Crinone 8% (90mg)vag Gel 15x1.125gm
It is used to help people get pregnant. It is used to treat people who do not have a monthly period cycle.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hormone, Progestin
Pharmacologic Class
Progestin
Pregnancy Category
Category B
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Crinone 8% is a vaginal gel containing the hormone progesterone. It is used to help support early pregnancy, especially in women undergoing fertility treatments, by preparing and maintaining the lining of the uterus.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Use the applicators only once and discard them after use.
Do not use other vaginal medications within 6 hours of using this medication.
Storing and Disposing of This Medication
To maintain the medication's effectiveness and safety:
Store it at room temperature.
Avoid refrigerating or freezing the medication.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose:
Take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Use the applicators only once and discard them after use.
Do not use other vaginal medications within 6 hours of using this medication.
Storing and Disposing of This Medication
To maintain the medication's effectiveness and safety:
Store it at room temperature.
Avoid refrigerating or freezing the medication.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose:
Take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Follow your doctor's instructions carefully regarding dose and duration.
- Administer at the same time each day.
- Avoid sexual intercourse or use of other vaginal products (e.g., douches, spermicides) for at least 6-8 hours after applying Crinone to ensure proper absorption.
- Wear a panty liner as some white discharge (gel residue) is common.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
90 mg (one applicatorful of Crinone 8%) once daily
Dose Range:
90 - 180 mg
Condition-Specific Dosing:
lutealPhaseSupport:
90 mg once daily starting after ovulation or embryo transfer, continued for up to 10-12 weeks of pregnancy.
assistedReproductiveTechnology (ART):
90 mg once daily starting after oocyte retrieval, continued for up to 10-12 weeks of pregnancy. If pregnancy occurs, dosing may be increased to 90 mg twice daily for continued support.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Dialysis:
Not available
Hepatic Impairment:
Mild:
Use with caution, as progesterone is metabolized by the liver.
Moderate:
Use with caution, as progesterone is metabolized by the liver. Consider lower doses or alternative therapies.
Severe:
Contraindicated in severe hepatic dysfunction due to extensive hepatic metabolism and potential for accumulation.
Confidence:
Medium
Pharmacology
Mechanism of Action
Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. It is necessary to establish and maintain pregnancy. Progesterone also relaxes uterine smooth muscle, inhibits uterine contractions, and supports the development of the decidua.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (vaginal route, compared to oral)
Tmax:
Approximately 7 hours (vaginal administration)
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not available (for vaginal gel specifically, but generally high for progesterone)
ProteinBinding:
Approximately 96-99% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration:
Limited systemic absorption from vaginal route, but progesterone itself can cross the blood-brain barrier.
Elimination:
HalfLife:
Approximately 16-20 hours (systemic half-life after vaginal administration)
Clearance:
Not available
ExcretionRoute:
Primarily renal (50-60%) as glucuronide and sulfate conjugates; also biliary/fecal (10%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours (for endometrial effects)
PeakEffect:
Not precisely defined for clinical effect, but peak plasma levels around 7 hours.
DurationOfAction:
Sustained release over 24 hours from vaginal gel.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred vision
Shortness of breath, significant weight gain, or swelling in the arms or legs
Difficulty walking
Severe dizziness or fainting
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Abnormal vaginal bleeding
Painful urination
Frequent urination
Depression or other mood changes
Memory problems or loss
This medication may cause fluid retention, leading to swelling or weight gain. Inform your doctor if you experience swelling, weight gain, or breathing difficulties. Seek immediate medical attention if you notice signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Dizziness, drowsiness, tiredness, or weakness
Headache
Constipation, diarrhea, vomiting, or stomach upset
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased interest in sex
Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred vision
Shortness of breath, significant weight gain, or swelling in the arms or legs
Difficulty walking
Severe dizziness or fainting
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Abnormal vaginal bleeding
Painful urination
Frequent urination
Depression or other mood changes
Memory problems or loss
This medication may cause fluid retention, leading to swelling or weight gain. Inform your doctor if you experience swelling, weight gain, or breathing difficulties. Seek immediate medical attention if you notice signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Dizziness, drowsiness, tiredness, or weakness
Headache
Constipation, diarrhea, vomiting, or stomach upset
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased interest in sex
Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache or migraine
- Sudden partial or complete loss of vision
- Sudden onset of proptosis (bulging eyes), diplopia (double vision), or papilledema (swelling of optic disc)
- Signs of blood clot (e.g., severe pain in your calf or thigh, sudden chest pain, shortness of breath, sudden numbness or weakness on one side of your body)
- Yellowing of skin or eyes (jaundice)
- Severe allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Unusual vaginal bleeding
- Depression or mood changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are influenced by estrogen or progesterone
Unexplained vaginal bleeding
A recent miscarriage
* Use of other vaginal products, such as:
+ Medications for fungal infections
+ Vaginal lubricants
+ Diaphragms
+ Condoms
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are influenced by estrogen or progesterone
Unexplained vaginal bleeding
A recent miscarriage
* Use of other vaginal products, such as:
+ Medications for fungal infections
+ Vaginal lubricants
+ Diaphragms
+ Condoms
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before undergoing certain types of surgery, and will provide guidance on when to resume taking it after the procedure.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your healthcare provider. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening and may lead to heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. It is also important to discuss with your doctor the risks of blood clots if you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Note that this medication is not a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your healthcare provider. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening and may lead to heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. It is also important to discuss with your doctor the risks of blood clots if you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Note that this medication is not a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Exaggerated side effects such as severe drowsiness, dizziness, nausea, vomiting, or breast tenderness.
