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Manufacturer
AMNEAL PHARMACE
SKU
65162080710

progesterone 100 mg capsule (generic prometrium)

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Uses

Progesterone is used orally to reduce the incidence of endometrial hyperplasia in postmenopausal women receiving estrogen replacement therapy.

Progesterone is used orally or intravaginally for the management of secondary amenorrhea.

Progesterone is used intravaginally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of assisted reproductive technology (ART) treatment of infertile women. Efficacy of progesterone vaginal insert for this indication has not been established in women 35 years of age or older.

Progesterone is used parenterally for the treatment of amenorrhea and for the treatment of abnormal uterine bleeding caused by hormonal imbalance in patients without underlying organic pathology such as fibroids or uterine cancer. Progesterone also is used parenterally to support embryo implantation and early pregnancy by supplementing corpus luteal function as part of ART treatment of infertile women.

Dosage and Administration

Administration

Progesterone is administered by orally, intravaginally, and by IM injection.

Progesterone capsules are administered orally once daily at bedtime. Women who have difficulty swallowing the capsules should be advised to swallow progesterone capsules while in an upright position and with adequate amounts of fluid (e.g., a glass of water). Administration at bedtime may alleviate some of the adverse effects (e.g., dizziness, blurred vision) associated with the drug.

Progesterone vaginal gel should not be administered concurrently with other intravaginal preparations. If therapy with another agent administered intravaginally is needed, such therapy should be administered 6 hours before or 6 hours after progesterone vaginal gel.

Concomitant use of progesterone vaginal inserts with other preparations that are administered intravaginally is not recommended. Although specific studies have not been undertaken, the possibility exists that concomitant administration of a progesterone vaginal insert with another preparation administered intravaginally may alter the release and absorption of progesterone from the vaginal insert.

Dosage

Amenorrhea

When progesterone capsules are used in the management of secondary amenorrhea, the recommended dosage of progesterone is 400 mg once daily at bedtime for 10 days.

When progesterone vaginal gel is used for the management of secondary amenorrhea, the contents of one prefilled applicator of progesterone 4% vaginal gel (approximately 1.125 g of gel containing 45 mg of progesterone) should be inserted intravaginally every other day for a total of 6 doses. Women who do not respond to the 4% gel may be given progesterone 8% vaginal gel. For these women, the contents of one prefilled applicator of the 8% vaginal gel (approximately 1.125 g of gel containing 90 mg of progesterone) should be inserted intravaginally every other day for a total of 6 doses. Women who require the higher dose should receive the 8% vaginal gel; increasing the volume of the 4% gel will not achieve the same progesterone concentrations as administration of the 8% gel.

When parenteral progesterone is used for the treatment of amenorrhea, the usual dosage of progesterone is 5-10 mg administered IM daily for 6-8 days. When sufficient ovarian activity is present to produce a proliferative endometrium, withdrawal bleeding will usually occur within 48-72 hours after discontinuing therapy with the drug. Spontaneous normal cycles may occur in some patients after a single course of therapy.

Assisted Reproductive Technology Treatment

When progesterone vaginal gel is used as part of an assisted reproductive technology (ART) treatment regimen in women who require progesterone supplementation, the contents of one prefilled applicator of progesterone 8% vaginal gel (approximately 1.125 g of gel containing 90 mg of progesterone) should be inserted intravaginally once daily. When progesterone vaginal gel is used in women with partial or complete ovarian failure who require progesterone replacement, the contents of one prefilled applicator of progesterone 8% vaginal gel (approximately 1.125 g of gel containing 90 mg of progesterone) should be inserted intravaginally twice daily. If pregnancy occurs, treatment with progesterone gel may be continued until placental autonomy is achieved, up to 10-12 weeks.

When progesterone vaginal inserts are used as part of an ART treatment regimen in women younger than 35 years of age, one vaginal insert containing 100 mg of progesterone is inserted intravaginally 2 or 3 times daily, starting at oocyte retrieval. Therapy may be continued for up to 10 weeks. The appropriate dosage for women 35 years of age or older has not been established.

Prevention of Endometrial Changes Associated with Estrogens

When progesterone capsules are used in conjunction with estrogen replacement therapy, progesterone is administered in a dosage of 200 mg once daily at bedtime for 12 consecutive days (e.g., days 17-28) of the 28-day cycle.

Uterine Bleeding

When parenteral progesterone is used for the treatment of abnormal uterine bleeding, the usual dosage of progesterone is 5-10 mg administered IM daily for 6 days. When estrogen therapy is used concomitantly with progesterone, progesterone therapy is usually initiated after 2 weeks of estrogen therapy. Therapy with progesterone is usually discontinued if menses occurs during the series of injections.

