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Drug overview for CRINONE (progesterone, micronized):
Generic name: progesterone, micronized (pro-JESS-ter-own)
Drug class: Progestins
Therapeutic class: Vaginal Products
Progesterone is a naturally occurring progestin secreted by the corpus luteum and is the prototype of the progestins.
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.
Generic name: progesterone, micronized (pro-JESS-ter-own)
Drug class: Progestins
Therapeutic class: Vaginal Products
Progesterone is a naturally occurring progestin secreted by the corpus luteum and is the prototype of the progestins.
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.
DRUG IMAGES
CRINONE 8% GEL
CRINONE 4% GEL
The following indications for CRINONE (progesterone, micronized) have been approved by the FDA:
Indications:
Amenorrhea secondary to ovarian dysfunction
Infertility secondary to progesterone deficiency
Professional Synonyms:
None.
Indications:
Amenorrhea secondary to ovarian dysfunction
Infertility secondary to progesterone deficiency
Professional Synonyms:
None.
The following dosing information is available for CRINONE (progesterone, micronized):
No enhanced Dosing information available for this drug.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CRINONE 4% GEL | Maintenance | Adults insert 1 applicatorful (90 mg) by vaginal route every other day up to a total of six doses |
| CRINONE 8% GEL | Maintenance | Adults insert 1 applicatorful (90 mg) by vaginal route once daily |
No generic dosing information available.
The following drug interaction information is available for CRINONE (progesterone, micronized):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Progestin Replacement Therapy/Ulipristal SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ulipristal is a progesterone receptor modulator and binds to the progesterone receptor with high affinity.(1)(2) CLINICAL EFFECTS: Concurrent use of ulipristal may make progesterone products ineffective.(1,2) These agents may also make ulipristal ineffective.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Products containing progestin should not be used within 12 days of ulipristal discontinuation.(3) DISCUSSION: Ulipristal is a progesterone receptor modulator and binds to the progesterone receptor with high affinity, thus it may interfere with the efficacy of progestin products.(1-3) These products may also make ulipristal ineffective.(3) |
ELLA |
There are 0 moderate interactions.
The following contraindication information is available for CRINONE (progesterone, micronized):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 7 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Carcinoma of breast |
| Cerebrovascular accident |
| Disease of liver |
| Malignant neoplasm of liver |
| Porphyria |
| Pulmonary thromboembolism |
| Thromboembolic disorder |
There are 0 severe contraindications.
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Asthma |
| Chronic heart failure |
| Depression |
| Diabetes mellitus |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Migraine |
| Seizure disorder |
The following adverse reaction information is available for CRINONE (progesterone, micronized):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 26 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Abnormal vaginal bleeding Irregular menstrual periods |
Endometrial hyperplasia |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute myocardial infarction Anaphylaxis Angioedema Depression Ectopic pregnancy Erythema multiforme Erythema nodosum Galactorrhea not associated with childbirth Hypersensitivity drug reaction Hypertension Malignant neoplasm of the ovary Menorrhagia Obstructive hyperbilirubinemia Optic neuritis Ovarian cyst Pancreatitis Pruritus of skin Pulmonary thromboembolism Retinal thrombosis Thromboembolic disorder Thrombophlebitis |
There are 37 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Edema Fatigue Headache disorder Myalgia Vaginitis Weight loss |
Dizziness Dyspepsia Ectropion of cervix Hypertonia Palpitations Vaginal discharge |
| Rare/Very Rare |
|---|
|
Acne vulgaris Alopecia Amenorrhea Body fluid retention Cervical discharge Chloasma Constipation Cystitis Drowsy Fever Fibrocystic breast disease Hirsutism Hyperglycemia Insomnia Irritability Mastalgia Migraine Nausea Nervousness Pain in extremities Skin rash Urinary incontinence Urticaria Weight gain |
The following precautions are available for CRINONE (progesterone, micronized):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) 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.
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. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) 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.
Progestins are reportedly distributed into milk. The manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CRINONE (progesterone, micronized):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CRINONE (progesterone, micronized)'s list of indications:
| Amenorrhea secondary to ovarian dysfunction | |
| E28.8 | Other ovarian dysfunction |
| E28.9 | Ovarian dysfunction, unspecified |
| N91.0 | Primary amenorrhea |
| N91.1 | Secondary amenorrhea |
| N91.2 | Amenorrhea, unspecified |
| Infertility secondary to progesterone deficiency | |
| N97.8 | Female infertility of other origin |
Formulary Reference Tool