DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Carcinoma of breast
Porphyria

There are 22 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Abnormal vaginal bleeding
Acute myocardial infarction
Benign hepatic cell adenoma
Cardiomyopathy
Cerebrovascular accident
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Coronary artery disease
Deep venous thrombosis
Diabetes mellitus
Hepatic cirrhosis
Hyperlipidemia
Hypertension
Malignant neoplasm of liver
Meningioma
Nephrotic syndrome
Osteopenia
Osteoporosis
Predisposition to thrombosis
Pulmonary thromboembolism
Sickle cell disease
Thromboembolic disorder
Thrombophlebitis

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Systemic lupus erythematosus

There are 29 severe adverse reactions.

More Frequent	Less Frequent
None.	Depression

Rare/Very Rare

Anaphylaxis Anemia Angioedema Arterial thrombosis Carcinoma of cervix Deep venous thrombosis Endometrial hyperplasia Erythema multiforme Erythema nodosum Facial palsy Fracture Galactorrhea not associated with childbirth Hypercalcemia Hypercortisolism Jaundice Neoplasm of breast Obstructive hyperbilirubinemia Osteopenia Osteoporosis Papilledema Pulmonary thromboembolism Rectal bleeding Retinal thrombosis Scleroderma Seizure disorder Squamous cell carcinoma of cervix Thromboembolic disorder Thrombophlebitis

There are 62 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal uterine bleeding Acute abdominal pain Dizziness Headache disorder Injection site sequelae Libido changes Menstrual disorder Nervousness Weight gain	Abdominal distension Acne vulgaris Alopecia Anorexia Arthralgia Back pain Cervical discharge Chest pain Constipation Cramps in legs Drug-induced hot flash Dysmenorrhea Dyspnea Dysuria Edema Fatigue General weakness Insomnia Irritability Mastalgia Nausea Ocular pain Pain in extremities Skin rash Symptoms of anxiety Tachycardia Urinary tract infection Vaginal discharge Vaginitis Vomiting

Rare/Very Rare
Abnormal glucose tolerance Amenorrhea Appetite changes Body fluid retention Body odor Chloasma Drowsy Dry skin Dyspareunia Euphoria Fever Hirsutism Hoarseness Increased libido Induration of skin Lactation deficiency Lipodystrophy Malaise Paresthesia Polydipsia Pruritus of skin Urticaria Varicose veins

Although progestins have been used beginning in the first trimester of pregnancy to prevent habitual abortion or to treat threatened abortion, there is no adequate evidence from well-controlled studies to substantiate the efficacy of progestins for these uses; however, there is evidence of potential adverse effects on the fetus when these drugs are administered within the first 4 months of pregnancy. In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova.

Masculinization of the female fetus has reportedly occurred when progestins were used during pregnancy. Clitoral hypertrophy and fusion of the labia have been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy; hypospadias in male neonates born to women receiving progestational agents occurs at approximately twice the rate of occurrence in male neonates born to women not receiving the drugs. Postpartum bleeding, postabortal bleeding, and missed abortion have been reported in women who received the drug during pregnancy.

An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) Use of progestins, including medroxyprogesterone, is not recommended during the first 4 months of pregnancy. If a woman becomes pregnant while receiving medroxyprogesterone or is inadvertently exposed to the drug during the first 4 months of pregnancy, she should be advised of the potential risks to the fetus.

To increase ensurance that the drug is not administered inadvertently to a pregnant woman, it is important that use of the drug be initiated only during the first 5 days after onset of normal menses, within 5 days postpartum if the woman is not lactating, or at the sixth postpartum week if she is. If more than 13-14 weeks has elapsed since the last dose of medroxyprogesterone, appropriate assessment should be performed to ensure that the woman is not pregnant prior to administering a dose. When medroxyprogesterone is used as a contraceptive, unintended pregnancies that occur within 1-2 months after IM injection of the drug may be characterized by impaired fetal growth as evidenced by low birthweights, which theoretically could result in an increased risk of neonatal death.

However, the attributable risk of this adverse effect is low because such pregnancies are unlikely. The risk of low birthweight was particularly evident when conception was estimated to occur within 4 weeks of medroxyprogesterone injection. While an increase in polysyndactyly, particularly among offspring of women younger than 30 years of age, and chromosomal anomalies also have been observed in neonates born to women who received IM medroxyprogesterone contraception, the unrelated nature of these effects, the lack of confirmation from other studies, the prolonged period of time between use of the drug and conception in many cases, and chance effects resulting from the multiple statistical comparisons applied make an association between these effects and the drug unlikely.

The possibility of ectopic pregnancy should be considered in any women using medroxyprogesterone contraception if pregnancy occurs or the woman develops complaints of severe abdominal pain. Medroxyprogesterone should not be used to induce withdrawal bleeding as a test for pregnancy.

Progestins reportedly are distributed into milk, and detectable amounts of medroxyprogesterone have been identified in milk of lactating women receiving the drug IM. Milk composition, quality, and volume are not affected adversely by medroxyprogesterone use. While the manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined, study of infants exposed to the drug via breast milk has revealed no evidence of adverse developmental or behavioral effects through puberty.

The effects of combined medroxyprogesterone acetate and estradiol cypionate therapy on lactation and nursing infants have not been established. However, because adverse effects such as jaundice and breast enlargement have been reported in nursing infants of women receiving estrogen-progestin combination oral contraceptives, the usual cautions and precautions associated with estrogens must be considered in lactating women receiving IM medroxyprogesterone acetate in fixed combination with estradiol cypionate. The manufacturer states that use of estrogen-progestin combination contraceptives should be deferred until 6 weeks postpartum. For additional information, see Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.

No enhanced Geriatric Use information available for this drug.