Crinone 4% (45mg)vag Gel 6 X1.125gm

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 essential for the development of decidual tissue and is necessary to maintain pregnancy. Progesterone also inhibits the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek 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 or swelling in the body. 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
Difficulty 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 minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

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 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.

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 adjust the dose of any medication without consulting your doctor first.

Important Information to Share with Your Healthcare Providers

Inform all of 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 certain surgical procedures. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your surgery or procedure.

Precautions and Warnings

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), talk to your doctor, as this medication may increase your blood sugar levels.

Regular Health Check-Ups

It is essential to have regular breast exams and gynecology check-ups. You should also perform breast self-exams as instructed by your healthcare provider.

Lab Tests and Blood Clots

This medication may affect certain laboratory tests. Be sure to inform all of your healthcare providers and lab personnel that you are taking this medication. There is a risk of blood clots associated with this medication, which can be life-threatening. Blood clots can occur in the form of heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Discuss with your doctor if you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, as this can increase your risk of blood clots.

Special Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not a form of birth control and will not prevent pregnancy. If you have questions, consult with your doctor.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor will need to discuss the benefits and risks of this medication to you and your baby.

• Drugs that induce or inhibit hepatic microsomal enzymes (e.g., CYP3A4 inducers like rifampin, carbamazepine, phenytoin; or inhibitors like ketoconazole, ritonavir) may alter progesterone metabolism, but clinical significance for vaginal administration is generally low.

• Vaginal irritation or discharge
• Headache
• Nausea
• Breast tenderness
• Abdominal pain
• Bloating
• Fatigue
• Mood changes (e.g., depression, irritability)
• Symptoms of thromboembolic events (e.g., sudden severe headache, visual disturbances, chest pain, shortness of breath, pain/swelling in leg)

Crinone 4% is indicated for progesterone supplementation in women undergoing Assisted Reproductive Technology (ART) procedures. It is used to support early pregnancy. Its use is generally considered safe and effective for this indication.

Progesterone is excreted in human milk. While no adverse effects on the infant have been reported, caution should be exercised when Crinone is administered to a nursing mother. The decision to breastfeed during treatment should consider the potential benefits of breastfeeding and the potential risks to the infant.

Safety and effectiveness in pediatric patients have not been established. Not indicated for use in this population.

Clinical studies of Crinone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Crinone is a vaginal gel designed for sustained release of progesterone, providing consistent levels.
• Patients should be instructed on proper administration technique, including the use of the applicator and avoiding leakage.
• Some vaginal discharge or clumping of the gel may occur, which is normal and generally not a cause for concern.
• It is crucial to continue therapy for the full duration prescribed, especially in ART, as premature discontinuation can lead to pregnancy loss.
• Vaginal progesterone may cause local irritation; if severe, alternative routes of progesterone administration may be considered.

• Oral micronized progesterone (e.g., Prometrium)
• Progesterone in oil (intramuscular injection)
• Progesterone vaginal suppositories (compounded or commercially available)
• Other vaginal progesterone inserts/tablets (e.g., Endometrin, Prochieve)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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.