Progesterone Injection

DRUG DESCRIPTION

Progesterone injection, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use.

Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils.

It has the following structural formula:

Progesterone structural formula illustration

C21H30O2 M.W. 314.47

Pregn-4-ene-3, 20-dione

Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s.

What are the precautions when taking progesterone injection (Progesterone Injection)?

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 (such as sesame oil), 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: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion").

Before using this medication, tell your doctor or pharmacist your medical history, especially of: migraine...

Read All Potential Precautions of Progesterone Injection


Progesterone Injection Consumer (continued)

SIDE EFFECTS: Pain/swelling at injection site, breast tenderness, headache, weight gain/loss, acne, nausea, increased body/facial hair, loss of scalp hair, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell 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 right away if you have any serious side effects, including: unusual vaginal bleeding/discharge (e.g., breakthrough bleeding, spotting), stopped menstrual periods (amenorrhea), breast lumps, swelling of the ankles/feet, mental/mood changes (e.g., depression, nervousness), dark patches on the skin/face, frequent/painful urination, dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting.

This drug may rarely cause blood clots. Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, vision changes (e.g., blurred/double vision, loss of vision), confusion, pain/redness/swelling of arms or legs, trouble breathing, sudden severe headache, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 (such as sesame oil), 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: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion").

Before using this medication, tell your doctor or pharmacist your medical history, especially of: migraine headaches, seizures, asthma, heart disease (e.g., coronary artery disease, congestive heart failure), kidney disease, depression, diabetes, high blood levels of cholesterol/triglycerides.

This drug may make you dizzy or 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.

If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may be needed.

Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen, and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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



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