Provera until after the first seven consecutive days of use, and a non-hormonal back-up method of birth control should be used during those 7 days.

 

The patient begins her next and all subsequent 21-day courses of Lo/Provera tablets on the same day of the week that she began her first course, following the same schedule: 21 days on, seven days off. Begin taking tablets on the eighth day after the last tablet in the previous pack, even if menstruation is still in progress. Should the patient start tablets later than the proper day, she should protect herself against pregnancy by using another method of birth control until she has taken a tablet daily for at least seven consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen.

 

Provera may be initiated no earlier than day 28 postpartum, in the non-lactating mother or after a second-trimester abortion due to the increased risk of inflammation in the veins due to blood clotting.

 

There is an increase risk of heart attack with contraceptive use. This risk is enhanced for women who smoke.

 

There is an increase risk of blood clotting in veins. And blood clots that can be carried by the blood stream, which may cause blockages in other areas. Use with caution especially if you have a history of this occurring. There is a risk of this occurring especially in the lungs. There is also an increased risk of cerebrovasculor related diseases, relating to blood vessels and to the brain. There has been a noted decline in high density lipoproteins which correlates to an increase in heart problems in women who use contraceptives. There is an increase risk of female related cancers such as cervical and breast cancer. There is also the possibility of tumor increase in the liver. Gall bladder disease has been shown to increase in contraceptive use. Contraceptives increase insulin production creating insulin resistance. Other problems that have been noted are: elevated blood pressure, headaches, bleeding irregularities and conception occurring outside uterine cavity.

 

This medicine will cause harm to an unborn baby. Once you are pregnant do not take this medication as it can have adverse effect on fetus and passes through breast milk.

 

You should consult a doctor before using this medication if you are allergic to medroxyprogesterone or similar medicines, or any of the other ingredients of Provera. 

 

Drug Interactions

Consult a doctor before taking Provera, if you are taking: antibiotics, anticonvulsants (Ampicillin, Penicillins, Tetracyclines, Rifampin, Barbiturates, Primidone, Modafinil, Topiramate Phenylbutazone, Rifabutin Phenytoin, Oxcarbazepine, Dexamethasone, Carbamazepine, Felbamate, and Griseofulvin), several of the anti-HIV protease inhibitors, St. John's Wort, medroxyprogesterone containing products, acetaminophen and increased clearance of temazepam, salicylic acid, morphine, atorvastatin, and Ascorbic acid. 

 

Before using this Provera, tell your doctor or pharmacist about all prescription and nonprescription medications, including herbal products and vitamins you may be taking. Other medications may affect how Provera works or might cause other unforeseen complications.

 

Adverse/Side Effects

It is common that Provera causes the following minor side effects: acne, cessation of menstruation, breakthrough bleeding, breast tenderness, changes in weight and appetite, nervousness, dizziness, vaginal itching or discharge, breast enlargement, mild nausea, vomiting, bloating, stomach cramps, breast pain, tenderness, or swelling, freckles or darkening of facial skin, problems with contact lenses, changes in your menstrual periods, decreased sex drive, and/or a tired feeling. If these side effects persist or become overly bothersome contact your doctor or health-care professional.

 

Infrequent side effects: vein inflammation caused by blood clotting, obstruction of pulmonary artery, blood vessel clots, heart attack, cerebral hemorrhage, cancer of skin tissue, abnormal uncontrolled growth of skin, anaphylactic reaction, severe respiratory circulatory, breast pain, changes in the cervix, blood clotting in heapatic veins, yellowing of skin or eyes, complex rapid body movements, rash, vaginitis, varicose veins, vomiting, weight change, appetite change, inflammation of the pancreas, menstrual change libido change, excessive hair growth, corneal change, cataracts, cystitis-like syndrome, break-up of red blood cells, kidney failure and inflammation of optical nerves.

 

If any of these side effects become bothersome, seek medical attention immediately. A very serious allergic reaction to this drug is unlikely. Get emergency medical help if you have any of these signs of an allergic reaction. This may not be a complete list of side effects and may be subject to change, consult with your doctor or pharmacist if you are experiencing any worrisome side effects.

 

Overdose

If you suspect overdose, contact your local poison control center or emergency room immediately.

 

Storage Instructions

Store at controlled room temperature 20C to 25C (68F to 77F), away from moisture and light, and out of reach of children and pets.