Crinone 8% (90mg)vag Gel 1.125gm
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
Progestin
Pharmacologic Class
Progestin; Steroid Hormone
Pregnancy Category
Category B
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Crinone 8% vaginal gel contains progesterone, a hormone essential for supporting early pregnancy. It helps prepare the lining of the uterus for a fertilized egg and maintains the pregnancy. It is applied directly into the vagina using a special applicator.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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.
Do not refrigerate or freeze 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 dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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.
Do not refrigerate or freeze 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 dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid using tampons, douches, or other vaginal products during treatment, as they may interfere with Crinone absorption.
- Do not have sexual intercourse while using Crinone, as it may interfere with absorption or cause irritation.
- Follow the instructions for using the applicator carefully. It's designed for single use and should be discarded after each application.
- Expect some white, clumpy discharge, which is normal and consists of the gel residue. This is not a sign of infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
90 mg (8% gel) once daily
Dose Range:
90 - 90 mg
Condition-Specific Dosing:
assistedReproductiveTechnology:
90 mg (8% gel) once daily starting the day after oocyte retrieval and continuing for 10-12 weeks into confirmed pregnancy.
lutealPhaseSupport:
90 mg (8% gel) once daily for infertility due to luteal phase defect.
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 studied; use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
Use with caution; progesterone is extensively metabolized by the liver. Reduced clearance may occur.
Severe:
Contraindicated or not recommended due to extensive hepatic metabolism and potential for accumulation.
Pharmacology
Mechanism of Action
Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. It binds to nuclear progesterone receptors in target cells (e.g., endometrium, breast, hypothalamus, pituitary). In the endometrium, it induces secretory changes, preparing it for implantation and maintaining pregnancy. It also inhibits uterine contractions and has thermogenic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly quantifiable due to vaginal administration bypassing first-pass metabolism; systemic exposure is achieved.
Tmax:
Approximately 7 hours (for serum progesterone levels after vaginal administration).
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not precisely determined for vaginal administration, but progesterone is highly lipophilic and widely distributed.
ProteinBinding:
>95% (primarily to albumin and corticosteroid-binding globulin).
CnssPenetration:
Limited systemic penetration from vaginal administration, but some CNS effects (e.g., sedation) can occur.
Elimination:
HalfLife:
Approximately 5-20 hours (for progesterone itself, variable depending on route).
Clearance:
Not precisely determined for vaginal administration.
ExcretionRoute:
Mainly renal (50-60% as metabolites), some fecal (10%).
Unchanged:
<1% (in urine).
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for endometrial effects).
PeakEffect:
Corresponds to Tmax of serum levels (approx. 7 hours).
DurationOfAction:
Maintains therapeutic levels for approximately 24 hours with once-daily dosing.
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 immediately or seek emergency medical attention:
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 tenderness, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, vomiting, or stomach upset
Stomach pain or cramps
Bloating
Breast enlargement or tenderness
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased libido
Irritation at the site of application
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 immediately or seek emergency medical attention:
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 tenderness, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness, drowsiness, fatigue, or weakness
Headache
Constipation, diarrhea, vomiting, or stomach upset
Stomach pain or cramps
Bloating
Breast enlargement or tenderness
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased libido
Irritation at the site of application
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Signs of a blood clot: sudden severe headache, sudden vision changes, sudden numbness or weakness on one side of the body, sudden chest pain, sudden shortness of breath, pain or swelling in one leg.
- Signs of an allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing.
- Unusual vaginal bleeding.
- Severe abdominal pain.
- Yellowing of the skin or eyes (jaundice).
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 may be 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 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 may be 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 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 surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or 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 known allergy to nuts or seeds, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may cause an increase in blood sugar levels.
Regular breast exams and gynecology check-ups are crucial while taking this medication. 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 it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening. Blood clots can manifest as heart attacks, strokes, or clots in the legs, lungs, or eyes. If you have a history of blood clots, inform your doctor. It is also important to discuss with your doctor any situations that may require prolonged periods of immobility, such as long trips, bed rest after surgery, or illness, as these can increase your risk of developing blood clots.
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 does not serve as a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication during these situations.