Cautions

Adverse Effects

Adverse effects reported in patients receiving oral progesterone include dizziness, breast pain, headache, abdominal pain, fatigue, viral infection, abdominal distention, musculoskeletal pain, emotional lability, irritability, and upper respiratory tract infection. Extreme dizziness and/or drowsiness, blurred vision, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, and shortness of breath have been reported in a few women receiving the drug. Hypotension and syncope have occurred rarely in women receiving progesterone capsules.

Adverse effects reported in patients receiving progesterone vaginal gel include breast pain/enlargement, somnolence, constipation, nausea, headache, and perineal pain.

Adverse effects reported in patients receiving progesterone vaginal insert include abdominal pain, nausea, and ovarian hyperstimulation syndrome.

Adverse effects reported in patients receiving IM progesterone include breakthrough bleeding, spotting, changes in menstrual flow, amenorrhea, changes in cervical erosion and secretions, edema, weight gain or loss, cholestatic jaundice, allergic rash with or without pruritus, breast tenderness, galactorrhea, alopecia, hirsutism, pyrexia, sleep disturbances, nausea, and mental depression. Pain and swelling at the site of injection may occur following IM administration of progesterone. Large doses (50-100 mg daily) of progesterone may cause a moderate catabolic effect and a transient increase in sodium and chloride excretion.

An association between pulmonary embolism and cerebral thrombosis and embolism and use of estrogen-progestin combination preparations has been shown. The possibility that thromboembolic disorders may occur in patients receiving progesterone should be considered and patients should be carefully observed for these effects during therapy with the drug. Although available evidence suggests that an association exists between neuro-ocular lesions such as optic neuritis or retinal thrombosis and use of estrogen-progestin combination preparations, such a relationship has been neither confirmed nor refuted.

Precautions and Contraindications

Progesterone shares the toxic potentials of progestins, and the usual precautions of progestin therapy should be observed. Prior to initiation of therapy with progesterone in women, a physical examination should be performed, including special attention to the breasts and pelvic organs and a Papanicolaou test (Pap smear). Women receiving progesterone should be given a copy of the patient labeling for the drug.

Progesterone should be used with caution, and only with careful monitoring, in patients with conditions that might be aggravated by fluid retention (e.g., asthma, seizure disorders, migraine, or cardiac or renal dysfunction). The drug should also be used with caution in patients with a history of mental depression; progesterone should be discontinued if depression recurs to a serious degree during therapy with the drug.

When breakthrough bleeding or irregular vaginal bleeding occurs during progesterone therapy, nonfunctional causes should be considered. Adequate diagnostic procedures should be performed in patients with undiagnosed vaginal bleeding.

Diabetic patients should be carefully monitored during progesterone therapy, since decreased glucose tolerance has been observed in women receiving estrogen-progestin combinations. Progesterone may mask the onset of climacteric in women.

The clinician and the patient using progesterone should be alert to the earliest signs and symptoms of myocardial infarction, cerebrovascular disorders, thromboembolism (e.g., venous thromboembolism, pulmonary embolism), thrombophlebitis, or retinal thrombosis. The drug should be discontinued immediately when any of these disorders occurs or is suspected.

If unexplained, sudden or gradual, partial or complete loss of vision; proptosis or diplopia; papilledema; retinal vascular lesions; or migraine occur during therapy with progesterone, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.

Because dizziness has been reported during therapy with oral progesterone, patients receiving such therapy should be advised to use caution while driving or operating machinery.

Progesterone is contraindicated in patients with thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a history of these conditions. The drug is also contraindicated in patients with undiagnosed vaginal bleeding, missed abortion, known sensitivity to the drug or any ingredient in the formulation, markedly impaired liver function or liver disease, or carcinoma of the breast or for use as a pregnancy test.

Progesterone capsules are contraindicated in individuals with known hypersensitivity to peanuts because the capsules contain peanut oil.

Mutagenicity and Carcinogenicity

The carcinogenic and mutagenic potentials of progesterone have not been specifically determined.

Administration of medroxyprogesterone to beagles has been associated with the development of mammary nodules, some of which were malignant. Although nodules occasionally occurred in control beagles, they were intermittent in nature; nodules in drug-treated beagles were larger, more numerous, persistent, and occasionally malignant with metastases. The clinical relevance of these findings to humans has not been established. For additional information on the carcinogenic potential of progestins, .

Pregnancy and Lactation

Pregnancy

Progesterone is used to support embryo implantation and maintain pregnancy as a component of assisted reproductive technology (ART) treatment in infertile women. Such use is associated with increased ongoing pregnancy rates.

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 during 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 has been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy. An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested. Use of progestins generally is not recommended during the first 4 months of pregnancy.

Progesterone should not be used to induce withdrawal bleeding as a test for pregnancy.

Lactation

Progestins are reportedly distributed into milk. The manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined.

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