13 Oct Progesterone
Available dosage forms:
|Troches||Up to 600mg|
|Capsules||Up to 250mg|
|Cream||Up to 10%|
|Injection / Oil||100mg/ml, 200mg/ml|
|Pessaries||100 / 200 / 400 mg|
What is Progesterone?
Progesterone is a hormone that is produced in the ovaries during the second half of the menstrual cycle. It is also secreted in smaller amounts by the adrenals. It is an essential hormone for preparing the uterus for pregnancy and to support pregnancy. Women with a lack of normal progesterone production may have difficulties getting pregnant and may also have a higher risk of miscarriage.
A bioidentical hormone refers to a substance which has the exact same chemical structure as a hormone which is naturally produced in the body. Natural hormones are produced by the body, bioidentical hormones are manufactured in a lab using chemical means. Most prescription progesterone, whether synthetic or bioidentical, is derived from soy or yams. Here at the Green Dispensary Compounding Pharmacy we use bioidentical progesterone in our creams, troches (soy), pessaries and capsules. Our injectable forms of progesterone are synthetic, however, the chemical structure of the progesterone used makes it easier to formulate into injectable form and when it is injected into the bloodstream the chemical reverts back to its bioidentical structure.
What is Progesterone used to treat
- Premenopausal women
- Premenstrual Dysphoric Disorder
- Mild to severe endometriosis
- Mild to severe menstrual bleeding/flooding
- Uterine fibroids
- Postpartum depression
- Infertility/Repeated first-term miscarriage
Please consult your doctor before commencing progesterone treatments.
Side effects depend upon the dose administered, hormone levels achieved, the duration of treatment and the route of administration.
Very Common side effects
- cramps, abdominal pain, perineal pain
- breast enlargement or breast pain
- feelings of severe sadness and unworthiness, decreased sexual drive, sleepiness, feeling emotional
- constipation, nausea
- passing urine at night
- changes in vaginal bleeding
Common side effects
- bloating, pain
- vaginal discharge, itching of the vaginal area, vaginal thrush
- diarrhea, vomiting
- painful sexual intercourse
- painful joints
side effects continued….
Rare side effects – these need to be reported to your doctor as soon as possible
- numbness or pain in the arm or leg
- pain in the chest, groin or leg
- sudden shortness of breath
- unusual weakness or tiredness
- vision or speech problems
- yellowing of skin or eyes
Please let your doctor know before taking any Progesterone treatments if you have any of the following conditions
- blood vessel disease, blood clotting disorder, or suffered a stroke
- breast, cervical or vaginal cancer
- heart, kidney or liver disease
- high blood lipids or cholesterol
- seizures (convulsions)
- abnormal vaginal bleeding
- an unusual or allergic reaction to progesterone, other hormones, medicines, foods, dyes or preservatives
- pregnant or trying to get pregnant
Progesterone may interfere with certain types of medications so you must let your doctor know what you are taking, even if they are not listed below, these include non-prescription medications, nutritional supplements or herbal products.
- barbituate medicines for inducing sleep or treating seizures (convulsions)
Your doctor will also need to know if you drink alcohol or caffeine frequently, if you smoke or if you use illegal drugs. These may affect the way your medication works.
Progesterone is a naturally occurring progestin. In the body, it is synthesized in the ovaries, testes, placenta, and adrenal cortex. Progesterone is primarily used to treat amenorrhea, abnormal uterine bleeding, or as a contraceptive. Progesterone is also used to prevent early pregnancy failure in women with corpus luteum insufficiency, including women undergoing assisted reproductive technology (ART).
Mechanism of Action
Endogenous progesterone is responsible for inducing secretory activity in the endometrium of the estrogen-primed uterus in preparation for the implantation of a fertilized egg and for the maintenance of pregnancy. It is secreted from the corpus luteum in response to luteinizing hormone. The hormone increases basal body temperature, causes histologic changes in vaginal tissues, inhibits uterine contractions, inhibits pituitary secretion, stimulates mammary alveolar gland tissues, and precipitates withdrawal bleeding in the presence of estrogen. The administration of progesterone to women with adequate estrogen production transforms the uterus from a proliferative to a secretory phase.
Progesterone is administered orally (Prometrium micronized soft gelatin capsules), intramuscularly, intravaginally (Crinone gel, Prochieve gel), or as a component of an intrauterine device (IUD). Vaginal suppositories are also compounded for use, however, pharmacokinetic data is unavailable. Once in the systemic circulation, progesterone is extensively (96—99%) bound to cortisol binding globulin, sex hormone binding globulin, and albumin. The drug is metabolized hepatically to pregnanediol and conjugated with glucuronic acid. The plasma elimination half-life ranges 5—20 minutes. The metabolites are excreted primarily in the urine (50—60%). About 10% is eliminated via the bile and feces.
