Crinone® (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, polypropylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension. Physically, Crinone has the appearance of a soft, white to off-white gel. The active ingredient, progesterone, is present in either a 4% or an 8% concentration (w/w). The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. The structural formula is: Progesterone exists in two polymorphic forms. Form 1, which is the form used in Crinone, exists as white orthorhombic prisms with a melting point of 127-131°C. Each applicator delivers 1.125 grams of Crinone gel containing either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide.

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Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3. TABLE 3 : Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Twice Daily
Study COL1620-007US (n = 61)
Body as a Whole     Bloating 7%   Cramps NOS 15%   Pain 8% Central and Peripheral Nervous System   Dizziness 5%   Headache 13% Gastro-Intestinal System   Nausea 7% Reproductive, Female   Breast Pain 13%   Moniliasis Genital 5%   Vaginal Discharge 7% Skin and Appendages   Pruritus Genital 5% In a second clinical study of 139 women using Crinone 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥ 5% of the women are shown in Table 4. TABLE 4 : Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Once Daily
Study COL1620-F01 (n = 139)
Body as a Whole     Abdominal Pain 12%   Perineal Pain Female 17% Central and Peripheral Nervous System   Headache 17% Gastro-Intestinal System     Constipation 27%   Diarrhea 8%   Nausea 22%   Vomiting   5%   Musculo-Skeletal System 8%   Arthralgia 8% Psychiatric   Depression 11%   Libido Decreased 10%   Nervousness 16%   Somnolence 27% Reproductive, Female   Breast Enlargement 40% Dyspareunia   Urinary System 6%   Nocturia 13% Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Crinone treatment that occurred in 5% or more of women are shown in Table 5. TABLE 5 : Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Estrogen Treatment and Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US
  Estrogen + Crinone 4%
n = 62 Estrogen + Crinone 8%
n = 65 Body as a Whole   Abdominal Pain 3 (5%) 6 (9%)   Appetite Increased 3 (5%) 5 (8%)   Bloating 8 (13%) 8 (12%)   Cramps NOS 12 (19%) 17 (26%)   Fatigue 13 (21%) 14 (22%) Central and Peripheral Nervous System   Headache 12 (19%) 10 (15%) Gastro-Intestinal System   Nausea 5 (8%) 4 (6%) Musculo-Skeletal System   Back Pain 5 (8%) 2 (3%)   Myalgia 5 (8%) 0 (0%) Psychiatric   Depression 12 (19%) 10 (15%)   Emotional Lability 14 (23%) 14 (22%)   Sleep Disorder 11 (18%) 12 (18%) Reproductive, Female   Vaginal Discharge 7 (11%) 2 (3%) Resistance Mechanism   Upper Respiratory Tract Infection 3 (5%) 5 (8%) Skin and Appendages   Pruritus Genital 1 (2%) 4 (6%) Read the Crinone (progesterone gel) Side Effects Center for a complete guide to possible side effectsLearn More »

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Assisted Reproductive Technology Crinone 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Crinone 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks. Secondary Amenorrhea Crinone 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Crinone 8% every other day up to a total of six doses may be instituted. It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed.

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No drug interactions have been assessed with Crinone. Read the Crinone Drug Interactions Center for a complete guide to possible interactions Learn More »

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Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%.

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Crinone should not be used in individuals with any of the following conditions:

1. Known sensitivity to Crinone (progesterone or any of the other ingredients)
2. Undiagnosed vaginal bleeding
3. Liver dysfunction or disease
4. Known or suspected malignancy of the breast or genital organs
5. Missed abortion
6. Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders

Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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There have been no reports of overdosage with Crinone. In the case of overdosage, however, discontinue Crinone, treat the patient symptomatically, and institute supportive measures. As with all prescription drugs, this medicine should be kept out of the reach of children.

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Crinone is available in the following strengths: 4% gel (45 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 52544-255-24: 6 Single-use prefilled applicators. 8% gel (90 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 52544-256-12: 15 Single-use prefilled applicators. Each applicator is wrapped and sealed in a foil overwrap. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children. For all medical inquiries contact: WATSON Medical Communications Parsippany, NJ 07054 800-272-5525 Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA. Revised August 2013 Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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General

1. The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear.
2. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.
3. Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
4. The pathologist should be advised of progesterone therapy when relevant specimens are submitted.
5. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
6. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogenprogestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy.

Information for Patients The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Carcinogenesis, Mutagenesis, Impairment of Fertility Nonclinical toxicity studies to determine the potential of Crinone to cause carcinogenicity or mutagenicity have not been performed. The effect of Crinone on fertility has not been evaluated in animals. Pregnancy (See Clinical Studies, Assisted Reproductive Technology) Crinone 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Crinone-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns. In the second study (COL1620-F01), Crinone 8% was used in the luteal phase support of women undergoing in vitro fertilization (“IVF”) procedures. In this multi-center, open-label study, 139 women received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up. Geriatric Use The safety and effectiveness in geriatric patients (over age 65) have not been established. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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