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Prochieve
Overview
What is Prochieve?
Prochieve (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, one piece polyethylene 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, Prochieve 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 CHOand a molecular weight of 314.5.
The structural formula is:
Progesterone exists in two polymorphic forms. Form 1, which is the form used in Prochieve, exists as white orthorhombic prisms with a melting point of 127-131°C.
Each applicator delivers 1.125 grams of Prochieve 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.
What does Prochieve look like?
What are the available doses of Prochieve?
Sorry No records found.
What should I talk to my health care provider before I take Prochieve?
Sorry No records found
How should I use Prochieve?
Prochieve® 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency.
Prochieve 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Prochieve 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.
What interacts with Prochieve?
- Prochieve® should not be used in individuals with any of the following conditions:
- Known sensitivity to Prochieve® (progesterone or any of the other ingredients)
- Undiagnosed vaginal bleeding
- Liver dysfunction or disease
- Known or suspected malignancy of the breast or genital organs
- Missed abortion
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders
What are the warnings of Prochieve?
Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
What are the precautions of Prochieve?
General
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 Prochieve administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage.
Drug Interactions
No drug interactions have been assessed with Prochieve®.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Nonclinical toxicity studies to determine the potential of Prochieve to cause carcinogenicity or mutagenicity have not been performed. The effect of Prochieve on fertility has not been evaluated in animals.
Pregnancy
(See )
Prochieve 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 Prochieve-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), Prochieve® 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 Prochieve 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.
What are the side effects of Prochieve?
Assisted Reproductive Technology
In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Prochieve 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3.
In a second clinical study of 139 women using Prochieve 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.
| Bloating | 7% |
| Cramps NOS | 15% |
| Pain | 8% |
| Dizziness | 5% |
| Headache | 13% |
| Nausea | 7% |
| Breast Pain | 13% |
| Moniliasis Genital | 5% |
| Vaginal Discharge | 7% |
| Pruritus Genital | 5% |
| Abdominal Pain | 12% |
| Perineal Pain Female | 17% |
| Headache | 17% |
| Constipation | 27% |
| Diarrhea | 8% |
| Nausea | 22% |
| Vomiting | 5% |
| Arthralgia | 8% |
| Depression | 11% |
| Libido Decreased | 10% |
| Nervousness | 16% |
| Somnolence | 27% |
| Breast Enlargement | 40% |
| Dyspareunia | 6% |
| Nocturia | 13% |
Secondary Amenorrhea
In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Prochieve 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Prochieve® treatment that occurred in 5% or more of women are shown in Table 5.
Additional adverse events reported in women at a frequency <5% in Prochieve ART and secondary amenorrhea studies and not listed in the tables above include:
Autonomic Nervous System–mouth dry, sweating increased
Body as a Whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia
Cardiovascular, General–syncope
Central and Peripheral Nervous System–migraine, tremor
Gastro-Intestinal–dyspepsia, eructation, flatulence, gastritis, toothache
Metabolic and Nutritional–thirst
Musculo-Skeletal System–cramps legs, leg pain, skeletal pain
Neoplasm–benign cyst
Platelet, Bleeding & Clotting–purpura
Psychiatric–aggressive reactions, forgetfulness, insomnia
Red Blood Cell–anemia
Reproductive, Female–dysmenorrhea, premenstrual tension, vaginal dryness
Resistance Mechanism–infection, pharyngitis, sinusitis, urinary tract infection
Respiratory System–asthma, dyspnea, hyperventilation, rhinitis
Skin and Appendages–acne, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria
Urinary System–cystitis, dysuria, micturition frequency
Vision Disorders–conjunctivitis
| Estrogen + Prochieve® 4%n=62 | Estrogen + Prochieve® 8% n=65 | |
|---|---|---|
| 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%) |
| Headache | 12 (19%) | 10 (15%) |
| Nausea | 5 (8%) | 4 (6%) |
| Back Pain | 5 (8%) | 2 (3%) |
| Myalgia | 5.(8%) | 0 (0%) |
| Depression | 12 (19%) | 10 (15%) |
| Emotional Lability | 14 (23%) | 14 (22%) |
| Sleep Disorder | 11 (18%) | 12 (18%) |
| Vaginal Discharge | 7 (11%) | 2 (3%) |
| Upper Respiratory Tract Infection | 3 (5%) | 5 (8%) |
| Pruitis genital | 1 (2%) | 4 (6%) |
What should I look out for while using Prochieve?
Prochieve® should not be used in individuals with any of the following conditions:
The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
What might happen if I take too much Prochieve?
There have been no reports of overdosage with Prochieve®. In the case of overdosage, however, discontinue Prochieve, treat the patient symptomatically, and institute supportive measures.
As with all prescription drugs, this medicine should be kept out of the reach of children.
How should I store and handle Prochieve?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.Prochieve is available in the following strengths: 4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-0406-1 - 6 Single-use prefilled applicators.8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.NDC-55056-1601-6 - 6 Single-use prefilled applicatorsNDC-55056-1601-5 - 15 Single-use prefilled applicators NDC-55056-1601-8 - 18 Single-use prefilled applicatorsEach applicator is wrapped and sealed in a foil overwrap.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is essential for the development of decidual tissue, and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Normal or near-normal endometrial responses to oral estradiol and intramuscular progesterone have been noted in functionally agonadal women through the sixth decade of life. Progesterone administration decreases the circulatory levels of gonadotropins.
Non-Clinical Toxicology
Prochieve® should not be used in individuals with any of the following conditions:The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
No drug interactions have been assessed with Prochieve®.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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