Drug Information

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Brand Name
Common Name
progesterone (vaginal)
How does this medication work? What will it do for me?

Progesterone vaginal gel and vaginal tablets belong to the class of medications called progestinsThese medications are used as part of an in-vitro fertilization (IVF) plan. They help to prepare the uterus lining so that a fertilized egg can be implanted (attached to the uterus) and to maintain a pregnancy once a fertilized egg has been implanted.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

Vaginal gel: The recommended dose of progesterone vaginal gel is 90 mg (one applicator) inserted into the vagina once or twice daily, starting the day of embryo transfer. If pregnancy occurs, treatment may be continued for up to 12 weeks.

To insert progesterone vaginal gel, hold the applicator by the thick end and shake down to ensure the contents are at the thin end. Twist off the tab and gently insert the thin end of the applicator into the vagina while you are in a sitting position or when lying on your back with your knees bent. Press the thick end of the applicator firmly to deposit the gel. Remove and discard the applicator. Applicators are intended for a single use only.

Vaginal tablets: The recommended dose of progesterone vaginal tablets is 100 mg inserted into the vagina 2 or 3 times daily starting the day after egg retrieval. If pregnancy occurs, treatment may be continued for up to 10 weeks.

To insert progesterone vaginal tablets, place one tablet in the space provided at the end of the applicator. The tablet should fit snugly and not fall out. While sitting, standing, or lying on your back with your knees bent, gently insert the thin end of the applicator (the one containing the tablet) well into the vagina. Push the plunger to release the tablet. Remove and discard the applicator. Applicators are intended for a single use only.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, use it the following day and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from extreme heat or cold, and keep it out of the reach of children.

What form(s) does this medication come in?

Each white to off-white oblong-shaped effervescent vaginal tablet, debossed with "FPI" on one side and "100" on the other side, contains progesterone 100 mg. Nonmedicinal ingredients: lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidial silicone dioxide.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to progesterone or any ingredients of this medication
  • had a miscarriage and the doctor suspects some tissue is still in the uterus
  • have abnormal vaginal bleeding that has not been checked by a doctor
  • have an ectopic pregnancy (a pregnancy that occurs outside of the womb)
  • have decreased liver function or liver disease
  • have diagnosed or suspected breast or genital cancer (e.g., vaginal, uterine, ovarian)
  • have diagnosed or suspected cancer that depends on progesterone to grow
  • have or have had inflammation of the veins or  a history of blood clots problems
  • have porphyria
What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • bloating
  • breast pain/tenderness
  • constipation
  • cramps
  • drowsiness
  • headache
  • mood swings
  • nausea
  • nervousness
  • pain
  • tiredness
  • vaginal discharge
  • vaginal irritation

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bleeding/spotting between menstrual periods
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • symptoms of liver problems (e.g., yellow eyes or skin, reduced appetite, abdominal pain, nausea and vomiting, pale stools, or dark urine)
  • symptoms of ovarian hyperstimulation syndrome (OHSS) (e.g., weight gain, bloating, fluid retention, nausea, vomiting, pelvic pain)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

Stop using the medication and seek immediate medical attention if any of the following occur:

  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • sudden partial or complete loss of vision
  • signs of stroke (e.g., sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg)
  • symptoms of a serious allergic reaction (such as shortness of breath, hives, or swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: This medication may cause blood clots. If you experience pain, swelling, or redness in your calf or leg; chest pain; shortness of breath; difficulty breathing; eye pain or vision changes; get immediate medical attention.

Depression: Hormones, such as progesterone, have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Diabetes: Progesterone may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

Drowsiness/reduced alertness: Progesterone may cause drowsiness. Do not drive or operate machinery until you know how this medication affects you.

Fluid retention: Progesterone can cause fluid retention. If you have epilepsy, migraines, asthma, or heart or kidney problems, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed.

Heart attack: The risk of heart attack is increased with the use of progesterone, due to the increased risk of blood clots. If you experience symptoms of heart attack, such as sudden chest pain or pressure on the chest, a sense of dread, difficulty breathing, nausea or pain radiating from the shoulder to the jaw or arm, seek immediate medical help.

Liver: This medication may cause liver problems. If you experience yellowing of the skin or eyes, nausea, vomiting, abdominal pain, light-coloured stools, or dark urine, contact your doctor. Your doctor will monitor your liver function while you are using this medication.

Other vaginal medications: Progesterone vaginal gel or tablets should not be used at the same time as other vaginal medications or products. Wait at least 6 hours after using progesterone vaginal gel before using other vaginal medications or products.

Stroke: This medication increases the risk of a stroke occurring. If you experience signs of a stroke, such as confusion, difficulty speaking, loss of coordination, sudden headache or vision changes, contact your doctor as soon as possible.

Vaginal bleeding: If you experience vaginal bleeding while using this medication, contact your doctor.

Pregnancy: This medication can be used for up to 10 to 12 weeks to maintain pregnancy.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are using vaginal progesterone, it may affect your baby. Breast-feeding is not recommended while you are using this medication.

Children: The safety and effectiveness of using this medication have not been established for children. This medication is not intended for use by children.

Seniors: This medication is intended for use by women of child-bearing age. Its safety and effectiveness have not been established for seniors.

What other drugs could interact with this medication?

There may be an interaction between progesterone vaginal gel or vaginal tablets and any of the following:

  • boric acid (topical)
  • bromocriptine
  • diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, liraglutide, lixisenatide, metformin, rosiglitazone)
  • other vaginal medications or treatments (e.g., clotrimazole, miconazole)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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