Crinone® 4% and Crinone® 8%
For Vaginal Use Only
Crinone® (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, 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.
What are the possible side effects of progesterone vaginal?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- sudden headache, numbness or weakness (especially on one side of the body), shortness of breath, or problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder;
- pain or swelling in one or both legs;
- nausea, stomach pain, low fever, loss of appetite, dark urine,...
What are the precautions when taking progesterone gel (Crinone)?
Before using progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unusual vaginal bleeding that has not been diagnosed by your doctor, liver disease, cancer of the breast or female reproductive organs, a miscarriage with some tissue remaining in the womb, blood clots.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, migraines, asthma, heart disease, kidney disease,...
Last reviewed on RxList: 1/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Crinone Information
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