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 known allergy to nuts or seeds, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may cause an increase in blood sugar levels.
Regular breast exams and gynecology check-ups are crucial while taking this medication. 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 it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening. Blood clots can manifest as heart attacks, strokes, or clots in the legs, lungs, or eyes. If you have a history of blood clots, inform your doctor. It is also important to discuss with your doctor any situations that may require prolonged periods of immobility, such as long trips, bed rest after surgery, or illness, as these can increase your risk of developing blood clots.
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 does not serve as a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication during these situations.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Dizziness
- Nausea
- Fatigue
- Vaginal irritation
What to Do:
Overdose with vaginal progesterone is unlikely due to the route of administration. If symptoms are severe or persistent, contact your healthcare provider or call a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease progesterone levels.
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase progesterone levels.
- Other vaginal products (e.g., antifungals, spermicides): May alter absorption of Crinone; separate administration by at least 6 hours.
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To confirm pregnancy status before initiation, if applicable.
Timing: Prior to initiation of therapy.
Physical examination (including pelvic exam)
Rationale: To rule out pre-existing conditions or abnormalities.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of thromboembolic events (e.g., leg pain, chest pain, shortness of breath, vision changes)
Frequency: Throughout therapy
Target: Absence of symptoms
Action Threshold: Immediate medical attention if symptoms occur.
Signs and symptoms of depression
Frequency: Periodically
Target: Stable mood
Action Threshold: Evaluate for depression if symptoms worsen or new symptoms appear.
Vaginal irritation or discharge
Frequency: Daily
Target: Minimal to no irritation
Action Threshold: Report significant discomfort or unusual discharge to healthcare provider.
Symptom Monitoring
- Vaginal irritation
- Vaginal discharge
- Headache
- Breast tenderness
- Nausea
- Fatigue
- Mood changes (e.g., depression, irritability)
- Abdominal pain
- Signs of allergic reaction (rash, itching, swelling)
- Signs of blood clot (leg pain/swelling, chest pain, sudden shortness of breath, vision changes)
Special Patient Groups
Pregnancy
Crinone is indicated for use in women as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. It is used to support early pregnancy. While classified as Category B, its use is specifically for maintaining pregnancy in certain conditions.
Trimester-Specific Risks:
First Trimester:
Used during the first trimester to support luteal phase and early pregnancy in ART.
Second Trimester:
May be continued into the second trimester (up to 10-12 weeks of gestation) as per ART protocols.
Third Trimester:
Not typically indicated for use in the third trimester for its primary indications.
Lactation
Progesterone is excreted in breast milk. While generally considered compatible with breastfeeding (L3), caution is advised. The amount transferred to the infant is small and unlikely to cause adverse effects.
Infant Risk:
Low risk of adverse effects to the breastfed infant. Monitor for any unusual changes in infant behavior or feeding.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in this population.
Geriatric Use
Crinone is not indicated for use in geriatric patients. Its primary indications are related to fertility and early pregnancy.
Clinical Information
Clinical Pearls
- Crinone is a vaginal gel that comes in a pre-filled applicator. It's crucial to use the applicator correctly and discard it after each use.
- The vaginal route of administration allows for direct delivery to the uterus, potentially leading to higher uterine tissue concentrations and reduced systemic side effects compared to oral formulations.
- Patients should be advised that some white, clumpy discharge is normal and represents the gel residue. This is not a sign of infection.
- Ensure patients understand the importance of consistent daily application for the duration prescribed, especially in ART cycles.
- Advise patients to avoid sexual intercourse, douching, or using other vaginal products (e.g., tampons, spermicides) during treatment to ensure optimal absorption and prevent irritation.
Alternative Therapies
- Other vaginal progesterone formulations (e.g., Endometrin vaginal inserts, Prometrium vaginal capsules, compounded progesterone suppositories)
- Oral progesterone (e.g., Prometrium capsules, generally not preferred for luteal phase support due to first-pass metabolism and systemic side effects)
- Injectable progesterone (e.g., Progesterone in oil, intramuscular injection)
Cost & Coverage
Average Cost:
$300 - $600 per 15 applicators (15-day supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.