Crinone

DRUG DESCRIPTION

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:

Crinone® (progesterone) Structural Formula Illustration

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 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,...

Read All Potential Precautions of Crinone »


Crinone Consumer (continued)

SIDE EFFECTS: Bloating, cramps, stomach pain, constipation, diarrhea, nausea, breast swelling/pain, pain around the vaginal area, drowsiness, tiredness, decreased interest in sex, joint pain, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

You may develop a vaginal discharge containing little white balls of gel from using this medication. This is normal and harmless. However, if you develop any unusual vaginal discharge, itching, or odor, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, nervousness, mood swings), signs of water weight gain (e.g., swollen feet/ankles), increased urination at night, abnormal vaginal bleeding, breast lumps, yellowing of the eyes or skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: pain/redness/swelling of arms or legs, trouble breathing, chest pain, weakness on one side of the body, slurred speech, vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, depression, diabetes.

Although unlikely, this medication can cause blood clots. Your risk is increased if you will be having surgery or if you need to stay in a chair or bed for a long period of time (e.g., a long plane flight). Notify your doctor beforehand of any of these events. Special precautions may need to be taken in these circumstances while you are using this drug.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. Be sure to check your blood sugar levels regularly.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. In general, alcohol is not recommended for pregnant or possibly pregnant women due to the increased risk of harm to the baby.

This medication may be used in pregnancy as directed by your doctor. Consult your doctor for more details.

This drug passes into breast milk. Consult your doctor before breast-feeding.



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