Oral Route: After oral administration, progesterone is significantly absorbed with peak serum concentration occurring within 3 hours. The absolute bioavailability, however, is not known.
It is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Progesterone is also used for the reduction of the incidence of endometrial hyperplasia, and the attendant risk of endometrial carcinoma in postmenopausal women receiving estrogen replacement therapy, as well as treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology such as fibroids or uterine cancer.
Who should not take this medication? Do not take this medicine if you have breast cancer, cardiac disease or dementia. Your health care provider needs to know if you have any of these conditions: autoimmune disease like systemic lupus erythematosus (SLE); blood vessel disease, blood clotting disorder, or suffered a stroke; breast, cervical or vaginal cancer; dementia; diabetes; kidney or liver disease; heart disease, high blood pressure or recent heart attack; high blood lipids or cholesterol; hysterectomy; tobacco smoker; vaginal bleeding; an unusual or allergic reaction to progesterone or other products; pregnant or trying to get pregnant; breast-feeding. This medicine can cause swelling, tenderness, or bleeding of the gums. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. This list may not include all possible contraindications.
Prometrium micronized progesterone capsules are classified in FDA pregnancy category B. Animal studies involving oral or intravaginal or in utero administration of progesterone have, in general, not indicated evidence of fetal harm. In general, several studies of women exposed to progesterone during pregnancy for luteal support have not demonstrated a significant increase in fetal malformations. A single case of cleft palate has been reported in an infant exposed to micronized progesterone in utero.
In general, the American Academy of Pediatrics considers progesterone to be compatible with breast-feeding.7 Detectable amounts of progestins have been identified in the milk of nursing mothers; in general the presence of progestins in the milk are not expected to have adverse effects on lactation production. However, the effects of progestins present in breast milk on the nursing infant have not been determined.8 6 The administration of any medication to nursing mothers should take into account the benefit of the drug to the mother and the potential for risk to the breast-fed infant.
Possible interactions include: barbiturate; medicines for sleep or seizures; bexarotene; carbamazepine; ethotoin; ketoconazole; phenytoin; rifampin This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
Adverse Reactions/Side Effects
Acne; fluid retention and swelling; increase in appetite; mood changes, anxiety, depression, frustration, anger, or emotional outbursts; nausea, vomiting; sweating or hot flashes. This list may not describe all possible side effects. Call your doctor for medical advice about side effects. Call your health care provider immediately if you are experiencing any signs of an allergic reaction: skin rash, itching or hives, swelling of the face, lips, or tongue; breast tissue changes or discharge; changes in vaginal bleeding during your period or between your periods; depression; muscle or bone pain; numbness or pain in the arm or leg; pain in the chest, groin or leg; seizures or tremors; severe headache; stomach pain; sudden shortness of breath; unusually weak or tired; vision or speech problems; yellowing of skin or eyes.
How is this medication best taken?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Talk to your pediatrician regarding the use of this medicine in children.
What do I do if I miss a dose?
If you are given your dose at a clinic or doctor’s office, call to reschedule your appointment. If you give your own injections and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Store this medication at 59°F to 86°F (15°C to 30°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the expiration date. Do not flush unused medications or pour down a sink or drain.
Do not share or take any one else’s medicine. Talk with your healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins. This medication was compounded specifically for you. This patient information summarizes the most important information about your medication; if you would like more information, talk with your doctor.
Have your doctor fax your prescription to (832) 678-4419 or ask them to use e-prescribe. Need help? Call (877) 562-8577.
1. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Eng J Med 2003;348:2379-85.
2. ACOG Committee on Obstetric Practice. Committee Opinion: use of progesterone to reduce preterm birth. Obstet Gynecol 2003;102:1115-6.
3. Fonseca EB, Celik E, Parra M, et al. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007;357:462-8.
4. Grady D, Rubin SM, Petitti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 1992;117:1016-37.
5. Endometrin (progesterone) vaginal insert package insert. Hunt Valley, MD: Pharmaceutics International, Inc.; 2014 Jun.
6. Crinone (progesterone vaginal gel) package insert. Parsippany, NJ: Watson Pharma, Inc.; 2011 Dec.
7. American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108:776-89.
8. Prometrium® (progesterone) package insert. Marietta, GA: Solvay Pharmaceuticals Inc.; 1998 Dec.
9. Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women. The Women’s Health Initiative Memory Study: A randomized controlled trial (WHIMS). JAMA 2003;289:2651-62.
10. Endometrin® (progesterone) package insert. Hunt Valley, MD: Pharmaceutics International, Inc.; 2007 Jun.