- Unlikely to occur with vaginal administration due to limited systemic absorption.
What to Do:
If overdose is suspected, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease progesterone plasma concentrations, potentially reducing efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase progesterone plasma concentrations, potentially increasing adverse effects.
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To confirm pregnancy status before initiation for luteal phase support.
Timing: Prior to first dose
Physical examination (including pelvic exam and Pap test)
Rationale: To rule out pre-existing conditions (e.g., undiagnosed vaginal bleeding, breast cancer, thromboembolic disorders).
Timing: Prior to initiation
Routine Monitoring
Signs of adverse reactions (e.g., vaginal irritation, breast tenderness, headache, nausea)
Frequency: Daily, or as symptoms arise
Target: Absence of severe or intolerable symptoms
Action Threshold: Report persistent or worsening symptoms to healthcare provider.
Signs of thromboembolic events (e.g., leg pain, chest pain, shortness of breath, sudden severe headache, vision changes)
Frequency: Throughout treatment
Target: Absence of symptoms
Action Threshold: Seek immediate medical attention if any signs occur.
Vaginal discharge/irritation
Frequency: Daily
Target: Minimal to no irritation
Action Threshold: If severe irritation or unusual discharge, consult healthcare provider.
Symptom Monitoring
- Vaginal discharge or irritation
- Breast tenderness
- Headache
- Nausea
- Fatigue
- Mood swings
- Bloating
- Abdominal pain
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of blood clots (sudden severe headache, vision changes, chest pain, shortness of breath, pain/swelling in leg)
Special Patient Groups
Pregnancy
Crinone 8% is indicated for use in early pregnancy (up to 10-12 weeks) for luteal phase support in women undergoing Assisted Reproductive Technology (ART) or for progesterone supplementation in women with progesterone deficiency. It is classified as Pregnancy Category B.
Trimester-Specific Risks:
First Trimester:
Used during the first trimester to support pregnancy. No increased risk of congenital anomalies has been associated with the use of progesterone during the first trimester.
Second Trimester:
Not typically indicated for routine use beyond the first trimester for its primary indications. Continued use would be off-label unless specific clinical need.
Third Trimester:
Not typically indicated for routine use beyond the first trimester. Progesterone levels naturally rise in the third trimester.
Lactation
Progesterone is excreted in human milk. While no adverse effects on the infant have been reported with the use of progesterone during lactation, caution should be exercised. The decision to breastfeed during treatment should consider the potential benefits of breastfeeding and the potential risks to the infant.
Infant Risk:
Low risk (L3 - Moderately safe, but some concern due to excretion in milk; monitor infant for drowsiness or feeding issues).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in this population.
Geriatric Use
Crinone 8% is not indicated for use in geriatric patients. The indications for Crinone are specific to reproductive-aged women.
Clinical Information
Clinical Pearls
- Crinone 8% is a sustained-release formulation, allowing for once-daily dosing, which can improve patient compliance compared to multiple daily doses of other progesterone formulations.
- The gel can cause a white, clumpy discharge as the inert ingredients accumulate. This is normal and not a sign of infection or lack of absorption. Patients should be advised to expect this.
- Administering the gel at bedtime may help minimize discomfort from discharge.
- Ensure proper administration technique: the applicator should be inserted deeply into the vagina.
- If a dose is missed, it should be applied as soon as remembered, unless it's almost time for the next dose. Do not double dose.
Alternative Therapies
- Progesterone vaginal suppositories (e.g., Endometrin, Prometrium vaginal inserts, compounded suppositories)
- Oral micronized progesterone (e.g., Prometrium capsules, though less preferred for luteal support due to first-pass metabolism and systemic side effects)
- Progesterone in oil injection (intramuscular)
Cost & Coverage
Average Cost:
$300 - $600 per 15 applicators (1.125 gm each)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.